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New York-based hair restoration company opens new office in New Jersey – amNY

A New York-based entity operating multiple hair restoration surgery centers has expanded into a new office in Paramus, New Jersey.

MAXIM Hair Restoration, which specializes in hair loss treatment via hair transplants, can now provide a more convenient option for their Northern New Jersey clients.

Dr. Hardik Doshi is a highly renowned hair transplant surgeon at the MAXIM Hair Restoration office in Paramus. He is a dual Board Certified, Ivy League-educated and fellowship-trained facial plastic and reconstructive surgeon specializing in all aspects of surgical and non-surgical face and neck rejuvenation including hair transplants.

There is a strong demand for high quality, MEGA Session, affordable hair transplant procedures in Bergen County, Northern New Jersey, Central New Jersey and South Jersey. Our New Jersey clients dont like going into Manhattan for their hair transplant surgery, said Mac Fadra, CEO of MAXIM Hair Restoration. They prefer to have it done in New Jersey. Hair Restoration is all we do and many of our doctors are general and plastic surgeons, not ordinary physicians. They perform the FUT (Follicular Unit Transplant) and FUE (Follicular Unit Extraction) hair transplant procedures as well as non-surgical procedures such as PRP. MAXIM also offers non-surgical procedures such as Scalp Micropigmentation (SMP) and Microneedling.

Baldness can be treated with a minor surgical procedure by transferring hair from the back and sides of ones own head and relocating it to the areas that are thinning or balding. The treatment has been proven to be a safe, natural, and highly effective procedure that produces long-term results. The hair transplant surgery itself is performed under local anesthesia and takes only a few hours to complete. As a result, one can return to their day to day within a couple of days following the procedure.

Hair transplant procedures have had more success in resolving the issue of hair loss than any other hair restoration methods such as artificial hair implants, hair pieces, wigs, toupees, shampoos, lotions, topical solutions, and other conventional options for the treatment of hair loss. Whereas Rogaine, Propecia, Biotin, laser hair therapy, and other OTC solutions may play a role in stemming hair loss, hair transplantation remains the only natural and permanent solution.

The future of hair restorationhas exponentially grown thanks to the advances in science and technology such as robotic hair restoration, stem cell therapy, exosomes for hair loss, follicular multiplication and other minimally invasive methods. These alternatives to balding have not only reduced the issue of hair loss, but have also created a platform for easier financial access including zero percent financing and convenience without jeopardizing the quality of the treatments results.

For more information about MAXIM and their procedures, visit http://www.maximhairrestoration.com.

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New York-based hair restoration company opens new office in New Jersey - amNY

Tiny organs grown from snake glands produce real venom – Science Magazine

Researchers grew tiny venom glands from nine different snake species, including the cape coral cobra.

By Erin MalsburyJan. 23, 2020 , 11:00 AM

Venomous snakes kill or permanently injure more than a half-million people every year. Yet researchers still know surprisingly little about the biology behind venom, complicating efforts to develop treatments. A new advance could help: Researchers have successfully grown miniature organs from snake stem cells in the lab that function just like snake venom glands; they even produce real venom.

Its a breakthrough, says Jos Mara Gutirrez, a snake venom toxicologist at the University of Costa Rica, San Jos, who was not involved in the study. This work opens the possibilities for studying the cellular biology of venom-secreting cells at a very fine level, which has not been possible in the past. The advance could also help researchers study the venom of rare snakes that are difficult to keep in captivity, he says, paving the way for new treatments for a variety of venoms.

Researchers have been creating miniorgansor organoidsfrom adult human and mouse stem cells for years. These so-called pluripotent cells are able to divide and grow into new types of tissues throughout the body; scientists have coaxed them into tiny livers, guts, and even rudimentary brains. But scientists hadnt tried the technique with reptile cells before.

Nobody knew anything about stem cells in snakes, says Hans Clevers, a molecular biologist at the Hubrecht Institute and one of the worlds leading organoid scientists. We didnt know if it was possible at all. To find out, Clevers and colleagues removed stem cells from the venom glands of nine snake speciesincluding the cape coral cobra and the western diamondback rattlesnakeand placed them in a cocktail of hormones and proteins called growth factors.

To the teams surprise, the snake stem cells responded to the same growth factors that work on human and mouse cells. This suggests certain aspects of these stem cells originated hundreds of millions of years ago in a shared ancestor of mammals and reptiles.

Miniature, lab-grown snakevenom glands

By the end of 1 week submerged in the cocktail, the snake cells had grown into little clumps of tissue, a half-millimeter across and visible to the human eye. When the scientists removed the growth factors, the cells began to morph into the epithelial cells that produce venom in the glands of snakes.The miniorgans expressed similar genes as those in real venom glands, the team reports today inCell.

The snake organoids even produced venom; a chemical and genetic analysis of the secretions revealed that they match the venom made by the real snakes. The labmade venom is dangerous as well: It disrupted the function of mouse muscle cells and rat neurons in a similar way to real venom.

Scientists didnt know whether the many toxins found in snake venom are made by one general type of cell or specialized, toxin-specific cells. By sequencing RNA in individual cells and examining gene expression, Cleverss team determined that both real venom glands and organoids contain different cell types that specialize in producing certain toxins. Organoids grown using stem cells from separate regions of the venom gland also produce toxins in different proportions, indicating that location within the organ matters.

The proportions and types of toxins in venom differ amongand even withinspecies. That can be problematic for antivenom production, says study author Yorick Post, a molecular biologist at the Hubrecht Institute. Most antivenoms are developed using one type of venom, so they only work against one type of snakebite.

Now that Clevers and his colleagues created a way to study the complexity of venom and venom glands without handling live, dangerous snakes, they plan to compile a biobank of frozen organoids from venomous reptiles around the world that could help researchers find broader treatments. This would make it much easier to create antibodies, Clevers says. The biobank could also be a rich resource for identifying new drugs, he adds. (Scientists think snake venom may hold the keyfor treatments against pain, high blood pressure, and cancer, for instance.)

Another new study, published earlier this month inNature, could also help. Researchers have assembled anear-complete genome for the Indian cobrathat could aid drug development. The organoids created by Cleverss team will provide an unprecedented and incredibly important new avenue to complement genomic information for venomous snakes, says the senior author of the cobra study, molecular biologist Somasekar Seshagiri of the SciGenom Research Foundation. Theyve done an amazing job making this work.

*Correction, 23 January, 1:35 p.m.: An earlier version of this story misspelledSomasekar Seshagiri's name.

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Tiny organs grown from snake glands produce real venom - Science Magazine

Asymmetrex Partners in Manufacturing USA Institute January 23, 2020The Advanced Regenerative Manufacturing Institute – PR Web

BOSTON (PRWEB) January 23, 2020

Asymmetrex LLC is part of a new public-private Manufacturing USA initiative, the Advanced Regenerative Manufacturing Institute (ARMI). Headquartered in Manchester, New Hampshire, ARMI is the 12th Manufacturing USA Institute. ARMI brings together a consortium of over 100 partner organizations from industry, government, academia and the non-profit sector to develop next-generation manufacturing processes and technologies for cells, tissues and organs.

Approximately $80 million from the federal government will be combined with more than $200 million in cost share to support the development of tissue and organ manufacturing capabilities. As part of continuing efforts to help revitalize American manufacturing and incentivize companies to invest in new technology development in the United States, ARMI will lead the Advanced Tissue Biofabrication (ATB) Manufacturing USA Institute on behalf of the Department of Defense.

Under the umbrella of Manufacturing USA, a public-private network that invests in the development of world-leading manufacturing technologies, ARMI will work to integrate and organize the fragmented collection of industry practices and domestic capabilities in tissue Biofabrication technology to better position the US relative to global competition. ARMI will also focus on accelerating regenerative tissue research and creating state-of-the-art manufacturing innovations in biomaterial and cell processing for critical Department of Defense and civilian needs.

We need to develop 21st century tools for engineered tissue manufacturing that will allow these innovations to be widely available similar to how a 15th century tool (the printing press) allowed knowledge to spread widely during the Renaissance, said inventor Dean Kamen, ARMIs chairman.

ARMIs efforts are supported by forty-seven industrial partners, twenty-six academic and academically affiliated partners, and fourteen government and nonprofit partners. The ARMI partnership continues to grow.

About AsymmetrexAsymmetrex, LLC is a Massachusetts life sciences company with a focus on developing technologies to advance stem cell medicine. The companys patent portfolio contains biotechnologies that solve the two main technical problems production and quantification that have stood in the way of successful commercialization of human adult tissue stem cells for regenerative medicine and drug development. Asymmetrex markets the first technology for determination of the dose and quality of tissue stem cell preparations (the AlphaSTEM Test) for use in stem cell transplantation therapies and pre-clinical drug evaluations. For more information, please visit http://www.asymmetrex.com.

About ARMIThe Advanced Regenerative Manufacturing Institute (ARMI), headquartered in Manchester, NH, is the 12th Manufacturing USA Institute. It brings together a consortium of over 150 partners from across industry, government, academia and the non-profit sector to develop next-generation manufacturing processes and technologies for cells, tissues and organs. ARMI will work to organize the current fragmented domestic capabilities in tissue Biofabrication technology to better position the U.S. relative to global competition. For more information on ARMI, please visit http://www.ARMIUSA.org.

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Asymmetrex Partners in Manufacturing USA Institute January 23, 2020The Advanced Regenerative Manufacturing Institute - PR Web

Genmab Announces European Marketing Authorization for DARZALEX (Daratumumab) in Combination with Bortezomib, Thalidomide and Dexamethasone in Frontli…

Copenhagen, Denmark; January 20, 2020 Genmab A/S (Nasdaq: GMAB) announced today that the European Commission (EC) has granted marketing authorization for DARZALEX (daratumumab) in combination with bortezomib, thalidomide and dexamethasone for the treatment of adult patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant (ASCT). The EC approval follows a positive opinion issued for DARZALEX by the CHMP of the European Medicines Agency (EMA) in December 2019. In August 2012, Genmab granted Janssen Biotech, Inc. (Janssen) an exclusive worldwide license to develop, manufacture and commercialize daratumumab.

With this approval, newly diagnosed patients with multiple myeloma who are eligible for ASCT may have the opportunity for treatment with a DARZALEX-containing regimen. We are extremely pleased that DARZALEX has received this latest approval and we look forward to the combination of DARZALEX plus bortezomib, thalidomide and dexamethasone being launched in Europe, said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

The approval was based on the Phase III CASSIOPEIA (MMY3006) study sponsored by the French Intergroupe Francophone du Myelome (IFM) in collaboration with the Dutch-Belgian Cooperative Trial Group for Hematology Oncology (HOVON) and Janssen R&D, LLC. Data from this study was published in The Lancet and presented at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting.

About the CASSIOPEIA (MMY3006) studyThis Phase III study is a randomized, open-label, multicenter study, run by the French Intergroupe Francophone du Myelome (IFM) in collaboration with the Dutch-Belgian Cooperative Trial Group for Hematology Oncology (HOVON) and Janssen R&D, LLC, including 1,085 newly diagnosed subjects with previously untreated symptomatic multiple myeloma who are eligible for high dose chemotherapy and stem cell transplant. In the first part of the study, patients were randomized to receive induction and consolidation treatment with daratumumab combined with bortezomib, thalidomide (an immunomodulatory agent) and dexamethasone (a corticosteroid) or treatment with bortezomib, thalidomide and dexamethasone alone. The primary endpoint is the proportion of patients that achieve a stringent Complete Response (sCR). In the second part of the study, patients that achieved a response will undergo a second randomization to either receive maintenance treatment of daratumumab 16 mg/kg every 8 weeks for up to 2 years versus no further treatment (observation). The primary endpoint of this part of the study is progression free survival (PFS).

About multiple myelomaMultiple myeloma is an incurable blood cancer that starts in the bone marrow and is characterized by an excess proliferation of plasma cells.1 Approximately 16,830 new patients were expected to be diagnosed with multiple myeloma and approximately 10,480 people were expected to die from the disease in the Western Europe in 2018.2 Globally, it was estimated that 160,000 people were diagnosed and 106,000 died from the disease in 2018.3 While some patients with multiple myeloma have no symptoms at all, most patients are diagnosed due to symptoms which can include bone problems, low blood counts, calcium elevation, kidney problems or infections.4

About DARZALEX (daratumumab)DARZALEX (daratumumab) intravenous infusion is indicated for the treatment of adult patients in the United States: in combination with bortezomib, thalidomide and dexamethasone as treatment for patients newly diagnosed with multiple myeloma who are eligible for autologous stem cell transplant; in combination with lenalidomide and dexamethasone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with bortezomib, melphalan and prednisone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy; in combination with pomalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor (PI); and as a monotherapy for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy, including a PI and an immunomodulatory agent, or who are double-refractory to a PI and an immunomodulatory agent.5 DARZALEX is the first monoclonal antibody (mAb) to receive U.S. Food and Drug Administration (U.S. FDA) approval to treat multiple myeloma. DARZALEX intravenous infusion is indicated for the treatment of adult patients in Europe: in combination with bortezomib, thalidomide and dexamethasone as treatment for patients newly diagnosed with multiple myeloma who are eligible for autologous stem cell transplant; in combination with lenalidomide and dexamethasone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with bortezomib, melphalan and prednisone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; for use in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy; and as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, whose prior therapy included a PI and an immunomodulatory agent and who have demonstrated disease progression on the last therapy6. The option to split the first infusion of DARZALEX over two consecutive days has been approved in both Europe and the U.S. In Japan, DARZALEX intravenous infusion is approved for the treatment of adult patients: in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone for the treatment of relapsed or refractory multiple myeloma; in combination with bortezomib, melphalan and prednisone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with lenalidomide and dexamethasone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant. DARZALEX is the first human CD38 monoclonal antibody to reach the market in the United States, Europe and Japan. For more information, visit http://www.DARZALEX.com.

Daratumumab is a human IgG1k monoclonal antibody (mAb) that binds with high affinity to the CD38 molecule, which is highly expressed on the surface of multiple myeloma cells. Daratumumab triggers a persons own immune system to attack the cancer cells, resulting in rapid tumor cell death through multiple immune-mediated mechanisms of action and through immunomodulatory effects, in addition to direct tumor cell death, via apoptosis (programmed cell death).5,6,7,8,9,10

Daratumumab is being developed by Janssen Biotech, Inc. under an exclusive worldwide license to develop, manufacture and commercialize daratumumab from Genmab. A comprehensive clinical development program for daratumumab is ongoing, including multiple Phase III studies in smoldering, relapsed and refractory and frontline multiple myeloma settings. Additional studies are ongoing or planned to assess the potential of daratumumab in other malignant and pre-malignant diseases in which CD38 is expressed, such as amyloidosis, NKT-cell lymphoma and B-cell and T-cell ALL. Daratumumab has received two Breakthrough Therapy Designations from the U.S. FDA for certain indications of multiple myeloma, including as a monotherapy for heavily pretreated multiple myeloma and in combination with certain other therapies for second-line treatment of multiple myeloma.

About Genmab Genmab is a publicly traded, international biotechnology company specializing in the creation and development of differentiated antibody therapeutics for the treatment of cancer. Founded in 1999, the company has two approved antibodies, DARZALEX (daratumumab) for the treatment of certain multiple myeloma indications, and Arzerra (ofatumumab) for the treatment of certain chronic lymphocytic leukemia indications. Daratumumab is in clinical development for additional multiple myeloma indications, other blood cancers and amyloidosis. A subcutaneous formulation of ofatumumab is in development for relapsing multiple sclerosis. Genmab also has a broad clinical and pre-clinical product pipeline. Genmab's technology base consists of validated and proprietary next generation antibody technologies - the DuoBody platform for generation of bispecific antibodies, the HexaBody platform, which creates effector function enhanced antibodies, the HexElect platform, which combines two co-dependently acting HexaBody molecules to introduce selectivity while maximizing therapeutic potency and the DuoHexaBody platform, which enhances the potential potency of bispecific antibodies through hexamerization. The company intends to leverage these technologies to create opportunities for full or co-ownership of future products. Genmab has alliances with top tier pharmaceutical and biotechnology companies. Genmab is headquartered in Copenhagen, Denmark with core sites in Utrecht, the Netherlands and Princeton, New Jersey, U.S.

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Genmab Announces European Marketing Authorization for DARZALEX (Daratumumab) in Combination with Bortezomib, Thalidomide and Dexamethasone in Frontli...

Advancells Group & IFC Concluded their 3-Day Workshop on Regenerative Medicine – Business Wire India

The key-note speaker of the workshop was Dr. Rita Bakshi, founder and chairperson of International Fertility Centre, the oldest fertility clinic and one of the most renowned IVF clinics in India, one of the organizers of the event. Participants also had a privilege to listen to Dr. Sachin Kadam, CTO, Advancells and gain hands-on experience in the preparation of PRP; Liposuction method; and Bone Marrow aspiration. All these techniques were talked about at length and demonstrated in the form of manual & kit-based models to help the candidates gain exposure.

Dr. Punit Prabha, Head of Clinical Research and Dr. Shradha Singh Gautam, Head of Lab Operations at Advancells successfully set the base of stem cell biology for the participants who were experts in gynecology field, stem cell research and pain specialist. With the help of detailed analysis of Application of PRP for Skin rejuvenation; Preparation of Micro-fragmented Adipose Tissue and Nano Fat & SVF (Stromal Vascular Fraction) from Adipose Tissue; and Cell Culturing and Expansion in a Laboratory, applicants understood the application of stem cells in aesthetics, cosmetology, and anti-aging.

Vipul Jain, Founder & CEO of Advancells Group said, Educating young scientists about stem cells is important for us. With this workshop we wanted to discuss and share the challenges and lessons we have learned in our journey of curing our customers. We wanted to establish more concrete knowledge base in the presence of subject matter experts and help our attendees in more possible ways. We are hopeful to have successfully achieved what we claimed with this workshop.

Given the resounding success of the Sub-Specialty Training in Application of Regenerative Medicine (S.T.A.R. 2020), its hoped that the future events shall offer even greater wisdom to the participants by helping them improve and the lead the community into the age of greater awareness.

About Advancells Group

Advancells is leading the field of stem cell therapies in India and abroad, with representative offices in Bangladesh and Australia. The company provides arrangements for stem cell banking and protocols for partner doctors and hospitals which they can use for treating the patients using regenerative medicine. With a GMP compliant research and processing center that works on different cell lines from various sources such as Bone Marrow, Adipose Tissue, Dental Pulp, Blood, Cord Tissue etc. Advancells also intends to file a patent for this processing technology soon.

For more information, visit https://www.advancells.com/

About International Fertility Centre

IFC is Indias leading fertility center under the leadership and guidance of Dr. Rita Bakshi. She along with her solid team of experienced doctors have create a network of 10+ IVF clinics located in India and Nepal. Their services include In-vitro Fertilization (IVF), Intrauterine Insemination (IUI), Intracytoplasmic Injection (ICSI), Egg Donation, Surrogacy, Blastocyst, Assisted Hatching, Hysteroscopy, Laparoscopy and much more.

For more information, visit https://www.internationalfertilitycentre.com/

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Advancells Group & IFC Concluded their 3-Day Workshop on Regenerative Medicine - Business Wire India

Biodegradable tube excels at treatment of nerve injuries – New Atlas

When someone has suffered a major nerve injury, there are two common treatments: performing a nerve graft, or utilizing a conduit to guide the regrowth of the injured nerve. While both approaches have their drawbacks, a new variation on the latter may succeed where they fail.

First of all, severed nerves are able to grow back together on their own. This is usually only the case if the gap between the two ends is no more than about a third of an inch, however. Any longer, and the regrowing nerve essentially misses its target, sometimes instead forming into a painful nerve-tissue ball known as a neuroma.

Therefore, for bridging larger gaps in places such as the arms, doctors usually perform a nerve graft. This most often involves harvesting a long, skinny sensory nerve from the back of the patient's leg; cutting that nerve into three pieces; bundling those pieces together laterally, in order to form one thicker length of nerve material; and then sewing that bundle onto the ends of the damaged nerve.

Unfortunately, doing so causes permanent numbness in the donor leg. Additionally, if the procedure is being used to repair a motor nerve, only about 40 to 60 percent of the original motor function typically returns.

Another option involves implanting a small conduit tube at the injury site. This guides the nerve as it regrows, ensuring that its two ends meet back up. According to scientists at the University of Pittsburgh, though, there are currently no commercially-available conduits that are FDA-approved for the bridging of gaps longer than one inch.

With that limitation in mind, those researchers have designed what they say is a better-performing tube. It's made from the same biodegradable polyester as dissolvable sutures, and is lined with microspheres of a growth-promoting protein called GDNF (glial-cell-derived neurotrophic factor). That protein is slowly released over the treatment period, continuously promoting nerve growth. No stem cells, which have been used in some other experimental conduits, are required.

N.B. Fadia et al., Science Translational Medicine (2019)

The device was tested on macaque monkeys, each of which had a 2-inch (51-mm) gap between the severed end of one of their forearm motor nerves and its associated muscle.

One group of the primates was treated using the new conduits, a second group was treated with empty polymer tubes, and a third group received nerve grafts. In the case of the latter, because monkeys' legs are too short for traditional nerve-harvesting, a section of nerve was simply extracted from their forearm, flipped around, and then sewn back in place. Because those grafts were made of the exact same material as the injured nerve, this scenario was expected to restore more function than traditional leg-to-arm grafts.

After a one-year recovery period, it was found that the Pittsburgh conduits outperformed the empty tubes, restoring about 80 percent of fine motor control to the thumbs of four of the monkeys. As compared to the grafts, the conduits restored approximately the same amount of functionality. That said, they did better at triggering the replenishment of Schwann cells these form an insulating layer around nerves, which both boosts the transmission of electrical signals and aids in nerve regeneration.

The tubes are made of a polymer known as poly(caprolactone)

The scientists are now commercializing the technology via spinoff company AxoMax Technologies, and hope to begin human clinical trials soon. In the meantime, a paywalled paper on the research can be found in the journal Science Translational Medicine.

"We're the first to show a nerve guide without any cells was able to bridge a large, 2-inch gap between the nerve stump and its target muscle," says Prof. Kacey Marra, who led the study alongside Neil Fadia and Lauren Kokai. "Our guide was comparable to, and in some ways better than, a nerve graft."

Sources: University of Pittsburgh, American Association for the Advancement of Science via EurekAlert

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Biodegradable tube excels at treatment of nerve injuries - New Atlas

European Commission Approves Darzalex (daratumumab) in Combination with Bortezomib, Thalidomide and Dexamethasone (VTd) for Patients with Newly Diag -…

BEERSE, BELGIUM, 20 January 2020 The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the European Commission (EC) has granted marketing authorisation for Darzalex (daratumumab) in combination with bortezomib, thalidomide and dexamethasone (VTd) for the treatment of patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant (ASCT). This approval is based on results from Part one of the Phase 3 CASSIOPEIA (MMY3006) study, published in The Lancet[5] in June 2019 and presented at the 2019 American Society of Clinical Oncology (ASCO) Meeting.

The effectiveness of first-line treatment is critical to maximise time until relapse. So, we asked ourselves, can we improve the standard of care that is bortezomib, thalidomide and dexamethasone (VTd) to provide patients with valuable extra time? said Philippe Moreau, M.D., principal investigator and Head of the Haematology Department at the University Hospital of Nantes, France. The CASSIOPEIA study answered that question definitively, demonstrating that the addition of daratumumab in combination with VTd can lead to very deep remissions and also prolong PFS. Im pleased to see the European Commission have recognised this as well.

Todays approval marks the first opportunity for newly diagnosed, transplant eligible patients to be treated with a monoclonal antibody, and the first new treatment for this patient population in over six years, said Dr Patrick Laroche, Haematology Therapy Area Lead, Europe, Middle East and Africa (EMEA), Janssen-Cilag. We are thrilled that newly diagnosed patients with multiple myeloma and their doctors will have a long-awaited additional frontline therapy.

The Phase 3 CASSIOPEIA trial is a two-part study. Results from this first part of the trial showed that after consolidation, the stringent complete response (sCR) rate was significantly higher in the daratumumab-VTd arm (29 percent) compared to VTd alone (20 percent) (Odds Ratio [OR] = 1.60; 95 percent confidence interval [CI], 1.21-2.12; P<0.0010).2 At a median follow-up of 18.8 months, PFS was significantly improved in the daratumumab-VTd group compared to VTd alone (Hazard Ratio [HR] = 0.47; 95 percent CI, 0.33-0.67; P<0.0001), and the median PFS was not reached in either arm.2 The addition of daratumumab to VTd resulted in an 18-month PFS rate of 93 percent compared to 85 percent for VTd alone.2

The most common (10%) Grade 3/4 treatment-emergent adverse events (TEAEs) for daratumumab-VTd and VTd, respectively, were neutropenia (28 percent vs. 15 percent), lymphopenia (17 percent vs. 10 percent), stomatitis (13 percent vs. 16 percent) and thrombocytopenia (11 percent vs. 7 percent).2 In the daratumumab-VTd combination arm, infusion-related reactions occurred in 35 percent of patients.2

This approval represents our commitment to investigate daratumumab in earlier disease stages of multiple myeloma and to develop more effective frontline treatment options for newly diagnosed patients who are eligible for transplantation, adds Craig Tendler, M.D., Vice President, Clinical Development and Global Medical Affairs, Oncology, Janssen Research & Development, LLC.

[1] Johnson & Johnson. European Commission Approves VELCADE As A Frontline Induction Therapy Before Stem Cell Transplantation. Press release August 8, 2013. Available at: https://www.jnj.com/media-center/press-releases/european-commission-approves-velcade-as-a-frontline-induction-therapy-before-stem-cell-transplantation Last accessed January 2020.

[2] Moreau P, Attal M, Hulin C, et al. Phase 3 randomized study of daratumumab (DARA) + bortezomib/thalidomide/dexamethasone (D-VTd) vs VTd in transplant-eligible (TE) newly diagnosed multiple myeloma (NDMM): CASSIOPEIA Part 1 results. Presented at Annual Meeting of the American Society of Clinical Oncology (ASCO), Chicago, IL, USA, 31 May 4 June 2019.

[3] Janssen. Data on file: RF-82203. Daratumumab: New patient starts launch to date. December 2019

[4] European Medicines Agency. DARZALEX summary of product characteristics, November 2019. Available at: https://ec.europa.eu/health/documents/community-register/2019/20191119146548/anx_146548_en.pdf Last accessed January 2020.

[5] Moreau P, Attal M, Hulin C, et al. Bortezomib, thalidomide, and dexamethasone with or without daratumumab before and after autologous stem-cell transplantation for newly diagnosed multiple myeloma (CASSIOPEIA): a randomised, open-label, phase 3 study. The Lancet. Volume 394, Issue 10192, P29-38, July 06, 2019.

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European Commission Approves Darzalex (daratumumab) in Combination with Bortezomib, Thalidomide and Dexamethasone (VTd) for Patients with Newly Diag -...

Breakthrough discovery could lead to one-size-fits-all cancer treatment – The Independent

A newly discovered type of killer immune cell has raised the prospect of a universal cancer therapy, scientists say.

Researchers at Cardiff University suggest the new T-cell offers hope of a one-size-fits-all cancer therapy.

T-cell therapies for cancer where immune cells are removed, modified and returned to the patient's blood to seek and destroy cancer cells are the latest paradigm in cancer treatments.

Sharing the full story, not just the headlines

The most widely used is known as CAR-T and is personalised to each patient.

However, it only targets a limited number of cancers and has not been successful for solid tumours, which make up the majority of cancers.

But scientists have now discovered T-cells equipped with a new type of T-cell receptor (TCR), which recognises and kills most human cancer typeswhile ignoring healthy cells.

Thousands of 999 patients in England are being told to get a taxi to hospital, figures have showed. The number of patients outside London who were refused an ambulance rose by 83 per cent in the past year as demand for services grows

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A vaping-related lung disease has claimed the lives of 11 people in the US in recent weeks. The US Centre for Disease Control and Prevention has more than 100 officials investigating the cause of the mystery illness, and has warned citizens against smoking e-cigarette products until more is known, particularly if modified or bought off the street

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Researchers in the US claim to have overcome one of the major hurdles to cultivating human follicles from stem cells. The new system allows cells to grow in a structured tuft and emerge from the skin

Sanford Burnham Preybs

A study in the journal Scientific Reports suggests that a dose of nature of just two hours a week is associated with better health and psychological wellbeing

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Exposure to air from traffic-clogged streets could leave women with fewer years to have children, a study has found. Italian researchers found women living in the most polluted areas were three times more likely to show signs they were running low on eggs than those who lived in cleaner surroundings, potentially triggering an earlier menopause

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Junk food adverts on TV and online could be banned before 9pm as part of Government plans to fight the "epidemic" of childhood obesity.Plans for the new watershed have been put out for public consultation in a bid to combat the growing crisis, the Department of Health and Social Care (DHSC) said

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On migrating from Africa around 70,000 years ago, humans bumped into the neanderthals of Eurasia. While humans were weak to the diseases of the new lands, breeding with the resident neanderthals made for a better equipped immune system

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The breath biopsy device is designed to detect cancer hallmarks in molecules exhaled by patients

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By their 10th birthdy, children have on average already eaten more sugar than the recommended amount for an 18 year old. The average 10 year old consumes the equivalent to 13 sugar cubes a day, 8 more than is recommended

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While there is not enough evidence of harm to recommend UK-wide limits on screen use, the Royal College of Paediatrics and Child Health have advised that children should avoid screens for an hour before bed time to avoid disrupting their sleep

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A study published in the New England Journal of Medicine has found that many elderly people are taking daily aspirin to little or no avail

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A study by the University of Minnesota's Masonic Cancer Centre has found that the carcinogenic chemicals formaldehyde, acrolein, and methylglyoxal are present in the saliva of E-cigarette users

Reuters

There has been a 41% increase in children with type 2 diabetes since 2014, the National Paediatric Diabetes Audit has found. Obesity is a leading cause

Reuters

The majority of antidepressants are ineffective and may be unsafe, for children and teenager with major depression, experts have warned. In what is the most comprehensive comparison of 14 commonly prescribed antidepressant drugs to date, researchers found that only one brand was more effective at relieving symptoms of depression than a placebo. Another popular drug, venlafaxine, was shown increase the risk users engaging in suicidal thoughts and attempts at suicide

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Researchers at the Baptist Health South Florida Clinic in Miami focused on seven areas of controllable heart health and found these minority groups were particularly likely to be smokers and to have poorly controlled blood sugar

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A major pressure group has issued a fresh warning about perilously high amounts of sugar in breakfast cereals, specifically those designed for children, and has said that levels have barely been cut at all in the last two and a half decades

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New guidance by the National Institute for Health and Care Excellence (NICE), the body which determines what treatment the NHS should fund, said lax road repairs and car-dominated streets were contributing to the obesity epidemic by preventing members of the public from keeping active

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A new class of treatments for women going through the menopause is able to reduce numbers of debilitating hot flushes by as much as three quarters in a matter of days, a trial has found.The drug used in the trial belongs to a group known as NKB antagonists (blockers), which were developed as a treatment for schizophrenia but have been sitting on a shelf unused, according to Professor Waljit Dhillo, a professor of endocrinology and metabolism

REX

Research from Oxford University found that more than one million extra people suffering from mental health problems would benefit from being prescribed drugs and criticised ideological reasons doctors use to avoid doing so.

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The family of a teenager who died from flu has urged people not to delay going to A&E if they are worried about their symptoms. Melissa Whiteley, an 18-year-old engineering student from Hanford in Stoke-on-Trent, fell ill at Christmas and died in hospital a month later.

Just Giving

The Government has pledged to review tens of thousands of cases where women have been given harmful vaginal mesh implants.

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The NHS will be asked to go further to prevent the deaths of patients in its care as part of a zero suicide ambition being launched today

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Human trials have begun with a new cancer therapy that can prime the immune system to eradicate tumours. The treatment, that works similarly to a vaccine, is a combination of two existing drugs, of which tiny amounts are injected into the solid bulk of a tumour.

Nephron

Mothers living within a kilometre of a fracking site were 25 per cent more likely to have a child born at low birth weight, which increase their chances of asthma, ADHD and other issues

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Thousands of cervical cancer screening results are under review after failings at a laboratory meant some women were incorrectly given the all-clear. A number of women have already been told to contact their doctors following the identification of procedural issues in the service provided by Pathology First Laboratory.

Rex

Most breast cancer patients do not die from their initial tumour, but from secondary malignant growths (metastases), where cancer cells are able to enter the blood and survive to invade new sites. Asparagine, a molecule named after asparagus where it was first identified in high quantities, has now been shown to be an essential ingredient for tumour cells to gain these migratory properties.

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A record number of nursing and midwifery positions are currently being advertised by the NHS, with more than 34,000 positions currently vacant, according to the latest data. Demand for nurses was 19 per cent higher between July and September 2017 than the same period two years ago.

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CBD has a broadly opposite effect to delta-9-tetrahydrocannabinol (THC), the main active component in cannabis and the substance that causes paranoia and anxiety.

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Mr Bransons company sued the NHS last year after it lost out on an 82m contract to provide childrens health services across Surrey, citing concerns over serious flaws in the way the contract was awarded

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The numbers of people accepted to study nursing in England fell 3 per cent in 2017, while the numbers accepted in Wales and Scotland, where the bursaries were kept, increased 8.4 per cent and 8 per cent respectively

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The paper found that there were 45,000 more deaths in the first four years of Tory-led efficiencies than would have been expected if funding had stayed at pre-election levels.On this trajectory that could rise to nearly 200,000 excess deaths by the end of 2020, even with the extra funding that has been earmarked for public sector services this year.

Reuters

Hours of commuting may be mind-numbingly dull, but new research shows that it might also be having an adverse effect on both your health and performance at work. Longer commutes also appear to have a significant impact on mental wellbeing, with those commuting longer 33 per cent more likely to suffer from depression

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It is not possible to be overweight and healthy, a major new study has concluded. The study of 3.5 million Britons found that even metabolically healthy obese people are still at a higher risk of heart disease or a stroke than those with a normal weight range

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When you feel particularly exhausted, it can definitely feel like you are also lacking in brain capacity. Now, a new study has suggested this could be because chronic sleep deprivation can actually cause the brain to eat itself

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David Lloyd Gyms have launched a new health and fitness class which is essentially a bunch of people taking a nap for 45 minutes. The fitness group was spurred to launch the napercise class after research revealed 86 per cent of parents said they were fatigued. The class is therefore predominantly aimed at parents but you actually do not have to have children to take part

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Tobacco and alcohol companies could win more easily in court cases such as the recent battle over plain cigarette packaging if the EU Charter of Fundamental Rights is abandoned, a barrister and public health professor have said

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A major new study into the side effects of the cholesterol-lowering medicine suggests common symptoms such as muscle pain and weakness are not caused by the drugs themselves

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New research has found that babies born to fathers under the age of 25 or over 51 are at higher risk of developing autism and other social disorders. The study, conducted by the Seaver Autism Center for Research and Treatment at Mount Sinai, found that these children are actually more advanced than their peers as infants, but then fall behind by the time they hit their teenage years

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Commuters who swap their car or bus pass for a bike could cut their risk of developing heart disease and cancer by almost half, new research suggests but campaigners have warned there is still an urgent need to improve road conditions for cyclists.Cycling to work is linked to a lower risk of developing cancer by 45 per cent and cardiovascular disease by 46 per cent, according to a study of a quarter of a million people.Walking to work also brought health benefits, the University of Glasgow researchers found, but not to the same degree as cycling.

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Scientists conducted the research on 71 car crash victims as they were waiting for treatment at one hospitals accident and emergency department. They asked half of the patients to briefly recall the incident and then play the classic computer game, the others were given a written activity to complete. The researchers, from Karolinska Institute in Sweden and the University of Oxford, found that the patients who had played Tetris reported fewer intrusive memories, commonly known as flashbacks, in the week that followed

Rex

Thousands of 999 patients in England are being told to get a taxi to hospital, figures have showed. The number of patients outside London who were refused an ambulance rose by 83 per cent in the past year as demand for services grows

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A vaping-related lung disease has claimed the lives of 11 people in the US in recent weeks. The US Centre for Disease Control and Prevention has more than 100 officials investigating the cause of the mystery illness, and has warned citizens against smoking e-cigarette products until more is known, particularly if modified or bought off the street

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Researchers in the US claim to have overcome one of the major hurdles to cultivating human follicles from stem cells. The new system allows cells to grow in a structured tuft and emerge from the skin

Sanford Burnham Preybs

A study in the journal Scientific Reports suggests that a dose of nature of just two hours a week is associated with better health and psychological wellbeing

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Exposure to air from traffic-clogged streets could leave women with fewer years to have children, a study has found. Italian researchers found women living in the most polluted areas were three times more likely to show signs they were running low on eggs than those who lived in cleaner surroundings, potentially triggering an earlier menopause

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Junk food adverts on TV and online could be banned before 9pm as part of Government plans to fight the "epidemic" of childhood obesity.Plans for the new watershed have been put out for public consultation in a bid to combat the growing crisis, the Department of Health and Social Care (DHSC) said

PA

On migrating from Africa around 70,000 years ago, humans bumped into the neanderthals of Eurasia. While humans were weak to the diseases of the new lands, breeding with the resident neanderthals made for a better equipped immune system

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Breakthrough discovery could lead to one-size-fits-all cancer treatment - The Independent

Illumia Therapeutics, Singapore’s Latest Full-Service Medispa, Lets You Address Your Beauty And Wellness Needs In One Place – Singapore Tatler

If you havent had the chance to visit Illumia Therapeutics, thelatest hotspot on OrchardRoad for transformative, nextlevel facial and body treatments, then you are missing out on an opportunity that is hard to find anywhere else. Thenewly opened fullservice medispa allows you to address your beauty and wellness needs all in one place, with skilled experts and staff focused on providing a restful escape from your hectic schedule.

Founded by aesthetic doctors and backed by plastic surgeons, Illumia Therapeutics offers clients the star treatment whenever they visit. Thename Illumia was chosen to signify that clients are at the centre of what we do. It all starts with u, the client, says CEOElizabethLeong. All the treatments at IllumiaTherapeutics are non-invasive, safe and clinically proven, andusually done one step at a time. We believe in subtle tweaking, so our clients look fresher and more youthful in phases rather than doing too much at onego,addsLeong.

We find out more about five treatments offered at the medispa.

(Related: What is Face Fitness? Look Out For This Major Beauty Trend in 2020)

Every treatment combines at least two or more highly effective technologies, including stem cell therapy, to provide unparalleled results. Leong explains, This proprietary combination approach is Illumias Hybrid2 Protocol. Different technologies target different skin layerssaving time and doubling results. We believe in visible changes with minimum effort at accessible prices that allow clients to get back to their normal routinesimmediately.

(Related: Biohack Your Way To Beauty And Health Using Your DNA And Stem Cells At These Wellness Retreats Around The World)

One of its signature treatments is the LDMFaceRegen, which is under the llumiaSkinBrite series of skin therapies. It is afavourite of brand ambassador and beauty connoisseur KimLim to maintain her velvety smooth, naturally clear and glowing skin. Thetreatment, which uses German technology based on dual-frequency ultrasound waves, increases elasticity for wrinkle reduction, enhancesrejuvenation, resolves acne issues andsoftens acnescars.

The Illumia FaceLift series, on the other hand, adopts the Korean-styled face design technique that defines the uniqueness of the facial contours. Take the Illumia HyfuUltra treatment, for instance. It is a speedy face-lifting method using ultrasound waves to tighten the skin, minimise wrinkles and eyebags, and fill out sunken cheeks with lastingresults.

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Illumia Therapeutics, Singapore's Latest Full-Service Medispa, Lets You Address Your Beauty And Wellness Needs In One Place - Singapore Tatler

Misplaced Assumptions, Where Investments Go Wrong – Seeking Alpha

You've heard the one about the physicist, chemist, and economist marooned on a desert island with a can of beans but no way to open it. With index finger on temple, the physicist opines, "Focus sunlight on the can to melt it." "No", the chemist interrupts, "We should pour saltwater on the lid to rust the can." The economist, matter-of-factly, ties off the debate, "Assume we have a can opener."

Richard Mason and Ian Mitroff might have called being stranded with no way to get at food in one's possession an "ill-structured" or "wicked problem". They would have encouraged the three academics to engage in some, "strategic assumption surfacing and testing" to:

Notice my insertion in brackets above, "[investment hypotheses]". In considering and revisiting such decisions, I repeatedly attempt to apply this technique to expose and evaluate strategic assumptions that may affect our results.

Not infrequently, revelation about assumptions comes to me after I have already moved forward with an investment. For example, a couple of years ago I made beefy bets on three CRISPR (gene editing) stocks following their IPO's - CRISPR Therapeutics (CRSP), Editas Medicine (EDIT), and Intellia Therapeutics (NTLA). We did very well on them but sold out because I felt they had gotten ahead of themselves although I wasn't entirely sure why.

Something was niggling me that I couldn't quite explain. While walking our daughter's Yorkie a few months later, I ran into a friend who is very learned in stem cells. I mentioned backing away from our gene editing investments wondering out loud how most people could afford such treatments.

"Henry", he looked at me, "This is an issue. Other than through early-stage research grants, patients must tap private resources or look to foundations." Disappointingly, my friend's expert opinion seemed to confirm that funding, at least for now, is a limiting factor in how far and fast gene editing stocks can grow. I felt I had made a good decision to sell and move on. At a level, Bayer (OTCPK:BAYRY) must agree because they just backed off their original position in CRISPR Therapeutics. Strategic assumption testing.

However, that conversation didn't turn me away from all medical treatments; far from it. I later added to our position in Merck (MRK) that continues to receive approvals from governments around the world for the use of Keytruda to fight various cancers, bladder, Hodgkin lymphoma, neck, melanoma, pancreatic, small cell lung, and urothelial carcinoma among them. The strategic assumption here being, more applications x more government approvals = more revenue = more income = higher stock price and dividends.

And, although the word "genetics" is in its name, as opposed to one-patient-at-a-time editing, I also recently bought into NewLink Genetics (NLNK) that is discovering, developing, and commercializing medicines that tap the body's own immune system to fight disease. It was NewLink that discovered and then licensed to Merck, a 100%-effective Ebola vaccine that was recently approved by the FDA. It is NewLink that is now partnering with Ellipses Pharma, a UK private limited company, on an ovarian cancer treatment (that Merck does not have; hmmm). If approved, it could catapult NLNK to much higher levels. Although NewLink is still losing money, its balance sheet is pristine; it's positioned for growth. And, intangibly, I like the fact that it is headquartered in the heartland, Ames, Iowa; smart, hard-working people there.

Therefore, while on the one hand, patient-by-patient genetic treatments are overwhelmingly important, my current assumption is that they are not there yet from a shareholder perspective. On the other hand, using therapies - mono and poly - to fight cancer seems to be mushrooming.

Before moving on, it's also worth challenging assumptions about the very definition of healthcare. For example, with regularity, apps and gadgets are introduced to monitor bodily functions and wellness. Fitbit (FIT), that is in the process of being acquired by Alphabet (GOOG) (GOOGL), is a notable case in point.

Indeed, Alphabet is also perfecting an AI-based system that, in most cases, improves the accuracy of breast cancer diagnosis. In addition to benefiting those at risk, this technology may lower the need for less accurate technicians and doctors. Let us not forget that clinics and hospitals are businesses and, that here in US at least, the war rages over the cost of healthcare.

And, at an even broader level, Alphabet appears to be setting its sights on becoming a leader in medical diagnostics. If ever there was an indication of this, it is in the Mayo Clinic's recent announcement that they are teaming with Google on cloud-based data mining and AI to improve healthcare. This is a big deal that could recalibrate some basic assumptions in the field.

In a completely different category of investments, many SA contributors and commenters apparently still embrace the assumption that the sun still rises for Tanger Factory Outlets (SKT) and Simon Property Group (SPG). Here, obvious limiting factors are suppressed, talked over, or tuned out - the competitive domination of on-line shopping, big-box retailing, remote fulfillment, etc. For example, this research available for purchase from Coresight (I have no relationship with them) reports that: a) e-commerce is relentlessly gaining market share at an accelerating pace, b) there is no letup in the growth of retail defaults and bankruptcies, and c) disappointment will continue as new stores open into a flat sales environment (and, with interest/cap rates perhaps on the march again). For retail REIT pundits and investors to believe that they will beat these odds defies Einstein's very definition of insanity:

"doing the same thing over and over again expecting different results."

Tanger and Simon are classic "hole-in-your-pocket investments" wherein most investors blithely put those dividends in their tattered Levi's (NYSE:LEVI) and walk on not realizing that they've fallen through. This can be easily and conclusively demonstrated by adding up those dividends over time and subtracting the corresponding loss in these REITs' market caps. The algorithm is such: a) Pick a medium-term timeframe; I'll use 3 years, b) Add up all the dividends paid by the Simon Property Group and Tanger Factory Outlet during that time, and c) Subtract the difference in before versus after market cap. Material amounts of shareholder value have been destroyed:

Moreover, open the SKT and SPG pages on SA, and scroll down the sentiment summaries to the left and you will see that most contributors going back are skewed toward the bullish side of neutral; some are still "very bullish" notwithstanding years of disappointment during which they were also very bullish; is your head spinning?

For those investors looking for a "tell" on when REIT experts may be coming to grips with their own misplaced strategic assumptions, you need to look no further than to those who have shifted from recommending common to recommending preferred stock as it has been for: CBL Properties (CBL), Pennsylvania Real Estate (PEI), and Washington Prime Group (WPG). Definitionally, the destruction in shareholder value is seen in common stock prices. However, it is usually triggered farther up the balance sheet as I know from my days predicting REIT bankruptcies by anticipating covenant defaults.

And, for mall REIT investors who want to know who is picking up that money falling through the hole in your pocket, look no further than to compare the stock performance of SKT and SPG to, say, Alibaba (BABA), Amazon (AMZN), Target (TGT), and Walmart (WMT). There is a reason these lines inversely correlate:

Or, take those of us who write about the relative (de)merits of internal combustion, battery electric, and fuel cell engines. With every post, we confront assumptions involving limiting factors. ICE vehicles must be phased out given that their emissions are sickening planet earth; they are. BEV growth assumes the unconstrained availability of heavy metals essential to their production. FC(E)V power coming from natural gas is not carbon-free.

Have we pushed strategic assumption surfacing and testing far enough in this space? If you listen to Elon Musk, there is nothing more to debate; BEV's and, specifically, his BEV's are it. For us mortals, as opposed to driving a single stake in the ground, it may be wiser to spread out over various forward-looking investments including, for me: a) Toyota (TM) that continues to innovate around diversified product line that will increasingly deemphasize ICE vehicles in favor of hybrids, pure BEV, and FCV's, b) Suzuki (OTCPK:SZKMY) that commands a major share in the world's third largest automobile market, India, and is well positioned with low-energy-consumption scooters and motorcycles best suited for use in densely populated cities and poorer countries, and c) ABB (ABB) and Ballard (BLDP) that are focused on bringing clean(er) energy to commercial vehicles including boats and ships; others are, as well.

Strategic assumption testing has also brought us to investing in miners of heavy metals that are essential to all manufacturers of batteries and cleaner ICE vehicles - Amplats (OTCPK:ANGPY), Glencore (OTCPK:GLNCY), Norilsk (OTCPK:NILSY), South32 (OTCPK:SOUHY), Sumitomo Metals (OTCPK:SMMYY) - platinum, palladium, rhodium, cobalt, nickel, and manganese. To reemphasize, for now we simply don't accept as fact that there is only one right way to invest in clean energy vehicles.

For the climate change / global warming deniers out there, the time has come to embrace the strategic assumption that the transformation to clean, renewable, sustainable energy is happening. If you don't believe me, no offense taken. Believe the largest institutional investors and fund managers on earth - like Norway's sovereign wealth management fund, or BlackRock (BLK) whose Chairman and CEO, Larry Fink. If you as an individual investor assume that you can successfully buck this movement, you assume wrong. Do yourself, your children, and the rest of us a favor - get on board.

Strategic assumption - many individuals own too many high-priced, underutilized, fixed assets whether second homes, automobiles, airplanes, or boats. Businesses figured out long ago that they need to better utilize real estate and equipment, two of the costliest factors of production. A trend developed in renting vs. owning as, for example, when farmers began resisting the temptation to buy that expensive combine in favor of outsourcing harvesting to a neighbor who wanted better utilization of the expensive combine he already owned. Makes sense.

Expedia (EXPE) through HomeAway/VRBO, and Airbnb (private) have begun to address the challenge of underused residential real estate by bringing vacation property owners together with those who have no interest in title but instead rather rent for a week, a month, or a season. I am no longer able to count the number of our friends who use one of these options to escape winters or summers to friendlier climes in America's playgrounds. A while back, competing hotels felt the squeeze such that they too got into the vacation rental business; deals are everywhere.

And, we have a parallel situation with automobiles. I'm talking about Uber Technologies (UBER) and Lyft, Inc. (LYFT) where owners with time on their hands are, in effect, renting out their cars and driving services. For "renters", the equation could make sense if you're comfortable with rising prices, lax pick-up service, or the probability of jumping into a car with a pervert. The model may also work for "the middlemen" - Uber and Lyft - and any other company who can develop the critical mass while steering clear of existential liability.

But the strategic assumption that keeps getting in my way is from the vantage point of the supply-side, the owners. Specifically, I wonder if every-day individuals who are long fixed assets really understand their total cost of ownership or if they are just trying to earn some pin money or cover some bills. Mind you, there is nothing wrong with that unless/until one starts focusing return on their investment (and labor). Depreciation, licensing fees, insurance premiums, deductibles, fuel costs, maintenance expenses, tax and tax prep all add up never mind waking up to discover that one is earning well less than minimum wage on all the time and hassle associated with operating and administering such assets and activities.

Wrap it all together and I'm hung up on the assumption that EXPE, UBER and LYFT are limited-life alpha investments that owe their existence to 'temporary' albeit rolling excesses. As a board member our HOA, I'm channeling on a neighbor who last year whined about all the costs associated with his three homes. When I said to him, "Your problem is that you have too many damn homes", his surprise instantly turned to laughter and then agreement (a few months later he sold one of his places).

The chart below suggests that Uber, and Lyft have quickly moved through the growth phase of their S-curves and are now more-or-less mature investments that may tip into decline as others compete for market share. Indeed, they appear to have been mature investments before their IPO's hit the market; strange, isn't it.

Mason, Mitroff, and others would say that strategic assumption testing can/should be applied in "dialectic discourse" to planning [and investing]. A fancy phrase for a simple concept in which two or more people holding different points of view about a subject wish to establish the truth through reasoned arguments. The approach resembles debate but excludes subjective elements such as emotional appeal and pejorative rhetoric.

Dialectic discourse is difficult to achieve where emotions run high protected by ideological worldviews - the ethics of gene editing, ancestral comfort with tangible property / real estate, defensiveness that we humans contribute to climate change, and so forth. Those of us who write on these topics at times face numbing bias in the form or trite accolades by sycophants, or incoherent criticism by haters. To some extent, SA's anonymous format obstructs dialectic discourse.

So, when the process isn't possible, we're left to our own devices. To this I say, there is nothing wrong with having a conversation with yourself starting with basic questions: a) Am I open or closed minded; am I boxing myself in?, b) How might I think about challenges differently?, c) What other (substitute) options are available?, d) Could 'the answer' be different in the short versus long-run?, e) Do I know what I don't know; how do I find out? Repeat.

Does dialectic discourse work even if only with oneself? I'm careful to think that it might. I've followed up with alpha-level evidence on many of my own articles and a review of portfolio performance confirms that we are handily beating the indexes including the S&P 500 (as well as Warren Buffett's Berkshire Class A (BRK.A) shares). Because investment challenges these days are ill-structured / wicked, I recommend strategic assumption testing.

Disclosure: I am/we are long BAYRY, MRK, NLNK, GOOGL, BABA, TM, SZKMY, ABB, BLDP, ANGPY, GLNCY, NILSY, SOUHY, SMMYY. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.

Additional disclosure: Always do your own due diligence in consultation with a licensed and competent financial adviser who understands your unique needs and puts your interests ahead of their own. Remember, there are added considerations in owning foreign securities including those associated with ADR sponsorship, buying and selling the pinks, foreign withholding taxes on dividends, and fees. (All my proceeds from contributing to SA go to charity.)

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Misplaced Assumptions, Where Investments Go Wrong - Seeking Alpha