Stem Cell Clinic

Why Superman 5 With Christopher Reeve Never Happened – Screen Rant

Despite Superman IV: The Quest for Peace's failure, there was a hope that Christopher Reeve would return for Superman V. Here's why it didn't happen.

Superman V never happened, and there are ample reasons why Christopher Reeve never performed as the Man of Steel again after the failure of 1987's Superman IV: The Quest for Peace. Christopher Reeve played Superman for a decade, starting with Richard Donner's 1978 Superman: The Movie and continuing on with Richard Lester's Superman II and Superman III. For a generation of fans, Reeve's earnest Superman is the definitive version and he remains the standard by which all other actors who have played the Man of Steel are judged.

The first two Superman movies, which were produced by Alexander and Ilya Salkind, were global blockbusters. Donner's original film innovated the special effects technology that made audiences believe Superman could really fly, and the first two films are wildlyimaginative and heartfelt adventures that pioneered the modern superhero movie. Unfortunately, Superman III, which co-starred the comedian Richard Pryor, was a disappointment; it was made with a slashed budget, grossed less than its predecessors, and the third film received mixed reviews from critics and audiences, despite novel ideas like an evil Superman fighting his good side, Clark Kent. After Superman III and the subsequent failure of the Supergirl spinoff in 1984 (which Reeve refused to appear in), the Salkinds decided the Superman movies had run their course and they sold the rights to Menahem Golan and Yoram Globus of Cannon Films.

Related: What Superman Returns 2 Was Supposed To Be About (& Why It Didn't Happen)

However, the Cannon Films-produced Superman IV: The Quest for Peace was a disaster. Cannon had numerous films under production and attempted to make Superman IV for even less money than Superman III, shortchanging everything from the sets to the obviously sub-par visual effects. Despite a socially-relevant story partly conceived by Reeve where Superman tries to rid the world of nuclear weapons, and the return of Gene Hackman as Lex Luthor, Superman IV was an embarrassment to everyone involved and grossed a paltry $36-million worldwide. With Superman IV crashing and burning, there was virtually no chance Reeve would agree to return for Superman V.

Despite their failure, Cannon Films did intend to make Superman V at one point and earmarked Reeve to return as the Man of Steel. Cannon's plan was to take an even cheaper route and cobble together 45 minutes of unused footage from Superman IV as the basis for a fifth movie. However, nothing came of it, and Cannon, which was in the red after numerous cinematic failures, folded in the early 1990s. The movie rights to Superman reverted back to the Salkinds, but they created a Superboy TV series instead of a movie.

Still, in 1991, screenwriter Cary Bates pitched an idea for Superman V to Alexander and Ilya Salkind, which would star Christopher Reeve once more. Bates' plan was to ignore Superman III and IV (something Bryan Singer also chose to do when he directed Superman Returns in 2006) and pit the Man of Steel against Brainiac in the Bottled City of Kandor. But at this point in the early '90s, the Salkinds were producing Christopher Columbus: The Discovery, which ran massively overbudget and ultimately lost the father-son producing team $40-million. The Salkinds quit the movie business afterward and the Superman movie rights reverted to Warner Bros. After Superman IV failed in 1987, it would take 19 years for the Man of Steel to return to the big screen in Superman Returns,despite an infamous attempt by Warners to make Superman Lives starring Nicolas Cage and directed by Tim Burton.

In 1995, Christopher Reeve suffered a tragic accident when he was thrown from his horse during an equestrian competition. The accident left Reeve a quadriplegic, although he heroically persevered. Following his rehabilitation, Reeve became a champion for stem cell research, spinal cord research, and people with disabilities, establishing the Christopher Reeve Foundation (which is now the Christopher and Dana Reeve Foundation). Reeve also returned to acting and he even appeared in season 2 of Smallville, where he passed the torch to the small screen's newest Man of Steel, Tom Welling. Christopher Reeve died on October 10, 2004, but the final years of his life proved the real-life man was more heroic than appearing in Superman V would ever allow him to be.

Next:Kingdom Come Superman Becomes [SPOILER] At The End Of Crisis on Infinite Earths

Scott Disick 'Flirting' with Kourtney Kardashian After Sofia Richie Split

John has been writing about what he likes - movies, TV, comics, etc. - for over a decade. He's worked in movies and rubbed shoulders with big names but somehow forgot to ask for money a lot of the time - hence, he is happy to be with Screen Rant. John can be found @BackoftheHead, counts a Black Canary and an Agent of S.H.I.E.L.D. among his friends, believes (correctly) that Superman is stronger than the Hulk, and he is a friend to all talking gorillas.

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Why Superman 5 With Christopher Reeve Never Happened - Screen Rant

Research On Global Stem Cell Cartilage Regeneration Market (impact of COVID-19), Analysis, Overview, Growth Forecast, Top key players Anika…

Global Stem Cell Cartilage Regeneration Market 2020 Research Report

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The key manufacturers covered in this report are:Anika Therapeutics,Zimmer Biomet,BioTissue Technologies,DePuy (Johnson & Johnson),Genzyme,CellGenix,EMD Serono,Sanofi Aventis,Smith & Nephew.

The final report will add the analysis of the Impact of Covid-19 in this report Stem Cell Cartilage Regeneration industry.

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Trending factors influencing the market shares of the Americas, APAC, Europe, and MEA.

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The report, focuses on the global Stem Cell Cartilage Regeneration market, and answers some of the most critical questions stakeholders are currently facing across the globe. Information about the size of the market (by the end of the forecast year), companies that are most likely to scale up their competitive abilities, leading segments, and challenges impeding the growth of the market are given.

Analysis tools such as SWOT analysis and Porters five force model have been inculcated in order to present a perfect in-depth knowledge about Stem Cell Cartilage Regeneration market. Ample graphs, tables, charts are added to help have an accurate understanding of this market. The Stem Cell Cartilage Regeneration market is also been analyzed in terms of value chain analysis and regulatory analysis.

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It helps in making informed business decisions by having complete insights of market and by making in-depth analysis of market segments

TABLE OF CONTENT:

1 Report Overview

2 Global Growth Trends

3 Market Share by Key Players

4 Breakdown Data by Type and Application

5 United States

6 Europe

7 China

8 Japan

9 Southeast Asia

10 India

11 Central & South America

12 International Players Profiles

13 Market Forecast 2020-2027

14 Analysts Viewpoints/Conclusions

15 Appendix

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Research On Global Stem Cell Cartilage Regeneration Market (impact of COVID-19), Analysis, Overview, Growth Forecast, Top key players Anika...

Readers ask about antibody tests, chimeras and public health and privacy – Finance Brokerage

Antibody mysteries

Antibody tests can help reveal who has been infected with the coronavirus, but the tests dont say whether the antibodies protect against future infections, Erin Garcia de Jesus reported in So many questions on antibody testing (SN: 6/6/20, p. 22).

Reader Bob Reckers asked if antibodies for cold-causing coronaviruses, which are detectable by the coronavirus antibody tests, could bind to the coronavirus. This could explain the wide variations in severity of COVID19 infections, he wrote. People who recently had a (cold) might have some level of protection.

Antibodies produced in reaction to some colds certainly could bind to the coronavirus that causes COVID-19, says Garcia de Jesus. But those antibodies dont appear to last long. Its unclear whether antibodies from a recent cold would offer protection or worsen COVID-19 symptoms, she says. For dengue viruses, antibodies sometimes can lead to severe symptoms. When people who have had dengue are infected with a different strain, antibodies from the previous infection help the new virus invade cells, putting those people at higher risk for severe symptoms. Theres no evidence in people either way for COVID-19, and not enough time has passed for researchers to fully study this question, Garcia de Jesus says.

Cell phone apps that have helped South Korea and China get a grip on the coronavirus spread could help public health workers in the United States, Jonathan Lambert reported in A sprint to contact tracing (SN: 6/6/20, p. 19).

To comply with contact tracing apps, people in the United States must know that their privacy is protected, reader Cielo DeCastro noted. It must be made explicit that identification between devices is anonymized and securely stored in encrypted form to prevent violation of privacy. The application should not gather any other information or track ones geolocation, he wrote. DeCastro acknowledged that phone tracking may be necessary for public health, but the peoples right to privacy must not be overlooked.

Lambert agrees that privacy around contact tracing apps is a major issue. The TraceTogether app mentioned in the story uses anonymized data gained through proximity tracking, whereby a phone exchanges encrypted data via Bluetooth with nearby phones. This method is considered less invasive than the geolocation tracking used by many apps on our phones (SN: 2/3/18, p. 18).

In June, U.S. legislators introduced the Exposure Notification Privacy Act. This bill would require anyone who operates a contact tracing app to collaborate with public health officials, make app use voluntary and prevent commercial use of data collected by the apps.

Scientists coaxed human stem cells into populating various organs and blood of growing mouse embryos, Laura Sanders reported in Mouse embryos host human cells (SN: 6/6/20, p. 7).

The story made my skin crawl, reader Jerome Knies wrote. What kind of moral supervision governs such experimentation?heasked.

Little clarity exists, Sanders says. Individual countries have an array of guidelines for conducting human chimera experiments, and individual research institutions often have their own approval committees, she says. For what its worth, the International Society for Stem Cell Research highlights two potential concerns: chimeras with humanlike brains and chimeras that can pass human genes to offspring. The organization flagged those scenarios as ones that require careful ethical considerations, Sanders says.

Quantum computings error problem (SN: 6/20/20, p. 18) explained how two photons within a superconducting microwave cavity might represent a value of 0, with four qubits representing 1. This is incorrect. Four photons would represent 1.

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Readers ask about antibody tests, chimeras and public health and privacy - Finance Brokerage

Gene variants and susceptibility to schizophrenia – The Hindu

Schizophrenia is a constellation of symptoms such as hearing voices, false beliefs and trouble with thinking and concentration, and its cause is not exactly known. In that sense, schizophrenia is still an enigma.

Studies of schizophrenia among groups of varied ethnicities across the world have shown associations of the disease with alleles (variant genes) related to the human leukocyte antigen an important part of the immune system and related to a group of genes on chromosome six. However, the specific allele that was found to be associated with schizophrenia varied from group to group.

Recently, a pilot study on a south Indian, Tamil-speaking group consisting of 97 people with schizophrenia and 103 controls was carried out by Schizophrenia Research Foundation (SCARF) and Jeevan Stem Cell Foundation, in Chennai. The study, published in International Journal of Immunogenetics finds an association of specific alleles with the disease.

The paper shows an association between HLA variations and schizophrenia. HLA is important for proper functioning of immune system and its variations can lead to immunological abnormalities. When the immune system acts up, as in autoimmune disorders, generating anti-NMDA receptor antibodies, for example, it can lead to schizophrenia, says Dr Vijaya Raghavan, Consultant Psychiatrist, Research, SCARF.

Earlier studies indicate that different variants of specific genes (these variants are called alleles) may be involved in different ethnic groups.

Studies done in Saudi Arabia and Tunisia have shown a particular HLA allele (DRB1*03) to be a risk factor for schizophrenia but in [a study involving a] Japanese population it was a different allele (DRB1*01) which predisposed to the disease condition, says Dr S. Vani Laboratory Director, Jeenomics, Jeevan Stem cell Foundation, Chennai, in an email to The Hindu.She is a principal investigator of the present study along with Dr. Vijaya Raghavan.

The occurence of different variants itself is not a problem, as HLA genes are extremely variable and are very different across human populations, according to Prof. Sanjeev Jain, Department of Psychiatry, National Institute of Mental Health and Neurosciences, Bengaluru, who was not involved in the study. The reasons are not entirely clear, but perhaps selection and memory of past selection pressures (infections) play a role, he adds.

In the present study, the researchers found that there was a higher frequency of HLA class I alleles ( HLA-A*01:01:01, -B*37:01:01 and -C*01:02:01) in individuals with schizophrenia as compared to the controls. Individuals carrying these alleles could be susceptible to schizophrenia.

They also found a negative correlation with some alleles (HLA-B*35:03:01 and HLA-DRB1*04:03:01) which were found in lower frequency in individuals with schizophrenia. These could be protective alleles in schizophrenia.

The paper adds a valuable piece of information, on the relation between immune response genes and schizophrenia, says Prof. Jain. It is a small sample, and the associations are observed only in a subset (often females only); correcting for multiple comparisons may reduce the significance of the findings he adds.

The researchers also studied the type of amino acid present in the peptide binding groove of HLA molecule and compared it among patients and controls, finding a significant difference. The amino acid level association study has not been reported earlier in schizophrenia, says Dr. Vani, adding that the results need to be strengthened further using a larger sample size.

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Gene variants and susceptibility to schizophrenia - The Hindu

How COVID-19 Pandemic Will Impact Australia & New Zealand Research Antibodies Market Business Opportunity, And Growth 2020-2026 Bulletin Line -…

Trusted Business Insights answers what are the scenarios for growth and recovery and whether there will be any lasting structural impact from the unfolding crisis for the Australia & New Zealand Research Antibodies market.

Trusted Business Insights presents an updated and Latest Study on Australia & New Zealand Research Antibodies Market 2019-2026. The report contains market predictions related to market size, revenue, production, CAGR, Consumption, gross margin, price, and other substantial factors. While emphasizing the key driving and restraining forces for this market, the report also offers a complete study of the future trends and developments of the market.The report further elaborates on the micro and macroeconomic aspects including the socio-political landscape that is anticipated to shape the demand of the Australia & New Zealand Research Antibodies market during the forecast period (2019-2029). It also examines the role of the leading market players involved in the industry including their corporate overview, financial summary, and SWOT analysis.

Get Sample Copy of this Report @ Australia & New Zealand Research Antibodies Market Size Report, 2026 (Includes Business Impact of COVID-19)

Industry Insights, Market Size, CAGR, High-Level Analysis: Australia & New Zealand Research Antibodies Market

The Australia & New Zealand research antibodies market size was valued at USD 98.4 million in 2018 and is anticipated to grow at a CAGR of 8.4% during the forecast period. Rise in the number of initiatives being undertaken by the Australian government to advance the biotechnology sector is expected to fuel the growth in the country. In May 2019, Federal Labor offered businesses an R&D tax offset for collaborating with science-based agencies and universities, such as The Commonwealth Scientific and Industrial Research Organisation (CSIRO), to promote innovation and knowledge in biotechnology sector. In addition, a 10% tax can be added to the calculated tax offset if a business is collaborating with any public institution. This plan would help in increasing R&D investments in Australia to 3% of GDP by 2030 and is expected to act as a key tool for fostering an alliance between research and industry, thereby improving industrial capabilities in Australia. R&D tax incentive in Australia has encouraged biotechnology companies in the region to conduct R&D. For instance, in 2018, Shape Pharmaceuticals, Inc. supported R&D investments in Australian biotechnology industry by conducting clinical trials to study the effect of SHP-141 on patients diagnosed with psoriasis. These tax incentives help companies achieve cost advantage while selecting clinical trial sites for R&D processes.

Rise in R&D investments by the government is also expected to boost the market. In 2018, the Victorian government allocated USD 1.5 million for establishment of an Advanced Biotechnology Manufacturing Platform to enhance production of antibodies, vaccines, stem cells, and growth factors, among others, for testing in human clinical trials. This facility would enable various Australian biotechnology companies to conduct R&D in the state, thereby generating jobs and propelling growth of various companies currently conducting clinical trials in Victoria. The government is also promoting development of the biotechnology sector through Future Industries Fund. Growth in stem cell and neurobiology-based research is expected to boost the market over the forecast period. The Center of Research Excellence in Neuromuscular Disorders Australia is a wide collaboration of neuromuscular experts, who use advanced technologies and approaches in science & medicine to improve diagnosis. In addition, it aims to transform treatment to effective therapy of neurological diseases from compassionate management. The Australian Neuromuscular Network was formed in the year 2010 by the Center of Research Excellence in Neuromuscular Disorders along with other neuromuscular specialists, scientists, and professionals across New Zealand and Australia. Rise in the prevalence of neurological disorders is expected to boost the market. According to the Neurological Foundation of New Zealand, by 2051, about one-third of the population in New Zealand will be 65 years and above. The prevalence of dementia is therefore expected to increase, leading to a rise in R&D pertaining to treatment for various neurological disorders. However, stringent government regulations that can limit research activities are expected to restrain market growth.

Product Insights of Australia & New Zealand Research Antibodies Market

On basis of product, Australia & New Zealand research antibodies market is segmented into primary and secondary antibodies. Primary antibodies held the largest share and is anticipated to witness the highest CAGR owing to rise in adoption of reagents developed using antibodies, due to the various benefits associated with them such as greater specificity, easy availability, and suitability in various research applications. Similarly, primary antibodies are anticipated to grow at a faster rate during the forecast period due to varied applications in research. In addition, rise in prevalence of chronic diseases, such as diabetes, cancer, and Alzheimers disease, is leading to an increase in adoption of primary antibodies. Increasing R&D in the country is further anticipated to boost the adoption of secondary antibodies as well. Thus, rising adoption of these antibodies in research for development of alternative therapies is anticipated to create significant demand for these products over the forecast period. End-use Insights Pharmaceutical & biotechnology companies held the largest share of the end-use segment in 2018, which can be attributed to increase in adoption of antibodies in drug development and research organizations. Contract research organizations are anticipated to grow at a lucrative CAGR during the forecast period owing to cost-effectiveness.

The academic & research institutes segment is expected to witness constant growth owing to the presence of various academic research groups that are involved in the study of complex biological systems using advanced reagents. Benefits such as greater understanding of biological processes and complex systems are anticipated to create growth opportunities in the segment. Contract research organizations are anticipated to grow at a lucrative CAGR during the forecast period. Majority of the companies prefer CROs owing to the various advantages associated with contract services. These benefits include cost advantage, increased efficiency of services, and enhanced productivity, which help a company focus on its core expertise.

Type Insights of Australia & New Zealand Research Antibodies Market

On the basis of antibody type, the market is segmented into monoclonal and polyclonal antibodies. Monoclonal antibodies held the largest market share due to increase in research on genomics and personalized medicine, which has led to increase in the use of these antibodies. As monoclonal antibodies are relatively cost-effective, they are anticipated to grow at a higher rate than polyclonal antibodies. Polyclonal antibodies have several advantages over monoclonal in various diagnostic settings. Polyclonal antibodies are often the most preferred option in routine laboratory tests such as Enzyme-Linked Immunosorbent Assay (ELISA), microarray assays, western blotting, flow cytometry, and immunohistochemistry. Their production does not require skilled professionals, and large batches can be produced as per client requirements. These antibodies can recognize multiple antigens on one epitope and can therefore be utilized in the study of various diseases ranging from cancer to metabolic Polyclonal antibodies are relatively inexpensive in comparison with monoclonal antibodies, which may fuel their demand in low-budget and non-funded research projects. However, polyclonal antibodies can differ from batch to batch depending upon manufacturing and quality control process. These antibodies can recognize multiple epitopes, thus increasing the probability of nonspecific antigen binding.

Technology Insights of Australia & New Zealand Research Antibodies Market

On the basis of technology, the Australia & New Zealand research antibodies market is segmented into western blotting, immunoprecipitation, immunochemistry, ELISA, immunofluorescence, flow cytometry, and other technologies. Western blotting held the largest share of the technology segment in 2018 owing to rising demand for rapid diagnostic methods. On the other hand, technical upgradation is anticipated to create growth prospects for technologies in pipeline. ELISA is anticipated to witness the highest CAGR during the forecast period owing to conventional use of polyclonal antibodies in sandwich ELISA. ELISA is an analytical test that essentially uses antibodies to identify substances in samples. These tests are most often used to accurately diagnose diseases, such as AIDS, Lyme disease, syphilis, pernicious anemia, Rocky Mountain spotted fever, squamous cell carcinoma, chickenpox, shingles, and other bacterial & viral infections. Western blotting held the largest share in 2018 owing to rise in prevalence of diseases with limited number of treatment options. Western blotting offers high accuracy and sensitivity and is considered a gold standard for testing. In addition, increase in government initiatives to fund research activities is one of the factors contributing to the highest market share held by this segment, as it is conventionally used in research laboratories. Source Insights The mouse segment held the largest share in 2018 as mice are convenient to use during production of antibodies for research purposes and have wide range of applications. Others segment is expected to grow exponentially, as it has a wide range of applications. The use of murine monoclonal antibodies is increasing in various end-use settings, which is expected to positively impact market growth. Mice have been predominantly used in production of antibodies. The structural similarities in mice and human antibodies is a prime factor responsible for high adoption. Cost-effectiveness and the ability to multiply quickly are among the factors fueling growth of this segment. Moreover, mouse-derived monoclonal and polyclonal antibodies are relatively easier to produce and possess greater specificity. Technological advancements in the development processes of these products, such as hybridoma technology that aids in production of monoclonal antibodies in specialized cells, are further augmenting demand for mouse antibodies. Rabbits are also extensively used for production of antibodies, owing to various advantages such as higher affinity and specificity in comparison with antisera obtained from other animal hosts. Higher specificity of these products makes them ideal for use in detection of small molecules, such as pollutants; toxins; hormones; drugs; nonprotein targets, such as carbohydrates & lipids; and post-translational alterations such as phosphorylation.

Application Insights of Australia & New Zealand Research Antibodies Market

Oncology held the largest share of the application segment in 2018. The largest share can be attributed to growing prevalence of cancer, which leads to an increase in the need for R&D pertaining to advanced therapeutics. On the other hand, stem cell is anticipated to witness lucrative CAGR during the forecast period owing to significant increase in stem cells research. Rising prevalence of infectious diseases, growing geriatric population, decreasing immunity levels, and rising awareness among people about communicable diseases are some of the high impact-rendering drivers of the market. Growing incidence of autoimmune diseases coupled with limited presence of advanced therapeutics is predominantly driving segment growth. Significant advancements in immunology research have boosted adoption of research antibodies in the recent years. Oncology accounted for the largest share of research antibodies in 2018.The segment is also anticipated to grow at a considerable CAGR owing to increasing incidence of cancer. According to WHO, the number of new cancer cases is anticipated to increase by approximately 70.0% in the next two decades. Monoclonal antibodies are also used for diagnosis of lymphoid & myeloid malignancies, tissue typing, and immunological intervention using passive antibody. Owing to the steady increase in the demand for transplantable tissues and low-quality donor cells, stem cell research segment is expected to grow. Moreover, increasing adoption of cell isolation and culture, which involves use of research antibodies, is further anticipated to broaden segment growth prospects.

Market Share Insights of Australia & New Zealand Research Antibodies Market

Some major players in this market are PerkinElmer, Inc.; F.Hoffmann La Roche Ltd.; Thermo Fisher Scientific; Merck Millipore; Bio-Rad Laboratories; Abcam PLC; BD; Lonza Group; Cell Signaling Technology, Inc.; and Agilent Technologies. Increase in the number of products launched by market players is expected to fuel market growth. For instance, in April 2019, Bio-Rad launched a range of isotype-specific secondary antibodies-IgG1, IgG2a, and IgG2b. These products are used to offer specificity when used in ELISA, imaging, western blotting, and flow cytometry, among others, as well as for improved signaling. Mergers & acquisitions and collaborations are some of the other strategic initiatives undertaken by leading players to gain market share, for instance, Abcam Plc acquired Calico Biolabs. This initiative helped the company expand its product portfolio through the addition of high-quality recombinant rabbit monoclonal antibodies for immunohistochemistry. As per the agreement, Abcam was to also expand its custom rabbit monoclonal antibody production. These factors are further anticipated to aid growth during the forecast period.

Segmentations, Sub Segmentations, CAGR, & High-Level Analysis overview of Australia & New Zealand Research Antibodies Market Research Report This report forecasts revenue growth at country level and provides an analysis on the latest industry trends in each of the sub-segments from 2015 to 2026. For the purpose of this study, this market research report has segmented the Australia & New Zealand research antibodies market report on the basis of product, type, technology, source application, end use, and country:

Product Outlook (Revenue, USD Million, 2019 2030)

Primary

Secondary

Type Outlook (Revenue, USD Million, 2019 2030)

Monoclonal Antibodies

Polyclonal Antibodies

Technology Outlook (Revenue, USD Million, 2019 2030)

Immunohistochemistry

Immunofluorescence

Western Blotting

Flow Cytometry

Immunoprecipitation

ELISA

Others

Source Outlook (Revenue, USD Million, 2019 2030)

Mouse

Rabbit

Goat

Others

Application Outlook (Revenue, USD Million, 2019 2030)

Infectious Diseases

Immunology

Oncology

Stem Cells

Neurobiology

Others

End-use Outlook (Revenue, USD Million, 2019 2030)

Academic & Research Institutes

Contract Research Organizations

Pharmaceutical & Biotechnology Companies

Quick Read Table of Contents of this Report @ Australia & New Zealand Research Antibodies Market Size Report, 2026 (Includes Business Impact of COVID-19)

Trusted Business Insights Shelly Arnold Media & Marketing Executive Email Me For Any Clarifications Connect on LinkedIn Click to follow Trusted Business Insights LinkedIn for Market Data and Updates. US: +1 646 568 9797 UK: +44 330 808 0580

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How COVID-19 Pandemic Will Impact Australia & New Zealand Research Antibodies Market Business Opportunity, And Growth 2020-2026 Bulletin Line -...

FDA Approves Monjuvi(R) (tafasitamab-cxix) in Combination with Lenalidomide for the Treatment of Adu – PharmiWeb.com

DGAP-News: MorphoSys AG / Key word(s): Regulatory Approval 01.08.2020 / 01:43 The issuer is solely responsible for the content of this announcement.

FDA Approves Monjuvi(R) (tafasitamab-cxix) in Combination with Lenalidomide for the Treatment of Adult Patients with Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL)

- First FDA approval of a second-line treatment for adult patients with relapsed or refractory DLBCL, helping fill a high unmet medical need

- FDA granted Monjuvi Fast Track, Breakthrough Therapy and Priority Review designations

- MorphoSys and Incyte will co-commercialize Monjuvi in the United States

- Joint analyst and investor conference call and webcast scheduled for Monday, August 3, 2020 at 8:00 a.m. EDT / 2:00 p.m. CEST

PLANEGG/MUNICH, Germany - August 1, 2020 and WILMINGTON, Del. - July 31, 2020 MorphoSys AG (FSE: MOR; Prime Standard Segment; MDAX & TecDAX; NASDAQ:MOR) and Incyte (Nasdaq:INCY) today announced that the U.S. Food and Drug Administration (FDA) has approved Monjuvi(R) (tafasitamab-cxix) in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT).1 Monjuvi, a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody, has been approved under accelerated approval by the U.S. FDA based on overall response rate (ORR). Continued approval may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). The FDA decision represents the first approval of a second-line treatment for adult patients who progressed during or after first-line therapy.

DLBCL is the most common type of non-Hodgkin lymphoma in adults worldwide2, characterized by rapidly growing masses of malignant B-cells in the lymph nodes, spleen, liver, bone marrow or other organs. It is an aggressive disease with about one in three patients not responding to initial therapy or relapsing thereafter.3 In the United States each year approximately 10,000 patients are diagnosed with relapsed or refractory DLBCL who are not eligible for ASCT.4,5,6

"We are incredibly proud that the FDA has approved Monjuvi in combination with lenalidomide as the first treatment in second-line for patients with relapsed or refractory DLBCL, and we thank all the health care professionals, patients and families involved in our Monjuvi trials," said Jean-Paul Kress, M.D., Chief Executive Officer, MorphoSys. "This approval marks an important step in MorphoSys' transformation into a fully integrated biopharmaceutical company. We remain committed to developing innovative treatments to improve the lives of patients with serious diseases."

"The FDA approval of Monjuvi in combination with lenalidomide helps address an urgent unmet medical need for patients with relapsed or refractory DLBCL in the United States," said Herv Hoppenot, Chief Executive Officer, Incyte. "At Incyte we are committed to advancing patient care and are proud to bring this new and much-needed targeted therapeutic option to appropriate patients and the clinical community."

"The FDA approval of Monjuvi brings a new treatment option to patients in dire need across the United States," said Professor Gilles Salles, M.D., Chair of the Clinical Hematology Department at the University of Lyon, France, and lead investigator of the L-MIND study. "Today's FDA decision offers new hope for patients with this aggressive form of DLBCL who progressed during or after first-line therapy."

The FDA approval was based on data from the MorphoSys-sponsored Phase 2 L-MIND study, an open label, multicenter, single arm trial of Monjuvi in combination with lenalidomide as a treatment for adult patients with relapsed or refractory DLBCL. Results from the study showed an overall response rate (ORR) of 55% (primary endpoint), including a complete response (CR) rate of 37% and a partial response rate (PR) of 18%. The median duration of response (mDOR) was 21.7 months (key secondary endpoint).1 Warnings and Precautions for Monjuvi included infusion-related reactions (6%), serious or severe myelosuppression (including neutropenia (50%), thrombocytopenia (18%), and anemia (7%)), infections (73%) and embryo-fetal toxicity. Neutropenia led to treatment discontinuation in 3.7% of patients. The most common adverse reactions (>= 20%) were neutropenia, fatigue, anemia, diarrhea, thrombocytopenia, cough, pyrexia, peripheral edema, respiratory tract infection, and decreased appetite.

The FDA previously granted Fast Track and Breakthrough Therapy Designation for the combination of Monjuvi and lenalidomide in relapsed or refractory DLBCL. FDA Breakthrough Therapy designation is intended to expedite development and review of drug candidates. It is granted if preliminary clinical evidence indicates that the drug candidate may demonstrate substantial improvement over existing therapies in the treatment of a serious or life-threatening disease. The Biologics License Application (BLA) for Monjuvi was granted Priority Review and approved under the FDA's Accelerated Approval program.

Monjuvi is expected to be commercially available in the United States shortly. MorphoSys and Incyte will co-commercialize Monjuvi in the United States. Incyte has exclusive commercialization rights outside the United States.

MorphoSys and Incyte are committed to supporting patients throughout their treatment journeys and are working together to help lower patient access barriers. As part of this commitment, the Companies have launched My Mission Support, a robust patient support program offering financial assistance, ongoing education and other resources to eligible patients who are prescribed Monjuvi in the United States. Program information will be available online at http://www.MyMissionSupport.com.

Conference Call Information MorphoSys and Incyte will host an analyst and investor conference call and webcast on Monday, August 3, 2020 at 8:00 a.m. EDT / 2:00 p.m. CEST. The live webcast and replay will be available via http://www.morphosys.com and investor.incyte.com.

To access the conference call, please dial 877-407-3042 for callers in the United States or +1 201-389-0864 for callers outside the United States. When prompted, provide the conference identification number 13706810.

If you are unable to participate, a replay of the conference call will be available for 90 days. The replay dial-in number for the United States is 877-660-6853 and the dial-in number for international callers is +1 201-612-7415. To access the replay, you will need the conference identification number 13706810.

About L-MIND The L-MIND trial is a single arm, open-label Phase 2 study (NCT02399085) investigating the combination of tafasitamab and lenalidomide in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who have had at least one, but no more than three prior lines of therapy, including an anti-CD20 targeting therapy (e.g., rituximab), who are not eligible for high-dose chemotherapy or refuse subsequent autologous stem cell transplant The study's primary endpoint is overall response rate (ORR). Secondary outcome measures include duration of response (DoR), progression-free survival (PFS) and overall survival (OS). In May 2019, the study reached its primary completion.

For more information about L-MIND, visit https://clinicaltrials.gov/ct2/show/NCT02399085.

About Monjuvi(R) (tafasitamab-cxix) Monjuvi is a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody. In 2010, MorphoSys licensed exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc. Tafasitamab incorporates an XmAb(R) engineered Fc domain, which mediates B-cell lysis through apoptosis and immune effector mechanism including antibody-dependent cell-mediated cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP).

Monjuvi is approved by the U.S. Food and Drug Administration in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT).

In January 2020, MorphoSys and Incyte entered into a collaboration and licensing agreement to further develop and commercialize Monjuvi globally. Monjuvi will be co-commercialized by Incyte and MorphoSys in the United States. Incyte has exclusive commercialization rights outside the United States.

A marketing authorization application (MAA) seeking the approval of tafasitamab in combination with lenalidomide in the EU has been validated by the European Medicines Agency (EMA) and is currently under review for the treatment of adult patients with relapsed or refractory DLBCL, including DLBCL arising from low grade lymphoma, who are not candidates for ASCT.

Tafasitamab is being clinically investigated as a therapeutic option in B-cell malignancies in a number of ongoing combination trials.

Monjuvi is a registered trademark of MorphoSys AG. XmAb(R) is a registered trademark of Xencor, Inc.

Important Safety Information What are the possible side effects of MONJUVI? MONJUVI may cause serious side effects, including:

- Infusion reactions. Your healthcare provider will monitor you for infusion reactions during your infusion of MONJUVI. Tell your healthcare provider right away if you get chills, flushing, headache, or shortness of breath during an infusion of MONJUVI.

- Low blood cell counts (platelets, red blood cells, and white blood cells). Low blood cell counts are common with MONJUVI, but can also be serious or severe. Your healthcare provider will monitor your blood counts during treatment with MONJUVI. Tell your healthcare provider right away if you get a fever of 100.4 F (38 C) or above, or any bruising or bleeding.

- Infections. Serious infections, including infections that can cause death, have happened in people during treatments with MONJUVI and after the last dose. Tell your healthcare provider right away if you get a fever of 100.4 F (38 C) or above, or develop any signs and symptoms of an infection.

The most common side effects of MONJUVI include:

- Feeling tired or weak

- Diarrhea

- Cough

- Fever

- Swelling of lower legs or hands

- Respiratory tract infection

- Decreased appetite

These are not all the possible side effects of MONJUVI. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Before you receive MONJUVI, tell your healthcare provider about all your medical conditions, including if you:

- Have an active infection or have had one recently.

- Are pregnant or plan to become pregnant. MONJUVI may harm your unborn baby. You should not become pregnant during treatment with MONJUVI. Do not receive treatment with MONJUVI in combination with lenalidomide if you are pregnant because lenalidomide can cause birth defects and death of your unborn baby.

- You should use an effective method of birth control (contraception) during treatment and for at least 3 months after your final dose of MONJUVI.

- Tell your healthcare provider right away if you become pregnant or think that you may be pregnant during treatment with MONJUVI.

- Are breastfeeding or plan to breastfeed. It is not known if MONJUVI passes into your breastmilk. Do not breastfeed during treatment for at least 3 months after your last dose of MONJUVI.

You should also read the lenalidomide Medication Guide for important information about pregnancy, contraception, and blood and sperm donation.

Tell your healthcare provider about all the medications you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Please see the full Prescribing Information for Monjuvi, including Patient Information, for additional Important Safety Information.

About MorphoSys MorphoSys is a commercial-stage biopharmaceutical company dedicated to the discovery, development and commercialization of exceptional, innovative therapies for patients suffering from serious diseases. The focus is on cancer. Based on its leading expertise in antibody, protein and peptide technologies, MorphoSys, together with its partners, has developed and contributed to the development of more than 100 product candidates, 27 of which are currently in clinical development. In 2017, Tremfya(R), marketed by Janssen for the treatment of plaque psoriasis, became the first drug based on MorphoSys' antibody technology to receive regulatory approval. Headquartered near Munich, Germany, the MorphoSys group, including the fully owned U.S. subsidiary MorphoSys US Inc., has ~500 employees. More information at http://www.morphosys.com.

Tremfya(R) is a registered trademark of Janssen Biotech.

About Incyte Incyte is a Wilmington, Delaware-based, global biopharmaceutical company focused on finding solutions for serious unmet medical needs through the discovery, development and commercialization of proprietary therapeutics. For additional information on Incyte, please visit Incyte.com and follow @Incyte.

MorphoSys Forward-Looking Statements This communication contains certain forward-looking statements concerning the MorphoSys group of companies, including the expectations regarding tafasitamab's ability to treat patients with relapsed or refractory diffuse large B-cell lymphoma, the further clinical development of tafasitamab, including ongoing confirmatory trials, additional interactions with regulatory authorities and expectations regarding future regulatory filings and possible additional approvals for tafasitamab as well as the commercial performance of tafasitamab. The words "anticipate," "believe," "estimate," "expect," "intend," "may," "plan," "predict," "project," "would," "could," "potential," "possible," "hope" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. The forward-looking statements contained herein represent the judgment of MorphoSys as of the date of this release and involve known and unknown risks and uncertainties, which might cause the actual results, financial condition and liquidity, performance or achievements of MorphoSys, or industry results, to be materially different from any historic or future results, financial conditions and liquidity, performance or achievements expressed or implied by such forward-looking statements. In addition, even if MorphoSys' results, performance, financial condition and liquidity, and the development of the industry in which it operates are consistent with such forward-looking statements, they may not be predictive of results or developments in future periods. Among the factors that may result in differences are MorphoSys' expectations regarding risks and uncertainties related to the impact of the COVID-19 pandemic to MorphoSys' business, operations, strategy, goals and anticipated milestones, including its ongoing and planned research activities, ability to conduct ongoing and planned clinical trials, clinical supply of current or future drug candidates, commercial supply of current or future approved products, and launching, marketing and selling current or future approved products, the global collaboration and license agreement for tafasitamab, the further clinical development of tafasitamab, including ongoing confirmatory trials, and MorphoSys' ability to obtain and maintain requisite regulatory approvals and to enroll patients in its planned clinical trials, additional interactions with regulatory authorities and expectations regarding future regulatory filings and possible additional approvals for tafasitamab as well as the commercial performance of tafasitamab, MorphoSys' reliance on collaborations with third parties, estimating the commercial potential of its development programs and other risks indicated in the risk factors included in MorphoSys' Annual Report on Form 20-F and other filings with the U.S. Securities and Exchange Commission. Given these uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements. These forward-looking statements speak only as of the date of publication of this document. MorphoSys expressly disclaims any obligation to update any such forward-looking statements in this document to reflect any change in its expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements, unless specifically required by law or regulation.

Incyte Forward-Looking Statements Except for the historical information set forth herein, the matters set forth in this press release contain predictions, estimates and other forward-looking statements, including without limitation statements regarding: tafasitamab's ability to treat patients with relapsed or refractory diffuse large B-cell lymphoma, the further clinical development of tafasitamab, including ongoing confirmatory trials , additional interactions with regulatory authorities and expectations regarding future regulatory filings and possible additional approvals for tafasitamab as well as the commercial performance of tafasitamab. These forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially, including unanticipated developments in and risks related to: obtaining regulatory approval for this planned collaboration; research and development efforts related to the collaboration programs; the possibility that results of clinical trials may be unsuccessful or insufficient to meet applicable regulatory standards or warrant continued development; other market or economic factors, including other scientific developments; unanticipated delays; the effects of market competition; risks associated with relationships between collaboration partners; the impact of governmental actions regarding pricing, importation and reimbursement for pharmaceuticals; and such other risks detailed from time to time in each company's reports filed with the U.S. Securities and Exchange Commission, including Incyte's annual report on Form 10-Q for the quarter ending March 31, 2020 and MorphoSys' Annual Report on Form 20-F for the fiscal year ended December 31, 2019. Each party disclaims any intent or obligation to update these forward-looking statements.

References

1. Monjuvi(R) (tafasitamab-cxix) Prescribing Information. Boston, MA, MorphoSys.

2. Sarkozy C, et al. Management of relapsed/refractory DLBCL. Best Practice Research & Clinical Haematology. 2018 31:209-16. doi.org/10.1016/j.beha.2018.07.014.

3. Skrabek P, et al. Emerging therapies for the treatment of relapsed or refractory diffuse large B cell lymphoma. Current Oncology. 2019 26(4): 253-265. doi.org/10.3747/co.26.5421.

4. DRG Epidemiology data.

5. Kantar Market Research (TPP testing 2018).

6. Friedberg, Jonathan W. Relapsed/Refractory Diffuse Large B-Cell Lymphoma. Hematology Am Soc Hematol Educ Program 2011; 2011:498-505. doi: 10.1182/asheducation-2011.1.498.

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