Tom Coburn, the Dr. No of Congress, Is Dead at 72 – The New York Times

Tom Coburn, an ultraconservative Oklahoma Republican and family physician who in 16 years in Congress crusaded for limited government, using a rule-book technicality to block so many bills that frustrated legislators called him Dr. No, died on Saturday in Tulsa. He was 72.

The cause was cancer, said John Hart, his former communications director. Mr. Coburn had said in 2013 that he was being treated for a recurrence of prostate cancer, and in 2014 he announced that he would retire.

Mr. Coburn was an obstetrician who treated some 15,000 patients and delivered 4,000 babies in a maternal and family practice in Muskogee, Okla., before embarking on his political career three terms in the House of Representatives (1995-2001) and, after a four-year hiatus, two terms in the Senate (2005-15). He retired two years before the end of his second term because of deteriorating health.

A visceral foe of Washington long before such disaffections coalesced into the Tea Party, Mr. Coburn swept into Congress with the class of 1994, when Republicans gained control of the House for the first time in 40 years and installed Newt Gingrich as speaker and his Contract With America agenda to shrink government, cut taxes and promote welfare reforms and business activity.

Mr. Coburn soon set about displeasing everyone, including the constituencies most politicians covet: his own partys activists, donors, leaders and congressional colleagues. He battled with Mr. Gingrich often, charging that he was drifting to the political center and away from his contractual pledges to the nation. He openly vented his disdain for career politicians.

His contempt for them is genuine, bipartisan and in many cases mutual, The New York Times reported years later. He once prescribed a spinal transplant for 70 percent of the Senate, and another time said his colleagues had reproductive organs the size of BBs.

As if separating himself from the pack, Mr. Coburn continued to deliver babies as a member of the House. (He gave up his obstetric moonlighting only after a dispute with ethics officials when he entered the Senate.) But he won grudging respect as a political maverick and was admired by some colleagues as one of the toughest fiscal and social conservatives of his era.

For the sake of smaller government, he voted against nearly all spending bills, particularly pork-barrel allocations for the pet projects of legislators. He opposed gay rights, same-sex marriage, embryonic stem-cell research and abortions except those to save a womans life. He denied that global warming was real. He favored term limits for elected officials and pledged to abide by them himself.

In the House, he supported gun rights and favored the death penalty, even for doctors who performed abortions. He also wrote laws aimed at protecting infants from AIDS and expanding medical care for the elderly. He helped reform welfare and other federal entitlement programs, and led workshops for young staff members on sexually transmitted H.I.V. infections.

He caused a stir in 1997 when he protested NBCs decision to televise, in prime time and without editing, Schindlers List, Steven Spielbergs Oscar-winning Holocaust film. He called it televisions all-time low, with full-frontal nudity, violence and profanity, adding, I cringe when I realize that there were children all across this nation watching this program.

He was heavily criticized, including by the American Jewish Congress, which said: This isnt Melrose Place, Mr. Coburn. This is the Holocaust. He apologized to all those I have offended, but insisted that the film should have been aired later in the evening.

Keeping his campaign pledge to serve no more than three consecutive terms in the House, Mr. Coburn did not run for re-election in 2000. He resumed his medical practice, and in 2002 was appointed by President George W. Bush as a co-chairman of his advisory council on H.I.V. and AIDS, giving him a prominent platform as he prepared to run for the Senate.

Mr. Coburn also wrote a book about his experiences in Congress, Breach of Trust: How Washington Turns Outsiders Into Insiders (2003, with Mr. Hart). In it, he called careerism the central tenet of Congress. Both parties today, he wrote, are ultimately controlled not by ideas, but by the desire to be in control, a posture that creates little motivation for bold change.

In 2004, Mr. Coburn won the Senate seat being vacated by a four-term Oklahoma Republican, Don Nickles. He handily defeated former Representative Brad Carson, a Democrat.

Mr. Coburn continued his conservative fiscal and social voting record, but with far wider public and media attention. He became notorious for using a procedural senatorial privilege, called a hold, with which a single senator could block bills from being voted on by the full Senate.

At first his obstructionist tactics were relatively innocuous. He blocked two 2007 bills honoring the 100th birthday of Rachel Carson and her landmark 1962 book, Silent Spring, which documented the environmental effects of pesticides. Mr. Coburn called the book junk science and the catalyst in the deadly worldwide stigmatization against insecticides, especially DDT.

Later bills blocked by Mr. Coburn included provisions for health care, penalties for child pornography and protections for natural resources. Senate business was dragging to a crawl under the tactical loophole he was exploiting.

In 2008, to expose and embarrass Mr. Coburn, the Senate majority leader, Harry Reid, introduced 35 of the most irresistible-sounding bills together as omnibus legislation. It was a benign collection that almost any senator would be ashamed to vote against: a Mothers Act to relieve postpartum depression, a Protect Our Children Act to thwart internet predators, and a shameless measure to commemorate The Star-Spangled Banner.

Tom Coburn put a hold on the package, which was mocked as the Tomnibus bill. He did not back down. Neither did Senate Democrats.

The struggle lasted two years, but came to a head when he put a hold on a bill to fund the disarming of the Lords Resistance Army, a Ugandan terrorist group that had massacred countless civilians and dragooned children into its ranks. After an 11-day round-the-clock protest outside Mr. Coburns office by people outraged that funds to suppress terrorists were being held up, he relented and the bill passed.

Re-elected in 2010, he pledged not to seek a third term. He left the Senate in early 2015 after retiring for health reasons, but continued to write and speak against government waste and profligate spending.

Thomas Allen Coburn was born in Casper, Wyo., on March 14, 1948, to Orin Wesley and Anita (Allen) Coburn. In Muskogee, where the family settled, his father was an optician who founded Coburn Optical Industries, which made ophthalmic equipment and eyeglass lenses. The company was sold to Revlon for $57 million in 1975, although the elder Mr. Coburn continued as president of the subsidiary. Tom Coburn graduated from Central High School in Muskogee in 1966.

In 1968 he married Carolyn Denton, the 1967 Miss Oklahoma. They had three daughters: Callie, Katie and Sarah, the operatic soprano. He is survived by his wife, his daughters and nine grandchildren.

At Oklahoma State University, Mr. Coburn was an honors student and president of the student business council. He graduated in 1970 with a bachelors degree in accounting. From 1970 to 1978, he was the manufacturing manager of the ophthalmic division of Coburn Optical Industries in Colonial Heights, Va.

After the family business was sold, he attended medical school at the University of Oklahoma and received his medical degree with honors in 1983. He interned at St. Anthony Hospital in Oklahoma City, had a residency at the University of Arkansas Health Education Center in Fort Smith and returned to Muskogee to open his family and obstetrics practice.

He was a deacon of the Southern Baptist Church and participated in medical missions to Haiti in 1985 and Iraq in 1992.

His decision to run for Congress in 1994 was a long shot. He narrowly won, becoming the first Republican to represent Oklahomas Second Congressional District in 73 years.

Mr. Coburn had homes in Muskogee and Tulsa. Besides Breach of Trust, he wrote two books: The Debt Bomb: A Bold Plan to Stop Washington From Bankrupting America (2012, with Mr. Hart) and Smashing the DC Monopoly: Using Article V to Restore Freedom and Stop Runaway Government (2017), about a plan for the states to amend the United States Constitution.

While he never drifted from his conservative convictions, Mr. Coburn forged a friendship in Washington that was as unlikely as it was enduring. Arriving in the Senate together in 2005, he and Barack Obama quickly bonded.

Shortly before he retired, Mr. Coburn said of Mr. Obama: I think hes a neat man. You dont have to be the same to be friends. Matter of fact, the interesting friendships are the ones that are divergent.

Jonathan Martin contributed reporting.

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Tom Coburn, the Dr. No of Congress, Is Dead at 72 - The New York Times

Iranian scientist claims to have invented drug for COVID-19 treatment – The Express Tribune

Masoud Soleimani says medicine can be used to treat coronavirus patients in three phases

Masoud Soleimani says medicine can be used to treat coronavirus patients in three phases. PHOTO: IRAN FRONT PAGE

As the novel coronavirus continues to wreak havoc across the world, an Iranian scientist has claimed that he has invented a drug using stem cells for COVID-19 treatment.

Masoud Soleimani, the Iranian stem cell scientist who has been recently released from the US prison, says many doctors had used his drug to treat coronavirus patients and found it effective against the highly contagious disease,Iran Front Page reported on Saturday.

He says the medicine can be used to treat coronavirus patients in three phases in a period of three to six days.

Russia claims it produces drug to treat COVID-19

The important point in the development of the coronavirus medicine is that clinical tests are still being conducted on it, and we hope we will achieve better results in the coming days, he told the Iranian publication.

Final and complementary research work is underway for final approval of the drug, the scientist added.

Iran is among the few countries most affected by the pandemic. On Friday, the health ministry reported a death toll of 2,378 and total confirmed infections at 32,332 in the country.

Earlier in the day, PresidentHassan Rouhani said the countrys health infrastructure is strong and ready to cope with a possible escalation in coronavirus cases.

This article originally appeared in Iran Front Page

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Iranian scientist claims to have invented drug for COVID-19 treatment - The Express Tribune

Stem Cell Therapy Market to Witness Growth Acceleration During 2017 2025 – Daily Science

Global Stem Cell Therapy Market: Overview

Also called regenerative medicine, stem cell therapy encourages the reparative response of damaged, diseased, or dysfunctional tissue via the use of stem cells and their derivatives. Replacing the practice of organ transplantations, stem cell therapies have eliminated the dependence on availability of donors. Bone marrow transplant is perhaps the most commonly employed stem cell therapy.

Osteoarthritis, cerebral palsy, heart failure, multiple sclerosis and even hearing loss could be treated using stem cell therapies. Doctors have successfully performed stem cell transplants that significantly aid patients fight cancers such as leukemia and other blood-related diseases.

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Global Stem Cell Therapy Market: Key Trends

The key factors influencing the growth of the global stem cell therapy market are increasing funds in the development of new stem lines, the advent of advanced genomic procedures used in stem cell analysis, and greater emphasis on human embryonic stem cells. As the traditional organ transplantations are associated with limitations such as infection, rejection, and immunosuppression along with high reliance on organ donors, the demand for stem cell therapy is likely to soar. The growing deployment of stem cells in the treatment of wounds and damaged skin, scarring, and grafts is another prominent catalyst of the market.

On the contrary, inadequate infrastructural facilities coupled with ethical issues related to embryonic stem cells might impede the growth of the market. However, the ongoing research for the manipulation of stem cells from cord blood cells, bone marrow, and skin for the treatment of ailments including cardiovascular and diabetes will open up new doors for the advancement of the market.

Global Stem Cell Therapy Market: Market Potential

A number of new studies, research projects, and development of novel therapies have come forth in the global market for stem cell therapy. Several of these treatments are in the pipeline, while many others have received approvals by regulatory bodies.

In March 2017, Belgian biotech company TiGenix announced that its cardiac stem cell therapy, AlloCSC-01 has successfully reached its phase I/II with positive results. Subsequently, it has been approved by the U.S. FDA. If this therapy is well- received by the market, nearly 1.9 million AMI patients could be treated through this stem cell therapy.

Another significant development is the granting of a patent to Israel-based Kadimastem Ltd. for its novel stem-cell based technology to be used in the treatment of multiple sclerosis (MS) and other similar conditions of the nervous system. The companys technology used for producing supporting cells in the central nervous system, taken from human stem cells such as myelin-producing cells is also covered in the patent.

The regional analysis covers:

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Global Stem Cell Therapy Market: Regional Outlook

The global market for stem cell therapy can be segmented into Asia Pacific, North America, Latin America, Europe, and the Middle East and Africa. North America emerged as the leading regional market, triggered by the rising incidence of chronic health conditions and government support. Europe also displays significant growth potential, as the benefits of this therapy are increasingly acknowledged.

Asia Pacific is slated for maximum growth, thanks to the massive patient pool, bulk of investments in stem cell therapy projects, and the increasing recognition of growth opportunities in countries such as China, Japan, and India by the leading market players.

Global Stem Cell Therapy Market: Competitive Analysis

Several firms are adopting strategies such as mergers and acquisitions, collaborations, and partnerships, apart from product development with a view to attain a strong foothold in the global market for stem cell therapy.

Some of the major companies operating in the global market for stem cell therapy are RTI Surgical, Inc., MEDIPOST Co., Ltd., Osiris Therapeutics, Inc., NuVasive, Inc., Pharmicell Co., Ltd., Anterogen Co., Ltd., JCR Pharmaceuticals Co., Ltd., and Holostem Terapie Avanzate S.r.l.

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Stem Cell Therapy Market to Witness Growth Acceleration During 2017 2025 - Daily Science

Indian doctors try to find out how they can build interferon through human cells to treat COVID-19 patients – Times Now

Indian doctors try to find out how they can build interferon through human cells to treat COVID-19 patients | Photo credits: Pixabay 

New Delhi: As researchers and doctors inch closer to finding specific cures, and vaccines for the novel coronavirus and the disease COVID-19 caused by it, the cases around the world are also on a rise. More than 700 positive cases were reported in India, on Friday morning. Indian doctors have revealed that they are trying to find out how they can build interferon through human cells to treat COVID-19 patients in the country.

According to a report by the ANI, Oncologist Vishal Rao, in a conversation with the news agency said that so far, what they have built through the Icrest Stem Cell Lab, along with NCG Cancer Centre, Bangalore is to look at immunological cells, which researchers have already been working on, to understand treatments for COVID-19.

He said that by studying immunological cells, they are trying to find out a way to build interferon through human cells. He further said that these human cells are formed when blood for regular check-ups is withdrawn, they get buffy coat which can be used to take out cells & form interferon, specifically, interferon gamas.

He further credited Dr Gururaj and Jyotsana, who he said were the key people behind the whole effort, who were able to show that these two chemicals, and other cytokines which are chemicals released by the cells, in a specific concoction could be potentially very useful in treating COVID-19.

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Indian doctors try to find out how they can build interferon through human cells to treat COVID-19 patients - Times Now

Explainer: what is cocooning and how can it be implemented? – Independent.ie

Taoiseach Leo Varadkar yesterday announced almost total lockdown for the country for the next two week period and said that those over 70 and those at high risk of catching the coronavirus should be cocooned until April 12.

ast night, the HSE released a document detailing exactly what this means and how to best implement it.

But what is cocooning?

According to the document, cocooning is a measure to protect those over 70 years or those extremely medically vulnerable by minimising interaction between them and others.

Those people should not leave their homes, and within their homes should minimise all non-essential contact with other members of their household.

This is in an effort to protect them from contracting COVID-19.

Who is extremely vulnerable to catching the virus?

According to the HSE, extremely vulnerable includes:

If you are over 70 years of age or have an underlying medical condition listed above, you are at very high risk of severe illness as a result of COVID-19, the document states.

You are strongly advised to stay at home at all times and avoid any face-to-face contact for a period of two weeks."

Visits should only continue from people who provide essential support, such as healthcare, personal support with daily needs or social care should continue. However, carers and care workers must stay away if they have any of the symptoms of COVID-19.

All people coming to your home should wash their hands with soap and water for at least 20 seconds on arrival to your house and often whilst they are there

An alternative list of people who can help you with your care if your main carer becomes unwell should be drawn up.

If you have someone else living with you, they are not required to adopt these protective cocooning measures for themselves. They should do what they can to support you in cocooning and they should follow guidance on physical distancing, reducing their contact outside the home.

They should wash their hands thoroughly and regularly, especially upon arrival home and observe good respiratory etiquette at all times

There are also face-to-face distancing measures that should be followed within the home for those who are being cocooned.

What exactly does face-to-face distancing mean?

What should you do if you are being cocooned but the other people in your house are not?

What about visitors?

Regular visitors should be contacted and informed that you are cocooning and that they should not visit. Essential visitors only are allowed, those who help with washing, dressing, or feeding.

For informal carers, only essential care should be provided.

This advice also applies to those over 70 years of age or extremely medically vulnerable persons living in long-term care facilities. Care providers should carefully discuss advice with families, carers and specialist doctors.

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Explainer: what is cocooning and how can it be implemented? - Independent.ie

Hematopoietic Stem Cell Transplantation (HSCT) Market Projected to Experience Major Revenue Boost During the Period Between 2019-2048 – Daily Science

Global Hematopoietic Stem Cell Transplantation (HSCT) Market Viewpoint

Decorated with a team of 300+ analysts, Hematopoietic Stem Cell Transplantation (HSCT) Market Report serves each and every requirement of the clients while preparing market reports. With digital intelligence solutions, we offer actionable insights to our customers that help them in overcoming market challenges. Our dedicated team of professionals perform an extensive survey for gathering accurate information associated with the market.

Hematopoietic Stem Cell Transplantation (HSCT) Market Research, in its latest business report elaborates the current situation of the global Hematopoietic Stem Cell Transplantation (HSCT) market in terms of volume (x units), value (Mn/Bn USD), production, and consumption. The report scrutinizes the market into various segments, end uses, regions and players on the basis of demand pattern, and future prospect.

In this Hematopoietic Stem Cell Transplantation (HSCT) market study, the following years are considered to project the market footprint:

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The following manufacturers are covered:Escape Therapeutics Inc.Cryo-Save AGRegen Biopharma Inc.CBR Systems Inc.ViaCord Inc.Lonza Group Ltd.Pluristem Therapeutics Inc.China Cord Blood Corp.

Segment by RegionsNorth AmericaEuropeChinaJapanSoutheast AsiaIndia

Segment by TypeAllogeneicAutologous

Segment by ApplicationPeripheral Blood Stem Cells Transplant (PBSCT)Bone Marrow Transplant (BMT)Cord Blood Transplant (CBT)

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The Hematopoietic Stem Cell Transplantation (HSCT) market research addresses the following queries:

After reading the Hematopoietic Stem Cell Transplantation (HSCT) market report, readers can

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The market study depicts an extensive analysis of all the players running in the Hematopoietic Stem Cell Transplantation (HSCT) market report based on distribution channels, local network, innovative launches, industrial penetration, production methods, and revenue generation. Further, the market strategies, and mergers & acquisitions associated with the players are enclosed in the Hematopoietic Stem Cell Transplantation (HSCT) market report.

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Hematopoietic Stem Cell Transplantation (HSCT) Market Projected to Experience Major Revenue Boost During the Period Between 2019-2048 - Daily Science

Stem Cell Assay Market: Qualitative Analysis of the Leading Players and Competitive Industry Scenario, 2048 – Daily Science

The Stem Cell Assay market research focuses on the market structure and various factors (positive and negative) affecting the growth of the market. The study encloses a precise evaluation of the Stem Cell Assay market, including growth rate, current scenario, and volume inflation prospects, on the basis of DROT and Porters Five Forces analyses. In addition, the Stem Cell Assay market study provides reliable and authentic projections regarding the technical jargon.

Stem Cell Assay Market Research, in its recent market report, suggests that the Stem Cell Assay market report is set to exceed US$ xx Mn/Bn by 2029. The report finds that the Stem Cell Assay market registered ~US$ xx Mn/Bn in 2018 and is spectated to grow at a healthy CAGR over the foreseeable period. This Stem Cell Assay market study considers 2018 as the base year, 2019 as the estimated year, and 2019 2029 as the forecast timeframe.

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The Stem Cell Assay market study answers critical questions including:

The content of the Stem Cell Assay market report includes the following insights:

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The following manufacturers are covered:GE HealthcarePromega CorporationThermo Fisher ScientificMerck KGaACell BiolabsHemogenixStemcell TechnologiesBio-Rad LaboratoriesBio-Techne CorporationCellular Dynamics International

Segment by RegionsNorth AmericaEuropeChinaJapanSoutheast AsiaIndia

Segment by TypeDermatology Stem Cell AssayCardiovascular Stem Cell AssayCentral Nervous System Stem Cell AssayOncology Stem Cell AssayOther

Segment by ApplicationRegenerative Medicine & Therapy DevelopmentDrug Discovery and DevelopmentClinical ResearchOther

All the players running in the global Stem Cell Assay market are elaborated thoroughly in the Stem Cell Assay market report on the basis of R&D developments, distribution channels, industrial penetration, manufacturing processes, and revenue. In addition, the report examines, legal policies, and comparative analysis between the leading and emerging Stem Cell Assay market players.

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Stem Cell Therapy Market 2020 | Growing Rapidly with Significant CAGR, Leading Players, Innovative Trends and Expected Revenue by 2026 – Skyline…

New Jersey, United States:The Stem Cell Therapy Market is carefully researched in the report while largely concentrating on top players and their business tactics, geographical expansion, market segments, competitive landscape, manufacturing, and pricing and cost structures. Each section of the research study is specially prepared to explore key aspects of the Stem Cell Therapy market. For instance, the market dynamics section digs deep into the drivers, restraints, trends, and opportunities of the Stem Cell Therapy Market. With qualitative and quantitative analysis, we help you with thorough and comprehensive research on the Stem Cell Therapy market. We have also focused on SWOT, PESTLE, and Porters Five Forces analyses of the Stem Cell Therapy market.

Global Stem Cell TherapyMarketwas valued at USD 86.62 million in 2016 and is projected to reach USD 221.03million by 2025, growing at a CAGR of 10.97% from 2017 to 2025.

Leading players of the Stem Cell Therapy market are analyzed taking into account their market share, recent developments, new product launches, partnerships, mergers or acquisitions, and markets served. We also provide an exhaustive analysis of their product portfolios to explore the products and applications they concentrate on when operating in the Stem Cell Therapy market. Furthermore, the report offers two separate market forecasts one for the production side and another for the consumption side of the Stem Cell Therapy market. It also provides useful recommendations for new as well as established players of the Stem Cell Therapy market.

Stem Cell Therapy Market by Regional Segments:

The chapter on regional segmentation describes the regional aspects of the Stem Cell Therapy market. This chapter explains the regulatory framework that is expected to affect the entire market. It illuminates the political scenario of the market and anticipates its impact on the market for Stem Cell Therapy.

Analysts who have authored the report have segmented the market for Stem Cell Therapy by product, application and region. All segments are the subject of extensive research, with a focus on CAGR, market size, growth potential, market share and other important factors. The segment study provided in the report will help players focus on the lucrative areas of the Stem Cell Therapy market. The regional analysis will help the actors to strengthen their position in the most important regional markets. It shows unused growth opportunities in regional markets and how they can be used in the forecast period.

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Overview: In addition to an overview of the Stem Cell Therapy market, this section provides an overview of the report to give an idea of the type and content of the study.

Market dynamics: Here the authors of the report discussed in detail the main drivers, restrictions, challenges, trends and opportunities in the market for Stem Cell Therapy.

Product Segments: This part of the report shows the growth of the market for various types of products sold by the largest companies.

Application segments: The analysts who have authored the report have thoroughly evaluated the market potential of the key applications and identified the future opportunities they should create in the Stem Cell Therapy.

Geographic Segments: Each regional market is carefully examined to understand its current and future growth scenarios.

Company Profiles: The top players in the Stem Cell Therapy market are detailed in the report based on their market share, served market, products, applications, regional growth and other factors.

The report also includes specific sections on production and consumption analysis, key results, key suggestions and recommendations, and other issues. Overall, it offers a complete analysis and research study of the Stem Cell Therapy market to help players ensure strong growth in the coming years.

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Tags: Stem Cell Therapy Market Size, Stem Cell Therapy Market Trends, Stem Cell Therapy Market Forecast, Stem Cell Therapy Market Growth, Stem Cell Therapy Market Analysis

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Positive Opinion from European Medicines Agency for Sanofi’s Isatuximab in R/R Multiple Myeloma – OncoZine

The European Medicines Agencys Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for isatuximab (Sarclisa; Sanofi), previously known as SAR650984.

The CHMP recommends isatuximab in combination with pomalidomide (Pomalyst; Celgene/Bristol-Myers Squibb) and dexamethasone (pom-dex) for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior therapies including lenalidomide (Revlimid; Celgene/Bristol-Myers Squibb)and a proteasome inhibitor such as bortezomib (Velcade; Takeda) and have demonstrated disease progression on the last therapy.

Following this positive review, the European Commission will review the CHMP recommendation and a final decision on the Marketing Authorisation Application for isatuximab in the European Union is expected in the coming months.

Isatuximab, developed in collaboration with ImmunoGen, was designated as an orphan medicine during its development.

A Significant BurdenAlthough considered a rare disease, multiple myeloma is the second most common hematologic malignancy, [1] with more than 138,000 new diagnoses worldwide every yearly.[2]

In Europe, approximately 39,000 patients are diagnosed with multiple myeloma each year.[3] Despite available treatments, multiple myeloma remains an incurable malignancy and is associated with a significant patient burden. Since multiple myeloma does not have a cure, most patients will relapse. The disease is generally associated with significant morbidity due to its end-organ destruction. As a result, the disease represents a major unmet medical need.

Multiple myeloma is a disease of the older population and its incidence in the African American population is twice that of the European American population. However, improvements in the treatment of the disease in the past couple of decades, beginning with the use of autologous stem cell transplantation followed by availability of novel treatments such as immunomodulatory drugs (ImIDs) and proteasome inhibitors (PIs) has transformed the natural history of the disease leading to longer survival times. [1]

ICARIA-MMThe CHMP positive opinion is based on data from ICARIA-MM study (NCT02990338), the first multicenter, multinational, randomized, open-label, two-arm, Phase III trial to evaluate an anti-CD38 monoclonal antibody (mAB) in combination with pom-dex.

The trial was conducted at 102 sites in Europe, North America, Asia, Australia, and New Zealand.

The study included 307 patients with relapsed and refractory multiple myeloma who had received at least two prior therapies including lenalidomide and a proteasome inhibitor. Patients were randomized (1:1) to receive either isatuximab-irfc with pomalidomide and low-dose dexamethasone (Isa-Pd,154 patients) or pomalidomide and low-dose dexamethasone (Pd, 153 patients).

In the ICARIA-MM study, isatuximab added to pom-dex (isatuximab combination therapy; n=154) demonstrated a statistically significant improvement of progression-free survival (PFS) with a median PFS of 11.53 months compared to 6.47 months with pom-dex alone (n=153; HR 0.596, 95% CI: 0.44-0.81, p=0.0010).

The combination therapy also demonstrated a significantly greater overall response rate (ORR) compared to pom-dex alone (60.4% vs. 35.3%, p<0.0001). In additional analyses, the isatuximab combination therapy compared to pom-dex alone showed a treatment benefit consistent across select subgroups reflective of real-world practice, including patients with high-risk cytogenetics, those aged 75 years and older, patients with renal insufficiency, and patients who were refractory to lenalidomide.

Adverse reactionThe most common adverse reactions (all grades occurring in 20% or more of patients) in patients who received isatuximab combination therapy were neutropenia (96%), infusion-related reactions (39%), pneumonia (31%), upper respiratory tract infection (57%) and diarrhea (26%). Serious adverse reactions that occurred in more than 5% of patients who received Sarclisa combination therapy included pneumonia (25.3%) and febrile neutropenia (12.3%). Permanent discontinuation of Sarclisa combination therapy due to an adverse reaction (Grades 3-4) occurred in 7% of patients, and 3% of patients discontinued due to an infusion-related reaction.

Relapsed and refractory multiple myeloma is a complicated disease that continuously develops resistance to treatment, creating a significant need for continued innovation, noted John Reed, M.D., Ph.D., Sanofis Global Head of Research & Development.

This positive CHMP opinion [..] brings us closer to our ambition to deliver a new treatment option for patients in Europe with relapsed and refractory multiple myeloma.

Mechanism of ActionCD38 is a transmembrane glycoprotein that highly and uniformly expressed on multiple myeloma cells and cell surface receptors, making it a potential target for antibody-based therapeutics such as isatuximab.

Isatuximab is an IgG1-derived monoclonal antibody (ATC code: L01XC38) that binds to a specific epitope on the CD38 receptor on multiple myeloma cells. It is designed to work through many mechanisms of action including programmed tumor cell death (apoptosis) and immunomodulatory activity. The clinical significance of these findings is under investigation.

Ongoing clinical studiesIsatuximab continues to be evaluated in multiple ongoing Phase III clinical trials in combination with current standard treatments across the multiple myeloma treatment continuum. It is also under investigation for the treatment of other hematologic malignancies and solid tumors.

FDA ApprovalEarlier this month, on March 2, 2020, isatuximab was approved by the U.S. Food and Drug Administration (FDA) in combination with pomalidomide and dexamethasone (pom-dex) for the treatment of adults with relapsed and refractory multiple myeloma who had have received at least two prior therapies including lenalidomide and a proteasome inhibitor. In the United States, the generic name for isatuximab is isatuximab-irfc, with irfc as the suffix designated in accordance with Nonproprietary Naming of Biological Products Guidance for Industry issued by the U.S. Food and Drug Administration.

In the United States, the launch price for isatuximab, which will be available in 100mg/5mL and 500mg/25mL single-dose vials for IV infusion, was has set at U.S. $ 650.00 per 100 mg vial and U.S. $ 3,250.00 per 500 mg vial. This represents a per infusion costs of U.S. $ 5,200.00 for an average patient treated in the United States. Based on the standard protocol, isatuximab is dosed every week for four weeks, and then every two weeks.

Sanofi did not disclose the pricing of the drug in Europe, which is based on reimbursement in each European member state.

According to analysts at the Jefferies Financial Group, isatuximab is expected to reach sales of more than U.S. $ 1 billion. However, the same anaylsts are concerned that the drug may struggle to catch up with daratumumab (Darzalex; Janssen Biotech), also an anti-CD38 drug, which was initially approved in 2015 and reached sales of nearly U.S. $ 3 billion in 2019.

Isatuximab is one of many multiple myeloma treatment options approved recently approved by reglators in the United States and Europe. With the potential approval novel therapies in the (near) future, including GSKs , investigational antibody-drug conjugate (ADC) belantamab mafodotin, also known as GSK2857916, a humanized, afucosylated, IgG1 anti-BCMA monoclonal antibody conjugated to monomethyl auristatin-F (MMAF), the number of novel drugs designed to treat multiple myeloma is growing exponentially.

Clinical trialsMultinational Clinical Study Comparing Isatuximab, Pomalidomide, and Dexamethasone to Pomalidomide and Dexamethasone in Refractory or Relapsed and Refractory Multiple Myeloma Patients (ICARIA-MM) NCT02990338

References[1] Kazandjian D. Multiple myeloma epidemiology and survival: A unique malignancy. Semin Oncol. 2016;43(6):676681. doi:10.1053/j.seminoncol.2016.11.004[2] International Myeloma Foundation. Myeloma Action Month. Online. Last accessed Match 26, 2020[3] Joo C, Costa C, Coelho I, Vergueiro MJ, Ferreira M, da Silva MG. Long-term survival in multiple myeloma. Clin Case Rep. 2014;2(5):173179. doi:10.1002/ccr3.76

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Positive Opinion from European Medicines Agency for Sanofi's Isatuximab in R/R Multiple Myeloma - OncoZine

Global Autologous Cell Therapy Market 2020-2024 | Evolving Opportunities with Bayer AG and Brainstorm Cell Therapeutics Inc. | Technavio – Business…

LONDON--(BUSINESS WIRE)--The global autologous cell therapy market is poised to grow by USD 1.97 billion during 2020-2024, progressing at a CAGR of almost 22% during the forecast period. Request free sample pages

Read the 120-page report with TOC on "Autologous Cell Therapy Market Analysis Report by Therapy (Autologous stem cell therapy and Autologous cellular immunotherapies), Application (Oncology, Musculoskeletal disorders, and Dermatology), Geography (North America, APAC, Europe, South America, and MEA), and the Segment Forecasts, 2020-2024".

https://www.technavio.com/report/autologous-cell-therapy-market-industry-analysis

The market is driven by the increasing demand for effective drugs for cardiac and degenerative disorders. In addition, the limitations in traditional organ transplantations are fueling the demand for stem cell therapies. All these factors are anticipated to boost the growth of the autologous cell therapy market.

The demand for effective drugs for cardiac and degenerative disorders has been increasing across the world. In addition, the discovery of possible cardiac autologous cells has enabled vendors to develop novel drugs for the treatment of various cardiac diseases. For instance, Mesoblast is developing MPC-150-IM. It is a Phase III candidate for the treatment of advanced and end-stage chronic heart failure. Similarly, Shire has been developing autologous stem cell therapies for chronic myocardial ischemia. These products are expected to be launched during the forecast period and will have a positive impact on the growth of the global autologous cell therapy market.

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Major Five Autologous Cell Therapy Market Companies:

Bayer AG

Bayer AG operates its business through segments such as Pharmaceuticals, Crop Science, Consumer Health, and Animal Health. The company offers induced pluripotent stem cells. They are developed by reprogramming mature body cells to behave like embryonic stem cells that are injected to restore diseased tissue in patients.

Brainstorm Cell Therapeutics Inc.

Brainstorm Cell Therapeutics Inc. operates its business through an unified business segment. NurOwn is the key offering of the company. It is a cell therapy platform, which develops mesenchymal stem cells for the treatment of human diseases such as immune and inflammatory diseases.

Daiichi Sankyo Co. Ltd.

Daiichi Sankyo Co. Ltd. operates its business through segments such as Innovative Pharmaceuticals, Generic, Vaccine, and OTC Related. Heartcel is the key offering of the company. It is an immune-modulatory progenitor cell therapeutic agent, which is used for ischemic heart failure.

FUJIFILM Holdings Corp.

FUJIFILM Holdings Corp. operates its business through segments such as Imaging solutions, Healthcare and material solutions, and Document solutions. The company uses induced pluripotent stem cells to derive differentiated cells, which are used in researching various diseases and conditions.

Holostem Terapie Avanzate Srl

Holostem Terapie Avanzate Srl operates its business through an unified business segment. Holoclar is the key offering of the company. It is an advanced therapy medicinal product containing stem cells indicated to repair the cornea after injury.

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Autologous Cell Therapy Market Therapy Outlook (Revenue, USD Billion, 2020-2024)

Autologous Cell Therapy Market Application Outlook (Revenue, USD Billion, 2020-2024)

Autologous Cell Therapy Market Regional Outlook (Revenue, USD Billion, 2020-2024)

Technavios sample reports are free of charge and contain multiple sections of the report, such as the market size and forecast, drivers, challenges, trends, and more.

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Related Reports on Healthcare Include:

Global Cancer Stem Cell Therapeutics Market Global cancer stem cell therapy market by type (allogeneic stem cell transplant and autologous stem cell transplant) and geography (Asia, Europe, North America, and ROW).

Global Mantle Cell Lymphoma Therapeutics Market Global mantle cell lymphoma therapeutics market by product (combination therapy and monotherapy) and geography (Asia, Europe, North America, and ROW).

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Global Autologous Cell Therapy Market 2020-2024 | Evolving Opportunities with Bayer AG and Brainstorm Cell Therapeutics Inc. | Technavio - Business...