FDA panel backs J&J's coronavirus vaccine, clearing way for shot's authorization

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  Deep Dive

  The first coronavirus vaccines have arrived. Here's where the rest stand.

  J&J's vaccine appears to be on the cusp of emergency authorization in the U.S., while China's CanSino Biologics plans to ask for approval there. 

  UPDATED: Feb. 24, 2021 at 11:43 a.m.

  Pharma

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  Sponsored by SGS

  Analytical quality by design: Development of cell-based bioassays

  Care needs to be taken during analytical development to ensure methodologies firstly, reflect the MoA, and are also reproducible, accurate, and robust.

  Biotech

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  Sarepta wins FDA approval of another drug for rare muscular dystrophy

  Amondys 45 is now cleared for the estimated 8% of Duchenne patients eligible for treatment. Like other Sarepta drugs, it comes with a high price tag and its clinical benefits haven't been confirmed.

  Biotech

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  Merck to buy autoimmune drugmaker for $2B

  The deal, which values Pandion Therapeutics at a more than 100% premium, would hand Merck a drug in early-stage testing for ulcerative colitis and lupus.

  Deals

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  FDA review supports safety, efficacy of J&J coronavirus vaccine

  In their review, agency scientists provided new details on the shot's protection against severe COVID-19 and different virus variants as well as its potential to reduce transmission.

  UPDATED: Feb. 24, 2021 at 11:45 a.m.

  FDA

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  Moderna, Pfizer ready multi-pronged plans for coronavirus variants

  Moderna has delivered a modified version of its vaccine to NIH scientists, while Pfizer has begun testing of an additional booster shot in a clinical trial, both precautionary steps against emerging strains.

  UPDATED: Feb. 25, 2021 at 10:29 a.m.

  Manufacturing

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  Icon to buy contract researcher PRA Health for $12B

  The cash-and-stock deal gives PRA shareholders roughly one-third ownership of the new company, which will be one of the larger providers of contract research support.

  Clinical Trials

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  Beam, capitalizing on stock surge, buys gene therapy tools developer for $120M

  Guide Therapeutics, the company Beam acquired, is working on ways to more efficiently deliver gene editing therapies into the body.

  Deals

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  Why this week's FDA meeting on J&J's coronavirus vaccine will be important

  The FDA is widely expected to authorize the drugmaker's one-dose shot. But the advisory committee meeting beforehand will offer a window into debate over several key issues.

  UPDATED: Feb. 23, 2021 at 9:28 p.m.

  FDA

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  FDA lays out shortened path for testing vaccines against new coronavirus variants

  Lengthy trials won't be needed for updating shots against emerging viral strains, the agency told developers in newly published guidance.

  FDA

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  Regeneron wins FDA OK in lung cancer for immunotherapy rival to Merck's Keytruda

  The approval of Libtayo in first-line lung cancer will pit Regeneron's drug, developed in partnership with Sanofi, against Merck's top-selling immunotherapy Keytruda.

  Biotech

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  Sanofi and GSK start trial of upgraded coronavirus vaccine after first version disappoints

  The companies think a new formulation will yield better results than their first attempt. But with several vaccines available, testing may be more challenging.

  Pharma

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  After FDA feedback, a biotech's ALS therapy faces murky path forward

  Brainstorm Cell Therapeutics said that, following a review of Phase 3 data, the agency felt the results were not enough to support an approval application.

  Biotech

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  AstraZeneca withdraws immunotherapy in bladder cancer after trial failure

  The British drugmaker's decision to pull Imfinzi from what was its first approved treatment setting hints at the limitations of immuno-oncology drugs.

  Pharma

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  Pfizer set to double weekly production of coronavirus vaccine

  The drugmaker will use production lines at its plant in McPherson, Kansas to help fill vaccine vials, company CEO Albert Bourla said Friday.

  Manufacturing

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  Novavax broadens reach of global coronavirus vaccine alliance with new deal

  As more transmissible variants spread across the globe, there's growing urgency to equitably allocate vaccine supplies. A deal between Novavax and COVAX will significantly bolster that effort.

  Marketing

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  Lilly wagers almost $1B on Rigel's drugs for immune and nervous systems

  For $125 million up front, Lilly secures rights to a drug about to enter mid-stage testing for autoimmune and inflammatory diseases, as well as preclinical assets targeting the central nervous system.

  Pharma

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  Pfizer, BioNTech ask FDA approval to ease temperature requirements for coronavirus shot

  Testing showed the vaccine could be safely stored at normal freezer temperatures, rather than the roughly minus 70 degrees Celsius now specified. The change, if cleared by the agency, will help distribution.

  Pharma

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  White House picks Brooks-LaSure to head Medicare, Medicaid, with big challenges ahead

  Brooks-LaSure takes over CMS with potentially significant changes coming to the structure of the Affordable Care Act and Medicare eligibility. 

  UPDATED: Feb. 19, 2021 at 11:14 a.m.

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  Investment firm raises $300M to fund medical research for overlooked diseases

  Adjuvant Capital's first fund drew interest from Merck and Novartis as well as philanthropies and other investment firms.

  Biotech

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  Gates Foundation backs Novartis' search for a sickle cell cure

  An initial grant will support a research team at Novartis' R&D labs whose sole focus will be to develop a single-administration gene therapy for sickle cell disease.

  Pharma

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  GSK returns to Vir with expanded deal to develop drugs for flu, other viruses

  The British drugmaker will pay the San Francisco-based biotech $225 million upfront, while also investing another $120 million in Vir shares.

  Biotech

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  Novartis expects sales lift from expanded heart drug approval

  The Swiss drugmaker's pill Entresto is now cleared in the U.S. for use in patients with stronger hearts, expanding the eligible population by two-thirds.

  Pharma

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  Bluebird stops studies of sickle cell gene therapy after new cancer cases

  The biotech is also suspending sales of its related treatment Zynteglo following a leukemia diagnosis in a clinical trial volunteer and a case of a cancer-like bone marrow disease in another.

  UPDATED: Feb. 16, 2021 at 10:24 a.m.

  Biotech

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  10 biotechs become 1: Centessa launches with $250M to prove unorthodox R&D model

  The new company will be led by Saurabh Saha, a former Bristol Myers executive, and Moncef Slaoui, who until recently led the U.S. government's coronavirus vaccine program.

  Biotech

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  A gene therapy pipeline takes shape for a cluster of rare diseases

  Lysosomal storage disorders, diseases of cellular metabolism gone wrong, are the focus of a fast-expanding lineup of experimental genetic medicines, a research boom that recalls biotech's roots.

  Biotech

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