Regeneron advances COVID-19 antibody cocktail into late-stage trials

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  Deep Dive

  The coronavirus vaccine frontrunners have emerged. Here's where they stand

  Pfizer and BioNTech, which this week disclosed early Phase 1 study results, expect to be able to make 100 million doses of their vaccine by the end of the year and 1.2 billion doses in 2021.

  UPDATED: July 2, 2020 at 10:54 a.m.

  Pharma

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  Sponsored by PRA Health Sciences

  Collaboration, not competition, will bring better pediatric medicines to market

  Drug developers and stakeholders must find ways to collaborate, rather than compete, as the RACE Act prompts the need for more pediatric research. 

  Clinical Trials

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  J&J, with new deal, plans for long-term manufacture of coronavirus vaccine

  A five-year agreement with Maryland's Emergent Biosolutions will provide for large-scale production of J&J's candidate, set to begin testing in July.

  Manufacturing

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  Federal coronavirus contracts dodge pricing oversight, advocacy group says

  Contracts with six companies waive "march-in rights" and omit provisions that could be used to object to high drug prices. Moderna's contract, however, includes those clauses. 

  UPDATED: July 1, 2020 at 4:10 p.m.

  Pharma

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  Ultragenyx wins early approval for rare disease drug

  Dojolvi, as Ultrangenyx's drug will be sold, is the first FDA-approved treatment for a group of genetic disorders that affect several thousand people in the U.S.

  Biotech

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  Gilead pricing suggests it will make a business out of COVID-19 drug

  Even at the lower end of its price range, remdesivir could earn Gilead a billion dollars. How well the drug's price is received will be an important test for other companies working on coronavirus treatments.

  Marketing

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  Tracking biopharma's response to the new coronavirus

  The ongoing outbreak is a huge test for the biopharmaceutical industry and its ability to supply, develop, and test new drugs without disruption. Keep up with all of BioPharma Dive's coverage here.

  UPDATED: July 5, 2020 at 2:36 p.m.

  Pharma

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  Without data, Inovio says study shows positive results for coronavirus vaccine

  The biotech is among the first few companies to disclose preliminary trial results for a coronavirus shot. But Inovio shared few details, making its announcement difficult to assess.

  Clinical Trials

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  Large UK study finds no benefit to HIV antiviral in COVID-19

  The results are the third significant clinical finding from the RECOVERY study, which recently determined the steroid dexamethasone improved survival.

  Clinical Trials

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  Intercept's NASH drug faces its biggest delay yet

  The FDA rejected obeticholic acid, asking for more data. If the agency ends up requiring outcomes results too, it could set Intercept's approval hopes back by two years or more.

  Biotech

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  Gilead sets price for COVID-19 drug remdesivir

  A typical course of treatment with remdesivir will cost between $2,340 and $3,120 in the U.S., a price range that likely ensures Gilead earns a profit on sales of the drug.

  Marketing

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  Vaccines can end the coronavirus pandemic. Will every country get them?

  Scientists around the world are racing to develop a coronavirus vaccine. But the factories slated to make the leading candidates are concentrated in a handful of countries, raising concerns about global access.

  Manufacturing

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  Two patients die in now-halted study of Audentes gene therapy

  The two patients, being treated for a rare neuromuscular disease, were given a high dose of Audentes' gene therapy, known as AT132.

  Clinical Trials

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  WHO lays out ambitious plan to deliver 2 billion coronavirus vaccine doses

  More than $18 billion will be needed for the WHO's plan, which would secure and allocate vaccine supplies for high-risk groups and lower-income countries.

  Manufacturing

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  Zogenix caps tumultuous ride with FDA OK for Dravet drug

  The agency approved Zogenix's drug Fintepla after an earlier rejection and two delays, setting up potential commercial competition with GW Pharmaceuticals.

  UPDATED: June 27, 2020 at 11:20 a.m.

  FDA

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  FDA rejects AbbVie's eye drug, citing safety concerns

  The drug, abicipar, was supposed to challenge market-leading drugs like Regneron's Eylea. But inner eye inflammation seen in clinical trials appear to have sunk its chances.

  Pharma

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  Deep Dive

  Venture capital found its footing in biotech. Then came the virus.

  There's been no better time for venture firms to invest in drug startups than the past few years. But when a virus upended the world, it raised new questions about what types of investors and investments would succeed moving forward.

  Biotech

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  Former BARDA director claims HHS leaders tried to 'thwart' him in new role

  Rick Bright, who was ousted as agency head and assigned to a job coordinating coronavirus diagnostics, alleges HHS Secretary Alex Azar sought to undermine him.

  UPDATED: June 26, 2020 at 4:10 p.m.

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  In a surprise, UniQure sells its hemophilia gene therapy for $450M

  The licensing deal with CSL Behring is one of the largest for a gene therapy, but the partnership could make a buyout of the Dutch firm less likely. 

  Deals

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  Federal government accuses Regeneron of kickback scheme for top-selling drug

  In a lawsuit, the U.S. attorney's office in Boston alleged Regeneron used a charity as a "conduit" to cover patient co-pays for its eye drug Eylea.

  Drug Pricing

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  Fauci 'cautiously optimistic' about coronavirus vaccine by 2021

  Anthony Fauci, the nation's top infectious disease official, told lawmakers the next few weeks will be critical as COVID-19 cases rise in many states.

  Clinical Trials

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  Merck strikes another neuroscience deal, tapping Yumanity for 2 brain drugs

  The pharma hasn't invested much in neuroscience since its Alzheimer's drug plans unraveled in 2017. Three deals in the past year, however, should help keep its options open.

  Pharma

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  Inovio gets U.S. government backing for vaccine delivery device

  The contract from the U.S. Department of Defense will help Inovio scale up production of its coronavirus vaccine, which, unlike many rivals, relies on an electroporation device.  

  Manufacturing

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  Price for Gilead's COVID-19 drug should shrink if cheap steroid widely used, ICER says

  The drug pricing watchdog calculated a lower cost-effective price for remdesivir if dexamethasone, newly shown to help the sickest COVID-19 patients live, becomes standard of care.

  Drug Pricing

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  By $4M, La Jolla outbids Melinta for struggling Tetraphase

  La Jolla's cash offer is the third attempt to take out Tetraphase, an antibiotic specialist once valued at nearly $2 billion but now worth less than $20 million.

  Biotech

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  Sanofi's fight for a better research reputation

  Competitive markets and questionable deals make it harder for Sanofi to deliver on claims it can lead in its now-favored areas of research.

  Pharma

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