BioSpace News Archive

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  Policy

  It’s CRL Day at the FDA as Axsome, Junshi and Coherus Get Bad News

  The FDA is quickly catching up after COVID-19 disrupted typical review timelines and planned inspections and Monday morning held bad news for Coherus, Junshi and Axsome.

  May 2, 2022

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  2 min read

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  Jazmine Colatriano M.S.
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  Drug Development

  Positive Blepharitis Data in Hand, Tarsus Gears Up for FDA Submission (Updated)

  Tarsus announced positive topline data from its Phase III clinical trial of TP-03 Demodex blepharitis, along with the commencement of an underwritten public offering of $50 million of shares of its common stock.

  May 2, 2022

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  2 min read

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  Hayley Shasteen
• 

  Policy

  We May Be Done with COVID-19, But it May Not Be Done with Us

  Public health officials are seeing a notable rise in cases and expressing concerns over more subvariants of the SARS-CoV-2 virus. For those stories and more, continue reading.

  May 2, 2022

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  6 min read

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  Mark Terry
• 

  Genetown

  Is Biogen Planning to Appeal CMS Aduhelm Reimbursement Decision?

  Speculations that Biogen might appeal the decision after reports of the company hiring several lobbyists, including Clyburn Consulting and Federal Street Strategies.

  May 2, 2022

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  3 min read

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  Mark Terry
• 

  Drug Development

  Verseon’s Atomic-Level Drug Design is Changing the Paradigm of Drug Discovery

  What sets Verseon apart is its use of molecular physics modeling to enable the atomic-level engineering of new molecules. The company has 14 small molecule drugs in development.

  May 2, 2022

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  5 min read

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  Gail Dutton
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  Drug Development

  FDA Approves New Nonstimulant Option for Adults with ADHD

  Notably, Qelbree is the first novel FDA approval of a novel non-stimulant treatment for ADHD in adults in 20 years.

  May 2, 2022

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  2 min read

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  Vanessa Doctor, RN
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  Business

  Patient Square Kickstarts Biotech Investment Firm Enavate Sciences

  Enavate Sciences launched with an initial capital investment of $300 million from health care investment firm Patient Square Capital. Enavate is a new biotech investment firm.

  May 2, 2022

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  3 min read

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  Mark Terry
• 

  FDA

  Orphalan Touts First FDA-Approved Wilson’s Disease Treatment Since 1970

  Orphalan announced the FDA has granted full approval to Cuvrior (trientine tetrahydrochloride) for the treatment of Wilson’s Disease, a rare genetic disorder.

  May 2, 2022

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  2 min read

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  Hayley Shasteen
• 

  Policy

  Pharma in the Courts: Purdue Settlement Trudges On, Walgreens Battles Opioid Suit

  Arguments regarding the Purdue Pharma opioid settlement continue to be heard in court, Natera battles a class-action lawsuit, Walgreens is involved in a public nuisance suit and more.

  May 2, 2022

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  3 min read

   · 

  Alex Keown
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  Drug Development

  Vertex Perplexed by FDA Hold on Cell Therapy for Type 1 Diabetes

  The FDA placed a clinical hold on the program due to a determination that there is insufficient information to support dose escalation with the product.

  May 2, 2022

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  3 min read

   · 

  Alex Keown