BioSpace News Archive

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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

   · 

  2 min read

   · 

  Vanessa Doctor, RN
• 

  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

   · 

  2 min read

   · 

  Jazmine Colatriano M.S.
• 

  Business

  Pfizer Vaccines Head Kathrin Jansen Stepping Down after Long, Illustrious Career

  Pfizer vaccine head Kathrin Jansen is stepping down from the pharma giant after spearheading the development of the COVID-19 vaccine Comirnaty.

  May 2, 2022

   · 

  3 min read

   · 

  Alex Keown
• 

  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

   · 

  6 min read

   · 

  Mark Terry
• 

  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

   · 

  2 min read

   · 

  Hayley Shasteen
• 

  Business

  Gilead Snaps Up Rights to Promising Dragonfly NK Engager Program

  Gilead and Dragonfly announced their collaboration today, with an end goal of bringing the DF7001 NK engager program designed for patients with cancer or inflammatory diseases.

  May 2, 2022

   · 

  2 min read

   · 

  Jazmine Colatriano
• 

  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

   · 

  3 min read

   · 

  Mark Terry
• 

  Business

  Emergent BioSolutions Founder Fuad El-Hibri Dies Weeks After Retirement

  Emergent BioSolutions Founder and former chief executive officer Fuad El-Hibri has died, the company reported.

  May 2, 2022

   · 

  3 min read

   · 

  Alex Keown
• 

  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

   · 

  3 min read

   · 

  Mark Terry
• 

  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

   · 

  3 min read

   · 

  Alex Keown