BioSpace News Archive

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  Business

  Aduhelm Approval Could Imperil Woodcock’s Future as FDA Commissioner

  Woodcock faces heavy opposition from an evenly divided U.S. Senate, particularly from West Virginia Sen. Joe Manchin, who has been critical of the approval process for Biogen’s Aduhelm, formerly known as aducanumab.

  August 20, 2021

   · 

  2 min read

   · 

  Alex Keown
• 

  Business

  J&J CEO Steps Down, Taps Successor Joaquin Duato

  The passing of the baton was announced late Thursday. Duato will take over as CEO on Jan. 3, 2022.

  August 20, 2021

   · 

  3 min read

   · 

  Alex Keown
• 

  Drug Development

  Runny Nose, Sneezing and Headache: Seasonal Allergies or Delta Variant Symptoms?

  As the delta variant continues to contribute to the majority of COVID-19 cases worldwide, many patients are reporting delta variant symptoms which is a great concern.

  August 20, 2021

   · 

  2 min read

   · 

  Brandon May
• 

  Drug Development

  E-Protein Channel Blockers May Lead the Next Fight Against COVID-19

  Research emerging from Israel identified eight already-approved compounds that inhibit the activity of the E-protein channels in the virus’s membrane.

  August 20, 2021

   · 

  4 min read

   · 

  Gail Dutton
• 

  Policy

  Although Rare, New Data Suggests Higher Rate of Myocarditis with Moderna Shot

  As governments and now even businesses push citizens to get vaccinated against COVID-19, anti-vaxxers are loading up more ammo for their argument with this week’s report.

  August 20, 2021

   · 

  2 min read

   · 

  Kate Goodwin
• 

  FDA

  FDA Grants Public Hearing for Makena Injection Amidst Controversy

  Makena injection currently remains on the market but is poised to be removed pending the outcome of the meeting. The final decision will be made in the public hearing.

  August 20, 2021

   · 

  2 min read

   · 

  Alex Keown
• 

  FDA

  FDA Action Alert: Cara/Vifor, Kadmon, BMS, Merck/Eisai

  The U.S. FDA has a busy schedule for the end of August and beginning of September. Let’s take a look.

  August 20, 2021

   · 

  4 min read

   · 

  Mark Terry
• 

  Drug Development

  Another ALS Hopeful Falls Short as Alexion Halts Phase III Trial

  The group said that the Phase III trial of Ultomiris (ravulizumab) lacked efficacy when it was used on adults diagnosed with amyotrophic lateral sclerosis.

  August 20, 2021

   · 

  2 min read

   · 

  Vanessa Doctor, RN
• 

  Business

  Former Google Health Exec to Take the Helm at Cerner

  Cerner has appointed former Google Health boss David Feinberg as its new chief executive and president effective October 1, 2021.

  August 20, 2021

   · 

  2 min read

   · 

  Vanessa Doctor, RN
• 

  Drug Development

  Clinical Catch-Up: August 16-20

  It was another busy week in clinical trial news. Here’s a look.

  August 20, 2021

   · 

  8 min read

   · 

  Mark Terry