BioSpace News Archive

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  Drug Development

  Manufacturing Frustration Sets Alnylam Back 3 Months with Vutrisiran

  The delay is related to a third-party secondary packaging and labeling facility that Alnylam planned to use for the launch of vutrisiran.

  April 4, 2022

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  3 min read

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  Hayley Shasteen
• 

  FDA

  Accelerated Approval Integrity Act Could Remove Therapies Before They Prove Merit

  The Accelerated Approval Integrity Act of 2022 (H.R. 6963) aims to remove loopholes in the FDA’s accelerated approval pathway. The bill, however, fails to adequately consider the whole picture.

  April 4, 2022

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  5 min read

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  Gail Dutton
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  Policy

  India’s Top COVID-19 Vaccine Makers Halt Production, “Dumb Luck” and a New Variant

  Two companies in India have halted vaccine manufacturing, which could be a sign that the pandemic may be coming to an end. For that and more COVID-19 news, continue reading.

  April 4, 2022

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  3 min read

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  Mark Terry
• 

  Drug Development

  Protalix and Chiesi Set to Seek Approval in Fabry Disease

  Fabry disease treatment is going to get new updates as Protalix and Chiesi are seeking approval. This can be a game-changer in the market. Here’s more about it.

  April 4, 2022

   · 

  2 min read

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  Alex Keown
• 

  FDA

  Gilead Jumps Out Ahead of BMS in Second-Line B-Cell Lymphoma

  Kite Pharma, a subsidiary of Gilead, announced that its Yescarta® has been approved by the U.S. Food and Drug Administration (FDA).

  April 4, 2022

   · 

  3 min read

   · 

  Hannah Chudleigh
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  Drug Development

  New Studies Support Benefit of Merck’s Molnupiravir

  Three studies supporting Merck and Ridgeback Biotherapeutics’ Lagevrio (molnupiravir) will be presented at the ECCMID 2022 in Lisbon from April 23-26.

  April 4, 2022

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  3 min read

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  Mark Terry
• 

  Drug Development

  Adial is Leveraging Genomics to Treat “Pervasive” Alcohol Use Disorder

  Alcohol use disorder is common among the population for a very long time. Adial is planning to leverage genomics that can treat pervasive alcohol use disorder.

  April 4, 2022

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  6 min read

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  Abbey Glasure
• 

  Drug Development

  BMS Presents Robust Mavacamten Results in HCM Ahead of FDA Decision

  Mavacamten is often referred to as “first-in-class” because it addresses the root cause of obstructions. Here’s everything you should know about its recent progress.

  April 4, 2022

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  3 min read

   · 

  Jazmine Colatriano M.S.
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  Drug Development

  AbbVie, Sage and MT Pharma Anchor Weekend Highlights at AAN

  The 2022 American Academy of Neurology (AAN) Annual Meeting kicked off on Saturday and will continue on through Thursday.

  April 4, 2022

   · 

  4 min read

   · 

  Hayley Shasteen
• 

  Job Trends

  Merck Expands Manufacturing Capacity for HPV Vaccines, Adds 150 Jobs

  Merck strengthened its HPV vaccines manufacturing capacity with the expansion of its facility in Elkton, Virginia. Also, an additional 150 new jobs are created.

  April 4, 2022

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  2 min read

   · 

  Vanessa Doctor, RN