BioSpace News Archive

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  Policy

  FDA Delays Decision for Biogen’s Alzheimer’s Drug Until June

  The decision by the FDA on the drug application was expected on March 7, but is now delayed until June 7, 2021.

  January 29, 2021

   · 

  4 min read

   · 

  Mark Terry
• 

  Drug Development

  Elevian Targets Aging to Solve Humanity’s Toughest Diseases

  Elevian believes that this single protein, a key player in the circulatory system, could be a game-changer in regenerative medicine.

  January 29, 2021

   · 

  6 min read

   · 

  Heather McKenzie
• 

  Novel Therapeutic May Offer Complete Response for Immuno-Inflammatory Diseases

  There are severely limited therapeutic options for immuno-inflammatory diseases such as acute graft vs. host disease (aGVHD), lupus and asthma.

  January 29, 2021

   · 

  5 min read

   · 

  Gail Dutton
• 

  FDA

  FDA Action Alert: Adamas, Mallinckrodt and Merck

  February is kicking off with a number of PDUFA dates for the U.S. FDA as well as a cancer advisory committee meeting. Here’s a look.

  January 29, 2021

   · 

  3 min read

   · 

  Mark Terry
• 

  Drug Development

  Johnson & Johnson COVID-19 Vaccine’s 66% Efficacy Rate Not the Entire Story

  Overall, against moderate-severe COVID-19 infection, the vaccine was 72% effective 28 days after vaccination in the U.S., 66% in hard-hit Latin America, and bottomed out at 57% in South Africa.

  January 29, 2021

   · 

  3 min read

   · 

  Heather McKenzie
• 

  Business

  Pharma Industry Comes Together to Support Manufacture of COVID-19 Vaccines

  The pharmaceutical industry continues to demonstrate its willingness to team up in the ongoing combat against the global COVID-19 pandemic.

  January 29, 2021

   · 

  2 min read

   · 

  Alex Keown
• 

  Drug Development

  Amgen Racks Up Success in Phase II Lung Cancer Trial

  Amgen announced data from the Phase II cohort of the CodeBreaK 100 trial of sotorasib (AMG 510) in 126 patients with KRAS G12C-mutated advanced non-small cell lung cancer.

  January 29, 2021

   · 

  3 min read

   · 

  Mark Terry
• 

  Drug Development

  Clinical Catch-Up: January 25-29

  It was a busy week for clinical trial news. Read on for more information.

  January 29, 2021

   · 

  9 min read

   · 

  Mark Terry
• 

  Drug Development

  New Amivantamab Data Bolsters Janssen’s Hopes for Approval in NSCLC Subpopulation

  Janssen presented additional positive data from its phase I study of its bispecific antibody amivantamab in metastatic or unresectable non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations.

  January 29, 2021

   · 

  2 min read

   · 

  Mark Zipkin
• 

  Drug Development

  Novavax Posts Positive First Look at Phase III COVID-19 Vaccine Results

  The Phase III analysis of its COVID-19 vaccine candidate shows the medication demonstrated 89.3% efficacy in a large-scale study conducted in the U.K. that included the most common strain of the virus, as well as variants.

  January 29, 2021

   · 

  4 min read

   · 

  Alex Keown