BioSpace News Archive

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  Drug Development

  Chromosomal “Abnormality” Forces Allogene to Halt Trial as Shares Crater

  Allogene placed its study on hold after sending a notification to the U.S. FDA about a chromosomal abnormality in its ALPHA2 study patient.

  October 8, 2021

   · 

  2 min read

   · 

  Vanessa Doctor, RN
• 

  Drug Development

  Takeda Wins Unanimous Vote of Confidence for Refractory CMV Drug

  Based on results from the Phase II and Phase III TAK-620-303 (SOLSTICE) trials, members of the AMDAC unanimously voted in favor of using maribavir.

  October 8, 2021

   · 

  2 min read

   · 

  Vanessa Doctor, RN
• 

  Policy

  Janssen, Brickell and ViiV are Knocking on FDA’s Door

  Two companies reported regulatory submissions to the FDA, and a third reported successful clinical trial data that will form the basis of submission in the coming months.

  October 8, 2021

   · 

  2 min read

   · 

  Mark Terry
• 

  Bio NC

  Clinical Catch-Up: October 4-8

  Another busy week for clinical trial news. Here’s a look.

  October 8, 2021

   · 

  16 min read

   · 

  Mark Terry
• 

  Business

  Mirati and Sanofi Unite on Trial for KRAS Inhibitor

  Mirati and Sanofi will assess the combination of adagrasib and SAR442720 in a Phase I/II study in patients with previously treated non-small-cell lung cancer who express KRASG12C mutations.

  October 8, 2021

   · 

  2 min read

   · 

  Alex Keown
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  Policy

  The White House Continues Strong-Arm Approach to COVID-19 Vaccination

  As US vaccination rates have been hovering in the 50% of the population range for two months, President Biden hit the old dusty trail to push his vaccine mandate even more.

  October 8, 2021

   · 

  4 min read

   · 

  Kate Goodwin
• 

  Business

  Succession Landscape Begins to Crystalize for FDA, NIH Leadership Roles

  Acting FDA Commissioner Janet Woodcock’s days as interim head of the agency are numbered due to federal regulations. Speculations are rampant on a number of potential choices.

  October 8, 2021

   · 

  3 min read

   · 

  Alex Keown
• 

  Drug Development

  Relay Therapeutics’ Liver Cancer Approach Paying Early Dividends

  Of these six patients, three had a partial response (PR) with their tumors shrinking by more than 30%.

  October 8, 2021

   · 

  2 min read

   · 

  Heather McKenzie
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  Business

  Three New Nasdaq Tickers and MPM Capital Secures $850 Million to Impact Oncology

  Cognition Therapeutics, Pyxis Oncology and IsoPlexis Corp. all announced IPO plans.

  October 8, 2021

   · 

  2 min read

   · 

  Alex Keown
• 

  FDA

  FDA Finally Approves ChemoCentryx’s Tavneos for ANCA Vasculitis

  The FDA approved ChemoCentryx’s Tavneos (avacopan) as an adjunctive treatment for adults with severe active anti-neutrophil cytoplasmic autoantibody-associated vasculitis (ANCA-associated vasculitis or ANCA vasculitis).

  October 8, 2021

   · 

  3 min read

   · 

  Mark Terry