BioSpace News Archive

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  Deals

  Amicus Splits into Two as FDA Sets PDUFA for Pompe Disease Treatment

  Amicus Therapeutics is launching a next-generation genetic medicine company called Caritas Therapeutics, Inc. through a merger deal with ARYA Sciences Acquisition Corp IV.

  September 29, 2021

   · 

  3 min read

   · 

  Alex Keown
• 

  Gene Editing Breakthroughs Accelerate Heart, Stroke Research

  Gene therapy research delivers breakthroughs this week with a CRISPR-edited droplet that could lead to a cure for heart disease and the possibility of turning glial brain cells into neurons.

  September 29, 2021

   · 

  2 min read

   · 

  Vanessa Doctor, RN
• 

  Drug Development

  IDWeek Presentations Highlight Continued Response to COVID-19

  As the 10th annual IDWeek (Infectious Disease Week) Conference begins, treatments aimed at COVID-19 will certainly dominate the program.

  September 29, 2021

   · 

  4 min read

   · 

  Alex Keown
• 

  Deals

  Report: Merck Strikes with $11 Billion Deal for Acceleron and Phase III PAH Drug

  Reports emerged late Wednesday afternoon that Merck emerged as the winning suitor with a deal valued at about $11 billion.

  September 29, 2021

   · 

  2 min read

   · 

  Alex Keown
• 

  Business

  A Fundamentally Different View into Complex Neurological Diseases

  Biomolecular condensates could hold the key to unlocking a number of neurological diseases that have baffled researchers the longest.

  September 29, 2021

   · 

  6 min read

   · 

  Heather McKenzie
• 

  Deals

  AstraZeneca Buys Caelum BioSciences in $500 Million Deal

  AstraZeneca’s Alexion plans to buy all remaining equity in Caelum Biosciences and pick up Caelum’s CAEL-101 in the process.

  September 29, 2021

   · 

  3 min read

   · 

  Mark Terry
• 

  Policy

  CRO Data Integrity Concerns Have Pharma Companies Scrambling to Repeat Bioequivalence Studies

  The announcement came following independent FDA analyses of inspections conducted at the two CROs in November 2019.

  September 29, 2021

   · 

  2 min read

   · 

  Heather McKenzie
• 

  Drug Development

  Pfizer Modifies MD Gene Therapy Trial Following Three Serious Adverse Events

  Pfizer reported three cases of muscle weakness, two of which involved inflammation of the heart (myocarditis).

  September 29, 2021

   · 

  3 min read

   · 

  Mark Terry
• 

  Drug Development

  New Relief for Migraine Sufferers as FDA Approves AbbVie’s Atogepant

  Qulipta is the first calcitonin gene-related peptide (CGRP) receptor antagonist specifically developed for this indication.

  September 29, 2021

   · 

  2 min read

   · 

  Alex Keown
• 

  Business

  Expansion Therapeutics Widens Funding by $80 Million for RNA-Linked Research

  Expansion said much of the funds will go into its SMiRNA platform to find clinical candidates in myotonic DM1, FTD, ALS, and several other tauopathies.

  September 29, 2021

   · 

  2 min read

   · 

  Vanessa Doctor, RN