BioSpace News Archive

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  Drug Development

  GSK’s Bad Week: Maternal RSV Vaccine Paused, Trade Secrets Violation Alleged

  GlaxoSmithKline has voluntarily paused activities in its Phase III GRACE trial on a candidate maternal vaccine for respiratory syncytial virus.

  February 18, 2022

   · 

  2 min read

   · 

  Vanessa Doctor, RN
• 

  Drug Development

  Survivability Data Set Up New Prostate Cancer Indication for Bayer’s Nubeqa

  Bayer is heading back to the FDA to seek approval for a new indication of its prostate cancer drug Nubeqa, following positive Phase III results.

  February 18, 2022

   · 

  3 min read

   · 

  Alex Keown
• 

  Genetown

  mRNA Leader Introduces Programs in HSV, YZV, Cancer

  Moderna announced the expansion of its mRNA vaccine pipeline with three new development programs.

  February 18, 2022

   · 

  2 min read

   · 

  Hayley Shasteen
• 

  6 Tips For Successful Pharma Startups

  Here are the top six tips you need to know if you want to run a successful pharma startup and make waves in the pharmaceutical industry.

  February 18, 2022

   · 

  5 min read

   · 

  Alina Zahid
• 

  Drug Development

  Sanofi, Regeneron Suffer Rare Dupixent Flop in CSU

  After roaring into February with positive data in five different indications, Regeneron and Sanofi announced today a late-stage Dupixent trial has been halted due to futility.

  February 18, 2022

   · 

  2 min read

   · 

  Alex Keown
• 

  Drug Development

  Clinical Catch-Up: Veru, Pfizer, Regeneron and More

  Clinical Catch-Up for February 21

  February 18, 2022

   · 

  7 min read

   · 

  Mark Terry
• 

  Drug Development

  FDA Action Alert: Immunocore, Reata, CTI, Gilead and Legend/Janssen

  The end of February picks up significantly from early this year for the U.S. Food and Drug Administration and its PDUFA dates.

  February 18, 2022

   · 

  3 min read

   · 

  Mark Terry
• 

  Drug Development

  FDA Approves First Disease-Modifying Drug for Rare Hemolytic Anemia Treatment

  The FDA has approved Agios Pharmaceuticals’ Pyrukynd for a rare type of hemolytic anemia treatment. Continue reading the article to know more about the new drug.

  February 18, 2022

   · 

  2 min read

   · 

  Vanessa Doctor, RN
• 

  Drug Development

  BioMarin PKU Study Still On Hold After FDA Requests More Data

  Biomarin indicated that the FDA had requested more data from non-clinical studies to evaluate the theoretical cancer risk to human trial participants. This is likely to take several quarters.

  February 18, 2022

   · 

  3 min read

   · 

  Mark Terry
• 

  Pharm Country

  Covid-19: A Vision for the “New Normal” and Pfizer’s Paxlovid

  Two-plus years into the pandemic, it’s obvious that COVID-19 isn’t going away, prompting discussion about what this “new normal” will actually look like.

  February 18, 2022

   · 

  5 min read

   · 

  Mark Terry