BioSpace News Archive

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  Drug Development

  Gilead Suspends Patient Enrollment for Magrolimab in Solid Tumor Trials

  While Gilead Sciences did not provide specific reasons for the halt, the company said it is “reviewing the benefit-risk” of its anti-CD47 antibody magrolimab across all ongoing trials.

  February 16, 2024

   · 

  2 min read

   · 

  Tristan Manalac
• 

  Business

  Novo Rides to Catalent’s Rescue in $16.5B Deal. Now What?

  Novo Nordisk seems to believe it can do a better job managing troubled Catalent than the contract manufacturer. However, the Danish drugmaker has its work cut out for it.

  February 16, 2024

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  3 min read

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  Greg Slabodkin
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  Policy

  FDA Accepts Sarepta’s Efficacy Supplement Seeking to Expand Elevidys Indication

  The regulator has granted a priority review of the efficacy supplement for Sarepta Therapeutics’ gene therapy Elevidys with a target decision date of June 21, 2024.

  February 16, 2024

   · 

  1 min read

   · 

  Tyler Patchen
• 

  Policy

  Pfizer Settles Lipitor Antitrust Suit for $93M, Ends Decade-Long Court Battle

  Pfizer plans to settle a lawsuit filed 12 years ago by distributors of Lipitor for $93 million. The pharma giant was accused of colluding with Ranbaxy Laboratories to delay generic versions of the drug.

  February 16, 2024

   · 

  2 min read

   · 

  Tyler Patchen
• 

  Policy

  Alvotech Reaches Settlement with J&J Over Stelara Biosimilar

  The Icelandic biotech Thursday said that it has settled its grievances with Johnson & Johnson regarding its Stelara biosimilar in markets with regulatory approval.

  February 16, 2024

   · 

  2 min read

   · 

  Tyler Patchen
• 

  Policy

  Karuna CEO, Board Sued by Shareholder over $14B BMS Acquisition

  Claiming that Karuna Therapeutics’ board of directors withheld crucial information, a shareholder has filed a lawsuit seeking to block the $14 billion merger with Bristol Myers Squibb.

  February 16, 2024

   · 

  2 min read

   · 

  Tristan Manalac
• 

  Business

  Astellas Inks Potential $800M Deal with Kelonia for In Vivo Gene Delivery Tech

  Kelonia Therapeutics’ in vivo gene placement system is being tapped to help Astellas Pharma expand its portfolio of in vivo CAR-T cell therapies for cancer.

  February 16, 2024

   · 

  2 min read

   · 

  Tristan Manalac
• 

  Policy

  How Will FDA’s Pivot to Overall Survival Affect Cancer Drug Development?

  The progression-free survival metric has helped shepherd many products across the regulatory finish line. Experts say the FDA’s new emphasis on overall survival will be felt especially by small biotechs.

  February 16, 2024

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  7 min read

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  Maddie Bender
• 

  Policy

  Inventiva Pauses Late-Stage NASH Trial, Keeps Field Open for Madrigal

  Following a patient case of severe liver enzyme elevations, Inventiva is suspending its Phase III NATiV3 study in non-alcoholic steatohepatitis as Madrigal Pharmaceuticals awaits a March 14 PDUFA date.

  February 16, 2024

   · 

  2 min read

   · 

  Tristan Manalac
• 

  Drug Development

  Alnylam Makes Endpoints Changes to ATTR Study for Amvuttra

  Alnylam Pharmaceuticals is modifying the primary and secondary endpoints of the Helios-B Phase III trial investigating its next-generation RNA interference therapy in patients with ATTR amyloidosis with cardiomyopathy.

  February 16, 2024

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  2 min read

   · 

  Tyler Patchen