BioSpace News Archive

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  Complete response letters

  FDA Rejects Camurus’ Rare Hormonal Disorder Treatment Due to Manufacturing Problems

  The regulator cited deficiencies at a third-party manufacturing facility. Camurus is seeking approval for its extended-release subcutaneous formulation of octreotide, which would allow more convenient once-monthly dosing for patients with acromegaly.

  October 22, 2024

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  2 min read

   · 

  Tristan Manalac
• 

  Employer Resources

  Report: Employer Branding: What Matters to Life Sciences Candidates

  October 22, 2024

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  1 min read

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  BioSpace Insights
• 

  Legal

  Lilly Ups Legal Offensive Against Tirzepatide Copycats as FDA Mulls Shortage Status

  Monday’s lawsuits from Eli Lilly are the first to be filed by the pharma since the regulator officially removed tirzepatide from its drug shortage database earlier this month.

  October 22, 2024

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  2 min read

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  Tristan Manalac
• 

  Alzheimer’s disease

  Roche Trims Another Alzheimer’s Prospect, Ending UCB Collabortion

  Roche drops a third Alzheimer’s candidate this year, terminating a partnership with UCB just four years after agreeing to work together on new treatments for the neurological disease.

  October 22, 2024

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  1 min read

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  Annalee Armstrong
• 

  Leadership

  Leadership Lab: 10 Ways Executives Can Stay Visible, Valuable Between Jobs

  For biopharma executives who are between roles, navigating the transitionary time can be challenging. However, they can remain visible and valuable so they’re ready to seize their next big opportunity.

  October 22, 2024

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  5 min read

   · 

  Michael Pietrack
• 

  Manufacturing

  Radiopharma-Focused CDMO Nucleus Unveils Two New Plants, Looks to Create 100 Jobs

  Nucleus RadioPharma’s two sites are meant to help address the industry’s lack of manufacturing and development capabilities, as well as geographic limitations associated with the short half-life of many radioactive components.

  October 22, 2024

   · 

  2 min read

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  Tristan Manalac
• 

  Business

  Activist Investor Starboard Takes Aim at J&J Spinoff Kenvue on Heels of $1B Stake in Pfizer

  Starboard Value contends that Kenvue, with strong consumer health brands like Tylenol and Listerine, is underperforming its rivals, according to The Wall Street Journal.

  October 22, 2024

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  2 min read

   · 

  Tristan Manalac
• Press Releases

  GRI Bio Announces Exercise of Warrants

  October 22, 2024

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  7 min read
• Press Releases

  Seamless Therapeutics to Present New Data at ESGCT Demonstrating its Ability to Reprogram Large Serine Recombinases to Specific Target Sites in the Human Genome

  October 22, 2024

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  4 min read
• Press Releases

  BioPorto is proud to have Nine of the top-ten best US Children’s hospitals as customers of NGAL

  October 22, 2024

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  4 min read