BioSpace News Archive

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• Student Resources

  To help you land your first post-university role, BioSpace has compiled this job search toolkit just for you. You’ll find tips as well as links to helpful articles and resources, including our newsletters and podcasts.

  August 12, 2024
• Thank you for your submission!

  Your document and payment have been successfully submitted. A BioSpace team member will review your submission within one full business day.

  August 12, 2024
• BioSpace Insights

  The BioSpace Insights teams performs research and analysis on industry trends for BioSpace and clients, producing industry reports, podcasts, events and articles.
• 

  Obesity

  5 Obesity Readouts to Watch in the Second Half of 2024

  Hundreds of companies are currently running clinical trials in the increasingly lucrative obesity space. BioSpace looks at five candidates with data expected before the end of the year.

  August 12, 2024

   · 

  5 min read

   · 

  Heather McKenzie
• 

  Partnered

  QARA Professionals Question a Future with Cybersecurity Issues, US Litigation, and the EU AI Act
  

  At a private event held amid the fallout from the CrowdStrike incident, cybersecurity issues took a front seat, with the consequences of the evolving EU AI Act and the Loper Bright and Corner Post decisions also raising concerns for quality assurance and regulatory affairs professionals.

  August 12, 2024

   · 

  8 min read

   · 

  BioSpace Insights
• 

  Rare diseases

  Ascendis’ Hypoparathyrodism Drug Secures FDA Approval Following Tough Regulatory Path

  Ascendis Pharma’s palopegteriparatide was previously rejected by the regulator due to manufacturing problems, and the review period for its resubmitted application was extended by three months.

  August 12, 2024

   · 

  2 min read

   · 

  Tristan Manalac
• 

  Regulatory

  FDA Needs More Time to Review Humacyte’s Blood Vessel Implant

  Humacyte’s stock price dropped 18% in after-hours trading Friday after the company announced the FDA requires additional time to review its Biologic License Application. No reason was given for the delay or an updated decision date.

  August 12, 2024

   · 

  1 min read

   · 

  Tristan Manalac
• 

  Startups

  Halda Therapeutics Raises $126M in Series B Extension to Advance Two Cancer Candidates

  The Connecticut-based biotech, which emerged from stealth last year, has secured $202 million to date as it looks to move two assets targeting prostate and breast cancer into the clinic.

  August 12, 2024

   · 

  2 min read

   · 

  Tyler Patchen
• 

  RSV

  Pfizer Nabs Pivotal Phase III Win for RSV Vaccine in Immunocompromised Adults

  Pfizer on Monday reported a “strong neutralizing response” against both subtypes of respiratory syncytial virus across all cohorts and age groups, according to topline data.

  August 12, 2024

   · 

  2 min read

   · 

  Nick Paul Taylor
• 

  Approvals

  ARS Pharma Gets FDA Green Light for First Nasal Spray for Severe Allergic Reactions

  ARS Pharma’s neffy on Friday became the first FDA-approved nasal spray to address severe allergic reactions, including those that might lead to life-threatening anaphylaxis.

  August 12, 2024

   · 

  2 min read

   · 

  Tristan Manalac