The Week in Biopharma, Feb 21-25

CDMO 

CRO 

AI 

  • Insilico Announces Successful Completion of Phase 0 Microdose Trial and Initiates Phase I Clinical Trial for its First AI-discovered Anti-fibrotic Product Candidate with Novel Target (China) 

 

WHO 

 

Biopharma 

  • FDA Approves Boehringer, Lilly’s Jardiance for Heart Failure (USA) 
  • Health Canada Approves Medicago, GSK’s COVIFENZ COVID Vax (Canada) 
  • Biohaven, BMS Enter Worldwide License Agreement for Taldefgrobep (USA) 
  • Sanofi, GSK to Seek Authorization for COVID-19 Vaccine (USA) 
  • Rani Therapeutics Develops High-Capacity Oral Biologics Device (USA) 
  • AbbVie ditches fibrosis program it paid Morphic $20M for in 2020 (USA) 
  • Takeda, Arch back hC Bioscience with $24M for transfer RNAs, following Flagship into the field (USA) 
  • Orphazyme goes soul searching as EU advisers add 2nd rejection for rare disease drug (Denmark) 
  • Merck cuts ties to Moderna’s early-phase KRAS vaccine, leaving mRNA specialist to mull next steps (USA) 
  • Amicus’ gene therapy SPAC merger folds, turning pipeline and R&D into target of $400M in cuts (USA) 
  • Kodiak’s Eylea rival hits ‘major disappointment’ with failure in first of 6 phase 3 studies (USA) 
  • Plexium nabs $102M for protein degradation work weeks after $500M Amgen tie-up (USA) 
  • Stability woes torpedo Marinus’ phase 3 seizure timeline, combining with COVID-19 to cause one-year delay (USA) 
  • Moderna’s RSV shot sails on to phase 3, tightening Big Pharma battle royale (USA) 
  • Takeda’s gene therapy ambitions rise another $2B in 4-program Code Bio pact (Japan) 
  • Building off Prevail buy, Lilly to construct $700M Boston research hub in gene therapy blitz (USA) 
  • BioNTech jumps into PRAME game, paying Medigene $29M for preclinical T-cell therapy program (Germany) 
  • Synairgen’s pivotal COVID-19 SPRINTER trial falls at final hurdle, sending stock into downward spiral (UK) 
  • DiscGenics Announces Presentation of Positive Interim Clinical Data from Phase 1/2 Study of Cell Therapy for Degenerative Disc Disease (USA) 
  • AIkido Pharma Inc. Announces $22 Million Registered Direct Offering (USA) 
  • Mikrogen and Phosphorus Announce Partnership to Provide Holistic, Preventative Genetic Insights to Reproductive Health Services in Turkey. (Turkey) 
  • Benchling Acquires Overwatch Research to Accelerate Breakthroughs for Biopharma Companies (USA) 
  • SK Biopharmaceuticals Becomes First Korean Company to Join Pharmaceutical Supply Chain Initiative (Korea) 
  • Synaptogenix Moves Forward with Clinical Development Plans for Bryostatin-1 as a Treatment for Multiple Sclerosis (USA) 
  • PANTHERx® Rare Selected by Aadi Bioscience to Distribute FYARRO™ (sirolimus protein-bound particles for injectable suspension) (albumin-bound) for advanced malignant perivascular epithelioid cell neoplasm (PEComa) (USA) 
  • Ardelyx Announces $27.5 Million Debt Financing Agreement with SLR Capital Partners (USA) 
  • Regulus Therapeutics Announces Completion of Enrollment in Phase 2 Clinical Trial of Lademirsen for Alport Syndrome (USA) 
  • Mirus Bio Expands TransIT-VirusGEN® SELECT Portfolio with the Addition of Transfection Kits to Increase Titers in Cell and Gene Therapy Manufacturing (USA) 
  • Protalix BioTherapeutics and Chiesi Global Rare Diseases Announce the Submission of a Marketing Authorization Application to the European Medicines Agency for PRX-102 for the Treatment of Fabry Disease (Israel/USA) 
  • Jupiter Neurosciences, Inc. Announces Completion of Phase I Safety Trial with Enhanced Resveratrol Product, JOTROL™ (USA) 
  • Foresee Pharmaceuticals and TRPharm Announce License and Co-Development Agreement (Taiwan/Turkey) 
  • 4D Pharma to trial LBPs in patients with Parkinson’s disease: ‘We are continuing to expand clinical pathways for the microbiome field’ (UK) 
  • Valneva revives Scottish vaccine manufacturing plans (Scotland) 
  • PerkinElmer’s Sirion to develop new generation AAV vectors for diabetes Gene Therapy (Germany) 
  • Moderna targets shingles in mRNA pipeline expansion (USA) 
  • Developer of therapeutic strategies for thrombosis, TargED raises millions in Series A round (USA) 
  • Semarion Ltd: A Startup looking to create paradigm shift in cell screening raises $2.89m in seed funding (UK) 
  • Seattle Biotech Magnolia Medical Raises $46M (USA) 
  • The ‘Golden Age’ for Research Tools: Parse Biosciences Raises $41.5M for Single-Cell Tech (USA) 
  • Curevo Nets $60M for Adjuvant-Saving Shingles Vaccine (USA) 
  • FDA Licenses Certara’s Immunogenicity Simulator (Switzerland) 
  • Vanderbilt and Neumora Therapeutics Strike Precision Medicine Partnership to Fight Brain Diseases (USA) 

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