The Week in Biopharma, March 21-25

CDMO 
  • Gerresheimer Expands Pharma Packaging Capabilities  (USA) 
  • Roquette Expands Capabilities as Excipient Supplier (France)
  • Germany Selects Celonic AG to Secure Long-Term Supply of Covid-19 Vaccines (Germany) 
  • Exothera Receives GMP Certification for Facilities in Jumet, (Belgium) 
  • Fujifilm to Acquire Shenandoah Biotechnology  (USA) 
  • Recro Pharma Rebrands to Societal CDMO Inc.  (USA) 
  • SEQENS Invests in U.S. R&D Lab Expansion  (USA)
  • Oasmia, Lonza Sign Mfg. Agreement for Ovarian Cancer Drug Candidate (Sweden/Switzerland) 
  • Indena Further Expands GMP Pilot Plant for APIs (Italy) 
CRO 
  • Chemveda Life Sciences to invest Rs 150 cr for expansion in Hyderabad (India)
  • Calyx Selected as Approved Partner by ProTrials Research (USA) 
  • NAMSA Announces Intent to Acquire Contract Research Organization, ÅKRN (Spain) 
AI 
Biopharma and Medical Devices
  • BiondVax Inks Agreement to Develop Pipeline of NanoAb Therapies (Germany) 
  • Sobi to Cease ReFacto Manufacturing in the First Quarter of 2024 (Sweden)
  • Heat Biologics Unveils Enhanced Allogeneic Cell Therapy Manufacturing Capabilities (USA) 
  • Abbott snags $1B U.S. government contract for rapid COVID-19 tests (USA) 
  • BMS’s Busy Week: a Milestone Approval, Reblozyl Delay and Action in Japan (USA/Japan) 
  • Icosavax Shares Crater as COVID-19 Vaccine Disappoints (USA) 
  • More Good News in HIV Space as FDA Greenlights Cabenuva Injectable (USA)
  • Novavax May Find COVID-19 Sweet Spot as a Booste (USA) 
  • Morphic Therapeutic Announces Initiation of EMERALD-1 Phase 2a Clinical Trial of MORF-057 in Patients with Ulcerative Colitis (USA) 
  • Health Canada Grants Marketing Authorization for KALYDECO (ivacaftor) for Patients With Cystic Fibrosis Between the Ages of 4 Months and 18 Years With the R117H Mutation in the CFTR Gene (Canada) 
  • Henlius Receives NMPA Approval for its First Innovative Monoclonal Antibody HANSIZHUANG (China) 
  • CARVYKTI® (ciltacabtagene autoleucel) Receives Positive CHMP Opinion for the Treatment of Patients with Relapsed and Refractory Multiple Myeloma (Belgium)
  • FDA Concerns Over P13K Inhibitors Snag MEI Pharma, Kyowa Kirin (USA) 
  • FDA Grants Breakthrough Therapy Designation for Pfizer Respiratory Syncytial Virus Vaccine Candidate (USA) 
  • New Data Show Majority of Adults with Moderate to Severe Plaque Psoriasis Treated with First-in-Class TREMFYA® (guselkumab) Experienced Durable Skin Clearance Through Five Years Regardless of Metabolic Syndrome Status, Baseline Disease Severity, or Treatment History (USA) 
  • AOTI Secures Major Expansion Funding from Leading Healthcare Financier (USA) 
  • NeuroSense Therapeutics Receives $4 Million Through Warrant Exercises (USA)
  • Leading U.S. Fertility Clinics Adopt New TMRW Technology for Safe Management of Frozen Eggs and Embryos; 12 Additional Clinics Onboard Revolutionary Specimen Management Platform (USA)
  • Halozyme Enters Global Collaboration and License Agreement with Chugai (USA/Tokyo) 
  • Biogen sets up network to leverage real-world data for neurological disease drugs (USA) 
  • Fresenius Kabi Announces FDA Approval of SMOFlipid® Lipid Injectable Emulsion for Pediatric Patients Requiring Parenteral Nutrition (USA) 
  • STALICLA Completes Successful Phase 1b Trials for the First Precision Medicine in Autism Spectrum Disorder (Switzerland)
  • Biomind Labs to Commence Commercial Clinical Trial on Its Proprietary Mescaline Candidate BMND06 (Canada) 
  • CytoImmune Therapeutics, Inc. Opens the Company’s Clinical Cell Manufacturing Facility in Toa Baja (Puerto Rico) 
  • Virus Geeks, Inc., a San Francisco-based, data-driven Bio-Health technology company, is taking HRSA’s COVID-19 testing for the uninsured into their own hands (USA) 
  • Young Pharmaceuticals Announces Exclusive North America Distribution Partnership With Lactobio For BAK Probiotic Skincare (USA) 
  • Geneos Therapeutics Secures $17 Million in Series A2 Financing to Advance Personalized Cancer Immunotherapy Platform (USA)
  • MoonLake Immunotherapeutics to initiate global Phase 2 study of the Nanobody® Sonelokimab in patients with moderate-to-severe hidradenitis suppurativa with HiSCR75 as the primary endpoint (Switzerland) 
  • Alligator Bioscience Announces mitazalimab OPTIMIZE-1 Trial Update: Successful Completion of Phase Ib, Phase II enrolling at 900 µg/kg (Sweden) 
  • LifeMine Therapeutics and GSK Enter Drug Discovery and Development Alliance (USA) 
  • Gamma Biosciences Launches New Initiative Through Mirus Bio (USA) 
  • AstraZeneca deepens digital ties with Huma in pursuit of clinical trial apps (UK)
  • CELLTREAT Acquires VistaLab Technologies (USA) 
  • Phylex Biosciences Publishes Positive Results Of Protection Study Against Sars-Cov-2 Delta Variant With Its Second-Generation mRNA Vaccine (USA) 
  • CARsgen Announces First Patient Enrollment in the Confirmatory Phase II Clinical Trial of CT041 in (China) 
  • Emmaus Life Sciences Receives U.A.E. Marketing Authorization for Endari (UAE) 
  • Phlow Expands Continuous Manufacturing R&D Services (USA)
  • Triastek and Siemens Enter Pharma 4.0 Collaboration (China) 
  • Sen-Jam Partners with Specialty Pharma Manufacturer (USA) 
  • Sanofi and Seagen Team Up to Grow a New Crop of ADC Cancer Drugs (USA) 
  • Moderna and the Japanese Government Reach an Agreement to Supply Japan with Additional 70 Million Doses of Moderna’s COVID-19 Booster Vaccine (Japan) 
  • physIQ and CellCarta Collaborate on Personalized Approach to Vaccine Development (Canada) 

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