Bio/Pharma News
GSK and CureVac’s Second-Generation mRNA COVID-19 Vaccine Candidate Shows Promising Results in Preclinical Study
Primates inoculated with CV2CoV show improved immune response and protection from various COVID variants.
Terumo Blood and Cell Technologies and PhotonPharma to Develop Cancer Immunotherapy
Terumo Blood and Cell Technologies and PhotonPharma announced a collaboration to develop a novel tumor-specific immunotherapy for solid tumors.
Precision NanoSystems Expands GMP Biomanufacturing Center
PNI expands global headquarters with a new 75,000-square-foot facility, which will include multiple GMP suites for manufacturing RNA therapeutics and vaccines.
Google and Lumen Bioscience Apply Machine Learning to the Manufacture of Spirulina-Based Biologic Drugs
The companies announce the results of a research collaboration that applied machine learning to significantly advance the scalability of spirulina-based biologic drugs.
Bayer Acquires Vividion Therapeutics for $1.5 Billion
Bayer has acquired Vividion Therapeutics, a US-based biopharmaceutical company.
Recro Acquires IRISYS for $50 Million
Recro acquires CDMO IRISYS, establishing a bi-coastal presence in the US.
FDA Grants Fast-Track Designation to Pfizer and Vivet Therapeutics for Treatment of Wilson Disease
FDA has awarded Fast Track designation to Vivet Therapeutics’ novel gene therapy, VTX-801.
Veraxa and Indivumed Collaborate on Development of Precision Oncology Antibody Drugs
Veraxa and Indivumed will work together to develop colorectal antibody drugs.
Moderna Plans to Build mRNA Vaccine Manufacturing Facility in Canada
Moderna will build an mRNA vaccine manufacturing facility in Canada to provide access to domestically manufactured vaccines against respiratory viruses.
European Commission Approves AstraZeneca’s Forxiga for Treatment of Chronic Kidney Disease
The EC has approved the drug in the EU for treatment of chronic kidney disease in adults with or without type-2 diabetes.
GW Pharmaceuticals’ Epidiolex Approved by MHRA for Seizure Treatment
The MHRA has approved GW Pharmaceuticals’ Epidiolex for the treatment of seizures associated with tuberous sclerosis complex.
Atovaquone Oral Suspension Recalled
KVK Tech is voluntarily recalling two lots of Atovaquone Oral Suspension, USP 750 mg/5mL because of customer complaints of unusual grittiness in the product.
FDA Approves New Treatment for Pompe Disease
FDA has approved the intravenous medication Nexviazyme for treatment of Pompe Disease.
AGC Biologics Acquires Cell and Gene Therapy Commercial Manufacturing Facility
AGC Biologics has acquired Novartis’ Longmont, Colorado, manufacturing facility for the commercial production of cell and gene therapies.
BeiGene to Build New Manufacturing and Clinical R&D Facility in New Jersey
BeiGene plans to build a new campus for R&D and commercial-scale biopharmaceutical manufacturing in Hopewell, NJ.
Catalent Finalizes RheinCell Therapeutics Acquisition
Catalent finalizes their acquisition of iPSC developer and manufacturer RheinCell Therapeutics.
Imugene and Celularity to Develop Solid Tumor Treatment
A research collaboration will combine Imugene’s oncolytic virus technology with Celularity’s allogeneic CAR T-cell therapy.
FDA Approves Expanded Label of Allergan’s Botox to Treat Upper Limb Spasticity
FDA approved an expanded Botox label, which now includes eight new muscles to treat adults with upper limb spasticity.
Nitric Oxide Nasal Spray for COVID-19 to Be Distributed to India and Other Asia Markets
Glenmark Pharmaceuticals has partnered with SaNOtize to manufacture, market, and distribute NONS to India, Singapore, Malaysia, Hong Kong, and more.
FDA Approves AstraZeneca’s Lupus mAb, Saphnelo
FDA has approved AstraZeneca’s Saphnelo, a type I interferon receptor antibody for treating systemic lupus erythematosus.
FDA Accepts Genentech’s Application for Bispecific Antibody to Treat Eye Diseases
FDA has accepted Genetech’s BLA for faricimab, a bispecific antibody in development for treating wet age-related macular degeneration and diabetic macular edema.
EC Makes Supply Agreement with GSK and Vir Biotechnology for mAb COVID-19 Treatment
The European Commission has entered into a supply agreement with GlaxoSmithKline and Vir Biotechnology for up to 220,000 doses of sotrovimab, an investigational mAb for treating COVID-19.
FDA Launches New Crowdsourcing Challenge for Pediatric Research Questions
FDA is launching a new crowdsourcing challenge to solicit ideas for pediatric research.
Regeneron Receives Expanded Authorized Use from FDA for Antibody COVID-19 Treatment
The expanded authorization from FDA enables the use of Regeneron Pharmaceuticals’ REGEN-COV antibody cocktail therapy for post-exposure prophylaxis in certain people exposed to SARS-CoV-2.
FDA Approves Interchangeable Biosimilar Insulin
FDA has approved Mylan Pharmaceuticals’ Semglee, the first interchangeable biosimilar insulin product for treating diabetes.
FDA Approves GSK’s Treatment for Chronic Rhinosinusitis with Nasal Polyps
GSK announced that FDA has approved a new indication for Nucala (mepolizumab), a monoclonal antibody that targets interleukin-5.
Byondis and Glycotope Partner on Discovery and Development of Glyco-Epitope-Targeting Antibodies
Byondis and Glycotope have formed an agreement to discover and develop antibodies that target specific glyco-epitopes.
FDA Approves Merck’s 15-Valent Pneumococcal Vaccine
Merck announced that FDA approved Vaxneuvance for active immunization for the prevention of invasive pneumococcal disease.
Meissa’s Intranasal COVID-19 Vaccine Yields Promising Preclinical Data
Meissa Vaccines’s MV-014-212, an intranasal recombinant live attenuated COVID-19 vaccine, induced mucosal and systemic antibodies against SARS-CoV-2 and two variants of concern.
PerkinElmer to Acquire BioLegend in $5.25-Billion Deal
PerkinElmer has entered into an agreement to acquire BioLegend, a global developer and manufacturer, in a deal valued at $5.25 billion.
