Biopharma News
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.
Syngene Announces Senior Level Appointments
Syngene International appoints two US-based executives to senior level positions.
BMS Gains European Approval for Opdivo
Bristol Myers Squibb has been granted approval by the European Commission for Opdivo (nivolumab) as an adjuvant treatment
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.
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.
EMA’s CHMP Adopts Positive Opinion for Moderna COVID-19 Vaccine Use in Adolescents
The EMA’s CHMP has adopted a positive opinion recommending marketing authorization for Moderna’s COVID-19 vaccine (Spikevax) to include adolescents 12 years of age and older.
Pfizer and BioNTech Announce Collaboration with Biovac to Manufacture and Distribute COVID-19 Vaccine Doses Within Africa
Pfizer Inc. and BioNTech SE announced the signing of a letter of intent with The Biovac Institute Ltd to manufacture the Pfizer-BioNTech COVID-19 vaccine for distribution within the African Union.
Samsung Biologics Partners with Kineta for Anti-VISTA Antibody Immunotherapy
Samsung Biologics and Kineta have entered into a strategic partnership for drug product manufacturing services and to support an IND filing of a novel antibody therapeutic.
BioNTech to Acquire Kite’s TCR Cell Therapy Platform and Manufacturing Facility
BioNTech will acquire a TCR cell therapy R&D platform as well as a manufacturing facility in Gaithersburg, Md., from Kite, a Gilead company.
Nkarta Establishes New NK Cell Therapy Manufacturing Facility and Headquarters
Nkarta will establish a new combined scalable NK cell therapy manufacturing facility and corporate headquarters in South San Francisco, Calif.
Cellares and Poseida Therapeutics Partner to Accelerate Cell Therapy Manufacturing
Cellares has entered into a strategic relationship with Poseida Therapeutics to advance a closed, automated, and scalable cell therapy manufacturing system.
AstraZeneca’s Extensive-Stage Small Cell Lung Cancer Treatment Approved in China
In combination with etoposide and either carboplatin or cisplatin, Imfinzi has been approved in the first-line setting of ES-SCLC by China’s National Medical Products Administration.
Lonza to Supply Prequalified Hepatocytes for Use on CN Bio’s Organ-on-a-Chip Range
The companies work to develop and supply advanced cell models that better reflect an in-vivo environment to improve drug discovery accuracy and efficiency.
Generate Life Sciences Establishes Newborn Stem Cell Manufacturing Facility
The GMP facility is designed to maximize bioprocessing efficiency of newborn stem cells and manufacturing at scale.
MorphoSys to Complete $1.7 Billion Acquisition of Constellation Pharmaceuticals
MorphoSys completes the acquisition of Constellation, a clinical-stage biopharmaceutical company.
Kriya Therapeutics to Advance Gene Therapies with $100 Million Financing
Kriya Therapeutics completes $100 Million Series B financing to advance its platform for designing, developing, and manufacturing gene therapies.
Zendal and IAVI to Advance Tuberculosis Vaccine Candidate into Efficacy Trials
MTBVAC has the potential to be used as an alternative to BCG vaccination in infants and for prevention of TB disease in adolescents and adults.
