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EMA Endorses Track-and-Trace Recommendations
The agency is endorsing recommendations for global track-and-trace systems developed by the International Coalition of Medicines Regulatory Authorities.
EMA’s PRAC Requests Additional Data on Guillain-Barré Syndrome in COVID-19 Vaccine
EMA’s Pharmacovigilance Risk Assessment Committee has requested more data for its evaluation of reports of Guillain-Barré syndrome after vaccination.
EMA Recommends Including Adverse Reaction Warning to Janssen COVID-19 Vaccine
The agency’s Pharmacovigilance Risk Assessment Committee recommended updating the product information for Janssen’s COVID-19 vaccine to list immune thrombocytopenia as an adverse reaction.
Emergent Approved to Export Vaccines in Latest COVID-19 Update
Emergent BioSolutions has been granted approval from FDA to ship certain lots of their AstraZeneca vaccine.
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.
FDA Issues NIR Guidance
The guidance aids in the development, validation, and use of near infrared-based analytical procedures.
Novavax and European Commission Finalize COVID-19 Vaccine Purchase Agreement
Novavax and European Commission have finalized an agreement to purchase up to 200 million doses of a COVID-19 vaccine.
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.
Analysis Demonstrates No Increased Incidence of Thrombosis with TTS After Vaxzevria Second Dose
A global safety database analysis has demonstrated no increased incidence of thrombosis with TTS after the second dose of Vaxzevria.
Nanoform, Boehringer Ingelheim Collaborate on Pre-Clinical Development Projects
Nanoform and Boehringer Ingelheim have executed a master services agreement in relation to pre-clinical development projects.
EC Confirms Go-Live Date for Clinical Trials Information System
EC has confirmed that the entry into application of the Clinical Trials Regulation and, as such, the go-live date for the Clinical Trials Information System (CTIS) will be Jan. 31, 2022.
University of Sheffield and CGT Catapult Launch Innovative Gene Therapy Program
The University of Sheffield has launched an innovative gene therapy program that could pave the way for novel treatments for neurodegenerative diseases.
CHMP Approves Manufacturing Scale-Up for Spikevax
EMA’s CHMP has approved the increased manufacturing capacity and supply of Moderna’s COVID-19 vaccine active substance in its US manufacturing site.
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.
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.
FDA’s Pazdur Challenges Attack on Accelerated Approval Program
The agency’s leading cancer expert lashed out at the alarmists and urged continued support for the early access process.
FDA Gives Green Light to Emergent BioSolutions to Resume COVID-19 Vaccine Manufacturing
Emergent BioSolutions is being allowed to restart manufacturing operations for the J&J COVID-19 vaccine at its Bayview, Baltimore, Md., facility.
18th Annual CPhI Pharma Awards to Take Place in Milan, Italy
Entries are now open for the 18th Annual CPhI Pharma Awards in Milan.
