News

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 BioSolutions has been granted approval from FDA to ship certain lots of their AstraZeneca vaccine.

FDA has approved the intravenous medication Nexviazyme for treatment of Pompe Disease.

AGC Biologics has acquired Novartis’ Longmont, Colorado, manufacturing facility for the commercial production of cell and gene therapies.

The guidance aids in the development, validation, and use of near infrared-based analytical procedures.

Novavax and European Commission have finalized an agreement to purchase up to 200 million doses of a COVID-19 vaccine.

BeiGene plans to build a new campus for R&D and commercial-scale biopharmaceutical manufacturing in Hopewell, NJ.

Catalent finalizes their acquisition of iPSC developer and manufacturer RheinCell Therapeutics.

A global safety database analysis has demonstrated no increased incidence of thrombosis with TTS after the second dose of Vaxzevria.

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.

The University of Sheffield has launched an innovative gene therapy program that could pave the way for novel treatments for neurodegenerative diseases.

EMA’s CHMP has approved the increased manufacturing capacity and supply of Moderna’s COVID-19 vaccine active substance in its US manufacturing site.

Bristol Myers Squibb has been granted approval by the European Commission for Opdivo (nivolumab) as an adjuvant treatment

A research collaboration will combine Imugene’s oncolytic virus technology with Celularity’s allogeneic CAR T-cell therapy.

FDA approved an expanded Botox label, which now includes eight new muscles to treat adults with upper limb spasticity.

Glenmark Pharmaceuticals has partnered with SaNOtize to manufacture, market, and distribute NONS to India, Singapore, Malaysia, Hong Kong, and more.

FDA has approved AstraZeneca’s Saphnelo, a type I interferon receptor antibody for treating systemic lupus erythematosus.

FDA has accepted Genetech’s BLA for faricimab, a bispecific antibody in development for treating wet age-related macular degeneration and diabetic macular edema.

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 is launching a new crowdsourcing challenge to solicit ideas for pediatric research.

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 has approved Mylan Pharmaceuticals’ Semglee, the first interchangeable biosimilar insulin product for treating diabetes.

GSK announced that FDA has approved a new indication for Nucala (mepolizumab), a monoclonal antibody that targets interleukin-5.

The agency’s leading cancer expert lashed out at the alarmists and urged continued support for the early access process.

Emergent BioSolutions is being allowed to restart manufacturing operations for the J&J COVID-19 vaccine at its Bayview, Baltimore, Md., facility.

Entries are now open for the 18th Annual CPhI Pharma Awards in Milan.

VICO Therapeutics’ drug candidate, VO659, for treating Huntington’s Disease was granted orphan drug designation by FDA.

In the first half of 2021, the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research approved 29 novel therapies.