News

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.

Syntec receives warning letter where FDA finds deviations from CGMP for APIs.

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

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

Metrics Contract Services announces the completion of a $10 million expansion to their Greenville, NC facilities.

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

Syngene International appoints two US-based executives to senior level positions.

TriRx continues to expand its manufacturing capabilities with the acquisition of the Elanco Animal Health Facility in Shawnee, Kansas.

BMG Pharma's clinical trial has demonstrated positive results in the efficacy of BMG0705 Nasal Spray and BMG0703A Mouth Rinse as treatments for asymptomatic COVID-19 patients.

Evonik has acquired the German biotech company JeNaCell, expanding its biomaterials portfolio.

Nanoform and Boehringer Ingelheim have executed a master services agreement in relation to pre-clinical development projects.

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

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.

WuXi STA has finalized its acquisition of Bristol Myers Squibb’s drug product manufacturing facility based in Couvet, Switzerland.

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

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

Bioiberica has received certification of its CSR management system as aligned with the United Nations Sustainable Development Goals.

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

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

Sanofi has acquired Translate Bio in a bid to further their mRNA research.

CMA fines Advanz and investors for more than £100 million (approximately US$139 million) after the company increased the price of thyroid tablet packs from £20 (US$23.74) in 2009 to £248 (approximately US$295) in 2017.

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.

BioMed X Institute and Janssen Research & Development to start two new research programs in the field of autoimmune diseases and drug delivery.

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.

DisperSol and Catalent announce manufacturing collaboration to accelerate DisperSol’s pharmaceutical production.