News

The President calls for granting Medicare authority to negotiate drug prices and penalties for pharma companies that raise prices faster than inflation.

The agency has amended the emergency use authorizations for the Pfizer-BioNTech and Moderna vaccines to allow certain immunocompromised people to receive an additional dose of the vaccine.

Recro acquires CDMO IRISYS, establishing a bi-coastal presence in the US.

A research team at the Keck Graduate Institute will work to adapt its decade-long low-cost vaccine R&D for developing countries into a COVID-19 vaccine.

FDA has awarded Fast Track designation to Vivet Therapeutics’ novel gene therapy, VTX-801.

A collaboration between Aldevron and Ginkgo Bioworks has resulted in a manufacturing enhancement that can improve production of an enzyme used for mRNA therapeutics.

Veraxa and Indivumed will work together to develop colorectal antibody drugs.

Lonza and Sheba Medical Center have successfully dosed four patients with a CD19 autologous CAR-T cell therapy using Lonza’s Cocoon automated manufacturing platform.

Moderna will build an mRNA vaccine manufacturing facility in Canada to provide access to domestically manufactured vaccines against respiratory viruses.

The Just - Evotec Biologics facility in Redmond, Wash., uses the company’s J.POD technology.

The EC has approved the drug in the EU for treatment of chronic kidney disease in adults with or without type-2 diabetes.

Nobelpharma has come to terms on an agreement to use ProBioGen’s vaccine manufacturing platform AGE1.CR.plX.

The MHRA has approved GW Pharmaceuticals’ Epidiolex for the treatment of seizures associated with tuberous sclerosis complex.

Datwyler offers the StarterPack packaging system designed to aid in the development of parenteral drug packaging.

The agency is endorsing recommendations for global track-and-trace systems developed by the International Coalition of Medicines Regulatory Authorities.

Kyowa Pharmaceutical Industry and Bora Pharmaceuticals have announced a partnership to produce generic-drug product for filing in Japan.

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

EMA’s Pharmacovigilance Risk Assessment Committee has requested more data for its evaluation of reports of Guillain-Barré syndrome after vaccination.

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 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.