Biopharma News

Symbiosis announced the successful completion of UK Research and Innovation project to enhance the manufacturing supply chain for ATMPs within the UK.

KeyPlants has shipped a first-of-its-kind vaccine manufacturing facility to Senegal in West Africa.

Sanofi and IGM Biosciences have announced a collaboration agreement for oncology, immunology, and inflammation targets.

Pfizer has issued a voluntary nationwide recall on lots of Accuretic tablets due to high levels of nitrosamine.

Novavax’ COVID-19 vaccine has been granted emergency use authorization for use in the adolescent population ages 12–18 in India.

Orion is planning to refocus its R&D efforts on the development of new proprietary products focused on cancer and pain.

FDA has approved Novartis’ targeted radioligand therapy Pluvicto for the treatment of progressive PSMA-positive metastatic castration-resistant prostate cancer.

EMA has recommended the approval of Roche’s Polivy plus R-CHP for the treatment of previously untreated diffuse large B-cell lymphoma in the EU.

Huma has acquired AstraZeneca’s digital health platform, and AstraZeneca has become a shareholder of Huma in a partnership to accelerate digital-first patient care.

EMA has recommended a conditional marketing authorization for a new gene therapy to treat adult patients with multiple myeloma.

Gamma Biosciences has announced an initiative through its subsidiary, Mirus Bio, to develop lipid-polymer nanocomplexes for improve mRNA delivery solutions.

Roquette is investing €25 million at its site in Lestrem, France to strengthen its position in the polyols market.

FDA has approved Opdualag for adults and pediatric patients 12 years of age and older with unresectable or metastatic melanoma.

FDA has approved ZTALMY as a treatment for seizures associated with CDKL5 deficiency disorder (CDD).

AstraZeneca’s antibody combination has been authorized for use in Great Britain to prevent COVID-19 in high-risk populations and people for whom vaccination may not be effective.

Moderna has reached an agreement with the Ministry of Health, Labor, and Welfare of Japan (MHLW) to supply Japan with an additional 70 million doses of its COVID-19 Booster Vaccine.

Sanofi is collaborating with Blackstone Life Sciences to accelerate the development of a treatment for multiple myeloma.

Sanofi and Seagen have entered an agreement to investigate three cancer targets.

Catalent has announced the completion of a $30 million project at its facility in Limoges, France focused on biopharmaceutical development and drug product manufacturing.

BioMed X and Merck KGaA, Darmstadt, Germany announced their collaboration on a research project to study T-cells and autoimmunity.

EMA has recommended that possible side effects of Spikevax and Janssen COVID-19 vaccines be added to product information.

NIH has launched one of the first Phase 1 clinical trials to examine mRNA technology for HIV.

Flow Eighteeen38 is receiving a €5 million (US$5.58 million) investment from its parent company, FairJourney Biologics.

SCG Cell Therapy has signed a collaboration agreement with A*STAR’s BTI to advance the development of antibodies for infectious diseases and cancer treatments.

Novartis will pay Voyager up to $1.75 billion for access to Voyager’s novel Tracer AAV capsids for potential use with three CNS targets.

Novo Nordisk will expand its existing research collaboration in novel delivery technologies with MIT and Brigham and Women’s Hospital.

UCB has announced it will build a new innovative gene therapy facility in Belgium.

Amgen has announced the groundbreaking of its newest biomanufacturing facility in North Carolina.