News

Rentschler Biopharma and Vetter are unveiling a strategic collaboration called Xpert Alliance.

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

Thermo Fisher Scientific’s new Gibco CTS Xenon Electroporation System aims to provide easier scale up for cell therapies, from clinical development to commercial manufacturing.

Under the two-year task order, ATCC will continue to support the DCEG MEAS program in receiving, processing, storing, analyzing, and distributing clinical specimens from different cancer types.

Researchers from the Telomere-to-Telomere Consortium have discovered new properties about junk DNA that could have wide-reaching implications.

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.

Consumer advocates continue to press for initiatives to lower drug prices by revising or reducing patent protections.

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

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.

Pfizer’s respiratory syncytial virus vaccine candidate has received Breakthrough Therapy Designation from FDA for the prevention of RS in older adults.

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

Congress is considering revising and improving policies related to drug development and regulation for possible inclusion in broader legislation to reauthorize FDA user fees.

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.

Moderna, Pfizer, and BioNTech are seeking FDA approval for a fourth dose of their respective COVID-19 vaccines.

New report released by USP offers a look into API supply-chain vulnerabilities.

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.