BioPharm International Editors

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.

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.

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

Spectrum Chemical is adding twelve products to its bioCERTIFIED product line.

ProteoGenix’s new XtenCHO Transient Expression can achieve up to ten times higher yields than market-leading CHO systems.

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

Evitria has entered into an agreement with mAbsolve that will allow the company to use mAbsolve’s gene silencing technology in their antibody cells.

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.

Various executives in the life sciences industry have started a petition calling for “complete economic disengagement” with Russia.

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

Curia and the US government have entered into a cooperative agreement to expand fill/finish capability for injectable medicines.

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

Spectrum Chemical has further expanded its bioCERTIFIED product portfolio to support the growing global demand for new vaccines and therapeutics.

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

Johnson & Johnson have announced a landmark agreement to enable the manufacturing and availability of its COVID-19 vaccine in Africa by an African company.