Industry News

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.

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).

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.

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.

The US Congress approved a federal spending package that increases funding for a range of programs to advance health and medicine.

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.

Biotech companies and medical product manufacturers have condemned the invasion of Ukraine, while also looking to maintain supplies of essential medicines.

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.

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.

Moderna has announced that it has entered a Memorandum of Understanding with the government of the Republic of Kenya to establish its first mRNA manufacturing facility in Africa.

Researchers at McGill University have made advancements with a novel method for growing synthetic bone tissue.

FDA’s CDER continues to make rare diseases a priority with drug approvals and programming to speed therapeutic development.