Industry News

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.

Olympia Pharmacy is voluntarily recalling eleven lots of seven compounded products due to out-of-specification results.

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

physIQ and CellCarta are conducting a study to evaluate individual patient response to vaccination using wearable biosensors.

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.

Emmes has acquired Casimir, marking its fourth major acquisition.

Viatris’ new drug-device is the first FDA-approved generic version of AstraZeneca’s Symbicort.

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

Envirotainer and Swiss WorldCargo have successfully completed the first commercial shipment using a new temperature-controlled air freight solution.

Novasep increases its production capacity for HPAPIs with an investment in its site in Le Mans, France.

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.

C4 Therapeutics has been granted orphan drug designation by FDA for CFT8634 for the treatment of soft tissue sarcoma.

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.

Evonik has launched new EUDRATEC technology to improve solubility and performance of oral small molecules.

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.

What if we are underestimating China’s response to US/EU inshoring?

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.