Bio/Pharma News

Merck has expanded its manufacturing facility in Elkton, Va. to further increase its HPV vaccine supply.

FDA has granted an expanded Emergency Use Authorization to Pfizer and BioNTech’s COVID-19 vaccine boosters in individuals aged 50 years and older.

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.

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

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

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.

Boehringer Ingelheim announced Empagliflozin Phase III EMPA_KIDNEY trial will stop early due to clear positive efficacy in people with chronic kidney disease.

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.

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.

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

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.

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.

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

Oculis has gained exclusive global rights to neuroprotective drug candidate for glaucoma through a licensing agreement with Accure Therapeutics.