Biopharma News

EMA has started its evaluation of an application for the use of a booster dose of Comirnaty in adolescents aged 12–15 years.

In an agreement with MaaT Pharma, Skyepharma will build MaaT a dedicated 1500-m² microbiome ecosystem therapies manufacturing site.

The agency approved Roche’s Vabysmo to treat neovascular or “wet” age-related macular degeneration and diabetic macular edema.

Janssen has submitted a MAA to the EMA for teclistamab as a treatment of relapsed or refractory multiple myeloma (RRMM).

Eli Lilly and Company is investing $1 billion to establish a new manufacturing stie in Concord, N.C., to manufacture parenteral products and devices.

Eli Lilly and Company has entered into a research and collaboration agreement with Entos Pharmaceuticals to develop new therapeutics for treating neurologic disorders.

Both Pfizer and Moderna have started clinical trials for their respective Omicron COVID-19 variant vaccine.

PhoreMost has entered into separate collaboration agreements with Polaris Quantum Biotech and NeoCura Bio-Medical Technology to discover and develop novel cancer therapeutics.

UCB and Zogenix have agreed to an acquisition deal totaling nearly $2 billion.

Pfizer will pay Beam $300 million upfront to conduct research on three undisclosed base editing targets in the liver, muscle, and central nervous system.

The UK’s National Institute of Health and Care Excellence has recommended the use of Janssen’s Darzalex (daratumumab) in combination with Velcade (bortezomib), thalidomide and dexamethasone (DVTd) to treat adults with multiple myeloma.

Fosun Pharma and Insilico Medicine will collaborate on AI-driven drug discovery and development of product candidates targeting multiple disease targets.

The collaboration between Bristol Myers Squibb and Century Therapeutics will combine Century’s iPSC-derived allogeneic cell therapy platform with Bristol Myers Squibb’s expertise in cell therapy and oncology drug development.

The agreeement will add to Merck KGaA’s LNP and mRNA capabilities.

The agreement expands Pfizer’s access to LNP formulation technology for mRNA vaccines and therapeutics.

The collaboration will leverage Alynlam’s proprietary small interfering RNA (siRNA) technology to inhibit a target discovered by Novartis.

FDA granted Oncoloze’s OM-301 an orphan drug designation for the treatment of acute myeloid leukemia (AML).

FDA has cleared an IND from Poseida Therapeutics, allowing continued development of the company’s allogeneic CAR-T cell therapy candidate for treating multiple solid tumors.

Neurimmune will receive up to $760 million for NI006, an investigational human monoclonal antibody in development for the treatment of transthyretin amyloid cardiomyopathy.

Moderna’s vaccine is weaker against the Omicron variant, but boosters can increase neutralizing antibody levels by as much as 83-fold.

Sanofi’s acquisition will grant access to Amunix's promising immuno-oncology pipeline.

Tezpire (tezepelumab-ckko) has been approved as an add-on maintenance treatment for severe asthma.

FDA approved American Regent’s Injectafer (ferric carboxymaltose injection) for the treatment of pediatric patients with iron deficiency anemia.

Pfizer invested $68.5 million in a facility in Durham, NC.

The European Medicines Agency has accepted Sanofi’s marketing authorization application for olipudase alfa, a potential new therapy for acid sphingomyelinase deficiency, a rare disease.

Pfizer’s $6.7 billion acquisition of Arena will give them access to a portfolio of immuno-inflammatory therapies.

GlaxoSmithKline, together with the University of Oxford, has launched the Oxford-GSK Institute under a new collaboration that aims to study complex diseases to accelerate the success of drug discovery and drug development efforts.

GlaxoSmithKline and Vir Biotechnology have received a conditional marketing authorization from MHRA for Xevudy (sotrovimab) in the treatment of COVID-19.