Biopharma News

Cambrex’s acquisition of Q1 Scientific expands the company’s storage services in the European market.

GSK’s acquisition of Affinivax will give the company access to their portfolio of next-generation pneumococcal vaccines.

Dupixent (dupilumab), developed by Regeneron Pharmaceuticals in partnership with Sanofi, has received FDA approval for a new indication—treating eosinophilic esophagitis, a chronic inflammatory disease.

AbbVie and Cugene have reached an exclusive license option agreement for CUG252, Cugene’s lead therapeutic candidate.

AstraZeneca's recombinant COVID-19 vaccine, originally invented by the University of Oxford, has been approved as a third dose booster vaccine in the EU.

EMA has recommended the marketing authorization of Xenpozyme (olipudase alfa) in the European Union.

AstraZeneca has signed a license agreement with RQ Biotechnology for monoclonal antibodies to treat COVID-19.

Catalent has announced a $175 million project to expand its manufacturing facility for large scale oral dose forms at its Winchester, Ky, site.

FDA has approved Mounjaro (tirzepatide) injections as a treatment to improve blood sugar control in adults with type 2 diabetes.

The companies have reached an agreement with the European Commission to update their COVID-19 vaccine supply agreement.

Avacta is relocating its therapeutics headquarters to Scale Space in Imperial College’s White City Campus, London, United Kingdom.

PCI Pharma Services is investing $100 million in manufacturing capabilities and capacity expansion to its Bedford, NH facility.

Lonza and Integral Molecular will collaborate to better assess the risks of off-target binding of biologic drug candidates.

FDA is limiting the use of Janssen’s COVID-19 vaccine to certain individuals.

Janssen has submitted a marketing authorization application to EMA for the approval of a treatment for patients with HRR gene-mutated metastatic castration-resistant prostate cancer.

FDA granted Quanterix’s neurofilament light chain plasma test a breakthrough device designation as a prognostic aid for relapsing-remitting multiple sclerosis.

VYDURA has been granted marketing authorization by the European Commission for both acute treatment of migraine and prophylaxis of episodic migraine.

Moderna has filed for emergency use authorization of its COVID-19 vaccine for use in young children six months to under six years of age.

ENHERTU has been granted breakthrough therapy designation in the US for patients with HER2 low metastatic breast cancer.

FDA has granted regenerative medicine advanced therapy (RMAT) designation to Autolus’ CAR-T cell therapy obe-cel.

GeoVax has received a patent for its malaria vaccine from the US Patent and Trademark Office.

Pfizer and BioNTech have submitted an application for Emergency Use Authorization for a COVID-19 vaccine booster dose in young children.

Johnson & Johnson has launched its next Satellite Center for Global Health Discovery at Holistic Drug Discovery and Development Centre, University of Cape Town.

Tremelimumab has been accepted under priority review in the US for patients with unresectable liver cancer in combination with Imfinzi.

FDA has approved Veklury to treat COVID-19 in pediatric patients under 12 years of age.

Pfizer has issued a voluntary nationwide recall of lots of Accupril due to N-nitroso-quinapril content.

EMA is recommending EU conditional approval of Roche’s potential first-in-class bispecific antibody mosunetuzumab for people with relapsed or refractory follicular lymphoma.

EMA has granted Novo Nordisk a positive scientific opinion on human insulin with more flexible storage without refrigeration.