Biopharma News

The European approval marks the first approval for a biosimilar in that region resulting from the companies’ joint portfolio.

The agency has accepted AstraZeneca’s biologics license application for an investigational leukemia drug candidate and granted it priority review.

Pfizer transfers CAR-T assets to Allogene Therapeutics under a new alliance to further develop immuno-oncology therapeutics.

The companies will co-develop and co-promote a CAR T cell therapy in the United States.

The acquisition strengthens Celgene’s position in the global cellular immunotherapy space.

EMA has recommended approval of the biosimilar for the same indications as Roche’s Herceptin (trastuzumab).

Novartis’ Sandoz is seeking approval of its biosimilar referencing Johnson & Johnson’s Remicade (infliximab) for all of Remicade’s indications across gastroenterology, rheumatology, and dermatology.

Takeda is considering approaching Shire with a possible offer.

In a $13-billion transaction, GSK will purchase Novartis’ share of the Consumer Healthcare Joint Venture.

The collaboration between the two companies aims to finish all necessary work needed to file for a first-in-human study by early 2019.

AbbVie and the International Myeloma Foundation will partner to study the role of a genetic mutation in outcomes of patients with multiple myeloma.

The companies intend to jointly develop and commercialize Lenvima (lenvatinib mesylate) as a monotherapy and an in-combination therapy for treating multiple cancer types.

Biogen will acquire an AMPA receptor potentiator for cognitive impairment associated with schizophrenia in a deal worth approximately $590 million.

The $11.6-billion acquisition strengthens Sanofi's position in hematology and specialty medicines.

The European Medicines Agency has called for the immediate suspension and recall of AbbVie and Biogen's multiple sclerosis drug Zinbryta (daclizumab beta).

Under this agreement, the companies will develop in parallel an antibody drug candidate and cell lines for other potential candidates.

The pharma major will spin out six molecules in early stage inflammation and autoimmune programs into a new company called Viela Bio.

Merck & Co. has acquired oncology-focused biopharmaceutical company Viralytics to strengthen Merck's oncology pipeline.

A jury verdict requiring Gilead Sciences to pay $2.54 billion for patent infringement to competitor Merck & Co. over Gilead's Harvoni (ledipasvir and sofosbuvir) and Sovaldi (sofosbuvir), two best-selling hepatitis C drugs, has been overturned.

Roche will acquire oncology-focused healthcare technology and services company Flatiron Health for $1.9 billion to further its personalized oncological healthcare strategy.

The companies have partnered to develop and commercialize vectorized antibodies against tau for Alzheimer's and other neurodegenerative diseases.

Fluarix Tetra has been approved for use in children aged six months and above.

The companies will work together on developing regenerative medicine therapies for heart failure.

Ferring Pharmaceuticals will expand its biologics capabilities at its headquarters and manufacturing site in Saint-Prex, Switzerland.

The acquisition strengthens an already existing collaboration between the companies to advance clinical development of therapies across multiple drug categories.

Through its Janssen pharmaceutical companies, Johnson & Johnson, has partnered with Theravance to develop and commercialize a therapeutic for inflammatory bowel diseases.

Paratek has completed submission of two new drug applications for oral and intravenous omadacycline, a new antibiotic for pneumonia and skin infections.

Amgen plans to invest approximately $300 million in a new biomanufacturing plant in the United States.