Biopharma News

The company received a complete response letter from FDA in response to the biologics license application for a proposed trastuzumab biosimilar.

LNC Therapeutics has appointed a new CEO and is strengthening its R&D for gut microbiome-based drugs.

Global investment firm Advent to acquire and invest in Sanofi’s European generics business, Zentiva, to boost its position in European market.

The transaction is part of Merck KGaA’s strategy to actively shape its product portfolio and focus on innovation-driven business.

The agency has granted breakthrough therapy designation to Roche’s hemophilia therapy for treating hemophilia A in patients without factor VIII inhibitors.

Johnson & Johnson’s Janssen partners with Bristol-Myers Squibb to advance next-generation therapies for cardiovascular diseases.

According to Alexion, the acquisition will help rebuild its clinical pipeline.

The new facility, to be built in Toronto, Canada, will significantly increase capacity for pediatric and booster vaccines.

The biopharmaceutical firm has chosen Rhode Island as the site of its next-generation biomanufacturing plant, which will offer flexibility, speed, and efficiency.

The acquisition is expected to accelerate progress towards personalized cancer healthcare.

Roche has acquired a program to develop regenerative therapies for multiple sclerosis.

Under this global collaboration, the companies will develop encapsulated cell therapies for treating Type 1 diabetes.

Celltrion received complete response letters from FDA for its rituximab and trastuzumab biosimilars.

Boehringer Ingelheim and OSE Immunotherapeutics have entered a global immuno-oncology partnership to develop a checkpoint inhibitor for treating advanced solid tumors.

The companies have created Syna Therapeutics, a joint venture that will develop biosimilars and new molecules.

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.

Hitachi will manufacture regenerative medicines developed by Daiichi Sankyo and SanBio Group.

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.