Therapeutic-Specific Areas

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

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

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

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

National Institutes of Health researchers use genomics to show that squamous cell carcinomas differ from other cancers, which could advance treatments for head and neck and other cancers.

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

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

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

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

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

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

The companies will work together to develop prescription digital therapeutics for patients with schizophrenia and multiple sclerosis.

The companies will join forces to develop next-generation ex vivo cell therapies in oncology.

The agency has approved a new treatment for a certain type of prostate cancer using novel clinical trial endpoint.

Researchers at the University of Illinois developed a method to transplant pancreatic islet cells from pigs more easily to treat type I diabetes.

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

The acquisition will strengthen Sanofi's R&D strategy and expands its franchise for rare blood disorders.

The acquisition would boost Sanofi's position in hematology and specialty medicines.

The acquisition builds on the companies' earlier collaboration to develop T-cell-based therapeutics.

The agency has expanded the indication of AstraZeneca’s anti-cancer drug to include treatment for breast cancer with a certain inherited genetic mutation.

The company will use funding from the Bill & Melinda Gates Foundation to develop a new production method for artemisinin, a therapeutic used to treat malaria.

Mallinckrodt has agreed to acquire biopharmaceutical company Sucampo Pharmaceuticals for $18 per share, or a transaction value of approximately $1.2 billion.

Roche has agreed to acquire Ignyta, an oncology company specializing in precision medicines, in an all-cash transaction valued at $1.7 billion.

The agency published guidance on the research and development of individualized therapies.

Research into an old antibiotic might open the door for new drugs to treat tuberculosis and other related microbial diseases.

Children with a rare brainstem-based cancer might be helped by a new immunotherapy that targets a mutated protein found exclusively in cancer cells.

Gilead Sciences will acquire Cell Design Labs to further cell-therapy research and development efforts.

New gene therapies and combination products require innovative regulatory approaches.

Biocad and Sothema Labs have partnered to release cancer-treating biosimilars into the North African market.

The new guidelines discuss GMPs and patient protection specific to advanced therapy medicinal products.