Therapeutic Specific Areas

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.

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 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.

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

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.

Biologic new molecular entities (NMEs) accounted for 26% of total NME approvals in 2017.

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

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

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

The companies will partner to further immuno-oncology research using humanized mice.

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 acquisition strengthens Charles River Laboratories’ capabilities in the oncology and immunology therapeutic areas.

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.

The company announced 15 new collaborations focused on addressing unmet medical needs, including using artificial intelligence in the early detection of Alzheimer’s disease, saliva testing for throat cancers, and using the microbiome to treat sleep disorders.

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.

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.

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

Commissioner Scott Gottlieb, MD, outlined a plan to support innovation of regenerative medicines while ensuring public safety.

The use of therapeutic vaccines presents a new way to manage diseases, such as cancer and sexually transmitted diseases.