Therapeutic Specific Areas

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.

This article explores some of the challenges, services, and technologies that go into ensuring that vaccines are properly temperature controlled and maintain product integrity for delivery to patients.

The companies will collaborate to develop and manufacture Grid’s lead therapeutic candidate for the treatment of solid tumors.

FDA has approved Mavyret (glecaprevir and pibrentasvir), a new molecular entity (NME), to treat chronic hepatitis C virus (HCV).

Pharma majors AstraZeneca and Merck & Co. form $8.5-billion partnership to develop cancer therapies revolving around AstraZeneca’s PARP inhibitor, Lynparza.

Pharmaceutical companies need to radically change to survive and thrive amid shifting healthcare and technology changes.

FDA is in the center of the debate over developing and pricing new cancer therapies.

A new report states that wider access to new antivirals for HCV and better screening of patients would help avert 90,000 deaths by 2030.

In a FDAVoice blog post, CBER Director Peter Marks discusses the new designation for cell therapies that treat life-threatening diseases.

A study of 53 cancer drugs found that new treatments extended patient life an average of 3.43 months when compared with treatments available in 2003.

Researchers in the University of Dundee have discovered a new method of activating drugs to combat visceral leishmaniasis. The discovery could lead to better treatments for neglected tropical diseases.

Scientists from the Fred Hutchinson Cancer Research Center have developed a semi-automated benchtop system for the manufacture of gene therapy.