Kyowa Hakko Kirin Co. Ltd. announced that the U.S. Food and Drug Administration has accepted for review the Biologics License Application for mogamulizumab to treat cutaneous T-cell lymphoma (CTCL) in patients who have received at least one prior systemic therapy, and has granted Priority Review status.

Regeneron Pharmaceuticals Inc. announced that the U.S. Food and Drug Administration has granted Breakthrough Therapy Designation status to evinacumab for the treatment of hypercholesterolemia in patients with Homozygous Familial Hypercholesterolemia (HoFH), an inherited disorder that can lead to premature cardiovascular disease due to very high levels of LDL cholesterol.

Only some doses of Trevena’s experimental opioid painkiller were found as effective as morphine in two late-stage studies, though the drug met its main study goals.

Irish drugmaker Shire Plc said it would buy the rights to an experimental bowel drug from Pfizer Inc to bolster its pipeline of gastrointestinal treatments.

Jazz Pharmaceuticals struck a deal to acquire Celator Pharmaceuticals and its promising leukemia drug for $1.5 billion.

Novartis received breakthrough therapy designation from the U.S. Food and Drug Administration for an investigational treatment for newly-diagnosed FLT3-mutated acute myeloid leukemia, the Swiss drugmaker said on Friday. Patients who received PKC412, also called midostaurin, combined with standard induction and consolidation chemotherapy experienced what Novartis called “a significant improvement in overall survival”. With the announcement, […]

The U.S. Food and Drug Administration has granted breakthrough therapy designation to AstraZeneca’s biggest new drug hope ‍durvalumab as a treatment in bladder cancer, the drugmaker said on Wednesday.   The experimental medicine is a so-called PD-L1 therapy that fights cancer by boosting the immune system. Breakthrough therapy designation expedites the development and review of […]

The pharma industry’s R&D concentration has been shifting towards specialty therapy areas as research and development returns decline for some leaders.

    First-in-class immunotherapy approved for multiple myeloma patients who have received three or more prior lines of therapy, including a proteasome inhibitor (PI) and an immunomodulatory agent or who are double refractory to a PI and an immunomodulatory agent PR Newswire, HORSHAM, PA, November 16, 2015 Janssen Biotech, Inc., a Janssen Pharmaceutical Company of […]

July 13, 2015By Mark Terry, Breaking News Staff South San Francisco, Calif.-based Genentech (RHHBY) announced positive results today for its urothelial bladder cancer (UBC) drug atezolizumab, or MPDL3280A. On Feb. 2, 2015, the U.S. Food and Drug Administration (FDA) granted the drug a second Breakthrough Designation. The drug, a monoclonal antibody that interferes with […]