Biogen successfully fended off a patent challenge from generic company Mylan over the multiple sclerosis (MS) drug Tecfidera.
SK Biopharmaceuticals and U.S. subsidiary SK Life Science announced that the U.S. Food and Drug Administration approved Xcopri (cenobamate tablets) for partial-onset seizures in adults.
Rockville, Maryland-based RegenxBio entered a license deal with Pfizer for a gene therapy for Friedreich’s ataxia, the most common hereditary ataxia.
When major depressive disorder does not respond to at least two different types of antidepressant treatments in a moderate-to-severe depressive episode, it’s reclassified as treatment-resistant depression (TRD). South San Francisco-based VistaGen Therapeutics’ AV-101 failed to meet the primary efficacy endpoints for TRD in a Phase II clinical trial.
Shares of Voyager Therapeutics skyrocketed after the company announced a collaborative deal to develop a gene therapy treatment for Parkinson’s disease with Neurocrine Biosciences.
PTC Therapeutics Inc. announced an agreement to acquire Agilis Biotherapeutics Inc., a biotechnology company advancing an innovative gene therapy platform for rare monogenic diseases that affect the central nervous system.
AstraZeneca announced that the U.S. Food and Drug Administration accepted a supplemental New Drug Application for the use of Tagrisso (osimertinib) – a third-generation, irreversible epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor with clinical activity against central nervous system metastases – in the first-line treatment of patients with metastatic non-small cell lung cancer whose tumors have EGFR mutations.
Torrent Pharmaceuticals said it would buy more than 120 brands from Unichem Laboratories in India and Nepal, and its manufacturing plant at Sikkim.
Patients taking Roche’s targeted lung cancer drug Alecensa have a far lower risk of their disease spreading in the brain than those on Pfizer’s Xalkori, new clinical trial data show.
Amarantus Bioscience Holdings Inc. announced that it has formed a wholly owned subsidiary named Elto Pharma Inc. for the purpose of creating investment vehicles focused exclusively on the further development of Eltoprazine, Amarantus’ mid-stage central nervous system (CNS) symptomatic treatment. Concurrently, Amarantus has formed the wholly owned subsidiary MANF Therapeutics Inc. for the purpose of the continued pre-clinical development of the internally discovered MANF program in development for the treatment of ophthalmological disorders.