Pharmaceuticals, Biotechnology and Life Sciences
The U.S. Food and Drug Administration (FDA) has cleared Neovacs’s Investigational New Drug (IND) application for IFNalpha Kinoid in the treatment of dermatomyositis, which allows the Company to initiate in the US its Phase IIa clinical trial already on-going in European countries.
The U.S. Food and Drug Administration has approved Puma Biotechnology’s neratinib for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer, to follow adjuvant trastuzumab-based therapy.
Novartis has confirmed positive 5 year efficacy and safety results for Cosentyx from a Phase III long-term extension study in patients with moderate-to-severe plaque psoriasis.
The U.S. Food and Drug Administration (FDA) has approved Janssen Biotech’s Tremfya (guselkumab) for the treatment of adults living with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
The US Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) has unanimously (10-0) recommended approval of CTL019 (tisagenlecleucel), an investigational chimeric antigen receptor T cell (CAR-T) therapy, for the treatment of relapsed or refractory (r/r) pediatric and young adult patients with B-cell acute lymphoblastic leukemia (ALL).
Eli Lilly has entered into a settlement agreement with generic companies to resolve pending patent litigation in the U.S. District Court for the Eastern District of Virginia regarding the Cialis (tadalafil) unit dose patent.
Boehringer Ingelheim has reported that final results from RE-VERSE AD study showed that idarucizumab, marketed in the U.S. as Praxbind, was able to immediately reverse the anticoagulant effect of Pradaxa (dabigatran etexilate mesylate) in patients in emergency situations.
Sanofi announced today it will acquire Protein Sciences, a privately held vaccines biotechnology company based in Meriden, Connecticut in the United States.
NOXXON Pharma, a biotechnology company whose core focus is on improving cancer treatment by targeting the tumor microenvironment, has treated first patients in its Phase 1/2 clinical trial in patients with metastatic colorectal and pancreatic cancer at the National Center for Tumor Diseases in Heidelberg, Germany.
Mylan N.V. <MYL.O> is best known for producing EpiPen emergency allergy treatments and generic drugs.