July 21, 2017
Diplomat to distribute Puma Biotechnology’s new cancer drug
Diplomat Pharmacy will distribute Puma Biotechnology’s new product, Nerlynx, a kinase inhibitor approved by the US Food and Drug Administration (FDA).
Pharmaceuticals, Biotechnology and Life Sciences
Category: North America
July 19, 2017
FDA accepts new IND to expand in U.S. IFNalpha kinoid clinical development program in dermatomyositis
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.
July 18, 2017
FDA OK’s Puma Biotechnology’s cancer drug
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.
July 16, 2017
Novartis confirms 5 year data for first and only fully-human IL-17A inhibitor Cosentyx reinforcing sustained efficacy and safety profile in psoriasis
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.
July 14, 2017
Janssen Biotech’s psoriasis drug wins FDA’s approval
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.
July 13, 2017
Novartis’s drug gets recommendation for treating children with leukemia
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).
July 12, 2017
Lilly reaches settlement agreement in U.S. Cialis patent litigation
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.
July 11, 2017
Boehringer Ingelheim reports results from life-threatening bleeding drug study
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.
July 11, 2017
Sanofi to acquire U.S. based vaccines biotechnology company
Sanofi announced today it will acquire Protein Sciences, a privately held vaccines biotechnology company based in Meriden, Connecticut in the United States.
July 4, 2017
First patients get NOX-A12 combined with Keytruda in certain cancers
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.