AbbVie , in cooperation with Neurocrine Biosciences, Inc. announced the initiation of the first of two planned Phase 3 clinical studies evaluating the safety and efficacy of Elagolix alone or in combination with add-back therapy compared to placebo.
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AbbVie , in cooperation with Neurocrine Biosciences, Inc. announced the initiation of the first of two planned Phase 3 clinical studies evaluating the safety and efficacy of Elagolix alone or in combination with add-back therapy compared to placebo.
OptiNose, a privately-held specialty biopharmaceutical company, announced that its licensing partner, Avanir Pharmaceuticals, Inc. has reported that the U.S. Food & Drug Administration (FDA) approved ONZETRA™ Xsail™ (sumatriptan nasal powder), formerly AVP-825, for the acute treatment of migraine with or without aura in adults. ONZETRA Xsail is the first product developed by OptiNose to receive FDA approval and is an intranasal medication delivery system using the novel Xsail Breath Powered Delivery Device.
Drug development company SCYNEXIS, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted both Fast Track and Qualified Infectious Disease Product (QIDP) designations for the intravenous (IV) formulation of SCY-078, SCYNEXIS' novel antifungal product, for the indications of invasive candidiasis (including candidemia) and invasive aspergillosis. SCYNEXIS is currently conducting a Phase 1 study of the IV formulation of SCY-078 to evaluate the safety, tolerability and pharmacokinetics of single-rising doses. The FDA granted QIDP and Fast Track designations for the oral formulation of SCY-078 for both the treatment of invasive candidiasis and invasive aspergillosis in 2014. The oral formulation is currently in Phase 2 development for both invasive candidiasis and vulvovaginal candidiasis.
Theravance Biopharma, Inc. announced the commercial launch of VIBATIV® (telavancin) in Canada. VIBATIV is a bactericidal, once-daily antibiotic with in vitro potency and a dual mechanism of action against Gram-positive bacteria, including difficult-to-treat pathogens such as methicillin-resistant Staphylococcus aureus (MRSA).
AstraZeneca announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation (BTD) for the oral poly ADP-ribose polymerase (PARP) inhibitor Lynparza™ (olaparib), for the monotherapy treatment of BRCA1/2 or ATM gene mutated metastatic Castration Resistant Prostate Cancer (mCRPC) in patients who have received a prior taxane-based chemotherapy and at least one newer hormonal agent (abiraterone or enzalutamide).
AbbVie , a global biopharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for the investigational agent venetoclax in combination with hypomethylating agents (HMAs) for the treatment of patients with untreated (treatment-naïve) acute myeloid leukemia (AML) who are ineligible to receive standard induction therapy (high-dose chemotherapy). Venetoclax is an inhibitor of the B-cell lymphoma-2 (BCL-2) protein being developed by AbbVie in partnership with Genentech and Roche.
Exelixis, Inc. announced that the U.S. Food & Drug Administration (FDA) has determined the company’s New Drug Application (NDA) for cabozantinib as a treatment for patients with advanced renal cell carcinoma (RCC) who have received one prior therapy to be sufficiently complete to permit a substantive review. The NDA will be considered officially filed 60 days from the date of the completion of the submission, or February 20, 2016. The FDA granted Priority Review to the filing and assigned a Prescription Drug User Fee Act action date of June 22, 2016
Merck, known as MSD outside the United States and Canada, announced that the U.S. Food and Drug Administration (FDA) has approved ZEPATIER™ (elbasvir and grazoprevir) for the treatment of adult patients with chronic hepatitis C virus (HCV) genotype (GT) 1 or GT4 infection, with or without ribavirin (RBV), following priority review by the FDA.
In October 2015, the Commission for the Protection against Sanitary Risk (COFEPRIS) gave Mexico the registry of the first recombinant vaccine against seasonal influenza in the world and designed to begin marketing in the first quarter of 2016.
Sugar-sweetened beverages account for every one in 200 deaths caused by India’s rising tide of cardiovascular disease, diabetes and obesity, according to a 2015 study.