Pharma News

Janssen Pharmaceuticals, Inc. (Janssen) announced the U.S. Food and Drug Administration (FDA) has approved INVOKAMET® XR—a once-daily, fixed-dose combination therapy of canagliflozin and metformin hydrochloride extended-release (XR)—for first-line use as an adjunct to diet and exercise to improve blood glucose control in adults with type 2 diabetes when treatment with the two medications is appropriate. INVOKAMET® XR combines INVOKANA® (canagliflozin), the most prescribed sodium glucose co-transporter 2 (SGLT2) inhibitor, with more than 9 million U.S. prescriptions since launch, and an XR formulation of metformin. Metformin is commonly prescribed as an initial therapy for the treatment of type 2 diabetes.

Takeda Pharmaceutical Company Limited and Affilogic jointly announced that the companies have entered into a research collaboration to explore using Affilogic’s proprietary Nanofitins platform in therapies targeting the central nervous system

H. Lundbeck A/S  announced the headline conclusions from the first clinical phase III study, STARSHINE, in the ongoing phase III programme evaluating the efficacy of the investigational drug idalopirdine for the symptomatic treatment of patients with mild to moderate Alzheimer's disease.

AstraZeneca announced its decision to withdraw the Marketing Authorisation Application (MAA) submitted to the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) in June 2015 for cediranib in combination with platinum-based chemotherapy followed by maintenance monotherapy for the treatment of adult patients with platinum-sensitive relapsed ovarian cancer (including fallopian tube or primary peritoneal sub types).

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A new, computer-based screening method could reveal the virus-fighting potential of drugs originally developed to treat other conditions, reports a study in PLOS Computational Biology.

Sarepta Therapeutics, Inc., a developer of innovative RNA-targeted therapeutics, announced that the US Food and Drug Administration (FDA) has granted accelerated approval for Exondys 51 (eteplirsen) as a once weekly intravenous infusion of 30 milligrams per kilogram for the treatment of Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation in the DMD gene that is amenable to exon 51 skipping.

DBV Technologies announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for Viaskin Milk, the Company’s investigational treatment for pediatric patients two years of age and older with Immunoglobulin E (IgE)-mediated cow’s milk protein allergy (CMPA), currently under clinical investigation in a Phase IIb trial. There are currently no approved treatments for CMPA, the most common food allergy in infants and young children. Fast Track is a process designed by the FDA to facilitate the development, expedite the review of drugs to treat serious conditions and fill an unmet medical need.

Baxter International Inc., a global leader in PN therapy, announced the European launch of NUMETA G13E 300 ml, the only ready-to-use parenteral (intravenous) nutrition (PN) product available to treat preterm infants (less than 37 weeks gestation age) who are at high risk for infection and malnutrition in the early hours and days of their lives. The announcement was made during the 38th ESPEN (The European Society for Clinical Nutrition and Metabolism) Congress in Copenhagen, September 17-20, with recognition that the first preterm patients have received PN therapy on NUMETA G13E in Sweden.

Vical Incorporated and Astellas Pharma Inc. announced topline results from a randomized, double-blind, placebo-controlled phase 2 study evaluating the safety and efficacy of cytomegalovirus (CMV) vaccine, ASP0113, versus placebo in kidney transplant patients receiving an organ from a CMV-seropositive donor. Results from the study demonstrated that the trial did not meet its primary endpoint, which was the proportion of patients having CMV viremia defined as a plasma viral load of = 1000 IU/ml by central laboratory assay through one year after first injection of study drug. Additionally, the secondary endpoints of CMV-associated disease and CMV-specific antiviral therapy, which were evaluated by an independent, blinded Adjudication Committee, were similar in both treatment groups.