Federal regulators are taking another look at Merck & Co.'s experimental drug for reversing effects of anesthesia after surgery, the drugmaker said. If approved, sugammadex would be the first in a new class of medicines in the U.S. for reversing effects of certain drugs that relax muscles during surgery.
Eli Lilly and Co. said a potential diabetes treatment it is developing with German drugmaker Boehringer Ingelheim proved more effective than a placebo according to initial results from four several late-stage studies. Empagliflozin, aims to reduce blood sugar levels in patients with type 2 diabetes.
Watson Pharmaceuticals Inc. said that a subsidiary has received regulatory approval for a generic drug designed for the treatment of heavy menstrual bleeding. Watson said the tranexamic acid tablets are the generic equivalent to Ferring Pharmaceuticals' drug Lysteda.
Merck & Co. has resubmitted its application for a combination cholesterol drug to the Food and Drug Administration, which rejected the experimental medication in March. The drugmaker is seeking approval for a pill that combines a generic version of Lipitor, the top-selling drug of all time, with Merck's cholesterol medicine Zetia.
Salix Pharmaceuticals Ltd. said that the Food and Drug Administration approved its drug Fulyzaq, which is designed to treat diarrhea in patients taking HIV and AIDS drugs. The company said Fulyzaq could have up to five years of marketing exclusivity.
The Food and Drug Administration says it has approved a Johnson & Johnson tuberculosis drug that is the first new medicine to fight the deadly infection in more than four decades. The agency approved J&J's pill, Sirturo, for use with other older drugs to fight hard-to-treat tuberculosis.
Regulators in Japan have approved the use of an anticlotting drug developed by Bristol-Myers and Pfizer. Eliquis can be used as a treatment for a type of irregular heartbeat called atrial fibrillation in patients who are at risk for strokes or dangerous clots called systemic embolisms.
Aegerion Pharmaceuticals Inc. said that the Food and Drug Administration approved its drug Juxtapid, a treatment for a rare inherited disease that causes extremely high levels of bad cholesterol. The FDA approved Juxtapid as a treatment for homozygous familial hypercholesterolemia.
U.K. regulators will grant marketing approval to Horizon Pharma's arthritis combination pill, pending review of a few final documents, the company announced. Duexis is used to treat osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis.
Medicines Co. has reported positive results for an experimental antibiotic to treat skin infections. The company said oritavancin worked as well as an older antibiotic, vancomycin, in treating infections; including those caused by the hard-to-treat bacteria, methicillin-resistant staphylococcus aureus, or MRSA.
Merck will not seek U.S. approval for its cholesterol drug Tredaptive and is recommending doctors abroad stop prescribing it to new patients, based on study results. Results from a 25,700-patient study showed that adding Tredaptive to traditional statin therapy did not lower the risk of heart attack, stroke, or related problems.
Results from the QUEST-1 and QUEST-2 trials found that 80% and 81% of treatment-naive patients with chronic genotype 1 hepatitis C infection who were treated with simeprevir achieved sustained virologic response 12 weeks after the planned end of treatment.
The European Medicines Agency has been formally notified by Only For Children Pharmaceuticals of its decision to withdraw its application for a centralized marketing authorization for the medicine Loulla, 10 mg/mL, tablets and solution for oral suspension.
The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the granting of a marketing authorisation for Selincro, a medicinal product intended for the reduction of alcohol consumption in adults with alcohol dependence.
German pharmaceutical company Merck KGaA says a late stage trial of a new lung cancer drug has failed to meet expectations. The company, based in Darmstadt, says the drug Stimuvax did not improve the overall survival of patients in the Phase 3 study.
Tokai Pharmaceuticals Inc. announced the treatment of the first patient in the ARMOR2 trial, a Phase 2 clinical study of its lead candidate galeterone in patients with castration-resistant prostate cancer. ARMOR2 is Tokai’s second study to evaluate galeterone.
PDC Biotech GmbH has successfully completed a Phase 1 clinical trial for its lead compound for the treatment of preterm labor. This study was designed to evaluate safety as well as provide proof-of-concept for the ability of the compound to inhibit excessive uterine contractility.
Biotron has completed the clinical stage of a Phase 1b/2a trial of its lead HIV drug candidate, BIT225. Patients enrolled in the trial were HIV-positive, with high levels of virus and good CD4 T cell counts, and had not previously received treatment with anti-retroviral drugs.
Shire plc announces a positive outcome from the European Decentralised Procedure for Elvanse. Elvanse is indicated as part of a comprehensive treatment program for attention deficit/hyperactivity disorder when response to previous methylphenidate treatment is considered clinically inadequate.
Tranzyme has announced the end of a mid-stage study of a treatment for diabetic gastroparesis because it failed to outperform a placebo. The Durham, N.C., company said the study involved three daily doses of its treatment, labeled TZP-102.
Viralytics Limited in its ongoing US-based Phase 2 melanoma trial of its virotherapy candidate Cavatak has achieved an interim efficacy milestone of three objective responses. This follows a recent review by the independent data monitoring committee of the trial.
Medivir AB announced the initiation of cohort 2 in the interferon-free Phase 2 trial combining simeprevir with sofosbuvir based on a safety and efficacy planned interim analysis of cohort 1 including prior null responder HCV genotype 1 infected patients without advanced hepatic fibrosis.
Federal health officials say they approved a new injectable drug from Human Genome Sciences to treat inhalable anthrax. The Food and Drug Administration says raxibacumab will provide an alternative to antibiotic drugs that are currently the standard treatment for anthrax infection.
SuppreMol GmbH announced interim results from an ongoing Phase 1b/2a clinical trial in ITP patients. Three out of four patients treated with 12 mg/kg of SM101 showed a clinically important and sustained increase in platelet count after a single cycle of treatment with SM101.
AOP Orphan Pharmaceuticals AG announced that based on promising Phase 2 data it will initiate a Phase 3 trial to support European Marketing Authorization of a novel mono-pegylated Interferon alpha 2b (AOP2014/P1101) for treatment of polycythemia vera.