Drug Pipeline
FDA Reviewing Merck's Sugammadex
January 7, 2013 12:59 pm | News | CommentsFederal 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.
Empagliflozin Fares Well In Latest Trials
January 7, 2013 12:09 pm | News | CommentsEli 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.
Generic Lysteda Gets FDA Approval
January 3, 2013 4:08 pm | News | CommentsWatson 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 Resubmits Cholesterol Pill to FDA
January 2, 2013 5:37 pm | News | CommentsMerck & 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.
FDA Approves Fulyzaq
January 2, 2013 11:38 am | News | CommentsSalix 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.
First Tuberculosis Drug in 40 Years Approved
December 31, 2012 10:24 am | News | CommentsThe 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.
Eliquis Approved In Japan
December 26, 2012 10:31 am | by Linda A. Johnson | News | CommentsRegulators 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.
Fda Approves Aegerion Cholesterol Disorder Drug
December 24, 2012 9:25 am | News | CommentsAegerion 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.
Horizon Pharma Gets Nod for Arthritis Drug
December 21, 2012 10:19 am | News | CommentsU.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. Releases Positive Antibiotic Data
December 20, 2012 3:03 pm | News | CommentsMedicines 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.
Tredaptive Fails Massive Study
December 20, 2012 11:51 am | News | CommentsMerck 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.
Medivir Releases Phase 3 Results
December 20, 2012 11:25 am | News | CommentsResults 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.
Loulla Application Withdrawn from Consideration
December 20, 2012 11:11 am | News | CommentsThe 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.
EU Regulators Recommend Selincro Approval
December 19, 2012 11:43 am | News | CommentsThe 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.
Setback for Merck KGaA Cancer Drug
December 19, 2012 6:42 am | News | CommentsGerman 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.
Phase 2 Prostate Cancer Trial Begins
December 18, 2012 4:27 pm | News | CommentsTokai 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.
Positive Results from PDC31 Study
December 18, 2012 4:20 pm | News | CommentsPDC 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 Wraps Up HIV Trial
December 18, 2012 4:14 pm | News | CommentsBiotron 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.
Elvanse Moves Towards Approval
December 18, 2012 12:22 pm | News | CommentsShire 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 Kills TZP-102 Study
December 17, 2012 11:35 am | News | CommentsTranzyme 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 Achieves Trial Milestones
December 14, 2012 4:31 pm | News | CommentsViralytics 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 Continues Phase 2 Trial
December 14, 2012 4:21 pm | News | CommentsMedivir 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.
FDA Approves Anthrax Treatment
December 14, 2012 4:20 pm | News | CommentsFederal 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.
SM101 Shows Sustained Clinical Activity
December 14, 2012 12:01 pm | News | CommentsSuppreMol 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 Planning Phase 3 Trial
December 14, 2012 11:36 am | News | CommentsAOP 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.
