The European Commission has granted marketing authorization for Teva Pharmaceutical Industries' Lonquex (lipegfilgrastim) to commercialize in all twenty eight countries of the European Union plus Norway, Iceland and Liechtenstein. ...
Swiss drugmaker Novartis has announced that once-daily dual bronchodilator, Ultibro Breezhaler (QVA149), has achieved positive CHMP opinion for the treatment of chronic obstructive pulmonary disease (COPD). Ultibro Breezhaler was ...
Japan-based Takeda Pharma has received positive CHMP opinion for its three new type 2 diabetes therapies from the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP). The therapies include Vipidia ...
Tags: Therapies, CHMP Opinion
Prana Biotechnology has obtained approval from Austin Health Human Research Ethics Committee (HREC) to intiate a 12-month open-label, non-randomised, extension study of the PBT2-204 IMAGINE Study in patients with Alzheimer's disease. ...
Biogen Idec is seeking FDA approval for Plegridy (Peginterferon Beta-1a) as multiple sclerosis (MS) medication. The company submitted a biologics license application (BLA) to the FDA for its pegylated subcutaneous injectable candidate ...
Tags: Biogen IDEC, FDA Approval
Sanofi and Regeneron Pharmaceuticals have announced the commencement of patient enrollment in two Phase 3 rheumatoid arthritis (RA) trials, the COMPARE and ASCERTAIN trials, with Sarilumab. The first fully human monoclonal antibody ...
The US Food and Drug Administration (FDA) has approved Biogen Idec's Tecfidera (dimethyl fumarate), a new first-line oral capsule for people suffering from relapsing forms of multiple sclerosis (MS). Tecfidera reduces relapses and ...
Tags: FDA, Biogen capsule, multiple sclerosis
The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion on Gilead Sciences' marketing authorization application (MAA) for stribild. The once-daily, single tablet regimen ...
Tags: Stribild drug, Medicines, Medicine
US-based biotechnology firm DART Therapeutics is developing a selective androgen receptor modulator (SARM) drug candidate for Duchenne muscular dystrophy (DMD). DMD is a pediatric rare disease that affects approximately one in 3,600 boys ...
The US Food and Drug Administration (FDA) has accepted to review Sanofi's new drug application (NDA) of lixisenatide, a once-daily a glucagon-like peptide-1 receptor agonist (GLP-1 RA), for the treatment of adults with type 2 diabetes ...
Phytopharm has announced results of its Phase II, randomised trial of Cogane in unmedicated patients with Parkinson's disease. More than four hundred subjects with early-stage Parkinson's disease were randomly chosen to receive either ...
Tags: PhytopharmPhase II, randomised trial, Parkinson's disease
Neurim Pharmaceuticals has announced positive results from a phase II clinical study reviewing the efficacy and safety of piromelatine. The novel investigational multimodal sleep medicine has been developed for the treatment of patients ...
Tags: Neurim Pharmaceuticals, positive results, phase II clinical study
Concert Pharmaceuticals has developed AVP-786 (CTP-786 or deuterated dextromethorphan) and reached a milestone under Avanir Pharmaceuticals collaboration. Avanir completed first of a two-stage pharmacokinetic study of AVP-786 in healthy ...
Tags: Concert Pharmaceuticals, Avanir Pharmaceuticals collaboration, AVP-786
Clinical stage biopharmaceutical company Apogenix's Apocept (APG101) has won FDA orphan drug designation to treat myelodysplastic syndromes (MDS). Apogenix also announced the commencement of Apocept Phase I trial in MDS patients in ...
Tags: FDA, orphan drug, biopharmaceutical
American pharmaceutical company BioDelivery Sciences (BDSI) has completed the safety and tolerability trial of BEMA Buprenorphine/Naloxone (BNX), which is indicated for the treatment of opioid dependent patients. BDSI claims that BNX, ...
Tags: BioDelivery Sciences, BEMA Buprenorphine, opioid dependent patients