December 21, 2016
FDA accepts Vernalis and Tris Pharma’s NDA for cough drug
U.S. Food and Drug Administration (“FDA”) has accepted Vernalis and Tris Pharma’s CCP-08 New Drug Application (“NDA”) for full review.…
Pharmaceuticals, Biotechnology and Life Sciences
Category: Approval
December 20, 2016
Pharnext enrolls patients for Charcot-Marie-Tooth disease study in Europe, US, and Canada.
A French biopharmaceutical company Pharnext set to produce treatments to tackle neuropathy diseases, has completed patient enrollment for its international…
December 20, 2016
GSKs two-drug HIV treatment regimen could become one tablet
Two phase III studies of two-drug HIV treatment regimen conducted by GSK’s HIV specialist ViiV Healthcare, Pfizer and Shinogi Limited,…
December 20, 2016
FDA approves Clovis Oncology’s new drug for advanced ovarian cancer
The U.S. Food and Drug Administration (FDA) has granted accelerated approval to orphan drug Rubraca (rucaparib) to treat women with…
December 20, 2016
Novartis, Conatus in borad deal to make treatments for liver diseases
Novartis and Conatus Pharmaceuticals have signed a multipurpose deal which will help the two drug makers to make liver-disease treatment,…
December 19, 2016
GSK/Ivannova study Relvar/Breo once-daily cobination
GlaxoSmithKline and Innoviva have started a phase III study to compare certain triple combination asthma therapy with a double combination…
December 19, 2016
FDA takes down highest warnings from Pfizer’s and GSK’s quitting smoking drugs
The U.S. Food and Drug Administration (FDA) has found that the mental-health side effect risk of Pfizer’s and GSK’s quitting…
December 19, 2016
Bangladesh-based drugmaker gets FDA’s approval for its generic Bristol-Myers’s diabetes tablets
Bangladesh-based drugmaker Beximco has received approval for its Bristol-Myers Squibb’s (BMS) generic equivalent Glucophage XR tablets, Metformin from the US…
December 19, 2016
Vertex announces German reimbursement agreement for its cystic fibrosis drug
Vertex Pharmaceuticals Incorporated has reached a pricing and reimbursement agreement for Orkambi (lumacaftor/ivacaftor) with the German Federal Association of the…
December 19, 2016
Hungarian Richter withdraws biosimilar drug marketing authorisation application from EMA
Gedeon Richter Plc., a Hungarian drugmaker has withdrawn its Marketing Authorization Application (MAA) from the European Medicines Agency (EMA) for…