FDA to review Amgen’s Repatha as a treatment for high cholesterol
30 April 2015 | By Victoria White
The FDA will review data supporting Amgen’s Biologics License Application (BLA) for Repatha (evolocumab) for the treatment of high cholesterol...
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CoLucid Pharmaceuticals announces initiation of first Phase 3 pivotal trial of lasmiditan in migraine
30 April 2015 | By Victoria White
CoLucid Pharmaceuticals has announced that the first patient has been randomised in its SAMURAI study, the Company’s Phase 3 pivotal trial of lasmiditan...
FDA accepts supplemental Biologics License Application for Opdivo in patients with previously untreated advanced melanoma
30 April 2015 | By Victoria White
The FDA has accepted for filing and review the sBLA for Opdivo for the treatment of previously untreated patients with unresectable or metastatic melanoma...
Jacketed reactors for any application from Glass Solutions
29 April 2015 | By kdm communications
Glass Solutions has launched a range of jacketed reactor systems combining excellent value with reliable performance for process development, reaction optimization, or production applications...
amp biosimilars AG appoints Rolf G. Werner as Chairman of the Scientific Board
29 April 2015 | By Victoria White
amp biosimilars has announced Professor Dr Rolf G. Werner is to head up the Scientific Board as "Chairman of the Scientific Board", effective immediately...
FDA grants fast track designation to Genzyme’s investigational substrate reduction therapy for the treatment of Fabry disease
29 April 2015 | By Victoria White
The FDA has granted Fast Track designation for the development of Genzyme’s GZ/SAR402671, an investigational substrate reduction therapy for Fabry disease...
Merck announces publication of pivotal data from Phase 3 clinical studies of Zerbaxa
29 April 2015 | By Victoria White
Results from Phase 3 clinical studies of Zerbaxa in complicated urinary tract infections and complicated intra-abdominal infections have been published...
Toujeo approved in the EU for the treatment of diabetes in adults
29 April 2015 | By Victoria White
The EC has granted marketing authorisation in Europe for Sanofi’s Toujeo for the treatment of type 1 and type 2 diabetes mellitus in adults...
WHO report finds systems to combat antibiotic resistance lacking in all regions of the world
29 April 2015 | By Victoria White
A survey has revealed there are major gaps in actions needed across all six WHO regions to reduce spread of antibiotic resistance...
Half of heart stent patients don’t follow oral antiplatelet therapy regime as prescribed
29 April 2015 | By Victoria White
A recent survey has found that 52% of 275 ACS patients who were currently taking an oral antiplatelet have missed taking or changed the way they take it...
TxCell appoints Stéphane Boissel as Chief Executive Officer and promotes Miguel Forte to Chief Operating Officer
28 April 2015 | By Victoria White
TxCell has appointed Stéphane Boissel as CEO. In addition, Dr. Miguel Forte, previously SVP Clinical and Regulatory, has been promoted to COO...
ElectroCore’s non-invasive vagus nerve (nVNS) stimulation therapy shown to be safe and to produce no meaningful cardiac adverse effects
28 April 2015 | By Victoria White
Open-label trial shows electroCore’s nVNS therapy does not cause any meaningful cardiovascular adverse effects in patients with asthma...
Mylan rejects Teva’s $40.1 billion cash and stock offer
28 April 2015 | By Victoria White
Mylan has announced that its Board of Directors has unanimously rejected the unsolicited expression of interest from Teva to acquire the Company...
Nabriva Therapeutics presents data on lefamulin at ECCMID 2015
27 April 2015 | By Victoria White
Three posters on the Extended Spectrum Pleuromutilins (ESP) Programme and one poster on lefamulin were presented at ECCMID 2015...
New innovations in upstream and downstream bioprocessing on display at Interphex 2015
Thermo Fisher Scientific Inc., the world leader in serving science, is unveiling new bioprocessing technologies to address the evolving needs for enhancing the efficiency and productivity of global biopharmaceutical manufacturers. These advancements include single-use systems, purification, cell culture media, analytical systems, adherent cell culture, customized fluid transfer systems and laboratory…
