November 19, 2015
(Edited) Dr Reddy’s refutes allegations
Dr. Reddy’s Laboratories has issued a press release reacting to certain statements that appeared in the certain media on Thursday.
Pharmaceuticals, Biotechnology and Life Sciences
Tag: featured
November 18, 2015
UK cost watchdog turns down Amgen’s new cholesterol drug
Amgen’s new injectable cholesterol drug Repatha has been turned down for use on Britain’s state health service, underscoring a worldwide debate about the value of such pricey medicines.
November 18, 2015
Anavex prepares for regulatory filings based on FDA guidance
Anavex is moving forward with the development program for ANAVEX 2-73 for the treatment of Alzheimer’s disease in a…
November 18, 2015
AmerisourceBergen in managerial changes. Adoption of proxy access
Steven H. Collis, the President and Chief Executive Officer (CEO) of AmerisourceBergen Corporation will succeed Richard C. Gozon as Chairman of the Board
November 18, 2015
Vertex gets EU approval for expanded use of its cystic fibrosis drug Kalydeco
The European Commission has approved expansion of the indication for Vertex Pharmaceuticals’ Kalydeco, to include children ages 2-5 with cystic fibrosis…
November 18, 2015
Hikma’s Portugal facility in compliance with US FDA
Hikma’s Portuguese facility back into compliance with the US FDA.
November 18, 2015
FDA accepts Sandoz regulatory submission for a biosimilar of cancer drug pegfilgrastim
The US Food and Drug Administration (FDA) has accepted Sandoz’s Biologics License Application (BLA) for its proposed biosimilar to Amgen’s US-licensed Neulasta (pegfilgrastim) – a recombinant human granulocyte colony-stimulating factor (G-CSF).
November 17, 2015
One dead, one injured in fire accident in Shasun’s API facility (India)
One worker died in a fire that broke out at India’s Shashun Pharmaceutical’s new production block during trial & commissioning in Cuddalore API facility on November 16, 2015.
November 17, 2015
Faron Pharmaceuticals Oy joins London stock exchange
Faron Pharmaceuticals Oy (Faron), the clinical stage biopharmaceutical company, has started dealing its Ordinary Shares on the AIM market of the London Stock Exchange with effect from 8.00 a.m. Tuesday after placing and subscription for 3,846,154 new Ordinary Shares, raising £10.0 million at a price of 260p per ordinary.
November 17, 2015
Gilead to early unblind Phase 3 study of Zydelig for chronic lymphocytic leukemia
Gilead Sciences, Inc. said Monday that its Phase 3 Study 115 evaluating Zydelig (idelalisib) added to standard therapy in previously-treated chronic lymphocytic leukemia (CLL) patients will be unblinded early.