November 18, 2015
Hikma’s Portugal facility in compliance with US FDA
Hikma’s Portuguese facility back into compliance with the US FDA.
pharmaceutical daily
Pharmaceuticals, Biotechnology and Life Sciences
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 18, 2015
French academic Xavier Darcos to preside Sanofi
Sanofi has appointed Xavier Darcos as President of the Sanofi Espoir Foundation, who succeeds Jean-François Dehecq. Under Dehecq’s Presidency, According to the…
November 17, 2015
Allergan and CDC to raise awareness of the threat of antibiotic resistance
Allergan has joined forces with CDC to spread the word about Antibiotic Stewardship During “Get Smart About Antibiotics Week.” According…
November 17, 2015
Mylan launches generic version of Axert in US. $1B share repurchase plan authorized
Mylan N.V. has launch Almotriptan Tablets USP, 6.25 mg and 12.5 mg, the generic version of Janssen Pharmaceutical’s AXERT in the U.S.…
November 17, 2015
Advaxis to get $1.6M through New Jersey Technology Business Tax (NOL) Program
Advaxis, a clinical-stage biotechnology company developing cancer immunotherapies, has received preliminary approval for a $1.8 million tax credit from the New Jersey Technology Business Tax Certificate Transfer (NOL) Program for the year 2015.
November 17, 2015
Two hundred patients for Futura Medical’s MED2002 ED gel study
Futura Medical’s pivotal efficacy study of MED2002, a novel gel for the treatment of erectile dysfunction (ED) is underway and recruitment of patients for the study is proceeding well, with 118 patients having enrolled in the study to date.
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
Amgen showcases abstracts from Imlygic study at 12th International Congress of the Society for Melanoma Research
Amgen will present eight IMLYGIC (talimogene laherparepvec) abstracts, including data from the Phase 3 trial and new data from its Phase 1b combination trial with Merck’s anti-PD-1 therapy, at the 12th International Congress of the Society for Melanoma Research …