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Endotoxin testing milestone reached with European Pharmacopoeia’s animal shift
The quality control (QC) standards publication sets animal-free bacterial endotoxins testing (BET) as the new norm in Europe.
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Merck’s investigational anti-PD-1 antibody, pembrolizumab, under regulatory review in Europe for the treatment of advanced melanoma
30 June 2014 | By Merck
Merck announced the European Medicines Agency has accepted for review a Marketing Authorization Application for pembrolizumab (MK-3475)...
Tiziana Life Sciences PLC licensing agreement to develop stem cell based breast cancer diagnostic building an oncology franchise
30 June 2014 | By Tiziana Life Sciences
Tiziana Life Sciences announces that it has entered into an exclusive license agreement with TTFactor S.r.l...
CHMP recommends EU approval of Roche’s Avastin for platinum-resistant recurrent ovarian cancer
27 June 2014 | By Roche
Roche announced that the EU Committee for Medicinal Products for Human Use recommended that the European Commission approve the use of Avastin® (bevacizumab)...
Pfizer declares 26-cent third-quarter 2014 dividend
27 June 2014 | By Pfizer
The board of directors of Pfizer Inc. declared a 26-cent third-quarter 2014 dividend on the company’s common stock...
Gilead submits New Drug Application to Japan’s Pharmaceutical and Medical Devices Agency for sofosbuvir for chronic hepatitis C
27 June 2014 | By Gilead
If approved, sofosbuvir would be the first all-oral treatment regimen for patients in Japan with genotype 2 HCV...
GSK announces the start of a phase III study with eltrombopag in patients with myelodysplastic syndromes
26 June 2014 | By GlaxoSmithKline
GlaxoSmithKline plc announced the start of a Phase III study, SUPPORT (TRC112121), to evaluate the platelet supportive care effects of eltrombopag (Promacta™/Revolade™)...
FDA Advisory Committee votes on accelerated approval for investigational medicine olaparib
26 June 2014 | By AstraZeneca
AstraZeneca today announced that the US Food and Drug Administration Oncologic Drugs Advisory Committee voted 11 to 2 that current evidence from clinical studies does not support an accelerated approval for use of olaparib...
AbbVie announces initiation of pivotal Phase III study of Veliparib (ABT-888) in patients with advanced breast cancer
26 June 2014 | By AbbVie
AbbVie announced the initiation of a Phase III clinical trial evaluating the safety and efficacy of its investigational compound, veliparib (ABT-888)...
Fighting for their lives: Economist Intelligence Unit report finds patient groups lead global efforts to address hepatitis C
26 June 2014 | By Janssen Pharmaceutica
New report calls on governments to play their part and improve surveillance, screening and diagnosis of hepatitis C worldwide...
Tecan unveils Fluent™ laboratory automation solutions
25 June 2014 | By kdm communications
Tecan has introduced the Fluent™ laboratory automation solution, the latest addition to its world-class laboratory automation portfolio...
FDA accepts Merck’s NDA for fixed-dose combination of Raltegravir with Lamivudine
25 June 2014 | By Merck
If approved, fixed-dose combination would be used with other antiretroviral agents for the treatment of HIV-1 in adults, adolescents and certain pediatric patients...
Johnson & Johnson Innovation announces immuno-oncology lung cancer collaboration with the Dana-Farber Cancer Institute’s Belfer Institute for Applied Cancer Science
25 June 2014 | By Johnson & Johnson
Johnson & Johnson Innovation, Boston and Janssen Biotech, Inc. announced a three-year immuno-oncology lung cancer collaboration with the Dana-Farber Cancer Institute...
Merck names Michael J. Holston as future General Counsel; Will succeed Bruce N. Kuhlik in July 2015
25 June 2014 | By Merck
Merck announced the future appointment of Michael J. Holston as general counsel, effective July 01, 2015...
Phase 3 first-line melanoma study of Nivolumab, an investigational PD-1 checkpoint inhibitor, demonstrates superior overall survival compared to Dacarbazine; study stopped early
25 June 2014 | By Bristol-Myers Squibb
Bristol-Myers Squibb Company announced that a randomized blinded comparative Phase 3 study evaluating nivolumab versus dacarbazine in patients with previously untreated BRAF wild-type advanced melanoma was stopped early...
Abbott to acquire Veropharm
24 June 2014 | By Abbott
Abbott announced a definitive agreement to acquire Veropharm, a leading Russian pharmaceutical manufacturer...
