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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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Teva comments on receipt of first paragraph IV notice for COPAXONE® 40 mg/mL (glatiramer acetate injection) formulation
8 August 2014 | By Teva
Teva Pharmaceutical Industries Ltd. confirmed that it has received the first paragraph IV notice for its three-times-a-week COPAXONE® 40 mg/mL...
WHO statement on the meeting of the International Health Regulations Emergency Committee regarding the 2014 Ebola outbreak in West Africa
8 August 2014 | By The World Health Organization
The first meeting of the Emergency Committee convened by the Director-General under the International Health Regulations (2005) [IHR (2005)] regarding the 2014 Ebola Virus Disease outbreak in West Africa was held by teleconference on Wednesday, 6 August 2014...
WHO to convene ethical review of experimental treatment for Ebola
8 August 2014 | By The World Health Organization
Early next week, WHO will convene a panel of medical ethicists to explore the use of experimental treatment in the ongoing Ebola outbreak in West Africa...
Europe to boost cooperation with international partners on generics
7 August 2014 | By The European Medicines Agency
European system to be used as model to facilitate assessment of medicines...
Novo Nordisk increased operating profit in local currencies by 12% in the first six months of 2014
7 August 2014 | By Novo Nordisk
7% sales growth in local currencies driven by Levemir® and Victoza®...
Daiichi Sankyo and Charleston Laboratories announce collaboration
7 August 2014 | By Daiichi Sankyo
... to develop and commercialize novel, fixed-dose combination hydrocodone products for pain and opioid-induced nausea and vomiting in the US.
Stem cells: from bench to drug development
Working in stem cell research can be both immensely rewarding and notoriously challenging. One of the most prominent challenges is taking what are often exciting new advances in stem cell biology made in the research lab, and translating these into viable, impactful therapies for patients.
Is the Ebola virus a real threat for Europe and the US?
6 August 2014 | By Frost & Sullivan
“The Zaire Ebola virus causes a highly contagious and lethal hemorrhagic fever leading to the death of the infected individuals..."
EU approves Roche’s Avastin for platinum-resistant recurrent ovarian cancer
6 August 2014 | By Roche
First new treatment option for women in Europe in more than 15 years for most difficult to treat form of ovarian cancer...
Merck publishes 2013 global corporate responsibility report
6 August 2014 | By Merck
Merck issued its 2013 global corporate responsibility report...
Roche to acquire Santaris Pharma to expand discovery and development of RNA-targeting medicines
5 August 2014 | By Roche
Roche announced that it has agreed to acquire Santaris Pharma, a privately held biopharmaceutical company based near Copenhagen, Denmark...
Merck completes tender offer to acquire Idenix
5 August 2014 | By Merck
Merck announced the successful completion of the tender offer for all of the outstanding shares of common stock of Idenix Pharmaceuticals, Inc. at a purchase price of $24.50 per share...
Boehringer Ingelheim receives two FDA approvals
4 August 2014 | By Boehringer Ingelheim
Boehringer Ingelheim today announced the U.S. Food and Drug Administration (FDA) approved two different products at the end of last week.
Amgen announces Phase 3 ASPIRE trial of Kyprolis® in patients with relapsed multiple myeloma met primary endpoint
4 August 2014 | By Amgen
Amgen and its subsidiary, Onyx Pharmaceuticals, Inc., announced that a planned interim analysis demonstrated that the Phase 3 clinical trial ASPIRE met its primary endpoint of progression-free survival...
European Medicines Agency looks to stimulate better use of genomic data and biomarkers in medicines development and safety monitoring
4 August 2014 | By The European Medicines Agency
The European Medicines Agency has released a draft concept paper for public consultation outlining the key elements that will be developed in a guideline on good genomics biomarker practices...
