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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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News
Student becomes first recipient of unique Strathclyde degree with GSK
4 July 2013 | By GlaxoSmithKline
A student has become the first to graduate from a landmark research programme run by the University of Strathclyde...
FDA grants Roche’s obinutuzumab (GA101) Priority Review for previously untreated chronic lymphocytic leukemia
3 July 2013 | By Roche
FDA decision on the GA101 BLA is expected by the end of 2013...
EMA approves extended Xaluprine shelf life
2 July 2013 | By Nova Laboratories Ltd
The European Medicines Agency has approved an extension of the in-use shelf life for Xaluprine...
Biogen Idec and Sobi present new data from the Phase 3 study of their long-lasting Hemophilia factor candidate ALPROLIX™
2 July 2013 | By Biogen Idec
Biogen Idec and Sobi presented new findings...
FDA grants Roche’s Perjeta regimen Priority Review for use before surgery in HER2-positive early-stage breast cancer
2 July 2013 | By Roche
The U.S. FDA has accepted the company’s sBLA for the use of a Perjeta®...
Roche Diagnostics has acquired Constitution Medical Inc.
2 July 2013 | By Roche
Strengthening Roche's commitment to hematology testing...
Merck receives Complete Response Letter for Suvorexant, Merck’s investigational medicine for insomnia
1 July 2013 | By Merck
“We will evaluate the requests outlined in the Complete Response Letter..."
FDA approves new U.S. labeling for ISENTRESS® (raltegravir)
1 July 2013 | By Merck
New U.S. labeling for ISENTRESS® (raltegravir) to include 240-week results from STARTMRK study...
GSK receives positive CHMP opinions for Tafinlar® (dabrafenib) and Tyverb® (lapatinib)
28 June 2013 | By GlaxoSmithKline
The EMA's CHMP is recommending marketing authorisation for two cancer drugs...
Genzyme receives positive CHMP opinion for LEMTRADA™ in Europe
28 June 2013 | By Sanofi
"Today’s CHMP opinions set the stage for the approval of two important new treatment options..."
Lyxumia® is first diabetes therapy of its class approved in Japan for use in combination with basal insulin
28 June 2013 | By Sanofi
Japan’s MHLW has approved the manufacturing and distribution of Lyxumia®...
AstraZeneca completes acquisition of Pearl Therapeutics
28 June 2013 | By AstraZeneca
AstraZeneca announced that on 27 June 2013 it completed its acquisition of Pearl Therapeutics...
Innovative genetic treatment to prevent mitochondrial disease
28 June 2013 | By Department of Health
Public consultation expected on draft regulations for IVF-based techniques to prevent mitochondrial disease later this year...
CHMP recommends EU approval of Roche’s subcutaneous Herceptin for HER2 positive breast cancer
28 June 2013 | By Roche
"Over the last 14 years, Herceptin has revolutionised the treatment of HER2-positive breast cancer..."
GSK’s drisapersen to receive FDA breakthrough therapy designation for potential treatment of patients with DMD
27 June 2013 | By GlaxoSmithKline
GlaxoSmithKline has received a verbal notification...
