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GSK Launches Cancer Research Consortium
GSK forms the Oncology Clinical and Translational Consortium, a scientific research network comprised of six international cancer centers.
Super Oversight for Generics
OGD is under pressure to improve review operations.
BMS Names New Board Member
Bristol-Myers Squibb has elected Thomas Lynch, Jr., MD to its board of directors.
Alvotech Plans Multimillion Biosimilars Investment
Alvotech plans investment in biosimilars portfolio and manufacturing facility.
LSNE Appoints New COO
LSNE appoints Shawn Cain as COO, a new position within the company.
European Medicines Agency Revises Orphan Drugs Policy
EMA revises its polices on fee reductions for orphan drugs for 2014.
TxCell's Manufacturing Facility Approved for Cell-Therapy Production
TxCell has received manufacturing accreditation status of its cell-therapy production site in Besancon, France, from the French National Agency for Drug Safety (ANSM).
SGS Poitiers Lab Receives GMP Certification
SGS Life Science Services announced that its bioanalytical laboratory in Poitiers, France has received GMP certification, following approval from ANSM.
President Obama Signs Drug Quality and Security Act
Drug Quality and Security Act gives FDA authority over compounding pharmacies.
USP and Other Organizations Unite in Campaign to Raise Awareness of Counterfeit Medicines
The international “Fight the Fakes” campaign will raise awareness about the dangers of counterfeit medicines.
Lilly Funds Start Up of Biosciences Research Institute
The Indiana Biosciences Research Institute will accelerate collaboration and focus on human-health solutions.
Merck KGaA Invests in Research Partnerships in Israel
Additional companies join Merck KGaA and Neviah Genomics in the Israel BioIncubator.
Almac Launches Logistics Support Services
Almac releases an enhanced third-party logistics customer billing application.
GSK and Amicus Therapeutics Revise Migalastat Agreement
GSK and Amicus Therapeutics revise Fabry agreement entered into in July 2012.
GlaxoSmithKline Plans Investment in Scotland
GlaxoSmithKline plans to invest nearly $41 million to expand its operations at its facility in Montrose, the United Kingdom.
EC Approves Acquisition of Life Technologies by Thermo Fisher, With Conditions
Thermo Fisher must divest of cell culture media and sera lines, and other businesses, in purchase of Life Technologies.
Coldstream Laboratories Names Head of Formulation Development
Coldstream Laboratories names director of formulation development.
Catalent, Pure MHC Partner
Pure MHC and Catalent sign an agreement to develop RL21A using Catalent's GPEx technology.
Catalent Opens Clinical Trial Supply Facility
Catalent opens clinical-trial supply facility in Shanghai, China.
Mylan Receives Approval for Biosimilar in India; Reaches Settlement with Teva on Copaxone
Mylan and the Indian biopharmaceutical company Biocon receive approval for a biosimilar version of trastuzumab in India. Also, Mylan and Teva reach settlement on Copaxone in the EU.
EMA Launches Vaccine Monitoring Project
European Medicines Agency announces the launch of the Accelerated development of vaccine benefit-risk collaboration in Europe (ADVANCE) project.
Merck KGaA Invests in China, Global HQ
Merck KGaA plans to build a new biomanufacturing facility in Nantong, China.
Catalent Signs RL21 Anti-Cancer Development Deal with Pure MHC
Catalent has signed a product development agreement with immunology company Pure MHC (major histocompatibility complex), which specializes in MHC-based diagnostics and therapeutics.
Pfizer and GlaxoSmithKline Form Pact in Combination Cancer Trial
Phase I/II study to evaluate treatment of patients with melanoma using Pfizer’s palbociclib and GSK’s trametinib.
Pharmaceutical Industry Growth Rebounds in Five-Year Outlook
Annual growth in spending for medicines is expected to rise from 2-3% in 2013 to 5-7% in 2017, the highest pace of growth since 2009.
Patheon to Merge with DSM Pharmaceutical Products
New CDMO to be formed from the combination of DSM Pharmaceutical Products and Patheon in a $2.6-billion transaction.
Collaboration Uses Next-Gen Sequencing for Biosafety Assessments
Covance Inc. and Pathoquest have announced a collaboration to provide next-generation sequencing based biosafety assessments to detect and identify viral contaminants within biologic compounds.
USP Seeks Experts for 2015-2020 Council of Experts
USP issues call for candidates for its 2015-2020 Council of Experts.
Eli Lilly Plans Insulin Manufacturing Investments
Ei Lilly announces investments in insulin manufacturing capacity for its sites in Indianapolis, Puerto Rico, France, and China.
Shire To Acquire Rare-Disease Company ViroPharma
Shire's agreement to acquire ViroPharma will strengthen its rare-disease portfolio.