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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.
AstraZeneca to Invest in New Manufacturing Facility for Injectable Drug
AstraZeneca will build a new facility in the United Kingdom to produce Zoladex, an injectable prostrate cancer treatment.
DCAT Names Officers
Lyra Myers, associate director and value creation agent at Roche, has been elected DCAT president.
Grifols Purchases Novartis Transfusion Diagnostics Unit
Grifols expands and diversifies portfolio with acquisition of diagnostic business.
BIO Throws its Support for Start-up Jobs and Innovation Act
Biotechnology Industry Organization President James Greenwood writes senators in support of Start-up Jobs and Innovation Act.
Novartis Announced as Facility of the Year Awards Overall Winner
ISPE names Novartis' US Flu Cell Culture facility as award winner.
ISPE Releases Report on Survey of Patient Experiences with Clinical Trial Materials
ISPE’s survey is industry’s first large-scale effort to collect data on patient experiences with clinical trial materials.
FDA Releases Pulmonary Tuberculosis Guidance
FDA releases guidance on pulmonary tuberculosis drugs.
DSM Pharmaceuticals Appoints Business Unit Director
DSM Pharmaceuticals appoints a new business unit director of its DSM Biologics/BioSolutions businesses.
J&J Fined $2.2 Billion for Off-label Marketing and Kickbacks
Allegations include off-label marketing for Risperdal, Invega and Natrecor and kickbacks to doctors and pharmacists.
DSM Signs Supply Pacts with Opthea and Sanquin
DSM Pharmaceutical signs manufacturing agreements with Opthea and Sanquin.
Repligen Completes Expansion of Manufacturing Facility
Repligen completes expansion of its manufacturing facilities at its Massachusetts headquarters.
Pfenex Awarded Subcontract by Leidos to Develop Malaria Antigen
Pfenex receives subcontract from Leidos to develop a production process for the malaria antigen Plasmodium falciparum reticulocyte-binding homolog 5 (Rh5).
FDA Grants KaloBios Pharmaceuticals Orphan Drug Designation for KB001-A
KaloBios Pharmaceuticals receives FDA Orphan Drug Designation for KB001-A in treatment of cystic fibrosis patients.
DSM Opens New Biopharmaceutical Manufacturing Facility in Australia
DSM Pharmaceutical Products opens a cGMP facility for biopharmaceutical contract manufacturing in Brisbane, Australia.
FDA Takes Actions to Prevent Drug Shortages
FDA releases a strategic plan and issues a proposed notification rule to improve prevention and resolution of drug shortage problems.