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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.
FDA Releases Report on Personalized Medicine
A new report details FDA's role and responsibilities in personalized medicine.
Teva CEO Steps Down
Jeremy Levin, CEO and president of Teva Pharmaceutical Industries steps down , and interim successor named.
Hospira Opens New Quality Laboratory at North Carolina Plant
Hospira opens a new quality and analytical testing laboratory at its Rocky Mount, North Carolina plant.
Novartis Files Petition with FDA to Maintain Naming Policy for All Biologics
Novartis files Citizen Petition with FDA to maintain naming policy for all biologics to help ensure patient safety.
WuXi PharmaTech Completes Cell Culture Capacity Expansion
WuXi PharmaTech has completed a cell culture capacity expansion, including two 2000 L disposable bioreactors.
GSK, Gates Foundation Seek Heat-Stable Adjuvants for Vaccines
GSK and the Gates Foundation will invest a combined $1.8 million in early stage research into vaccine thermostability.
FDA Approves Extended-Release, Single-Entity Hydrocodone Product
Zhoydro ER is the first drug to have updated labeling now required for all ER/LA opioid analgesics.
SGS Life Science Services Opens Center of Excellence for Biophysical Analysis
SGS Life Science Services opens a Center of Excellence for Biophysical Analysis in the UK.
Novartis, Amgen, and Bristol-Myers Squibb Report Sales Up in Third Quarter
Big pharma companies Novartis, Amgen, and Bristol-Myers Squibb announce positive third-quarter 2013 results.
Beckman Coulter, Hach Company Combine Particle Characterization and Counting Businesses
Beckman Coulter Life Sciences combines its particle characterization business with the Hach Company particle counting business.
Amarin Cuts Staff Following FDA Vote
Amarin cuts staff in half after an FDA committee rejects its product label expansion.
FDA Awards 15 Grants to Stimulate Drug, Device Development for Rare Diseases
FDA has awarded 15 grants totaling more than $14 million to boost the development of products for patients with rare diseases.
FDA Takes Enforcement Action Against Dietary Supplement Manufacturer
FDA is seeking a permanent injunction against a dietary supplement manufacturer following the company?s repeated distribution of unapproved drugs and adulterated dietary supplements.
Novozymes Biopharma To Collaborate with Almac
Novozymes Biopharma will collaborate with Almac to provide a combined service for drug development applications.
Abbott Reports Third-Quarter 2013 Results
Abbott?s third-quarter 2013 global sales increased slightly but were affected by a disruption in the International Nutrition business.