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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.
Johnson & Johnson Reports Third-Quarter 2013 Results
J&J announces 2013 third-quarter sales increased 3% over 2012 third-quarter sales.
Cornerstone Pharmaceuticals Receives FDA Orphan Drug Designation
The FDA grants Cornerstone Pharmaceuticals orphan drug designation for CPI-613 for the treatment of myelodysplastic syndrome.
Public Opinion Sought on USP Medicare Model Guidelines
The US Pharmacopeial Convention posted for public comments on its revisions to the USP Medicare Model Guidelines, which are posted for a 30-day public comment period, beginning Oct. 1, 2013.
PhRMA Reports 450 Medicines in Development for Rare Diseases
PhRMA reports 452 new medicines are in development for rare diseases, including genetic disorders, neurological conditions, infectious diseases, and autoimmune disorders.
Sartorius and BD Diagnostics Collaborate On Microbiological Diagnostics
Sartorius and BD Diagnostics plan to collaborate on ready-to-use, prefilled media products for microbiological applications.
California Governor Jerry Brown Vetoes Biosimilar Bill
Governor Jerry Brown cites physician notification requirements for dispensing biosimilars as premature in the absence of FDA specifications for interchangeability.
Genzyme to Expand Downstream Biologics Manufacturing Capacity
Genzyme will build a facility in Massachusetts to expand purification capacity for Fabrazyme (agalsidase beta).
AstraZeneca's MedImmune Acquires Spirogen and Strengthens Antibody-Drug Conjugate Capability
MedImmune expands its antibody-drug conjugate capability through acquisition and collaboration.
Roche Plans Major Biologics Manufacturing Investment
Roche plans multimillion biologic manufacturing expansions in California, Switzerland, and Germany.
Teva Announces Further Restructuring
The generic-drug manufacturer Teva Pharmaceutical Industries plans to cut 10% of its workforce.
Vetter Expands Filling Capacity
Vetter is investing $100 million to expand filling capacity in Germany and the United States.
Janssen Pharmaceuticals Forms Partnerships with CureVac and DCPrime
Janssen Pharmaceuticals collaborates with CureVac and DCPrime in vaccines.
ABC Laboratories Subsidiary to Relocate to Missouri
ABC Laboratories plans to move operations of its subsidiary, Morse Laboratories, based in California, to Missouri.