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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.
Pfenex, BARDA Extends Anthrax Vaccine Pact
Pfenex modifies its contract with US government for Anthrax vaccine.
Carbogen Amcis Expands ADC Capacity
Carbogen Amcis has made several investments to increase capabilities in supplying antibody drug conjugates.
Waters Introduces Mass Detector for Chromatography Separations
The Waters ACQUITY QDa Detector is a mass detector designed to bring high-quality, mass spectral data to chromatographic separations.
FDA Activities Continue During Government Shutdown
During the ongoing federal government shutdown, FDA activities will be limited to work involving the safety of human life or the protection of property, and activities funded by carryover user fee balances PDUFA, GDUFA, and MDUFA.
PhRMA Report Shows New Vaccine Development
PhRMA report reflects robust R&D in vaccine development.
Ben Venue to Cease Production
The sterile injectable manufacturer Ben Venue decides to end production despite efforts to remediate cGMP violations.
Advanced Biosciences Laboratories, PATH Partner in Vaccine Production
Advanced Biosciences Laboratories will support the development and production of a novel Shigella vaccine candidate for PATH.
Malvern Instruments Acquires NanoSight
Malvern Instruments has acquired NanoSight, the UK-based nanoparticle characterization company.
Gallus BioPharmaceutical Aquires CMO Laureate Biopharmaceutical Services
he CMO Gallus BioPharmaceutical has acquired the biologics CMO Laureate Biopharmaceutical Services.
Soligenix Awarded Multimillion BARDA Contract for OrbeShield
Soligenix has been awarded a multimillion BARDA contract for the advanced preclinical and manufacturing development of OrbeShield, a treatment for gastrointestinal acute radiation syndrome.
Predictions: ADC, Single-Use Technologies, Regulatory Transparency
The first part of CPhI's Annual Expert Industry Report examines ADCs, single-use technology, and regulatory failure.
GSK Agrees to Sell Thrombosis Brands and Manufacturing Site to Aspen
GlaxoSmithKline?s sale of its thrombosis brands is part of a focus on its late-stage pipeline.
Fujifilm Diosynth Biotechnologies Opens New Manufacturing Facility
Fujifilm Diosynth Biotechnologies? new mammalian cell-culture facility uses primarily single-use technologies.
Merck Cuts 8,500 Positions, Moves Headquarters
Merck announced plans to reduce its workforce by 8,500 and move its headquarters in order to sharpen its commercial and R&D focus.
DSM Pharmaceuticals Appoints New CEO
DSM Pharmaceutical Products appoints a new CEO and President.
FDA Publishes ANDA Submission Guidance
FDA publishes guidance on ANDA submissions.
EMA Releases HIV Treatment Guideline for Consultation
EMA revises HIV treatment guideline.
