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Using mAbs to Access Undruggable Targets
Monoclonal antibodies can facilitate the entry of radiopharmaceuticals into cells, David Scheinberg said at BIO 2015.
CPhI China Scheduled for Shanghai
CPhI China and co-located events bring together suppliers of raw materials, ingredients, packaging solutions, machinery, and manufacturing.
Teva’s Patent for Copaxone Invalidated
The ruling will facilitate the market entry of generic versions of Copaxone, a widely prescribed drug to treat multiple sclerosis.
FDA Fights Online Counterfeit Drugs
The agency takes action against websites that illegally sell unapproved medications.
ICH Moves Q7 Q&A Guideline on APIs to Implementation Stage
The International Conference on Harmonization finalizes Q&A document on APIs.
NIH Plan Addresses Sterile Manufacturing Deficiencies
NIH provides an interim corrective action plan to correct deficiencies found in its Clinical Center Pharmaceutical Development Section.
Biomax Informatics Collaborates with Pierre Fabre on Therapeutic Antibody Development
Biomax Informatics AG and Pierre Fabre announced that they have entered into a collaboration to create an integrated antibody sequence and knowledge database.
GSK Invests $95 Million in Gene Control Research
GSK announces it will invest $95 million to launch a US-based non-profit research institute, Altius, to research technologies and approaches in understanding gene control.
Grace Becomes Germany’s Eighth EXCiPACT Certified Site
EXCiPACT announces that DQS awarded Grace GmbH an EXCiPACT Certificate for its Worms, Germany excipient-manufacturing site.
FDA Launches New REMS Website
The agency streamlines risk and mitigation information.
Business Confidence in Pharma and Biotech Sectors Continue
EvaluatePharma's report shows upward trends in R&D and drug approvals.
Lonza Invests in Viral Gene and Cell Therapies Facility
Lonza’s planned facility will be used to develop and manufacture viral gene therapies and virally modified cell therapies
FDA Issues Guidance on Generic Tablets and Capsules
The agency publishes guidance on the physical attributes of generic tablets and capsules.
MFG Tray Recognizes Distributor
MFG Tray names ChemTech International as its first Master Pharmaceutical Distributor.
SGS to Open New QC Lab Near Paris
A new SGS Life Science Services laboratory outside Paris is designed for bio/pharmaceutical quality control testing.
Allergan Acquires Kythera for $2.1 Billion
Kythera announces that it entered into a definitive agreement to be acquired by Allergan for $2.1 billion.
A visit to Eppendorf’s cell culture lab at ACHEMA
Experts at Eppendorf discuss common challenges in cell culture and share insights on possible solutions.
Trends and Concerns in Capsule Production
Stan Matthews, sales manager, processing division at MG America, spoke with Pharmaceutical Technology about trends and concerns in capsule production.
Penn Announces Gene Therapy Collaboration with WuXi
The University of Pennsylvania announces that it will collaborate with WuXi AppTech to research and develop gene vectors derived from recombinant viruses.
BIO Stresses Innovation with Name Change
The Biotechnology Industry Organization announced a name change to the Biotechnology Innovation Organization, effective in early 2016.
Catalent expands packaging capabilities in Singapore
Catalent’s Singapore facility is awarded GMP certification.
Vetter Completes Expansion at Chicago Facility
Vetter completes on-site expansion activities of visual inspection and in-process control at Chicago facility.
PhRMA Elects New Members of Board of Directors
Bayer Healthcare, Bristol-Myers Squibb, Sucampo Pharmaceuticals, Takeda Pharmaceuticals, and Horizon Pharma representatives join PhRMA board.
West Breaks Ground on Facility in Ireland
West Pharmaceutical began construction on its component manufacturing facility located in Waterford, Ireland.
CQDM Invests with MaRS in Orally Bioavailable Peptide Drug Research
At BIO 2015, CQDM and MaRS Innovation announced an investment in Encycle Therapeutics to research chemical properties needed to make peptide-like molecules orally bioavailable.
EMA Launches Pediatric Drug Pilot Project
The agency creates initiative to stimulate pediatric drug development.
CPhI Announces New Award Categories
CPhI Worldwide announces five new categories for the 2015 CPhI Pharma Awards.
BPTF Calls for Changes to GDUFA
BPTF seeks changes in performance goals and fee payment schedule in GDUFA renegotiations.
New England Biolabs to Build Manufacturing Plant
A new GMP facility in Massachusetts will produce enzymes and other reagents for in-vitro diagnostics.
With Processes, It’s All About Optimization
With drug development trends shifting towards personalized medicines, new technologies are needed for the manufacture of these highly sensitive drug products.
