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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.
Tips for Automated Washing
Careful choice of wash-water parameters and attention to water quality and basket loading are important for optimal cleaning.
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.
FDA Advisory Panel Backs Amgen's Repatha
An advisory panel deemed Amgen’s Repatha (evolocumab) to be safe overall.
REGENXBIO and WuXi AppTec Collaborate on Gene Therapy Manufacturing
The exclusive manufacturing collaboration will establish production for adeno-associated virus gene-therapy treatments incorporating REGENXBIO’s NAV Technology.
FDA Panel Recommends Approval of Praluent
An FDA advisory panel voted 13-3 in favor of approval of Sanofi and Regeneron Pharmaceuticals' cholesterol-homeostasis therapy Praluent (alirocumab).
Novasep Inks Partnership Agreements with Two Japan-Based Companies
The supplier will add Allied Laboratories and AR Brown to its list of global partners.
Mylan Launches First Generic Combination Therapy for Asthma
The product, marketed as Sirdupla in the United Kingdom, is the generic version of GSK’s beta agonist and corticosteroid combination treatment for asthma.
FDA Issues Guidance on Duchenne Muscular Dystrophy Therapies
The agency issues draft guidance on the development of drugs to treat Duchenne muscular dystrophy.
Patheon Files Registration For IPO
A year after its merger with DSM Pharmaceutical Products, Patheon announces that it has filed an IPO.
Will New PCSK9 Drugs Affect Overall Drug Spending?
As FDA advisory committees meet on two potential PCSK9 inhibitors, Prime Therapeutics analyzes the impact that this class of drugs may have on overall drug spending.
CMO Announces Distribution of Commercial Drugs from New England Facility
Lyophilization Services of New England announces inspection approvals that will allow its Bedford, NH facility to begin manufacturing commercial drugs for US distribution.
