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GSK Plans Major R&D Overhaul
Pharma major aims to focus majority of R&D capital into priority therapy areas and plans to cut approximately 30 R&D programs.
Takeda in Anti-Cancer Pact Worth Up to $340 Million
Takeda Pharmaceutical partners with US biopharmaceutical company, TESARO, in deal worth up to $340 million to develop and commercialize PARP inhibitor.
Lonza Launches New Biomanufacturing Complex
Lonza introduces new modular complex that offers flexibility and individually tailored solutions to biomanufacturing challenges.
Corning and Gerresheimer Collaborate on Valor Glass
Corning and Gerresheimer have been working together to accelerate innovations for pharmaceutical glass packaging.
FDA Launches Expanded Access Tool
The agency is offering patients with life-threatening diseases a how-to tool on accessing investigational drugs.
Eli Lilly, Incyte RA Drug Delayed to Beyond 2017
Eli Lilly and Incyte face a roughly 18-month application delay for rheumatoid arthritis drug, baricitinib, in the US with a request from FDA for additional clinical data.
Recipharm and LIDDS Establish Industrial Manufacturing Capabilities for Prostate Cancer Drug
Recipharm set up a manufacturing line at its facility in Sweden using LIDD’s NanoZolid technology.
Testing and Sterility Deficiencies Found at Illinois Facility
FDA sent a warning letter to Sage Products, Inc. regarding CGMP failures involving test methods, sampling, and sterilization procedures.
Boehringer Ingelheim Expands Fremont Manufacturing Facility with $217 Million Investment
Manufacturing capacity will be increased by one third and approximately 300 new high-wage and highly-skilled jobs will be created at the Fremont site.
GE, Oritain Partner on Bovine Serum Traceability
GE Healthcare partners with Oritain for an independent test that can confirm the country of origin of fetal bovine serum (FBS), a component of biopharmaceutical production.
BioPhorum Launches Biomanufacturing Technology Roadmap
Industry collaboration group releases technology roadmap to address pressure on biopharmaceutical manufacturers to innovate biomanufacturing processes.
FDA to Lead International Effort to Secure the Supply Chain
The agency will lead an international team to create a Supply Chain Security Toolkit of resources to educate the pharmaceutical and healthcare industries on supply chain vulnerabilities.
Catalent and Rutgers University to Study Pediatric Drug Challenges
Catalent Applied Drug Delivery Institute announced a partnership with Rutgers University to examine the challenges of pediatric drug formulation and delivery.
Merck and Pfizer Collaborate with Corning to Modernize Pharmaceutical Glass Packaging
A Merck, Pfizer, and Corning collaboration resulted in development of Corning Valor Glass for improved drug storage and delivery and will create US jobs.
Report: Dose CMOs Stuck in Idle
Contract manufacturers await a promising pipeline of drug products to jump-start stagnant growth.
New Guide Outlines Risks for Cross Contamination
Updated ISPE guidance offers risk assessment guidance to avoid cross contamination in multiproduct pharmaceutical manufacturing facilities.
EMA Recommends Five Orphan Drugs
The agency recommended a total of 11 drugs at its July meeting, including five orphan drugs.
Avantor Opens New Collaborative Research Center in New Jersey
The Bridgewater facility will provide a range of contract services for biopharmaceutical and pharmaceutical manufacturers, and also serve electronics chemicals suppliers.
GSK Plans Changes to UK Manufacturing Network
GSK plans to invest in several UK manufacturing sites and to close its Slough site in conjunction with the sale of the Horlicks brand manufactured in Slough.
Alcami Relocates Headquarters to Research Triangle Park, NC
Alcami will move its headquarters to Durham, NC while maintaining its manufacturing and laboratory operations in Wilmington, NC.
Catalent Adds Early Development Offerings to OptiForm Platform
Catalent expands the scope of the OptiForm Solution Suite to bridge gap from late-stage discovery to Phase I trials.
Nitto Denko Avecia Announces Manufacturing Expansion
The addition of 20,000 sq. ft. of manufacturing and office space increases Avecia’s Milford, Ma, oligonucleotide capacity to 3.0 mol.
NIH Study May Lead to New Therapies for Neurodegenerative Diseases
Researchers have demonstrated how an investigational drug currently in testing works against Niemann-Pick type C1, which may lead to treatments for other similar disorders.
Tubilux Pharma S.p.A. Receives FDA Warning Letter
The agency cited the Italian company for aseptic processing failures.
Opioid Report Recommends Coordinated Effort to Fight Epidemic
The National Academies of Sciences, Engineering, and Medicine released a report on its findings on the opioid abuse epidemic, citing the need for a prescribing culture change.
GSK Ships Seasonal Influenza Vaccines for US Market
GSK plans to deliver up to 40 million doses of its quadrivalent flu vaccine for the 2017–2018 season.
Larger Peristaltic Pumps Allow Scale-Up for Biopharm Projects
Higher-flow peristaltic pumps from Watson-Marlow Fluid Technology Group are designed for upstream and downstream bioprocessing with single-use fluid path assemblies.
Industry Groups Applaud House Passage of FDARA
BIO and PhRMA issued statements expressing the groups’ approval of the continuation of user fee programs.
NIH Researchers' HIV Finding May Lead to New Treatments
The National Institutes of Health says researchers have found a way to block a step in the HIV invasion process that may lead to the development of new drugs.
FDA Warns India Facility Over Sterility Failures
The agency sent a warning letter to Vista Pharmaceuticals Limited for CGMP failures related to equipment cleaning and process control.
