GSK to study injectable PrEP therapy | EMA releases analysis on challenges of CNS drug development | GSK seeks EMA approval for shingles vaccine
December 1, 2016
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GSK to study injectable PrEP therapy
GlaxoSmithKline will launch trials in Thailand and the Americas of HIV drug cabotegravir as an injectable pre-exposure prophylaxis drug. Injections offer privacy and steady levels of the drug and could be followed by long-acting implants.
Reuters (11/29) 
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Europe
EMA releases analysis on challenges of CNS drug development
Research on drugs for the central nervous system is more complex and has a higher failure rate during clinical development compared with treatments in other medical fields, according to an analysis published by the European Medicines Agency. More than a third of applications for CNS drugs had issues regarding clinical safety and efficacy in late-stage studies, and the agency advised that drugmakers be more careful in designing their early-stage studies to increase their chances of success.
Regulatory Focus (11/29) 
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GSK seeks EMA approval for shingles vaccine
A marketing authorization application has been submitted to the European Medicines Agency by GlaxoSmithKline for its shingles vaccine Shingrix. The filing was backed by late-stage study data that demonstrated the drug's ability to reduce the overall incidence of postherpetic neuralgia in addition to reducing the incidence of shingles.
PharmaTimes (U.K.) (11/28),  PharmaBiz.com (India) (11/28) 
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EU grants conditional approval to Takeda's multiple myeloma treatment
Takeda Pharmaceutical's Ninlaro, or ixazomib, has received conditional approval from the European Commission for use along with lenalidomide and dexamethasone as a treatment for multiple myeloma in adult patients who have received at least one previous therapy. Late-stage study data showed the combination treatment improved median progression-free survival compared with only dexamethasone or lenalidomide.
OncLive (11/28) 
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Asia Pacific
Trial begins for Micell's drug-eluting absorbable polymer coronary stent
The first patient in a randomized, double-blind trial of the MiStent SES sirolimus eluting absorbable polymer coronary stent in Japan has been enrolled by Micell Technologies. The 10-site study will compare target lesion failure after 12 months in patients who have coronary artery disease and are using the device with those using the Xience V everolimus eluting coronary stent.
Drug Delivery Business News (11/29) 
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Financing round brings in $260M for Chinese biotech
A Series D funding round has brought in $260 million for China-based Innovent Biologics. The funding will be used to broaden the firm's manufacturing capabilities and develop its pipeline of 12 compounds, including biologics and biosimilars.
BioCentury (11/29) 
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North America
Scripps researchers move opioid vaccines to human trials
The Scripps Research Institute has developed two types of opioid vaccines that could reduce the risk of addiction-related overdose death. Human trials are being planned, and the vaccines' effects lasted months in animal studies.
The San Diego Union-Tribune (tiered subscription model) (11/22) 
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House removes financial disclosure exemption from Cures bill
The House's proposed 21st Century Cures Act will not include a provision that would have exempted from disclosure rules drug and medical device industry payments for continuing medical education, textbooks and journals, according to a spokeswoman for Rep. Diana DeGette, D-Colo., one of the bill's sponsors. Sen. Chuck Grassley, R-Iowa, had threatened to hold up the bill if it contained the exemption.
STAT/Pharmalot (11/29) 
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Global
Parallel drug-price increases undercut effectiveness of competition
Manufacturers of competing drugs often raise their prices in tandem. Parallel increases can be legal as long as the companies do not coordinate.
The Wall Street Journal (tiered subscription model) (11/27) 
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Analysis predicts growth for global lumbar spine fusion market
A Market Reports World analysis predicts the worldwide lumbar spine fusion market will see a 4.9% compound annual growth rate through 2020 due to an increase in spinal disorder cases. Key market players include DePuy Synthes, Medtronic, Stryker, NuVasive and Zimmer Biomet.
BeckersSpine.com (11/29) 
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