Boston Scientific reports EU Spectra approval

By Galen Moore Boston Scientific (NYSE: BSX) on Friday announced it has European regulators’ approval to sell its Spectra spinal cord stimulator (SCS) system in Europe.  A BSX ...

NeuroPace’s epilepsy implant lands a date with the FDA after more than 2 years

By MassDevice staff More than 2 years after submitting its original premarket approval application, California device maker NeuroPace lands an FDA panel meeting to review its epilepsy-treating ...

Florida Asks FDA Approval to Eliminate Dengue Fever With Genetically Modified Mosquitoes

By DANIEL CLARK Mosquito control officials in the Florida Keys are awaiting approval from the federal government to begin releasing hundreds of thousands of genetically modified mosquitoes ...

Sunland Asking FDA for Permission to Shell Peanuts

BY NEWS DESK  The U.S. Food and Drug Administration (FDA) is under increasing pressure to at least allow the shelling of Valencia peanuts grown during the past season that are now ...

PAAB releases new pharmaceutical advertising standards

By Julius Melnitzer   The Pharmaceutical Advertising Advisory Board has revised its Code of Advertising Acceptance. The new version is available on the PAAB website and will ...

New drug policy to cut cap prices of 650 common drugs

By RUPALI MUKHERJEE MUMBAI: Prices of 652 commonly used medicines under 27 therapeutic areas are likely to come down by 10-15% once the National Pharmaceutical Pricing Policy 2012 ...

House panel seeks compounder group papers in meningitis probe

(Reuters) – A U.S. congressional committee that oversees drug safety issues has asked a compounding pharmacists’ industry association to provide documents on the group’s ...

FDA panel opposes pure hydrocodone painkiller

By MATTHEW PERRONE WASHINGTON—Government health experts overwhelmingly voted against a stronger version of hydrocodone on Friday, questioning the need for a new form of one of most ...

Cubist gets priority review for 2 antibiotics

By Don Seiffert wo late-stage antibiotic candidates being developed by Cubist Pharmaceuticals Inc. (Nasdaq:CBST) have been designated as Qualified Infectious Disease Products (QIDP) ...

High court to rule on ‘pay for delay’

The deals involve drug makers paying rivals to defer selling lower-priced generics. By David G. Savage WASHINGTON — The U.S. Supreme Court said it would decide whether pharmacy companies ...

Blood Thinner From Pfizer, Bristol-Myers Blocks Leg Clots

By Drew Armstrong Pfizer Inc. (PFE) and Bristol-Myers Squibb Co. (BMY)’s experimental drug Eliquis prevented blood clots in the legs and lungs and kept them from recurring, a study ...

This Week in Biotech

By Sean Williams With the SPDR S&P Biotech Index up 31% year to date, it’s evident that investment dollars are willingly flowing into the biotech sector. Keeping that in ...
© 2018 Global Regulatory Science. All rights reserved. Site Admin · Entries RSS · Comments RSS