Topic:
Regulatory
Latest Headlines
Latest Headlines
Amarin gets BASF approved to make Vascepa
Amarin, which has been setting up a global network of contractors for manufacturing its fish oil product Vascepa so it is ready to go when it starts its hard push for the heart drug, has forged two more links in the chain of manufacturing facilities.
Don't confuse Kadcyla with Herceptin, FDA says
The FDA is picky about drug names. It's been known to reject brand monikers because they're too similar to others already out there in the market, worried that harried physicians and pharmacists might accidentally give patients the wrong one.
DEA finally acts on Belviq, clearing Arena for diet drug's launch
The DEA has made its decision on Belviq, the weight-loss drug that's been sitting on Arena's launching pad since its FDA approval last June. Belviq is now officially a Schedule IV controlled substance, and Arena can fire up its engines for a launch next month.
Device tax opponents take message to employees
Foes of the 2.3% tax on medical device revenue have been making their case to lawmakers for years, and now they're looping in the workers who could be affected by the charge, hosting sessions to educate employees on what they can do support the repeal effort.
Sanofi sees Shantha Biotech's Shan5 back in 2014
When Sanofi bought an 80% stake in Indian vaccinemaker Shantha Biotech in 2009, the talk was of the deal accelerating growth in emerging markets.Things played out a little differently though.
J&J gains pivotal PMA for computer-aided surgical sedation device
Johnson & Johnson achieved a pivotal FDA PMA approval for what is being billed as the first computer-assisted sedation system, now available for endoscopy procedures.
J&J's propofol administration device finally wins FDA nod
Johnson & Johnson won FDA approval for its Sedasys device to administer the sedative propofol.
Johnson & Johnson, Pfizer target painkiller revivals as FDA warms to abuse deterrents
The FDA has fueled a pharmaceutical arms race in the painkiller market with the agency's decision last month to bar the sale and production of generic OxyContin, which has become one of the most widely abused opioids among Americans.
Indian watchdogs pull J&J plant's license on baby-powder sterilization issue
South Korean regulators have forced Johnson & Johnson to halt production at an over-the-counter drug plant, and Indian watchdogs are doing the same at a consumer healthcare facility in their country.
Medtronic wins FDA nods for next-gen cardiac devices
Medtronic is padding its fleet of U.S.-approved cardiac devices, winning the FDA's blessing to market new Viva and Evera implants.
