While it's still unclear how long copycats will take to make a serious dent in GlaxoSmithKline's respiratory franchise once generic competition inevitably erodes sales of the $8.8 billion-selling Advair, Glaxo may soon have a new building block with European regulators' new recommendation for combo med Anoro.
Biogen Idec's hot-selling multiple sclerosis drug Tecfidera has to win reimbursement in individual European countries where governments have gotten stingy about parting with healthcare dollars. A decision Thursday by U.K. price watchdog NICE is an indication of the cost hurdles to be faced.
Global CRO Parexel International is looking to expand its regulatory consulting, launching a dedicated unit focused on the post-approval needs of drug and medical device developers.
The FDA accepted Merck's application for V503, a next-generation HPV vaccine designed to usurp Gardasil, setting the stage for a near-term approval and some likely blockbusting sales figures.
GlaxoSmithKline's lung drug Anoro Ellipta, key to rebuilding its respiratory franchise after megablockbuster Advair meets generic competition, won approval from European authorities.
The FDA and other regulators have made it clear they want drugmakers to audit their suppliers to make sure ingredients are safe and sound. The International Pharmaceutical Excipients Council has announced a handful of certifications of companies around the world as suppliers scramble to meet the new expectations.
GlaxoSmithKline says it's worried about adequate regulation for e-cigarettes, and it's pushing Europe to require more. After all, more red tape to cut through for e-cigarette makers can't hurt the British pharma giant, which competes against them directly with its Nicorette gum and other quit-smoking products.
The explosion in the size of pharma's global supply chain has left the FDA sometimes scrambling to focus its efforts to protect patients from subpar, dangerous and counterfeit drugs and ingredients. In a move to target those players and products that pose the biggest risk, the FDA will give a pass to some companies which don't.
In the last 15 months, HeartSine Technologies has continued to deal with a Class I global recall of its Samaritan defibrillators, after 5 patients died due to possible device malfunctions. But the FDA slapped the Irish company with a new letter warning that its post-recall actions have generally fallen short.
Medtronic scored both a CE mark and FDA 510(k) clearance for a super-small wireless cardiac monitoring device-implant, and the Minnesota device giant is now pursuing a global rollout.