Any drugmaker knows that no matter what a drug's sticker price, its sales can only go as far as its patient pool will take it. So for Vertex, whose cystic fibrosis med Kalydeco had reached nearly all eligible patients in the U.S. and Europe, a new FDA approval to treat more CF sufferers is pretty significant.
Johnson & Johnson is moving ahead with its renal denervation program in the wake of Medtronic's major setback, winning CE marking for its Renlane renal denervation system, which doctors in Europe are already using to treat drug-resistant hypertension.
A European Medicines Agency committee has recommended approval for another COPD treatment from GlaxoSmithKline, setting the stage for a likely nod in the coming months as the drugmaker looks to bolster its respiratory franchise.
The FDA is taking steps to approve over-the-counter drugs and respond to safety concerns faster, a shift that the industry has been anticipating and which accounts for part of the reason so many drugmakers are in the process of buying or selling OTC units.
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.