Congressional 21st Century Cures initiative aims to accelerate device approvals and liberalize device marketing
Initial legislative proposals emerging from the 21st Century Cure Initiative to "accelerate the pace of cures in America" call for the FDA to "establish a program to provide priority review for breakthrough technologies that meet certain qualifying criteria," the document says.
After leapfrogging pharma stalwarts like Eli Lilly and Bristol-Myers Squibb with its 2014 revenue haul, Amgen is enjoying its new status as one of the industry's top-selling drugmakers. And it's hoping new regulatory filings for multiple myeloma drug Kyprolis can help it keep the sales leaps coming.
St. Jude Medical has won FDA approval for its FlexAbility Ablation Catheter. This is the first irrigated ablation catheter with a flexible tip to be available in the U.S. The technology is used by electrophysiologists in the treatment of cardiac arrhythmias.
Respiratory devicemaker PARI picked up an approval from the FDA for its eRapid nebulizer system, which is the first electronic one to deliver Genentech's cystic fibrosis treatment Pulmozyme.
Roche got an FDA green light for its drug-resistant MRSA/SA test, chalking up another regulatory win and expanding the company's offerings on its cobas 4800 system.
Medical device approvals continued at a steady clip in 2014 despite mounting pressure from lawmakers to roll out a more stringent review process.
The Marketing Authorization Application for SB4, the Enbrel (etanercept) biosimilar candidate developed by Korean biopharmaceutical company Samsung Bioepis, has been validated and accepted for review by the European Medicines Agency. It will become the first Enbrel biosimilar subjected to regulatory review in the European Union.
Boots on the ground underlies the expansion of Vygon, the specialist single-use medical devices group, into Singapore as Southeast Asia heads toward a regional economic pact and public and private hospitals mushroom in China and Indonesia.
MerLion Pharmaceuticals said it is in sustained talks with potenial investors to take its successful Phase II trials of a urinary tract infection application for its finaloxacin antibiotic into Phase III as it moves into a competitive landscape for the fluoroquinolone class of antibiotics with approval for an ear infection treament by the U.S. FDA.
The summit meeting between President Barack Obama and India Prime Minister Narendra Modi resulted in no breakthroughs, such as on intellectual property, but did lead to about a dozen smaller agreements on various issues affecting the pharmaceutical industries.