Beginning next week, the U.S. patent system will be in step with the rest of the world. But to keep pace, the Patent and Trademark Office (PTO) and industry will have to manage a steep learning curve as the nation switches from first-to-invent patent claims to a globally accepted first-to-file system.
Seeking to lift the veil on its approval process, the FDA released a draft five-year plan describing the steps it's taking to further develop and implement a structured benefit-risk assessment to be used in agency reviews of drugs and biologics.
Drugmakers with calcitonin salmon products under development for postmenopause osteoporosis (PMO) may have to do a lot more work to get the drugs approved following a joint FDA advisory committee meeting Tuesday.
The thin thread suspending Damocles' sword inches from federal budgets snapped Friday as Congress and the president threw up their hands on averting a sequester that will bring across-the-board cuts to most government programs, including those at the FDA and National Institutes of Health.
Depomed Inc.'s Serada could become the first approved nonhormonal therapy for menopausal hot flashes, but its advisory committee debut Monday doesn't look like it's going to be a walk in the park.
In a split decision that will make it more costly for drugmakers to defend against "fraud-on-the-market" class actions, the Supreme Court ruled against Amgen Inc., saying the company wanted to "put the cart before the horse" in its challenge to the certification of a shareholders class in a securities fraud suit involving statements about the safety of its anemia drugs, Epogen and Aranesp.
Despite what the New York Times and its echoers have said, makers of innovative biologics have legitimate reason to sound alarms about automatic substitution of biosimilars that have not proven their interchangeability – and it’s not just because of the potential impact to their bottom line. That point was driven home by the recent recall of Affymax Inc. and Takeda Pharmaceutical Co. Ltd.’s Omontys (peginesatide). Although Omontys is not a biosimilar, the unexpected postmarketing reports of serious hypersensitivity reactions linked to the erythropoiesis-stimulating agent (ESA) served as a reminder of the variability of biologics, their sensitivity to minute manufacturing changes...
Since the public pays for it, the public should have access to it. That's the reasoning behind a White House memo giving federal agencies six months to come up with a draft plan to make data from federally funded research publicly and freely accessible, while protecting intellectual property and other confidential information.
Provided budget constraints don't derail the FDA's plans, the agency is on track to begin conducting biennial inspections of all drug facilities, both domestic and foreign, in five years, according to FDA Commissioner Margaret Hamburg.
