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.
While Congress and the president debate how best to postpone the broad federal spending cuts sequestration is set to inflict late next week, the president's top deficit reduction experts are calling for more targeted, but even deeper cuts – especially in health care.
If biopharma companies heed the advice of their patent attorneys, there will be a mad dash to the Patent and Trademark Office (PTO) over the next few weeks as firms rush to file new patents before the reforms of the America Invents Act (AIA) take effect March 16.
While other countries are building a strong lineup of biosimilars, the U.S. entry into the game could be delayed until 2022 – if Abbott Laboratories succeeds in making its case that allowing a biosimilar of a reference drug approved before March 23, 2010, would be an illegal government taking of private property.
Are risk evaluation and mitigation strategies (REMS) actually making any difference when it comes to drug safety? Enquiring minds at the Health and Human Services' Office of Inspector General (OIG) want to know. The trouble is the FDA doesn't have the data to answer the question.
With sequestration set to trigger in less than three weeks, the FDA, National Institutes of Health (NIH) and other federal agencies are preparing for the worst while still hoping to be spared.
