WASHINGTON – The biotech industry isn't so sure about the spin the House is putting on the America Invents Act, which aims to reform the U.S. patent system by placing it on a first-to-file basis like the rest of the world.
WASHINGTON – Instead of running dry, the drug pipeline for rare diseases may be flowing with hope. As of last month, more than 450 drugs were in clinical trials for rare diseases or awaiting FDA approval.
A lot is riding on the European approval of Plenadren. For patients with adrenal insufficiency, it could be the first innovative treatment in more than half a century. And for DuoCort Pharma AB, it could be a payday of up to nearly $165 million.That's how much ViroPharma Inc.
WASHINGTON – Still in the dark about how the government wants them to collect data about their payments to doctors beginning Jan. 1, 2012, drugmakers are seeking a little leniency and some swift clarity about what's expected of them under the Physicians Payment Sunshine provision.Since the Department of Health and Human Services (HHS) missed its Oct.
WASHINGTON – As the ball for the reauthorization of PDUFA bounces toward the congressional court, biopharma is keeping its fingers crossed that Congress doesn't interfere with the rules of the game that the FDA negotiated with industry over the past year.In urging Congress to act quickly to reauthorize PDUFA, the Pharmaceutical Research and Manufacturers of America (PhRMA) asked lawmakers to refrain from adding provisions that could delay the legislative process or create excessive regulatory burdens or uncertainty for the FDA, industry and other stakeholders.
WASHINGTON – When it comes to violations of the Federal Food, Drug and Cosmetic Act (FDCA), it's usually the FDA going after a drugmaker. But Par Pharmaceutical Inc. has turned the tables on the agency, saying the FDA is violating the FDCA and the First Amendment by restricting truthful speech about approved uses of Par's Megace ES.
While the FDA's efforts at transparency have had little impact on industry, a push for more transparency at the Centers for Medicare & Medicaid Services (CMS) could prove revolutionary.
WASHINGTON – Creating arbitrary subsets of patients to game the orphan drug process is one of the loopholes the FDA intends to close with a proposed amendment meant to clarify its orphan drug regulations.
