What with federal Sunshine reporting, state transparency rules and a Medicare data dump, drugmakers are awash in a sea of data that could come back to swamp them.
Hoping for a checkmate, generic drugmakers petitioned the Supreme Court Monday to either clear the board for a late May launch of generic versions of Copaxone or force Teva Pharmaceuticals USA Inc. to post a hefty bond to reimburse them for their losses if its final patent on the multiple sclerosis (MS) drug remains struck down on appeal.
In striking down Roche AG's method of osteoporosis treatment claims for once-monthly Boniva, the Federal Circuit may have raised the bar for using a life cycle approach to protect blockbuster drugs from generic and biosimilar competition.
The U.S. Patent and Trademark Office (PTO) is looking to the power of the crowd to strengthen the quality of patents by weeding out claims that aren't innovative.
Including the patient voice in the drug approval process could produce a fundamental shift in the risk-benefit equation of a new drug. But first, the FDA has to figure out how to do it, and that may take a broader societal discussion, FDA Commissioner Margaret Hamburg said. Speaking at the annual meeting of the Pharmaceutical Research and Manufacturers of America, Hamburg ticked off a few issues that we as a society must address. For instance, in the absence of a cure, patients with chronic or terminal diseases want a better quality of the life they have left. But the FDA...
Lengthening delays in the Drug Enforcement Administration's (DEA) scheduling of new prescription drugs as controlled substances are impeding patient access to much-needed therapies and could be costing lives, a House subcommittee was told during a hearing on legislation intended to improve transparency and predictability at both the DEA and FDA.
In the midst of escalating criticism about its approval of Zohydro ER (hydrocodone), the FDA approved Kaleo Inc.’s Evzio (naloxone autoinjector) to rapidly reverse an opioid overdose.
Anticipating FDA approval early next year of its infliximab biosimilar, Celltrion Inc. is trying to clear the patent path so it can launch Remsima in the U.S. as soon as the approval comes down.
If the FDA approved drugs and devices based on the populations adequately tested in clinical trials, most medical products would be indicated only for white men younger than 65.
Citing the need for a bigger arsenal in the war against infectious diseases, the FDA’s Anti-infective Drugs Advisory Committee (AIDAC) unanimously supported approval Monday of two new weapons to treat acute bacterial skin and skin structure infections caused by certain gram-positive bacteria, including methicillin-resistant Staphylococcus aureus (MRSA).
