The Patent and Trademark Office granted 300,678 patents last year, up 8 percent from 2013, according to a new report from the Intellectual Property Owners Association (IPO), which lists the top 300 organizations in terms of patents granted. The list includes 21 drug- and device-makers, as well as a number of universities, institutes and conglomerates that conduct R&D related to prescription drugs, diagnostics or medical devices in addition to products in other fields.
Drugmakers are beginning to lower the cost and improve the efficiency of their R&D operations, and not just by slashing head count and shuttering facilities, according to a report from the Tufts Center for the Study of Drug Development. The report, Profiles of New Approaches to Improving the Efficiency and Performance of Pharmaceutical Drug Development, concluded that biopharmas are launching successful initiatives in four principal areas: 1) new approaches to validate drug targets, 2) integration of real-world data into the R&D process, 3) adoption of adaptive clinical trial designs and 4) implementation of green manufacturing techniques.
The Biotechnology Industry Organization issued a statement opposing an amendment to the 21st Century Cures Initiative legislation filed by Rep. Dave Brat (R-Va.) that would convert the mandatory funding for the NIH to discretionary funding.
Properly reporting and mitigating a potential drug shortage could cost drugmakers up to $40.5 million, the FDA said in a new rule finalizing amendments to its drug shortage reporting requirements. But those costs are far outweighed by the public health benefits of preventing or resolving a critical shortage that could delay life-saving treatment, cost lives or obstruct clinical trials. Today, 71 drugs are in short supply in the U.S., according to the FDA's drug and biologics databases. While that's down considerably from just a few years ago, current shortages of chemo drugs or even basic products like saline solution can have a big impact on patient care. "Shortages can also result in providers prescribing second-line alternatives, which may be less effective or higher risk than first-line therapies," the agency said.