The U.S. Senate and House of Representatives have not yet come to terms on FDA user fee legislation, a quinquennial source of melodrama that leaves the agency in an awkward position with current employees. However, FDA principal deputy commissioner Janet Woodcock said recently that prospective employees are also watching how Congress handles its business, adding that some of these pending hires may take jobs elsewhere rather than wait on Congress to send a user fee bill to the White House.
No one denies that fewer new drugs will be a consequence of the Medicare drug pricing provisions the Democrats are trying to push through the U.S. Congress ahead of the midterm election campaign season. Less attention has been paid to the negative impact on drug-device combinations and new diagnostics that accompany innovative treatments.
The controversies over the use of ethylene oxide (EtO) as a medical device sterilant were quelled by the COVID-19 pandemic, but the U.S. Environmental Protection Agency (EPA) has resurrected the issue.
The difficulty in resolving multiple rounds of patent litigation can foster a willingness on the part of both parties to settle their differences and go on their respective ways, which seems to be the end result of litigation between San Diego-based Illumina Inc., and subsidiaries of BGI Group of Shenzen, China. While Illumina is on the hook for a $325 million payout in this agreement, the company will receive a license to practice some of BGI’s affiliate’s patents, but the handshake also forecloses any further litigation over the disputed patents for three years.
A rash of recent announcements in the diabetes market speak to the brisk pace of developments and keen competition in the field. Dexcom Inc. reported good news in the U.K. and Europe, offset by delays in the U.S., while Insulet Corp. gave investors assurance that it was moving full speed ahead in the release of its Omnipod artificial pancreas system. On the pharma side, Arecor Therapeutics plc signed a contingent agreement to acquire Tetris Pharma Ltd. and commercialize Ogluo in the U.K., E.U. and other countries.
The U.S. Centers for Medicare & Medicaid Services (CMS) has wrapped up its rulemaking for the next Medicare inpatient prospective payment system, and several companies managed to score important rate-setting wins for their devices. Microtransponder Inc., of Dallas, won a new technology add-on payment (NTAP) for its Vivistim device for treatment of stroke, as did W.L. Gore & Associates Inc. for its TAG thoracic branch endoprosthesis (TBE), just two among several winner in the Medicare inpatient final rule for fiscal 2023.
Perkinelmer Inc. agreed to divest three businesses in a sale to private equity firm New Mountain Capital for $2.45 billion in cash to create a “pure-play, high growth, high margin life sciences and diagnostics company with unique scale,” said Perkinelmer president and CEO Prahlad Singh.
Think Surgical Inc. is deepening ties with South Korean company Curexo Inc. through a new development and distribution deal. Under the terms of the agreement, Think will have exclusive rights to distribute Curexo’s Cuvis-Joint robotic platform, including any additional technology, in the U.S. and other countries. The orthopedic robot is currently used by surgeons in Korea and India for pre-planning surgery.
Patent litigation is notoriously drawn out in some instances, as is the case with disputes between Boston Scientific Corp. (BSX), of Natick, Mass., and Nevro Corp., of Redwood City, Calif. However, the two announced Aug. 1 that they have come to terms over several lawsuits, with each enjoying the right to practice some of the disputed patents and Nevro taking in a net payment of $85 million.
Dyansys Inc. obtained its second greenlight from the FDA this month for its Primary Relief device to alleviate pain following caesarean-section birth. The company received 510(k) clearance for its First Relief system for painful diabetic neuropathy on July 18. Both systems stimulate nerves on the outer surface of the ear using a percutaneous electrical nerve stimulator (PENS) system.
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