When the U.S. Congress resumes next week, its top priority will be the passage of a massive budget bill that once again includes long-promised – or threatened, depending on a person’s perspective – provisions intended to bring down prescription drug prices.
Ono Pharma Korea Co. Ltd. has received approval in South Korea for Velexbru (tirabrutinib hydrochloride), its oral Bruton’s tyrosine kinase (BTK) inhibitor, as treatment of recurrent or refractory B-cell primary central nervous system lymphoma.
Given the negative response to a proposed amendment allowing the price of NHS-dispensed drugs to be listed on labeling, the U.K.’s Medicines and Healthcare Products Regulatory Agency (MHRA) has decided not to go forward with the policy, it announced Nov. 11.
Endovascular stent grafts for abdominal aortic aneurysms don’t generate the fanfare that other circulatory system devices create, but an FDA advisory panel recently made some extensive recommendations regarding postmarket follow up for these devices.
The FDA has taken a hands-off approach to general wellness products that take up residence in smartphones, but that doesn’t mean these products aren’t subject to regulatory drift.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Neuropace, Sight Sciences.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ascletis, Enlivex, Evofem, Iveena, Kalvista, Kyowa, Mei, Moderna, Modus, Pfizer, Promore, Sofie.
Kaléo Inc. agreed to pay $12.7 million to end whistleblower allegations that the Richmond, Va.-based company caused the submission of false claims for Evzio (naloxone hydrochloride), an injectable drug used to reverse opioid overdoses.
India is home to just one of several regulatory entities that have overhauled their med-tech regulatory apparatus in recent years, but the Central Drugs Standard Control Organization (CDSCO) has also joined the COVID-19 regulatory delay club as well.
Entities that lack experience in FDA regulation of medical devices may find the going both expensive and time consuming, but there are resources available to these players in the digital health space. Bakul Patel, director of the Digital Health Center of Excellence at the FDA’s device center, said that while he understands that reading through agency guidance is an unpleasant task, the companies that take the time to do so may find their interactions with the agency less iterative and more productive, thus speeding their path to market.
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