The FDA added its green light to Klox Technologies Inc.’s Lumiheal fluorescent and blue light therapy system with de novo clearance for scar management of post-surgical incisions. The system uses fluorescence biomodulation technology to activate cellular processes and treat skin and soft tissue disorders.
Cardiologist Robert Califf has been nominated a second time to lead the FDA, and drug pricing was again high on the agenda at the Dec. 14 Senate hearing for his nomination.
Even as it strives for self-reliance, India is struggling to wean itself off a reported 75% increase in med-tech imports from China. China led the contribution to India’s med-tech imports with ₹91.12 billion (US$1.2 billion) worth of goods in the 2021 fiscal year (April 2020 to March 2021), according to an analysis of data from India’s Department of Commerce by the Association of Indian Medical Device Industry (AIMED).
U.S. regulators continued to be plagued in 2021 with accusations of politicization, most of which revolved around the expansion of the COVID-19 vaccine. Despite the Biden administration’s avowed commitment to follow the science in regulatory decision-making, the White House COVID-19 Response Team appeared to jump ahead of the science Aug. 18 when it announced the Sept. 20 rollout of a nationwide booster program for all adults. The program called for boosters to be administered eight months after the final dose of the vaccine. But just a few days earlier, government health officials had stressed that boosters were only needed for people who were immunocompromised.
Minhai Biotechnology Co. Ltd. has won approval from the NMPA for its 13-valent pneumococcal conjugate vaccine, which makes it the third company with such a vaccine to be greenlighted in China.
India’s drug regulator has approved 31 fixed-dose combination (FDC) drugs out of more than 300 banned products, after an assessment by its drugs technical advisory board. It has also asked for more phase IV postmarketing data for 19 others.
PERTH, Australia – The Treasury Department is seeking feedback from industry stakeholders on its discussion paper on a patent box policy, which was first announced in the May 2021 federal budget.
For the first time ever, Canada will be granting patent term adjustments beginning in January. That’s welcome news for the biopharmaceutical and med-tech industries, and it’s long overdue, Jeffrey Morton, a partner at Snell & Wilmer LLP, told BioWorld.
Statements Cytodyn Inc. made about the potential for its investigational monoclonal antibody, leronlimab, to treat COVID-19 continue to reverberate with U.S. authorities.
