Xlear Inc., of Salt Lake City filed a petition in U.S. district court that could terminate the Federal Trade Commission’s practice of demanding substantiation of health care claims.
The Department of Health and Human Services and private payers have promised to streamline the controversial prior authorization processes in a bid to reduce the attendant controversies.
Jyong Biotech Ltd. raised $20 million from its Nasdaq debut June 17 to advance a pipeline of botanical drugs targeting male urinary disorders. The New Taipei City, Taiwan-headquartered company’s shares began trading under the ticker MENS, and closed at $10.11 apiece at the bell, up 34.80% from its listing price of $7.50 per share. Shares had kicked up to $15 at opening, reaching double its offering price.
Avata Biosciences Holdings Ltd. and Oceanus Bio Inc. have inked a drug discovery and development deal worth up to $95 million for two of Avata’s cannabidiol compounds.
Using informed consent to do what Congress couldn’t, the U.S. FDA is flexing its regulatory authority to halt clinical trials that involve sending cells from American patients to China or other adversarial nations for genetic engineering and subsequent infusion back into the patient.
Barely a day before the eight new members of the U.S. CDC’s Advisory Committee for Immunization Practices (ACIP) are supposed to hold their first meeting, Sen. Bill Cassidy, R-La., called for the June 25 meeting to be postponed.
Post pandemic, Moderna Inc. is broadening the applications of mRNA technology to cancer, rare diseases, latent viruses and respiratory viruses, “taking advantage” of the revenue generated by Spikevax (elasomeran), its mRNA-based vaccine for COVID-19.
“I expressed deep concerns with your nomination, Secretary Kennedy, and somehow, unfortunately, you have exceeded my expectations in the worst possible ways,” U.S. Rep. Frank Pallone, D-N.J., told Health and Human Services (HHS) Secretary Robert Kennedy during a June 24 House subcommittee hearing.
Atopic dermatitis data from Nektar Therapeutics Inc. put investors even more in the mood for further results with rezpegaldesleukin (rezpeg), an IL-2 pathway agonist and regulatory T-cell proliferator, also in the works for severe to very severe alopecia areata.
Taking an unconventional path to market for its targeted therapies for RAS-addicted cancers, Revolution Medicines Inc. secured access to $2 billion in capital to build its own global commercial infrastructure, instead of partnering outside the U.S. as it had originally intended. “We’ve concluded that the best way for us to achieve our goals with our rich pipeline is to direct our own global development and commercial strategies and to operationalize these both inside and outside the U.S. through our own organization,” Mark Goldsmith, president and CEO of Revolution Medicines (Revmed), told investors June 24.
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