The U.K.'s Medicines and Health Care Products Regulatory Agency posted a series of draft new regulations that will increase the requirements for device makers doing business in the U.K.
The U.S. FDA declared that Michelle Tarver is the permanent replacement for Jeff Shuren as the director of the agency’s device center. The news is hardly a surprise as Shuren confirmed the appointment in an October 2024 public meeting.
Baxter International Inc., whose North Cove manufacturing site in Marion, North Carolina, was significantly impacted by the rain and storm surge from Hurricane Helene – including flooding of the facility – in September, reported that restoring the physical facilities has exceeded its expectations, with meaningful advances in site cleanup and remediation.
The U.K. National Institute for Health and Care Excellence endorsed the Qb Test by Qbtech AB of Stockholm to aid in diagnosis of attention deficit/hyperactivity disorder in those aged 6 to 17.
U.S. biotechs and regulators ushered in the era of gene therapy in 2023, experts at Bio Japan said, but medical reform is needed to pave the way for the “year of cell therapy” in 2024 and implement wider access to ultra-expensive cell and gene therapies.
Adcentrx Therapeutics Inc. has received FDA clearance of its IND application for ADRX-0405 for the treatment of select advanced solid tumors. A first-in-human phase Ia/b trial of ADRX-0405 in patients with select advanced solid tumors, including metastatic castration-resistant prostate cancer, will begin enrollment and dosing this quarter.
Legislation that would give the U.S. government a cut of some big pharma profits has once again surfaced in Congress. First introduced in the 114th Congress and every Congress since, the Medical Innovation Act was reintroduced Oct. 18 as a way to tap into the profits of some large biopharma companies to augment research dollars at the FDA and NIH for future drugs and diagnostics, as well as for regulatory science and to support early career scientists.
The first bispecific antibody to win regulatory approval is about to make a comeback 10 years after being taken off the market in Europe for commercial reasons. Catumaxomab, then called Removab, and now reborn with the brand name Korjuny, received a positive opinion for the treatment of malignant ascites from the EMA’s Committee for Medicinal Products for Human Use (CHMP,) at its monthly meeting Oct. 14 to 17.
The U.S. Supreme Court's landmark decision in the case of Loper Bright continues to reverberate across the legal landscape, including in the realm of False Claims Act litigation.
The U.S. FDA urged doctors and patients to use CT imaging if possible, when the MRI compatibility of any electronic implanted devices is unknown because problems with CT imaging are "extremely low" in these circumstances.
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