Drugs
Some biotech companies are considering moving drug trials overseas due to fears about instability in FDA staff and resources. Reuters reports from London that the companies worry that layoffs and policy changes at FDA may delay regulatory reviews. The article says the news service talked with seven biotech executives, investors,
Drugs
FDA has approved a Merck NDA for Welireg (belzutifan), an oral drug for treating adults and pediatric patients aged 12 and older with locally advanced, unresectable, or metastatic pheochromocytoma or paraganglioma (PPGL), which are rare neuroendocrine tumors. The approval marks a significant advance in the treatment of PPGL, offering a
Drugs
FDA has granted AbbVie accelerated approval for its Emrelis (telisotuzumab vedotin-tllv) for treating adult patients with locally advanced or metastatic, non-squamous non-small cell lung cancer with high c-Met protein overexpression. Approval was based on overall response rate and duration of response data. “Findings from the study
Devices
FDA has cleared a BrightHeart 510(k) for the B-Right Views, an artificial intelligence (AI)-powered tool that automatically detects the standard views required for second- and third-trimester fetal heart ultrasound evaluations within routine anatomy scans. “The software supports fetal heart exams by confirming when all recommended views
FDA Policy/General
In a 5/7 letter to HHS secretary Robert F. Kennedy, Jr., the Government Accountability Office (GAO) highlights open recommendations for FDA that it says warrant his attention. The letter particularly references a recommendation that HHS ensure effective FDA oversight. It says that protecting public health through enhanced oversight of
Drugs
A 10/14-10/17/2024 FDA inspection at BioAsia Worldwide Sdn Bhd in Sitiawan, Perak, Malaysia, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A just-released 3/25 Warning Letter says specific violations were: * failure to conduct at least one test to verify
Drugs
Cytokinetics says topline results from its Phase 3 MAPLE-HCM clinical trial demonstrated that investigational drug aficamten significantly improved exercise capacity in patients with symptomatic obstructive hypertrophic cardiomyopathy (HCM) when used as a stand-alone treatment. The study compared aficamten to metoprolol, a standard beta blocker therapy. According to the
Drugs
FDA has accepted for priority review a Regenxbio BLA seeking accelerated approval for gene therapy RGX-121 (clemidsogene lanparvovec) for treating mucopolysaccharidosis II (MPS II), also known as Hunter syndrome. The agency has set a user fee review action target date of 11/9. “Supported by positive biomarker data and
FDA Policy/General
An FDA 11/18-11/21/2024 inspection at the Taizhou Jingshang Cosmetics Technology Co. drug manufacturing facility in Taizhou, Zhejiang Province, China, identified significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A just-released 4/3 Warning Letter says the specific violations were: * failure to
FDA Policy/General
The CDER Office of Prescription Drug Promotion (OPDP) says a professional presentation for Mayne Pharma’s Nextstellis (drospirenone and estetrol tablets) for oral use makes false or misleading claims and presentations about the drug’s risks. A 4/28 Untitled Letter says the presentation speaker slide deck “creates a misleading
Drugs
GSK and development partner iTeos Therapeutics are ending the development program for belrestotug, an anti-TIGIT monoclonal antibody in previously untreated, unresectable, locally advanced or metastatic PD-L1 high non-small cell lung cancer. The decision is based on new interim analyses from the phase 2 GALAXIES Lung-201 and
Drugs
Former FDA commissioner David Kessler, who is using a popular weight loss drug to deal with the weight he gained while co-leading Operation Warp Speed during the Covid-19 pandemic, says FDA needs to develop a plan for the long-term use of the GLP-1 drugs. “There is
Devices
FDA has cleared a Capillary Biomedical 510(k) for its SteadiSet, a wearable infusion set that delivers insulin from a pump to the body for up to three days of use in Type 1 diabetes patients. The device features an integrated inserter with a hidden needle designed for one-handed
Devices
FDA has approved GE HealthCare’s ultrasound imaging agent Optison 9 (perflutren protein-type a microspheres injectable suspension) for use in pediatric patients. The drug, which contains gas-filled microbubbles that enhance the visibility of heart chambers and walls during ultrasound imaging, was previously approved for adult use in 1997.
Drugs
A 9/2024 inspection of Indian active pharmaceutical ingredient (API) manufacturer Mentha & Allied Products resulted in a just-posted 4/16 Warning Letter that cites the firm for significant GMP violations. The letter also takes issue with a 12/2024 response to the inspection’s Form FDA 483, saying
FDA Policy/General
FDA and HHS have launched a public Request for Information to “identify and eliminate outdated or unnecessary regulations.” An FDA statement says the initiative is part of a broader federal effort to reduce regulatory burdens and increase transparency in line with President Donald J. Trump’s Executive Order on “Unleashing
Drugs
An FDA 11/12-11/19/2024 inspection at the Excelvision drug manufacturing facility in Ardeche, France, identified significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 5/7 Warning Letter says specific violations were: * failure to thoroughly investigate any unexplained discrepancy or failure of a
Drugs
FDA 5/13 announced plans to remove from the market concentrated ingestible fluoride prescription drug products for children, citing safety concerns and a lack of formal approval. The products, typically prescribed for infants and toddlers, differ from fluoride toothpaste or mouth rinses because they are meant to be swallowed, an
Drugs
Assertio Therapeutics, formerly known as Depomed, has agreed to pay $3.6 million to resolve claims that it violated the False Claims Act by causing the submission of false claims for the transmucosal immediate-release fentanyl (TIRF) drug Lazanda for individuals who did not have breakthrough cancer pain. The fentanyl
Drugs
FDA has granted Thermosome an orphan drug designation for THE001 and its use in treating soft tissue sarcomas (STS). “In its decision, the FDA recognized that Thermosome's innovative doxorubicin-encapsulating thermosensitive liposomes may be clinically superior to currently approved non-liposomal forms of doxorubicin due to its potential
Drugs
In a head-to-head trial of two leading weight loss drugs, Eli Lilly’s Zepbound (tirzepatide) demonstrated significantly greater weight loss than Novo Nordisk’s Wegovy (semaglutide), according to new data from a Phase 3b clinical study cited by Lilly. The findings are from the SURMOUNT-5 trial and
Drugs
While FDA historically has no authority to regulate or set drug prices, under the Trump administration it appears the agency’s role is about to expand to help the White House implement a new executive order to bring the prices Americans and taxpayers pay for prescription drugs in line with