Drugs
Roivant says its Kinevant Sciences unit is discontinuing its development of namilumab for treating sarcoidosis after a Phase 2 study failed to show treatment benefit. The Phase 2 RESOLVE-Lung study (NCT05314517) “failed to meet the primary endpoint of proportion of subjects with a rescue event during the double-blind
FDA Policy/General
Applying lessons learned from the Covid-19 public health emergency in terms of speeding the dissemination of FDA recommendations and policies to industry and other interested parties, agency staff, and patients and consumers, FDA has issued a 2024 Report and Plan on Best Practices for Guidance. The final report follows
Devices
FDA has published a guidance, Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions, to provide a “forward-thinking approach to promote the development of safe and effective artificial intelligence-enabled medical devices.” The document specifically provides recommendations on the information to include
Drugs
A 3/18-3/22 FDA inspection at the LCC Ltd. drug manufacturing facility in Chungcheongbuk-do, South Korea, found significant violations of current good manufacturing practice (CGMP) regulations and unapproved new drug violations. An 11/21 Warning Letter says specific CGMP violations were: * failure to test samples of each
Drugs
FDA has granted Merck a breakthrough therapy designation for sacituzumab tirumotecan (sac-TMT) and its use in treating patients with advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) mutations (exon 19 deletion [19del] or exon 21 L858R) whose disease progressed on or
Biologics
The House Select Subcommittee on the Coronavirus Pandemic has issued its final 550-page report that generally praises actions taken under the Trump administration and criticizes actions taken by the Biden administration. A committee statement (including a link to the full document) says “After Action Review of the Covid-19
Drugs
An FDA 4/29-5/3 Bioresearch Monitoring Program inspection at Applied Therapeutics in New York, NY, found that the firm did not adhere to the applicable statutory requirements and regulations governing the conduct of clinical investigations. The findings are presumably related to FDA’s recent action to issue a
FDA Policy/General
Federal Register notice: FDA is announcing that a priority review voucher was issued to PTC Therapeutics for its qualified rare pediatric disease product Kebilidi (eladocagene exuparvovec-tneq), which was approved 11/13 for treating adult and pediatric patients with aromatic L-amino acid decarboxylase deficiency. To view the notice, click
FDA Policy/General
Federal Register notice: FDA is reopening the comment period associated with a 10/21 public meeting on ‘‘Advancing Smoking Cessation: Food and Drug Administration and National Institutes of Health Priorities.” The meeting addressed the need for novel smoking cessation products to help individuals stop smoking. The agency says reopening the
Drugs
FDA has accepted for review a Cytokinetics NDA for aficamten, a cardiac myosin inhibitor for treating obstructive hypertrophic cardiomyopathy (HCM). The agency set a user fee review action target date of 9/26/2025. The submission is based on data from the Phase 3 SEQUOIA-HCM pivotal trial, which demonstrated
Devices
Baxter is recalling (Class 1 device correction) its AK 98 dialysis machines based on recent recalls by other manufacturers related to the potential risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated biphenyls (PCBs) when using certain peritoneal dialysis and hemodialysis devices. Baxter says
FDA Policy/General
Federal Register notice: FDA is making available a final guidance entitled “Use of Circulating Tumor DNA for Curative-Intent Solid Tumor Drug Development.” The document is intended to help sponsors planning to use the biomarker in cancer clinical trials or to support marketing approval of drugs and biological products for
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension entitled “Financial Disclosure by Clinical Investigators.” The collection supports FDA regulations that require applications relying on clinical studies to include a complete list of clinical investigators who participated in a covered clinical study. The investigators must either certify
FDA Policy/General
Federal Register notice: FDA is announcing a 1/10 Anesthetic and Analgesic Drug Products Advisory Committee meeting. Panel members are scheduled to discuss a Seikagaku Corp. BLA for condoliase injection and its proposed indication for treating radicular leg pain associated with lumbar disc herniation in adults. To view the notice,
FDA Policy/General
Former FDA Commissioner Scott Gottlieb (Trump Administration’s first term) is predicting a difficult hurdle for Robert F. Kennedy Jr. to win Senate confirmation as HHS secretary due to his extreme vaccine hesitancy stance. Gottlieb said this during an 11/29 appearance on CNBC’s “Squawk Box,” where he also
Drugs
Johnson & Johnson has submitted two supplemental BLAs for Tremfya (guselkumab) for treating children six years and older with moderate-to-severe plaque psoriasis (PsO) and children five years of age and older with active juvenile psoriatic arthritis (jPsA). Tremfya is currently approved for treating adults with moderate to severe
Drugs
FDA has issued Applied Therapeutics a complete response letter on its NDA for govorestat, a central nervous system-penetrant aldose reductase inhibitor (ARI) for treating classic galactosemia. The letter cited “deficiencies in the clinical application,” the company says, adding that it is requesting a meeting with the agency to discuss
Devices
FDA has approved a Mentor Worldwide PMA for its MemoryGel Enhance Breast Implants for primary and revision reconstruction breast surgery in women. The silicone gel-filled implant line “features an expanded range of base widths, projections, and volumes in an entirely new range of sizes extending from 930 cc to
Drugs
FDA has published a guidance, Use of Circulating Tumor DNA for Curative-Intent Solid Tumor Drug Development, to help sponsors planning to use circulating cell-free plasma-derived tumor DNA (ctDNA) as a biomarker in cancer clinical trials conducted under an IND and/or to support marketing approval for drugs
Drugs
FDA has released the form FDA-483 issued following a 5/18-5/26/2023 inspection at the Patheon Italia sterile drug manufacturing facility in Monza, Italy. The four inspection observations were: * aseptic processing areas are deficient regarding the system for monitoring environmental conditions; * failure to establish, write, and follow
FDA Policy/General
Federal Register notice: FDA is making available a draft guidance entitled “Recommended Follow-up Testing for an Ames-Positive Drug (Active Ingredient) or Metabolite To Support First-in-Human Clinical Trials With Healthy Subjects.” The document provides recommendations on follow-up testing for Ames-positive active ingredients in circumstances when
FDA Policy/General
Federal Register notice: FDA is making available a draft guidance entitled “Assessment of Ovarian Toxicity in Premenopausal Adults During Drug Development for Oncologic Products.” The document provides recommendations on the measurement of ovarian toxicity using clinical measures and biomarkers of ovarian function in relevant cancer clinical trials that enroll premenopausal