Drugs
FDA has granted in part and denied in part a 4/2024 petition submitted by Healthy Women concerning the class labeling of fenofibrates and pemafibrate clinical data. The agency’s 6/6 response says Healthy Women asked FDA to: * revise the labeling for all currently approved fenofibrate drugs to (a)
Drugs
FDA has placed a clinical hold on Gilead’s HIV treatment trials of GS-1720, an investigational integrase strand transfer inhibitor, and GS-4182, an investigational capsid inhibitor, due to safety concerns. The agency action is based on the company’s “identification of a safety signal of decreases in CD4+
Drugs
The CDER Office of Prescription Drug Promotion (OPDP) says the Sprout Pharmaceuticals CEO made a false or misleading post about the company’s Addyi (fibanserin) tablets, for oral use, on her Instagram account. A 5/29 Warning Letter says the post made representations about Addyi’s benefits, failed to include
FDA Policy/General
Church & Dwight is recalling (Class 1) all lots of Zicam Cold Remedy Nasal Swabs, Zicam Nasal AllClear Swabs, and Orajel Baby Teething Swabs due to potential microbial contamination identified as fungi in cotton swab components. “Swabs found to contain microbial contamination can potentially present a significant risk to the
Drugs
FDA says a 4/17-5/3/2024 Bioresearch Monitoring Program inspection at American Behavioral Research Institute (ABRI) in Boca Raton, FL, found that the institute failed to submit an IND for a study evaluating the effects of Relaxium in subjects with sleep disorder. A just-released 4/30 Warning
Devices
AI researchers in the U.S. and Canada are calling on FDA to foster an agile, transparent, and ethics-driven artificial intelligence (AI) oversight system that can balance innovation with patient safety, ensuring that AI-driven medical technologies enhance, rather than compromise, healthcare outcomes. Writing in the open-source PLOS
FDA Policy/General
FDA commissioner Martin Makary and CBER director Vinay Prasad are listing five priorities for their vision of “a new FDA” that is based on gold-standard science and common sense. Writing in a JAMA Viewpoint article, the two say the agency “will transition from a purely reactionary healthcare system to
Drugs
Insmed is reporting positive results from a Phase 2b clinical trial of its once-daily inhaled therapy treprostinil palmitil inhalation powder (TPIP) and its use in treating pulmonary arterial hypertension (PAH). According to the company, the placebo-controlled trial met its primary and all secondary efficacy endpoints. The therapy showed
FDA Policy/General
After an 11-year stint at FDA, former regulatory counsel Jessica Ritsick has joined Alston & Bird’s FDA practice in Washington, DC., where she will counsel clients that design, manufacture, sell and distribute drugs, biologics, medical devices, food and other regulated products. During her career at FDA, Ritsick provided
Drugs
FDA has accepted for review an Innoviva Specialty Therapeutics NDA for zoliflodacin, an investigational first-in-class spiropyrimidinetrione oral antibiotic for treating uncomplicated gonorrhea in adults and pediatric patients 12 years and older. Innoviva says that if approved, zoliflodacin would be the first new antibiotic for treating gonorrhea in decades.
Drugs
A 5/5 executive order issued by President Donald J. Trump to increase domestic drug production includes an intention to conduct more unannounced inspections of overseas manufacturers to meet the level of scrutiny given to domestic firms. A Med Shadow post says the inspection policy could make a difference if
Drugs
Jaguar Health says it is planning to conduct a pivotal trial of crofelemer for cancer therapy-related diarrhea (CTD) in breast cancer patients. A recent Type C meeting with FDA led to agreement on the trial after the agency reviewed data from the company’s OnTarget trial, which did not
Drugs
FDA has granted Pheast Therapeutics a fast-track designation for PHST001 and its use in treating patients with advanced platinum-resistant ovarian cancer or in combination with chemotherapy in platinum-sensitive ovarian cancer. The company describes PHST001 as an investigational anti-CD24 monoclonal antibody designed to enhance innate immune recognition
FDA Policy/General
HHS says it is “totally reconstituting” the CDC’s Advisory Committee for Immunization Practices (ACIP), an advisory committee that makes recommendations on the clinical need of vaccines. The current 17 sitting ACIP members are being replaced with new members currently under consideration, HHS secretary Robert F. Kennedy Jr. says. “Today
Drugs
FDA has approved a Merck BLA for Enflonsia (clesrovimab-cfor) for preventing respiratory syncytial virus (RSV) lower respiratory tract disease in neonates and infants who are born during or entering their first RSV season. The long-acting monoclonal antibody is designed to provide direct, rapid and durable protection through five
Drugs
Axsome Therapeutics says it will conduct another clinical trial of fibromyalgia drug AXS-14 (esreboxetine) following an FDA refusal to file letter that found its NDA was not complete enough to permit a substantive review. The letter cited one of two placebo-controlled trials included in the submission because of
Drugs
Merck is announcing promising topline results from two Phase 3 clinical trials evaluating investigational enlicitide decanoate, an oral PCSK9 inhibitor for use in adults with hyperlipidemia already on statin therapy. The trials — CORALreef HeFH and CORALreef AddOn — met all primary and key secondary endpoints, showing significant reductions in low-density
Biologics
FDA’s full approval last month of Novavax’s Covid-19 vaccine is raising alarms due to its unusual delay and politically entangled review process that diverged from long-established regulatory norms, according to former agency and HHS officials writing in a 6/9 JAMA viewpoint article. The vaccine had
Devices
Baxter has recalled (Class 1 device correction) its Novum IQ large volume pump after becoming aware of the potential for underinfusion following use of the device’s “standby mode” feature, or if the device is powered off with the set loaded. “Keeping the administration set loaded in the pump for
Drugs
A House Agriculture, Rural Development, Food and Drug Administration Appropriations Subcommittee 6/5 markup voted 9 to 7 along party lines to vote out and advance the agency’s FY 2026 spending bill to the full committee. The budget bill is in line with the Trump Administration’s budget proposal
Drugs
FDA has approved a Phathom Pharmaceuticals citizen petition that corrects an agency Orange Book listing to recognize the “proper 10 years of new chemical entity exclusivity for Voquezna (vonoprazan) tablets, extending through 5/3/2032.” Phathom says it has in-licensed the exclusive rights to vonoprazan, a first-in-class
Drugs
Amneal Pharmaceutical is recalling (Class 1) three lots of sulfamethoxazole/trimethoprim tablets because they may exhibit black spots on their tablet surface due to microbial contamination. “Oral products contaminated with Aspergillus may result in serious and life-threatening infections,” a recall notice says. “The use of the defective product in