Drugs
FDA says the CDER Center for Clinical Trial Innovation’s Bayesian Statistical Analysis demonstration project supports the goal of increasing the use and understanding of Bayesian statistical methods in simple clinical trial settings across sponsors, CDER clinical reviewers, and CDER statisticians. An online post says the demonstration provides a structured
Drugs
The Federal Trade Commission and the Department of Justice Antitrust Division are scheduling three live-streamed listening sessions on aspects of the push to lower the cost of prescription drugs for Americans. “The listening sessions will focus on improving the affordability of pharmaceuticals by increasing generic and biosimilar availability and
Drugs
FDA has approved an AbbVie expanded label for Mavyret (glecaprevir/pibrentasvir) to include treating adults and pediatric patients three years and older with acute or chronic hepatitis C virus (HCV) infection without cirrhosis or with compensated cirrhosis. With this approval, the oral pangenotypic direct-acting antiviral therapy is the first
Drugs
FDA has approved a Nuvation Bio NDA for Ibtrozi (taletrectinib), a kinase inhibitor for adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer. Approval was based on data from two multicenter, single-arm, open-label clinical trials, TRUST-I (NCT04395677) and TRUST-II (NCT04919811), an FDA
Drugs
FDA commissioner Marty Makary says the agency will improve the communication channels between reviewers and companies to help speed innovation and medical product development. Makary shared this upcoming improvement in a just-posted podcast that discussed some of the feedback he and other officials are receiving as part of an
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
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
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
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
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
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
Drugs
Arvinas has submitted an NDA for vepdegestrant for treating patients with estrogen receptor-positive human epidermal growth factor receptor 2-negative ESR1-mutated advanced or metastatic breast cancer previously treated with endocrine-based therapy. The submission is based on results from VERITAC-2 (NCT05654623), a Phase 3 trial evaluating vepdegestrant
Drugs
FDA has published the International Council for Harmonization (ICH) Clinical Electronic Structured Harmonized M11 Technical Specification guidance. The document says its purpose is to be a technical representation of the ICH M11 protocol template. “This technical specification is aligned with the latest version of the ICH M11 guideline and protocol