Drugs
FDA has accepted an Antag Therapeutics IND for its lead molecule, AT-7687, to begin a Phase 1 clinical trial to evaluate its safety, tolerability, and pharmacokinetics in both healthy lean and healthy obese subjects. The study will also explore AT-7687 as a monotherapy and in combination with Novo
Devices
FDA has published a list of three final guidances and 18 draft guidances it intends to publish in FY 2024. The list also shows two final and one draft guidances the Center says will be published as guidance development resources permit. The final guidance topics it intends to publish are:
Drugs
In a 10/8 letter denying a Parenteral Technologies petition regarding enforcement of directions for pediatric acetaminophen, FDA indicates it intends to issue a proposed safety order on pediatric acetaminophen that addresses dosage strengths of oral, single-ingredient pediatric acetaminophen products, and will propose adding weight- and age-based dosing
Devices
The Department of Justice says Magellan Diagnostics, headquartered in Billerica, MA, was sentenced in a Massachusetts federal court on 10/9 for criminal charges related to concealing a device malfunction that produced inaccurately low lead test results. A department statement says the company pleaded guilty to two counts of introducing
Drugs
FDA has approved Genentech’s Itovebi (inavolisib) with palbociclib (Pfizer’s Ibrance) and fulvestrant (Faslodex) for adults with endocrine-resistant, PIK3CA-mutated, HR-positive, HER2-negative, locally advanced or metastatic breast cancer as detected by an FDA-approved test, following recurrence on or after completing adjuvant endocrine therapy. An agency
Drugs
FDA has approved an IDE for Iota Biosciences, an Astellas Pharma subsidiary, to conduct a feasibility study of its investigational implantable device designed to deliver electrical stimulation directly to the bladder wall to stimulate contractions that assist with bladder emptying in individuals impacted by underactive bladder (UAB). The condition is
Drugs
A recently released FDA final guidance on electronic records and systems used in clinical trials has a broader scope than proposed in an earlier draft guidance, according to an analysis by attorneys at Hogan Lovells. The prior version, Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and
Drugs
Teva Pharmaceuticals has agreed to pay $450 million to resolve two civil cases that allege the company violated the Anti-Kickback Statute (AKS) and the False Claims Act (FCA). In one kickback settlement, Teva has agreed to resolve separate allegations that it conspired with other generic drug manufacturers to fix
Drugs
FDA has released the eight-page form FDA-483 issued following an 11/13-11/21/2023 inspection at the Nanchang Anobri drug product manufacturing facility in Nanchang City, China. The 12 inspection observations were: * failure to fully follow the quality control unit’s applicable policies and procedures; * failure to
Devices
Zyno Medical is recalling (Class 1 device correction) various models of its Z-800 Infusion System because there is a defect in the air in-line software algorithm. FDA determined the cause to be related to the firm’s “process change control,” according to a recall notice. An “Urgent: Medical
Drugs
A bipartisan group of 21 House members is urging FDA to take additional actions to minimize the potential for disruptions to the drug supply and patient care as the stabilization period for implementation of the Drug Supply Chain Security Act (DSCSA) ends on 11/27. In a 10/7 letter
Drugs
Neuvivo has submitted an NDA for NP001 (sodium chlorite infusion) to treat amyotrophic lateral sclerosis (ALS, also known as Lou Gehrig’s disease). The investigational treatment aims to “restore balance over uncontrolled inflammation within the body’s own innate immune system,” the company says, adding that it targets ALS from
Drugs
The FDA Science Advisory Board New Alternative Methods (NAMs) Subcommittee says the agency should create a centralized office to coordinate work on NAMs to evaluate regulated products while reducing dependence on animal testing. A Regulatory Affairs Professional Society (RAPS) report on the Science Board 10/7 meeting (includes links to
Biologics
GSK says the latest trial data on its Arexvy respiratory syncytial virus (RSV) vaccine indicate protection through three RSV seasons. A company statement says Arexvy is the only RSV vaccine with efficacy and safety data available through three full seasons, including in people at increased risk. The company says Arexvy
Drugs
FDA says six Baxter products are in shortage and may be further affected until the Baxter North Cove facility in Marion, North Carolina, resumes operations after being closed due to the effects of Hurricane Helene. The agency list includes two dextrose IV solutions, two sodium chloride products, and two sterile
Devices
FDA has approved a Procept BioRobotics IDE for a clinical trial comparing its Aquablation therapy to radical prostatectomy in men with Grade Group 1 to 3 localized prostate cancer. The trial, WATER IV PCa, will enroll up to 280 patients at up to 50 centers and follow them for 10
Drugs
FDA has issued Zealand Pharma a complete response letter (CRL) on its NDA for dasiglucagon and its use in preventing and treating hypoglycemia in pediatric patients seven days of age and older with congenital hyperinsulinism (CHI) for up to three weeks of dosing. “The CRL is related to the timing
Drugs
FDA has accepted a Bayer NDA for elinzanetant, a non-hormonal investigational compound for treating moderate-to-severe vasomotor symptoms (VMS, also known as hot flashes) associated with menopause. The submission is based on the positive results from the OASIS Phase 3 studies evaluating elinzanetant versus placebo. Bayer says the
Drugs
FDA has issued an exemption from the enhanced drug distribution security requirements of the Drug Supply Chain Security Act for eligible trading partners. An agency notice says the exemption applies to any product transacted by eligible trading partners, trading partners who have successfully completed or made documented efforts to complete
Drugs
A 7/17-7/26/2023 FDA inspection at the Louisiana State University Health Science Center institutional review board (IRB), New Orleans, LA, conducted as part of the agency’s Bioresearch Monitoring Program, determined that the IRB “did not adhere to applicable statutory requirements….” A 9/27 Warning Letter emphasizes
Drugs
FDA has released the form FDA-483 issued following a 9/23-9/27 inspection at the Apitoria Pharma Private Limited active pharmaceutical ingredient manufacturing facility in Telangana, India. The 10 inspection observations were: * equipment used in the manufacturing of drug substances and intermediates is not of adequate upkeep to
Drugs
FDA has released the form FDA-483 issued following a 9/17-9/27 inspection at Biocon Sdn Bhd, a sterile drug product manufacturer in Johor, Malaysia. The eight inspection observations were: * failure to establish or follow written procedures designed to prevent microbiological contamination of drug products purporting to be