Drugs
FDA has accepted for priority review a GSK NDA for gepotidacin, an investigational, first-in-class oral antibiotic with a novel mechanism of action for treating female adults and adolescents with uncomplicated urinary tract infections (uUTIs). The company says new treatments are needed as uUTIs caused by drug-resistant bacteria
Drugs
Jazz Pharmaceuticals says it will file a supplemental NDA next year following “positive top-line results” from its Phase 3 clinical trial evaluating Zepzelca (lurbinectedin) in combination with the PD-L1 inhibitor atezolizumab (Roche’s Tecentriq) compared to atezolizumab alone when administered as a maintenance treatment for adults with extensive-
Drugs
Writing in the CDER year-two annual report of its Accelerated Rare disease Cures (ARC) program, Center director Patrizia Cavazzoni says CDER partnered with CBER in 2023 to launch the Support for clinical Trials Advance Rare Disease Therapeutics (START) pilot program. The report says START offers selected participants enhanced communication
Drugs
FDA has posted seven things consumers should know about how CDER manages drug shortages. The items are: * the CDER Drug Shortage Staff (DSS) is the focal point for evaluating and managing drug shortages; * for many drugs, manufacturers must notify FDA about permanent discontinuances in manufacturing and manufacturing interruptions that are
Drugs
A 3/25-3/29 FDA inspection at Outin Futures Corp.’s drug manufacturing facility in Chungcheongbuk, Republic of Korea, identified significant current good manufacturing practice (CGMP) regulation violations for finished drugs. A just-released 9/25 Warning Letter also says the firm’s Neogen Dermalogy Airy sunscreen product is
Drugs
FDA has released the form FDA-483 issued following a 2/6-3/19 inspection at the Qualgen outsourcing facility in Edmond, OK. The 14 inspection observations were: * failure to fully follow the responsibilities and procedures applicable to the quality control unit; * failure to follow procedures describing the handling of
Drugs
FDA has cleared a Heidelberg Engineering 510(k) for its Spectralis Flex Module, which the company describes as a multimodal, diagnostic imaging-only platform designed for imaging the posterior segment of pediatric and adult patients in a supine position. “The Flex Module mounts the renowned Spectralis to a movable stand
Drugs
FDA has accepted for review a PTC Therapeutics NDA for sepiapterin, which the company says is )indicated for treating pediatric and adult patients with phenylketonuria (PKU), including all age groups and the full spectrum of disease subtypes. The agency has a user fee review action target date of 7/29/
Drugs
FDA says it is now accepting proposals from drug companies to participate in its fiscal year 2025 site visitation program, which is part of the agency’s ongoing effort to gain deeper insight into drug development and commercial manufacturing. The CDER Office of Pharmaceutical Quality (OPQ) program allows FDA staff
Drugs
FDA has released an immediately-in-effect guidance titled "Temporary Policies for Compounding Certain Parenteral Drug Products". HHS has determined that public health emergencies (PHEs) exist as a result of manufacturing and supply disruptions caused by hurricanes Helene and Milton. This guidance describes FDA’s regulatory and enforcement
Drugs
FDA has approved a Pfizer BLA for Hympavzi (marstacimab-hncq) for preventing or reducing bleeding episodes in patients aged 12 and older with hemophilia A or B who do not have inhibitors to factor VIII or IX, respectively. The approval marks the first treatment to target a specific protein involved
Drugs
Denali Therapeutics says its strategic partner Sanofi has decided to discontinue a Phase 2 study evaluating the safety and efficacy of oditrasertib (SAR443820/DNL788) on serum neurofilament light chain levels in participants with multiple sclerosis. In a SEC filing, Denali says the study failed to meet primary and key secondary
Drugs
FDA has released the form FDA-483 issued following a 10/16-10/20/2023 inspection at Aqualex Co., Ltd., a drug and cosmetic manufacturer in Seongnam-si, Gyeonggi-do, Republic of Korea. The six inspection observations were: * failure to have in writing and fully follow the responsibilities and procedures
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
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
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
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