Drugs
Corcept Therapeutics is announcing promising results from its pivotal Phase 3 ROSELLA trial, demonstrating that relacorilant in combination with nab-paclitaxel significantly improves progression-free survival (PFS) in patients with platinum-resistant ovarian cancer. In meeting the trial’s primary endpoint, relacorilant was shown to reduce the risk of disease
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FDA has issued Milestone Pharmaceuticals a complete response letter on its NDA for Cardamyst (etripamil) nasal spray and its use to convert acute episodes of paroxysmal supraventricular tachycardia (PSVT) to sinus rhythm in adults. PSVT is described as a sudden, rapid, and irregular heartbeat (arrhythmia) that originates in the upper
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FDA is rescheduling a previously planned joint meeting of its Drug Safety and Risk Management Advisory Committee and Anesthetic and Analgesic Drug Products Advisory Committee. Panel members are scheduled to discuss the findings of completed postmarketing epidemiologic studies that examined the serious risks and predictors of misuse, abuse, addiction, and
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FDA has approved a Novartis supplemental NDA to expand the indication for Pluvicto (lutetium Lu 177 vipivotide tetraxetan) to include adults with prostate-specific membrane antigen(PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor pathway inhibitor (ARPI) therapy and are delaying taxane-based
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FDA is notifying NDA and ANDA holders about data integrity and study conduct concerns with bioequivalence studies conducted at contract research organization (CRO) Raptim, which is based in Navi Mumbai, India. An agency notice says that in vitro studies conducted by Raptim are not acceptable, and if any studies were
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FDA has accepted for review a Liquidia NDA resubmission for Yutrepia (treprostinil) inhalation powder to treat pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD). The agency confirmed that the resubmission was a complete Class 1 response to an 8/2024 action letter, which granted
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FDA has approved a Sanofi NDA for Qfitlia (fitusiran) for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients 12 years of age and older with hemophilia A or B , with or without Factor VIII or IX inhibitors (neutralizing antibodies). “Qfitlia does not
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Sens. Charles Grassley (R-IA), Richard Durbin (D-IL), Thom Tillis (R-NC), Peter Welch (D-VT), and Chris Coons (D-DE) have introduced the Interagency Patent Coordination and Improvement Act to establish a task force between FDA and the U.S. Patent and Trademark Office to “improve communication and
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FDA has approved a Soleno Therapeutics NDA for Vykat XR (diazoxide choline) extended-release tablets for treating hyperphagia in individuals with Prader-Willi syndrome (PWS). Soleno says hyperphagia, an insatiable hunger that is common in PWS, can severely impact the lives of individuals and their caregivers. Approval was based on
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FDA has accepted for review a Merck BLA for a subcutaneous formulation of Keytruda (pembrolizumab) for its use across all previously approved solid tumor indications. The agency has set a user fee review action target date of 9/23. The submission is based on data from Merck’s pivotal 3475A-
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FDA has approved the Fresenius Kabi BLAs for the denosumab biosimilars Conexxence (denosumab-bnht) and Bomyntra (denosumab-bnht) for all indications of the reference products, Amgen’s Prolia (denosumab) and Xgeva (denosumab) respectively. The company says it has reached a global settlement with Amgen for its denosumab biosimilars to permit
Drugs
An FDA 9/23-9/27/2024 inspection at the Yangzhou Sion Commodity Co. drug manufacturing facility in Yangzhou, Jiangsu, China, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 3/12 Warning Letter says the specific violations were: * failure to test samples of each
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The Washington-based law firm of Buchanan Ingersoll & Rooney is asking FDA to continue restrictions on ANDAs citing Waylis’ Tabloid (thioguanine) as the reference-listed drug. The 3/24 petition asks the agency to: * maintain and strictly apply the requirements of the current product-specific guidance (PSG) to any
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A 9/16-9/21/2024 FDA inspection at the Aspen Biopharma Labs Private Limited drug manufacturing facility in Hyderabad, Telangana, India, found significant deviations from current good manufacturing practice (CGMP) regulations for active pharmaceutical ingredients (APIs). A just-released 3/5 Warning Letter says the specific deviations were: * failure
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Cassava Sciences says topline results from the Phase 3 REFOCUS-ALZ study of simufilam in mild-to-moderate Alzheimer’s disease show that the study did not meet each of the prespecified co-primary, secondary and exploratory biomarker endpoints. The co-primary endpoints were the change in cognition and function
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FDA researchers say most non-oncologic rare disease marketing applications approved between 2020 and 2023 used a single adequate and well-controlled trial plus confirmatory evidence to demonstrate effectiveness. Writing in Clinical Pharmacology and Therapeutics, the researchers say that although different types of confirmatory evidence were used in different applications,
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FDA has appointed former consultant Barclay Butler as deputy commissioner for operations and chief operating officer. In this capacity, Butler has “leadership authority over the management of business programs and operations across the FDA enterprise level, including human resources and facilities,” according to his just-posted bio. Before joining FDA,
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Advantage Silver Dental Arrest, Seattle, WA, is petitioning FDA to regulate silver diamine fluoride and silver fluoride agents for dentin hypersensitivity as drugs rather than medical devices and thus rescind premarket clearance of such products. The 3/17 petition says silver diamine fluoride is a liquid drug that is topically
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Axsome Therapeutics says the FOCUS Phase 3 trial of solriamfetol to treat attention deficit hyperactivity disorder achieved its primary and secondary endpoints, demonstrating statistically significant improvements in symptoms and disease severity with solriamfetol compared to placebo. A company statement says the drug was safe and well tolerated in the trial
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Tonix Pharmaceuticals says FDA has decided not to require an advisory committee meeting to discuss its recent NDA for TNX-102 SL (cyclobenzaprine HCl sublingual tablets) for managing fibromyalgia. If approved, the company says the non-opioid analgesic would be the first new treatment option for fibromyalgia patients in 15
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FDA has granted Secretome Therapeutics a fast track designation for STM-01, the company’s neonatal cardiac progenitor cell therapy for treating heart failure with preserved ejection fraction (HFpEF). The debilitating condition affects millions of patients worldwide, characterized by impaired heart relaxation and elevated left ventricular filling pressure despite a
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As part of the Trump Administration’s regulatory freeze while it reviews pending FDA actions, the effective date of a recent final rule entitled “Nonprescription Drug Product With an Additional Condition for Nonprescription Use (ACNU)” is delayed from 3/21 to 5/27. Previously, the rule was delayed for the