Drugs
FDA has approved Biocon Biologics’ Bosaya and Aukelso, biosimilars for Amgen’s Prolia (denosumab) and Xgeva (denosumab). The agency also granted provisional interchangeability for both biosimilars. A Biocon announcement says that Bosaya (denosumab-kyqq) 60 mg/mL injection for subcutaneous use in a single prefilled syringe, is approved to treat
Drugs
FDA has published a draft guidance, Safety Labeling Changes—Implementation of Section 505 (o)(4) of the Federal Food, Drug, and Cosmetic Act, to provide information on the agency’s implementation of a provision authorizing it to require application holders for certain drugs to make labeling changes based on new
Drugs
FDA has approved an AstraZeneca supplemental NDA for Airsupra (albuterol/budesonide) to expand the drug’s labeling to reflect a 46% reduction of severe exacerbation risk in patients with mild asthma compared with albuterol. This finding came from the BATURA Phase 3b trial, which examined the efficacy of as-needed
Drugs
FDA has published a draft guidance, Symptomatic Nonerosive Gastroesophageal Reflux Disease (sGERD): Developing Drugs for Treatment, to help sponsors in the clinical development of such drugs for adults. The document specifically addresses FDA’s current recommendations on clinical trials for drugs intended to treat sGERD in adults, including considerations for
Drugs
Johnson & Johnson says data from the Phase 3 ICONIC-ADVANCE 1 and 2 studies showed that its experimental psoriasis drug icotrokinra outperformed Bristol Myers Squibb’s oral therapy deucravacitinib in patients with moderate-to-severe plaque psoriasis.Pesented at the European Academy of Dermatology and Venereology (EADV) Congress, the
Drugs
FDA commissioner Martin Makary, through his actions rather than his words, has given the impression that he does not value the agency’s advisory committee system. That’s the analysis of FDA Matters founder Steven Grossman, who notes that Makary has the prerogative to run the agency as he deems
Drugs
AstraZeneca says its RESOLUTE Phase 3 trial of Fasenra (benralizumab), despite showing numerical improvement, did not achieve the primary endpoint in patients with chronic obstructive pulmonary disease (COPD). Fasenra (benralizumab) is currently approved in the U.S. for two eosinophil-driven conditions: severe eosinophilic asthma and eosinophilic granulomatosis with polyangiitis.
Drugs
FDA has published a draft guidance, Disseminated Coccidioidomycosis: Developing Drugs for Treatment, to assist sponsors in developing drugs to treat the disease caused by Coccidioides species. The document presents the agency’s current thinking about clinical trial design issues, choice of trial population, and endpoints for the affected patient population.
Drugs
Eli Lilly says its investigational oral diabetes drug orforglipron achieved stronger blood sugar and weight loss results than Novo Nordisk’s oral semaglutide in a large late-stage head-to-head study. In the 52-week ACHIEVE-3 Phase 3 trial, orforglipron cut average A1C levels — a key measure of
Drugs
Recently fired CDC director Susan Monarez told senators that FDA and other health agencies are facing similar political pressure that she experienced to fire senior career officials and replace them with compliant appointees who are willing to carry out directives from HHS secretary Robert F. Kennedy Jr. Testifying 9/17
Drugs
The Department of Justice has charged David Ralph Webber of Henderson, NV, with smuggling and selling misbranded prescription drugs marketed as sexual enhancement supplements. Webber, the owner of two Nevada companies, allegedly imported hundreds of thousands of capsules containing sildenafil and tadalafil — the active ingredients in Viagra and Cialis — from
Drugs
FDA has released the form FDA-483 issued following a 7/8-7/17 inspection at the Lupin drug manufacturing facility in Madhya Pradesh, India. The four inspection observations were: * failure to follow procedures designed to prevent microbiological contamination of drug products purporting to be sterile; * aseptic processing areas are
Drugs
FDA’s ongoing crack down (see earlier story) on drug direct-to-consumer (DTC) promotional activities has led to three just-released Warning Letters to Eli Lilly and one to Novo Nordisk that cite the companies for their alleged violative claims about GLP-1 receptor agonists. In the first Lilly
Drugs
A direct-to-consumer TV ad for CSL Behring’s Hizentra (immune globulin subcutaneous (human)) overstates the drug’s effectiveness and minimizes safety information, thus misbranding it, according to a CBER Warning Letter. The letter says the Hizentra labeling describes it as a 20% liquid subcutaneous immune globulin indicated to
Drugs
A 2/10-2/21 FDA inspection at the Somerset Therapeutics Private Limited drug manufacturing facility in Bengaluru, Karnataka, India, identified significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 9/4 Warning Letter says the specific violations were: * failure to thoroughly investigate any unexplained discrepancy
Drugs
A Center for Innovation in Regulatory Science (CIRS) briefing paper says that in recent years, there has been significant progress in reducing delays in new drug approvals in China. The latest CIRS briefing looks at new active substance (NAS) approvals in Australia, Canada, China, Europe, Japan, Switzerland, and the U.
Drugs
FDA has posted a draft guidance entitled “Erosive Esophagitis: Developing Drugs for Treatment” that outlines recommendations for the clinical development of drugs to treat erosive esophagitis (EE) in adults. It provides a framework for drugmakers designing trials to evaluate therapies for both the healing of EE and the maintenance of
Drugs
aTyr Pharma is reporting mixed topline results from its Phase 3 EFZO-FIT study of efzofitimod in pulmonary sarcoidosis, a chronic inflammatory lung disease. While the trial did not meet its primary endpoint, the therapy demonstrated encouraging improvements in quality-of-life measures and steroid reduction, the company says. aTyr
Drugs
FDA has granted Merck and Daiichi Sankyo a breakthrough therapy designation for raludotatug deruxtecan (R-DXd), an investigational drug for treating patients with certain forms of platinum-resistant ovarian, primary peritoneal, or fallopian tube cancers. The designation covers patients whose tumors express CDH6 and who have previously been treated with
Drugs
Tandem Diabetes Care is recalling (Class 1 device correction) certain t:slim X2 insulin pumps after identifying a potential speaker-related issue that can trigger an error that will stop insulin delivery and render the pump no longer operational. The issue is called a “Malfunction 16” error and is caused
Drugs
FDA has approved a Corstasis Therapeutics NDA for Enbumyst (bumetanide), a nasal spray loop diuretic for treating edema linked to congestive heart failure, liver disease, and kidney disease, including nephrotic syndrome in adults. The approval offers a new outpatient option for patients who often face limited choices between oral and
Drugs
FDA has issued Olympia Pharmaceuticals a three-item Form FDA-483 following a 7/28-8/8 inspection of the firm’s Orlando, FL manufacturing facility. The inspection cited Olympia over the following GMP deficiencies: * Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not