Drugs
FDA has released a draft guidance entitled “Diabetic Foot Infections: Developing Drugs for Treatment.” The document is intended to assist developers that are developing such drugs where concomitant bone and joint issues are not involved. It provides FDA’s current thinking regarding the overall development program and clinical trial designs
Drugs
A new CDER Office of Generic Drugs pilot program to offer meeting opportunities to ANDA applicants who intend to use model-integrated evidence (MIE) approaches for bioequivalence (BE) determinations is drawing skepticism from some food and drug lawyers. “The use of MIE approaches for BE establishment is increasingly prevalent, particularly
Drugs
FDA has approved a Pfizer NDA for Velsipity (etrasimod), an oral, once-daily, selective sphingosine-1-phosphate receptor modulator for adults with moderately to severely active ulcerative colitis (UC). “Velsipity provides adults living with moderately to severely active UC the opportunity to achieve steroid-free remission with an oral, once-
Drugs
FDA has published a draft guidance, Quality Considerations for Topical Ophthalmic Drug Products, discussing quality considerations for ophthalmic drugs such as solutions, suspensions, emulsions, gels, ointments, and creams intended for topical delivery in and around the eye. The document specifically discusses: * approaches to evaluating visible particulate matter, extractables and leachables,
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) says it is concerned that an FDA draft guidance on QTc information in drug and biological product labeling does not fully embrace approaches discussed in a related International Council on Harmonization guideline. “We have concerns that the draft guidance effectively discourages the use
Drugs
Rep. Abigail Spanberger (D-VA) and 14 other House Democrats are asking FDA and the Drug Enforcement Administration (DEA) for more information on their efforts to end the shortage of attention deficit hyperactivity disorder (ADHD) medications. In a statement (includes the text of the letter to the agencies), Spanberger and
Drugs
FDA has lifted a clinical hold against PepGen that will allow the company to begin the Phase 1 FREEDOM-DM1 study of PGN-EDODM1 in patients with myotonic dystrophy Type 1 in the U.S. The company says the condition (also known as Steinert’s disease) is a progressively disabling,
Drugs
Sen. Richard Blumenthal (D-CT) is now urging FDA to investigate whether Philips Respironics criminally hid complaints about its faulty CPAP breathing devices over the course of 11 years before launching a massive recall in 2021. Last week, the senator asked the Department of Justice (DoJ) to investigate the company
Drugs
Positive efficacy data have prompted Novo Nordisk to stop a kidney outcomes trial (FLOW) that was studying the effects of Ozempic (semaglutide) versus placebo on the progression of renal impairment in people with Type 2 diabetes and chronic kidney disease (CKD). The company says its decision to stop FLOW was
Drugs
FDA has sent Warning Letters to two online marketers promoting unapproved glucagon-like peptide-1 receptor agonists semaglutide (Novo Nordisk’s diabetes and weight-loss drug under trade names Ozembic and Wegovy) and tirzepatide (Eli Lilly’s Mounjaro). “There are inherent risks to consumers who purchase unapproved new drugs and
Drugs
The Duke-Margolis Center for Health Policy says it supports any notion suggesting that several guidances issued by FDA on real-world data (RWD) and real-world evidence (RWE) and early conversations with the relevant agency review divisions should form the basis around uses of RWD/E to answer research
Drugs
FDA has released the form FDA-483 issued following a 2/8-3/24 inspection at Spectrum Laboratory Products, a New Brunswick, NJ, repacker/relabeler. The FDA-483 contains these 14 inspection observations: * failing to conduct repackaging operations under appropriate environmental conditions to avoid contamination and cross-contamination; * failing to
Drugs
An FDA Bioresearch Monitoring Program inspection at the clinical site maintained by Dr. Antonio Blanco/Vista Health Research in Miami, FL, found objectionable conditions that did not adhere to the requirements in the law and regulations governing the conduct of two clinical investigations and the protection of human subjects. A
Drugs
FDA says there is increased interest in compounded ketamine products, including oral formulations, for treating psychiatric disorders. An online post says patients and healthcare providers should know: * ketamine is not approved by the agency to treat any psychiatric disorder because it has not determined that the products are safe and
Drugs
The National Center for Health Research (NCHR) says that while an FDA guidance is needed to help sponsors develop labeling that includes clinically relevant information about the QTc interval, the guidance the agency has drafted “is too vague to be clinically useful or to meaningfully improve patient care.” In its
Drugs
The Regulatory Affairs Professionals Society (RAPS) says FDA is on schedule to publish a draft guidance on diversity plans before the end of this year. The society’s Regulatory Focus post says the guidance will take into consideration the unique challenges of conducting medical device clinical trials, citing an agency
Drugs
Merck says the Phase 3 KEYNOTE-671 trial evaluating Keytruda (pembrolizumab) as a perioperative treatment regimen for patients with resectable Stage II, IIIA or IIIB non-small cell lung cancer (NSCLC) met its dual primary endpoint of overall survival (OS). During a recent interim analysis, the company says “Keytruda plus
Drugs
FDA has approved a Foundation Medicine PMA for its FoundationOne CDx to be used as a companion diagnostic for Eli Lilly’s Retevmo (selpercatinib), which was approved for treating adult patients with locally advanced or metastatic solid tumors with a RET gene fusion that have progressed on or following prior
Drugs
FDA has issued Alnylam Pharmaceuticals a complete response letter on a supplemental NDA for Onpattro (patisiran) for treating cardiomyopathy of transthyretin-mediated (ATTR) amyloidosis. Onpattro was approved in 2018 to treat hereditary ATTR amyloidosis polyneuropathy, and the sNDA rejection has no affect on the original approval, according to the company.
Drugs
FDA has issued Biocon Biologics a complete response letter on its BLA for insulin aspart. While the letter did not identify any outstanding scientific issues with the product, the company did say it references a requirement for a “satisfactory resolution of deficiencies from the pre-approval inspection (PAI) of our
Drugs
AstraZeneca is asking FDA to provide more detailed guidance or recommendations on how early in the drug development process sponsors should start to collect data/information on diverse representative populations. In just-released comments on the agency’s draft guidance entitled “Postmarketing Approaches to Obtain Data on Under-Represented Populations
Drugs
FDA has approved Novartis’ intravenous (IV) Cosentyx (secukinumab) formulation for treating adults with psoriatic arthritis, ankylosing spondylitis and non-radiographic axial spondyloarthritis. The non-tumor necrosis factor alpha IV formulation offers patients a monthly 30-minute, weight-based dosing option, requiring no pre-medication and no lab monitoring, the company