Drugs
Responding to a recent Novartis lawsuit against FDA that seeks a preliminary injunction to reverse its approval of MSN Laboratories’ generic version of Novartis’s Entresto (sacubitril/valsartan), the agency says the motion should be denied because the company has not met its burden to show that it is “entitled
Drugs
FDA has accepted for review an Exelixis supplemental NDA for Cabometyx (cabozantinib) and its use for treating adults with previously treated, locally advanced/unresectable or metastatic, well- or moderately differentiated pancreatic and extra-pancreatic neuroendocrine tumors. The agency assigned a standard review with a user fee review action target date
Drugs
Senators Jack Reed (D-RI) and Shelley Moore Capito (R-WV) have introduced a bipartisan bill entitled “Innovation in Pediatric Drugs Act” (S 4905) that would attempt to accelerate research and treatment advances for pediatric rare diseases. The measure would make changes to the Best Pharmaceuticals for Children Act and
Drugs
Attorney James Beck (Reed Smith) says the Supreme Court decision in Loper Bright overturning judicial deference to administrative agencies could lead to significant changes to FDA’s ban on off-label speech. Writing online in the Drug and Device Law Blog, Beck says FDA has been relying on a “very
Drugs
A 12/4-12/8/2023 FDA inspection at the Guangzhou Baiyunshan Jingxiutang Pharmaceutical Co. Ltd. in Guangdong Sheng, China, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. An 8/1 Warning Letter says the specific violations were: * failing to establish laboratory controls that include
Drugs
A Florida federal judge has sentenced Jonathan Cosie, of Chesterfield, VA, to two years in federal prison for introducing misbranded drugs into interstate commerce with the intent to defraud or mislead. A Department of Justice post says Cosie pleaded guilty on 5/30/2023. Court documents show that from about
Drugs
FDA says it inspected the Velocity Pharma drug manufacturing facility in Melville, NY, from 11/3-12/14/2023 after an agency inspection at Velocity’s ophthalmic drug contract manufacturer, Kilitch Healthcare India Limited, found violative conditions. A just-released 7/17 Warning Letter to Velocity says the Kilitch current
Drugs
Public Citizen is urging HHS to use its authority under 28 USC. § 1498 to permit generic competitors to manufacture Novo Nordisk’s semaglutide, the active ingredient in diabetes drug Ozempic and weight-loss drug Wegovy. In an 8/5 petition, the advocacy group argues that its request for the government
Drugs
Federal Register notice: FDA is announcing the renewal of the Drug Safety and Risk Management Advisory Committee for an additional two years beyond the charter expiration date. The new charter will be in effect until 5/31/2026. To view the notice, click here.
Drugs
FDA has granted Labcorp a de novo marketing authorization for its PGDx elio plasma focus Dx kitted assay, a pan-solid tumor liquid biopsy test that enables tumor mutation profiling. PGDx elio is described as a qualitative next-generation sequencing-based in vitro diagnostic device that uses targeted high throughput
Drugs
FDA has granted META Pharmaceuticals a rare pediatric disease designation for META-001-PH, an investigational drug for treating primary hyperoxaluria (PH), rare genetic disorder that can lead to kidney stone formation, renal failure, and can be life-threatening in severe cases. Those with PH overproduce oxalate that is then
Drugs
FDA has granted Adaptimmune accelerated approval for its BLA for Tecelra (afamitresgene autoleucel), a gene therapy indicated for treating adults with unresectable or metastatic synovial sarcoma who have received prior chemotherapy, are HLA antigen(s) A*02:01P, -A*02:02P, -A*02:03P, or -A*02:06P positive, and
Drugs
FDA has granted Cellectis an orphan drug designation (ODD) for CLLS52 (alemtuzumab), an investigational therapy for treating relapsed/refractory B-cell acute lymphoblastic leukemia (ALL). “The importance of adding alemtuzumab to a lymphodepletion regimen has been demonstrated in Cellectis’ BALLI-01 study, where the addition of this lymphodepletion agent to
Drugs
FDA has approved an Octapharma supplemental NDA for the expanded approval of Fibryga (fibrinogen lyophilized powder for reconstitution) for fibrinogen replacement in bleeding patients with acquired fibrinogen deficiency (AFD). The company says AFD often results from severe bleeding and can weaken blood clot formation, increasing hemorrhage risk in patients. The
Drugs
CDER has posted a revised guidance agenda for calendar year 2024. The agenda lists 101 new, revised draft, and immediately effective guidances in these 17 categories: Administrative/Procedural (11), Biosimilars (4), Clinical/Antimicrobial (1), Clinical/Medical (20), Clinical Pharmacology (1), Compounding (7), Drug Development Tools (1), Drug Safety (3), Generics
Drugs
FDA has published an International Council on Harmonization (ICH) guidance, M12 Drug Interaction Studies Questions and Answers, to respond to questions posted to the ICH draft guidance comment period. The document says it was developed to provide clarity around some of the concepts related to the evaluation of drug interactions
Drugs
Sens. Dick Durbin (D-IL) and Bill Cassidy (R-LA) have introduced the bipartisan Reforming Evergreening and Manipulation that Extends Drug Years (REMEDY) Act to promote competition by removing FDA barriers to approving lower-cost generic drugs. In a statement, Durbin says the bill responds to some efforts by the
Drugs
FDA researchers are using an open-source article in Drug Safety to introduce LabelComp, an artificial intelligence (AI) tool that automates the identification of changes in adverse event terms made during drug labeling updates. The article says that traditional methods of updating drug labeling with new adverse event information have
Drugs
FDA has approved an sBLA for GlaxoSmithKline’s Jemperli (dostarlimab) with carboplatin and paclitaxel followed by Jemperli as a single agent to treat adults with primary advanced or recurrent endometrial cancer. A company statement says the approval broadens the previous indication for Jemperli plus chemotherapy to include patients with mismatch
Drugs
Abbott has initiated a medical device correction for a “small number” of FreeStyle Libre 3 sensors because they may provide incorrect high glucose results. The affected devices were distributed in the U.S. during the first half of May, the company says. FreeStyle Libre 3 includes a sensor, reader and
Drugs
Novartis has filed a lawsuit against FDA that seeks to reverse the agency’s recent approval of MSN Laboratories’ generic version of Novartis’s Entresto (sacubitril/valsartan), indicated for reducing the risk of cardiovascular death and hospitalization in adult patients with chronic heart failure. Novartis argues that FDA’s conduct
Drugs
FDA has issued Telix Pharmaceuticals a refuse-to-file letter on its BLA for TLX250-CDx (89Zr-DFO-girentuximab), an investigational imaging agent for clear cell renal cell carcinoma. “During the 60-day administrative review, the FDA has identified a filing issue in the chemistry, manufacturing and controls (CMC) package,