Drugs
Ionis Pharmaceuticals says it will file an NDA early next year after reporting Phase 3 topline results of olezarsen in people with familial chylomicronemia syndrome (FCS). The company says the trial met its primary efficacy endpoint with a statistically significant reduction in triglyceride levels with the olezarsen 80 mg monthly
Drugs
Four Foley Hoag attorneys say a recent FDA draft guidance, Regulatory Considerations for Prescription Drug Use Related Software, both answers and raises questions as it proposes a regulatory framework for software disseminated by a drug sponsor that supplements or relates to a prescription drug. Writing in an online post, the
Drugs
FDA has sent Botanix Pharmaceuticals a complete response letter on its NDA for sofpironium bromide gel, indicated for treating primary axillary hyperhidrosis. The company says it will need to revise the printed Instructions for Use document proposed for inclusion with the product, and other unspecified points raised in the letter.
Drugs
A Reuters analysis of FDA regulatory alerts found that the agency is “cracking down on lax testing practices by dozens of makers of healthcare products following hundreds of deaths overseas from contaminated cough syrups.” The news service says FDA has flagged more manufacturers for failing to test raw materials susceptible
Drugs
The Justice Department says a Florida man has pleaded guilty to distributing at least $16.7 million of adulterated HIV drugs that were ultimately dispensed to unsuspecting patients across the country. An agency statement says Armando Herrera, 43, of Miami, and co-conspirators established companies in Florida, Texas, Washington, and
Drugs
Vanda Pharmaceuticals says it has uncovered a “striking example of … generic corner-cutting and regulatory looking-the-other-way for an ANDA application submitted by MSN Pharmaceuticals seeking to market a generic equivalent to Vanda’s product Hetlioz (tasimelteon).” In a suit against FDA and HHS filed in DC federal
Drugs
Novartis says the Phase 3 NETTER-2 trial met its primary endpoint of improvement in progression-free survival and the key secondary endpoint of objective response rate in patients with Grade 2 and 3 advanced gastroenteropancreatic neuroendocrine tumors (GEP-NETs) who received first-line treatment with Lutathera in combination with
Drugs
FDA reviewers say clinical data submitted in a BrainStorm Cell Therapeutics BLA for NurOwn, a stem cell therapy for treating amyotrophic lateral sclerosis (ALS and also known as Lou Gehrig’s Disease), do not demonstrate efficacy and that survival was worse at study completion for subjects who received the therapy.
Drugs
VistaPharm (Largo, FL) has recalled one lot of sucralfate oral suspension, 1g/10mL, due to Bacillus cereus contamination in the product. Microbial contamination can result in disseminated, life-threatening infections, such as endocarditis and necrotizing soft tissue infections, in immunocompromised patients, according to a recall notice. To date, VistaPharm has
Drugs
FDA has issued Coherus BioSciences a complete response letter on its BLA supplement for Udenyca Onbody, the company’s on-body injector presentation of Udenyca (pegfilgrastim-cbqv). The agency letter said the rejection was solely due to an ongoing review of inspection findings at a third-party filler, according to
Drugs
Pfizer says it has restarted most manufacturing lines at its Rocky Mount, NC facility following severe tornado damage back in July. “The resumption of production also includes the launch of one line in the site’s new sterile injectable manufacturing area referred to as R3, a state-of-the-art
Drugs
FDA’s Endocrinologic and Metabolic Drugs Advisory Committee 9/21 voted 19 to 0 against approving Intarcia Therapeutics’ implantable ITCA 650 (exenatide in DUROS device), indicated for improving glycemic control in adults with Type 2 diabetes, because the implantable drug-device combination’s benefits do not outweigh its risks. In
Drugs
FDA has released a two-item Form FDA-483 citing GMP issues documented at Novo Nordisk’s Clayton, NC facility during a 7/6-13 inspection. The document’s release comes on the heels of a 9/21 unusual agency statement provided to FDA Webview (see story) discussing the inspection
Drugs
FDA has approved Boehringer Ingelheim and Eli Lilly’s Jardiance (empagliflozin) 10 mg tablets to reduce the risk of sustained decline in estimated glomerular filtration rate, end-stage kidney disease, cardiovascular death and hospitalization in adults with chronic kidney disease (CKD) at risk of progression. Approval was based on data
Drugs
Senators Edward Markey (D-MA) and Joe Manchin (D-WV) are calling on FDA to curb the use of enriched enrollment randomized withdrawal (EERW) studies, which they say have been used to investigate opioid treatment options for patients with chronic pain but carry the risk of biasing outcomes in favor
Drugs
FDA has published a draft guidance, Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products, with recommendations on formal meetings relating to the development and review of drug or biological drug products regulated by CDER and CBER. The document does not apply to ANDAs, applications for biosimilar
Drugs
FDA has published a draft guidance, Alternative Tools: Assessing Drug Manufacturing Facilities Identified in Pending Applications, giving applicants information on how the agency intends to use alternative tools to assess manufacturing facilities identified in an NDA, ANDA, BLA, or supplements to any of those applications. The document says it does
Drugs
Travere Therapeutics says it plans to seek full approval in an sNDA in the first half of 2024 for its accelerated approval drug Filspari (sparsentan), based on confirmatory trial data that “demonstrated long-term kidney function preservation and achieved a clinically meaningful difference in estimated glomerular filtration rate (eGFR) total
Drugs
An NPR report says the European Medicines Agency is looking into the risk of thoughts of self-harm and suicidal thoughts associated with using Novo Nordisk’s Ozempic (semaglutide) and similar drugs. The diabetes drugs are being used off-label to promote weight loss. NPR says that FDA has not
Drugs
FDA has accepted for priority review a Merck supplemental BLA for Keytruda (pembrolizumab) and its combination use with external beam radiotherapy plus concurrent chemotherapy, followed by brachytherapy, as a treatment for newly diagnosed patients with high-risk locally advanced cervical cancer. The submission is based on data from the KEYNOTE-
Drugs
FDA has approved an orphan drug designation for Puma Biotechnology’s alisertib, described as a selective, small-molecule, orally administered inhibitor of aurora kinase A, to treat patients with small cell lung cancer. A company statement says FDA cleared Puma’s IND for the clinical development of aliserib monotherapy to
Drugs
FDA has taken the unusual step of issuing a statement about recent agency inspections at Novo Nordisk’s Clayton, NC manufacturing facility to quell concerns about any quality issues involving products made there. Standard operating procedure for FDA is to not make any direct statements regarding recent inspections and any