Drugs
CDER researchers who conducted a systematic review and meta-analysis to determine if there were safety outcome differences between individuals who switched between a biosimilar and a reference product and individuals who did not switch say there were no statistical differences in the number of deaths, non-fatal serious adverse
Drugs
The Defense Department has been paying for independent laboratory testing of some FDA-approved generic drugs because it doesn’t trust FDA’s approvals based on inspections without testing samples. A lengthy Bloomberg News report says that while generic drugs have saved taxpayers and consumers hundreds of billions of dollars
Drugs
Roche says it will discuss with FDA and other health authorities “positive results” from the Phase 3 INAVO120 study of inavolisib in combination with palbociclib (Pfizer’s Ibrance) and fulvestrant (AstraZeneca’s Faslodex) as a potential first-line treatment option for people with PIK3CA-mutated, hormone receptor (HR)-positive, HER2-
Drugs
FDA has just released an 8/8 untitled letter issued following an 11/28-12/9/2022 inspection at the Novartis manufacturing facility in Morris Plains, NJ. The letter says agency investigators documented significant deviations from current good manufacturing practice (CGMP) requirements in the manufacturing of the company’s Kymnah
Drugs
FDA has placed a clinical hold on a Genentech multiple sclerosis clinical development program for fenebrutinib. The agency action was based on two recent cases of hepatic transaminase (liver enzyme) elevations along with elevated bilirubin that suggests a drug-induced liver injury that was observed in the blinded Phase 3
Drugs
FDA says it is continuing to advance its compliance activities associated with required clinical trial information postings in the ClinicalTrials.gov database. “Transparency of clinical trial information, including through ClinicalTrials.gov, is essential to scientific advancement,” FDA commissioner Robert Califf says in an online post about reporting trial results. “Making
Drugs
FDA has granted Eli Lilly accelerated approval for Jaypirca (pirtobrutinib) 100 mg & 50 mg tablets for treating adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have received at least two prior therapies, including a Bruton's tyrosine kinase (BTK) inhibitor and a BCL-
Drugs
Researchers from Duke University and the University of Maryland say there is a “pressing need” to explore alternative methods for inspecting overseas and domestic drug manufacturing facilities to help keep an eye on drug quality. The early Covid-19 pandemic period saw FDA pausing inspections of most domestic and overseas
Drugs
FDA has told Travere Therapeutics that data appear to support a supplemental NDA to convert the company’s accelerated approval to full approval for Filspari (sparsentan) in IgA nephropathy. Travere says it will submit a supplemental NDA in the first quarter of 2024 on the endothelin and angiotensin II receptor
Drugs
FDA has granted Johnson & Johnson a breakthrough therapy designation for TAR-200 for treating patients with Bacillus Calmette-Guérin (BCG)-unresponsive high-risk non-muscle-invasive bladder cancer (HR-NMIBC), who are ineligible for or elected not to undergo bladder removal. The company describes TAR-200 as a “novel
Drugs
Despite pharmaceutical researchers' skepticism for decades on the effectiveness of over-the-counter (OTC) drugs that contained the decongestant phenylephrine, why did it take FDA so long to finally consider withdrawing the products? This is the question the House Oversight Committee’s Subcommittee on Health Care and Financial Services
Drugs
Pfizer says it will not advance its twice-daily weight-loss drug danuglipron into Phase 3 studies due to high discontinuation rates in a just-reported Phase 2b clinical trial. Instead, the company plans to advance a once-daily formulation of the oral Glucagon-like peptide-1 receptor agonist (GLP-
Drugs
FDA has granted Genmab a breakthrough therapy designation for epcoritamab, an investigational T-cell engaging bispecific antibody administered subcutaneously for treating adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy. Epcoritamab, under the brand name Epkinly, is currently FDA-approved for certain
Drugs
CDER appears to be clearing its deck of unresolved citizen petitions that have lingered for more than five years at the agency without producing formal responses. In a letter to petition holder BakerHostetler, the Center it has been reviewing unresolved petitions assisgvpned to for action. “One goal of this review
Drugs
Novo Nordisk says it is pursuing legal proceedings against two compounding pharmacies for selling adulterated and misbranded drugs claiming to contain semaglutide, the active ingredient in the firm’s Ozempic, Rybelsus, and Wegovy. A company statement identifies the pharmacies as Wells Pharmacy, a nationwide compounding pharmacy network, and Brooksville Pharmaceuticals
Drugs
AbbVie says it will engage with FDA about filing for accelerated approval of telisotuzumab-vedotin (Teliso-V) in patients with c-Met protein overexpression, epidermal growth factor receptor wild type, advanced/metastatic nonsquamous non-small cell lung cancer (NSCLC). The decision to seek accelerated approval is based on just-announced
Drugs
Global biopharm UCB associates itself with comments submitted by Pharmaceutical Research and Manufacturers of America on an FDA workshop on optimizing the use of post-approval pregnancy studies and the development of a framework. It asks the agency to further consider these points: * routine pharmacovigilance is currently considered out of
Drugs
FDA has granted Arcturus Therapeutics an orphan drug designation for ARCT-032 and its use to treat cystic fibrosis (CF). The company says the first CF patient in its Phase 1b study “successfully” completed two administrations of ARCT-032, adding that interim data will be reported in the first half
Drugs
FDA has granted fast-track designation to eFFECTOR Therapeutics for its zotatifin in combination with fulvestrant and abemaciclib (ZFA triplet) to treat ER+/HER2- advanced metastatic breast cancer. The company says the designation covers the use of ZFA triplet for second- or third-line treatment of adult patients with disease
Drugs
The Association for Accessible Medicines (AAM) says that while it recognizes FDA’s significant efforts and investments to design a quality management maturity (QMM) program, it and its members have questions and concerns about the design and planned implementation of the program. In its comment letter, AAM raises these issues:
Drugs
FDA says the CDER Next Gen Portal now includes a Drug Supply Chain Security Act (DSCSA) portal that enables the agency and trading partners to communicate when FDA requests information about investigations of suspect or illegitimate products or during a recall. An online notice says the DSCSA portal is used
Drugs
FDA has denied a 10/3/2017 petition submitted by Axinn, Veltrop & Harkrider requesting permission to submit an ANDA for apixaban tablets 10 mg, with a reference-listed drug of Bristol-Myers Squibb’s Eliquis in 2.5 mg and 5 mg doses. The denial letter says the proposed