Drugs
FDA’s Oncology Center of Excellence and real-world evidence company Syapse say they have renewed a four-year agreement to collaboratively develop and implement specific research projects to “advance the use of real-world data (RWD) and explore the potential strengths and limitations of using real-world evidence to
Drugs
FDA says its review of a Web site maintained by Belmont Eyecare in Chicago, IL, determined that the site offers six types of eye drops for sale in the U.S. that are unapproved new drugs that are being marketed illegally. A 12/1 Warning Letter says the products are
Drugs
Lilly says results of the MONARCH trial of its Verzenio (abemaciclib) plus an aromatase inhibitor (AI) compared to an AI alone had positive results in HR+, HER2- advanced or metastatic breast cancer. A company statement says that at eight years of follow-up, MONARCH showed women taking the Verzenio and
Biologics
A panel presentation at the 2023 AFDO/RAPS Healthcare Products Collaborative stressed the positive role FDA Project Jurisdiction Officers (PJO) play in coordinating the consideration of combination products. “The PJO is your best contact if you know, or think you know, your product’s Center or if you already have
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
Biologics
FDA has accepted for priority review an ImmunoGen supplemental BLA to convert the accelerated approval of Elahere (mirvetuximab soravtansine-gynx) to full approval for treating patients with folate receptor alpha-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have been given one to three prior systemic
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-
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension entitled “Medical Devices; Device Tracking — 21 CFR Part 821.” The collection supports the agency’s authority to require by order that a manufacturer adopt a method for tracking a Class 2 or 3 medical device, if the device
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
Devices
FDA has granted ABK Biomedical a breakthrough device designation for its proposed Eye90 microspheres and its use in treating patients living with unresectable hepatocellular carcinoma (HCC). The company recently initiated enrollment in Route90, its pivotal, prospective, multicenter trial to establish the safety and efficacy of Eye90 microspheres in the patient
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
FDA Policy/General
Federal Register notice: FDA is announcing that it has issued a priority review voucher to Genzyme after gaining a qualified approval for Xenpozyme (olipudase alfa-rpcp), indicated for treating non-central nervous system manifestations of acid sphingomyelinase deficiency. The voucher was awarded under the agency’s voucher program for rare
FDA Policy/General
Federal Register notice: FDA has announced that CBER has modified organizational structures in the Office of Blood Research and Review (OBRR) and the Office of Vaccines Research and Review (OVRR). The organization structures were approved by HHS 6/27. In OBRR, the Center established the Laboratory of Pathogen Reduction to
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
Devices
FDA has cleared a West Pharmaceutical Services 510(k) for its Vial2Bag Advanced 13mm admixture device. It is intended to serve as a connection between a 50, 100 or 250ml intravenous (IV) bag, vial with 13mm closure, and an external IV administration set. “The integrated vial adapter makes it possible
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension entitled “Registration of Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and Associated Fees Under Section 744K.” The collection supports the annual registration of such facilities