Drugs
The CDER Office of Pharmaceutical Quality (OPQ) 2022 annual report says FDA will continue to use remote regulatory assessments to augment on-site inspection activities. When Covid-19 restricted travel, the report says, OPQ turned to alternative tools such as requesting information from a facility instead of an inspection. “In
Drugs
FDA has accepted for review an Ocuphire Pharma NDA for Nyxol (phentolamine ophthalmic solution 0.75%) for treating pharmacologically-induced mydriasis. The company says patients often are troubled by the effects of prolonged eye dilation, and a reversal drop would significantly improve patient experiences and productivity. The agency has set
Drugs
A new JAMA research article says that between 2018 and 2021, FDA approved 210 new drugs and 21 (10.0%) were approved based on pivotal studies with “null findings for one or more primary efficacy endpoints.” The researchers, from Yale Medical Scholl and Brigham and Women’s Hospital, say their
Drugs
FDA has issued India’s Biocon Biologics a complete response letter on its BLA for a biosimilar version of bevacizumab (Genentech’s Avastin), which is indicated for treating six cancer types: metastatic colorectal cancer; recurrent or metastatic non-squamous non-small cell lung cancer; recurrent glioblastoma; metastatic renal cell carcinoma;
Drugs
FDA has completed an inspection of a Laurus Labs formulations manufacturing facility (Visakhapatnam, Andhra Pradesh, India. The inspection was conducted 2/6-10 and resulted in a Form 483 with two undisclosed observations, a company release says, adding that they were “procedural in nature,” It says the observations will be
Drugs
FDA has published a draft guidance entitled “Long-Term Clinical Neurodevelopmental Safety Studies in Neonatal Product Development” that provides a framework for neurodevelopmental evaluations that could be useful to assess long-term safety of a medical product intended for use in neonates. The document is focused on long-term evaluations
Drugs
FDA’s Oncologic Drugs Advisory Committee (ODAC) has voted 8 to 5 that GlaxoSmithKline’s proposals for two single-arm clinical trials of its Jemperli (dostarlimab) are sufficient to characterize its benefits and risks in the curative intent setting for patients with locally advanced, treatment-naïve, mismatch-repair deficient or
Drugs
FDA has approved a Pfizer supplemental NDA for Cibinqo (abrocitinib), expanding its indication to include adolescents (12 to 18 years) with refractory, moderate-to-severe atopic dermatitis whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies is inadvisable. The drug
Drugs
A just-posted HHS “Covid-19 Public Health Emergency Transition Roadmap” says FDA and other agencies will continue to have “significant flexibilities and actions that will not be affected” as the Biden Administration transitions out of the current public health emergency in May (see earlier story). The roadmap says the
Drugs
FDA has issued two complete response letters to Phathom Pharmaceuticals — one for an NDA for vonoprazan for treating erosive esophagitis, and the other for a post-approval supplement for Voquezna Triple Pak (vonoprazan, amoxicillin, clarithromycin) and Voquezna Dual Pak (vonoprazan, amoxicillin). Phathom said both letters address specifications and controls for
Drugs
Ropes & Gray attorneys say FDA will publish a notice in the Federal Register explaining the effect the HHS decision to terminate its Covid-19 public health emergency (PHE) on 5/11 will have on FDA guidances and enforcement policies. In an online post, the attorneys say that at the
Drugs
Questions are being raised about Eiger BioPharmaceutical’s decision not to seek an FDA emergency use authorization (EUA) for its peginterferon lambda as a treatment for Covid-19. Bloomberg reports that a New England Journal of Medicine report found that those who were treated with Eiger’s therapeutic had a
Drugs
FDA has approved Regeneron Pharmaceuticals’ Eylea (aflibercept) injection to treat preterm infants with retinopathy of prematurity (ROP). With this approval, the drug is now indicated to treat five retinal conditions caused by ocular angiogenesis. “Retinopathy of prematurity is a leading cause of childhood blindness worldwide,” the company says. “ Until now,
Drugs
The Department of Justice (DoJ) has asked the 3rd Circuit Court of Appeals to reinstate conspiracy charges against KVK-Tech, a Newtown, PA, generic drug manufacturer. Courthouse News Service reports that in February 2022 a Pennsylvania federal court rejected the conspiracy charges, saying the government’s indictment failed to state
Drugs
FDA has revised its emergency guidance on compounding certain ibuprofen oral suspension products to address ongoing product shortages. Last month, FDA has issued an immediately-in-effect guidance on compounding certain ibuprofen products, which describes regulatory and enforcement priorities regarding the compounding of certain ibuprofen oral suspension products in outsourcing
Drugs
The Senate Judiciary Committee 2/9 cleared five drug-related bills and they now head to the Senate floor for consideration. The bipartisan bills were voted out of committee the previous Congress. In opening remarks, Sen. Chris Coons (D-DE) said more has to be done to ensure Americans have
Drugs
FDA has granted full approval to GSK’s Jemperli (dostarlimab-gxly) for adult patients with mismatch repair deficient (dMMR) recurrent or advanced endometrial cancer that has progressed on or following a prior platinum-containing regimen in any setting and are not candidates for curative surgery or radiation. Previously, the drug
Drugs
FDA is convening its Oncologic Drugs Advisory Committee (ODAC) 2/9 to consider GlaxoSmithKline’s proposals for two single-arm clinical trials of its Jemperli (dostarlimab), hoping to file a BLA and seek accelerated approval of a new rectal cancer indication. In advance of the meeting, FDA released a briefing
Drugs
CDER researchers are working on applying artificial intelligence/machine learning in the form of convolutional neural networks (CNNs) to enable the processing of large collections of images with high efficiency and accuracy by distinguishing complex “textual features” that are not readily delineated with existing image processing software. An online report
Drugs
The FDA Oncology Center of Excellence (OCE) slowed its launch of new projects in 2022 to allow existing projects to grow in depth and strength. That’s the analysis from OCE director Richard Pazdur in his message in the 2022 OCE annual report. “This year,” he writes, “our work examined
Drugs
In response to a request for comment from the United States Patent and Trademark Office (USPTO) on collaboration with FDA, the Biotechnology Innovation Organization (BIO) challenges “some of the misconceptions and unwarranted concerns that were raised at the 1/19 Listening Session.” BIO says the empirical data do not support
Drugs
The DC District Court has dismissed for lack of standing a Pharmaceutical Research and Manufacturers of America (PhRMA)-led lawsuit that sought to block HHS and FDA from implementing a program to permit the importation of some drugs from Canada. The 12/2020 suit had asked the court to hold