Drugs
FDA has accepted for review an Omeros BLA resubmission for narsoplimab for treating hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA). The resubmission has been assigned a user fee review action target date of late September. In 2021, FDA issued a complete response letter on the BLA, saying it
FDA Policy/General
Sen. Eric Schmitt (R-MO) has introduced legislation to create new inspectors general for FDA, the Centers for Disease Control and Prevention, and the National Institutes of Health. In a statement, Schmitt says the Improving National Safety, Public Health, Ethics, and Clinical Trials (INSPECT) Act is needed because “Americans’ trust
Drugs
FDA is announcing a two-day (5/20-21) Oncologic Drugs Advisory Committee meeting to review and vote on four cancer drug submissions. During the morning session on 5/20, panel members will discuss a supplemental BLA for Genentech’s Columvi (glofitamab) injection and its use in combination with gemcitabine
Biologics
FDA is announcing a 5/22 Vaccines and Related Biological Products Advisory Committee meeting to discuss and make recommendations on the selection of the 2025-2026 formula for Covid-19 vaccines for use in the U.S. The meeting should shed some light on how FDA intends to regulate Covid-
FDA Policy/General
FDA associate commissioner for inspections and investigations Michael Rogers, who has worked for the agency for more than 30 years, is retiring effective 5/14, reportedly over staff frustration with commissioner Martin Makary. “I have decided to retire,” Rogers told CBS News. “It was my decision, but it was time
FDA Policy/General
FDA has tapped former Booz Allen Hamilton chief technologist Jeremy Walsh to lead its artificial intelligence (AI) and information technology efforts in a newly created leadership role — Chief AI Officer. Walsh announced his appointment via LinkedIn and it was first reported by Politico. Walsh served for 14 years as chief
FDA Policy/General
FDA has approved Teva Pharmaceuticals and Alvotech’s Selarsdi (ustekinumab-aekn) injection as an interchangeable biosimilar to Janssen’s reference biologic Stelara (ustekinumab) for treating psoriatic arthritis and plaque psoriasis, as well as Crohn’s disease, and ulcerative colitis. Ustekinumab is a human monoclonal antibody that selectively targets the p40
Drugs
FDA says it will expand unannounced inspections at foreign manufacturing facilities that produce medical products, drugs, and food intended for U.S. consumers and patients. A 5/6 statement says the intent is to “ensure that foreign companies will receive the same level of regulatory oversight and scrutiny as domestic
Drugs
President Donald Trump signed 5/5 an Executive Order directing FDA to cut the amount of time it takes to approve domestic drug manufacturing plants by eliminating duplicative and unnecessary requirements, streamlining reviews, and working with domestic manufacturers to provide early support before facilities come online. “We don’t want
FDA Policy/General
FDA has appointed University of California, San Francisco professor and vocal FDA-industry critic Vinay Prasad to serve as CBER’s new director, replacing Peter Marks, who abruptly resigned last month rather than support what Marks described as HHS secretary Robert F. Kennedy Jr.’s “misinformation and lies” (see earlier
FDA Policy/General
Drug study information in NDAs/BLAs will need to be electronically submitted, beginning 12/2026, in a certain format to assist FDA in planning its bioresearch monitoring (BIMO) inspections, according to a just-posted agency Webinar. CDER says it uses the data and information described in a recent guidance to
FDA Policy/General
FDA canceled a scheduled meeting with the National Treasury Employees Union (NTEU), which represents about 9,000 FDA employees, that was to spend five hours discussing the layoffs that hit the agency earlier this year. Union leaders say the agency did not set another date for the meeting, Reuters reports.
Drugs
FDA has approved an RM Pharma 505(b)(2) for HemiClor (12.5 mg chlorthalidone) tablets for treating hypertension in adults. Chlorthalidone, a thiazide-like diuretic, has been approved and marketed over several decades, and until now, only higher-dose chlorthalidone tablets (25 mg and 50 mg) have been available
Biologics
FDA commissioner Martin Makary told the 5/6 American Hospital Association annual meeting that the agency is encouraging companies seeking approval for Covid-19 vaccine booster shots to use “gold standard science,” including clinical trials involving healthy people. In an online post on Makary’s presentation, Health Day says the
Devices
FDA has cleared a Teleflex 510(k) for an expanded indication for its QuikClot Control+ Hemostatic Device to include all grades of internal and external bleeding. The device was previously indicated for temporary control of Class III and Class IV internal organ space bleeding, severely bleeding surgical wounds, mild and
Drugs
A 2/12-2/16/2024 FDA Bioresearch Monitoring Program inspection at Amicis Research Center, operated by Dr. Nana Barseghian in Northridge, CA, found that Barseghian failed to ensure that a clinical investigation was conducted according to the investigational plan. A 4/28 Warning Letter acknowledges the corrective and preventive
Drugs
The Trump administration 5/5 asked a federal judge to dismiss a lawsuit filed by Idaho, Kansas, and Missouri that seeks to block access to the abortion pill mifepristone via telehealth. In court filings, attorneys for the Department of Justice (DoJ) maintained the legal strategy established under the Biden administration,
Drugs
Johnson & Johnson says its gene therapy botaretigene sparoparvovec missed the primary endpoint in the Phase 3 LUMEOS study that is evaluating it for treating X-linked retinitis pigmentosa (XLRP). The company describes XLRP as a genetic eye disease, which primarily affects males, caused by a defect in the RPGR
Drugs
A new report from IQVIA says drug spending in 2024 accelerated, with net prices growing at an 11.4% rate last year compared with a 4.9% increase in 2023. “Greater use of medicines with significant clinical benefits is driving spending growth, while net price growth is flat,” the report
Drugs
Researchers from Genentech find that FDA’s Drug Development Tools (DDTs) Qualification program has had a very “limited” impact on development programs. Writing in an online post on physiciansweekly.com, the researchers note that the DDT pathway for evaluating clinical outcome assessments (COAs) gets bogged down and takes longer for
Drugs
Public health researchers are warning about the broader impact to emerging technologies in a March ruling (see story) by a Texas federal judge that struck down FDA’s final rule establishing a regulatory framework for ensuring the safety and effectiveness of laboratory-developed tests (LDTs). Writing in a 5/5
Biologics
FDA has issued ImmunityBio a refusal to file letter for its recent supplemental BLA submission seeking approval for Anktiva (nogapendekin alfa inbakicept-pmln) plus Bacillus Calmette-Guerin (BCG) for treating papillary disease in non-muscle invasive bladder cancer (NMIBC) patients. Papillary diseases are characterized by tumors with a papillary growth