Drugs
FDA has granted Nurix Therapeutics a fast track designation for NX-5948, a highly selective degrader of Bruton’s tyrosine kinase (BTK) for treating adult patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma after at least two lines of therapy, including a BTK inhibitor and a
Drugs
Many doctors are not familiar with how FDA regulates new drugs and medical devices, according to the results of a survey conducted by researchers at the University of California San Francisco (UCSF). The researchers say that doctors may be under the impression that the data supporting drug and medical device
Drugs
Hemogenyx Pharmaceuticals says it has submitted a complete response to the FDA clinical hold on the company’s IND for HEMO-CAR-T. A company statement says the complete response is necessary before it can obtain agency consent to start Phase 1 trials of HEMO-CAR-T in acute myeloid
Drugs
An FDA summary of its 10/18-10/19/2023 virtual public meeting on “Mitigating Clinical Study Disruptions During Disasters and Public Health Emergencies,” calls for maintaining momentum started under the Covid-19 public health emergency to embrace modernization and continue innovations in clinical research. The meeting and publication of
Drugs
FDA has granted Hyloris Pharmaceuticals an orphan drug designation for PTX-252 for the treatment of acute myeloid leukemia (AML). “This product candidate, developed in collaboration with Pleco Therapeutics BV incorporates a novel molecular entity that is a derivative of a known established molecule and is designed to enhance the
Drugs
Reps. Doris Matsui (D-CA) and Larry Buschon (R-IN) have introduced the Mapping America’s Pharmaceutical Supply (MAPS) Act to help the federal government prepare for and mitigate future drug shortages by identifying drug supply chain vulnerabilities. A Matsui news release (includes a link to the full bill text)
Drugs
In recent years, FDA has demonstrated increased interest in regulating “off-label” communications, according to attorney Chia-Feng Lu (Greenberg Traurig). Writing in an online National Law Review post, Lu sees greater risk for medical product firms coming from uncertainty over a recent FDA guidance on communication of scientific information
Drugs
U.S. Reps. Anna G. Eshoo (D-CA), Diana DeGette (D-CO) and Kim Schrier (D-WA) have introduced the Pediatric Cancer Drug Supply Act of 2024, legislation that is intended to ensure there is a stable supply of essential pediatric cancer drugs in the U.S. The bill would
Drugs
CDER says that the majority (45%) of drug Warning Letters issued in fiscal year 2023 cited GMP requirement violations. The next highest category of letters issued (22%) was for misbranding/unapproved drug product violations, according to a just-released Office of Compliance FY 2023 Annual Report. Compared to last year,
Drugs
Fresenius Kabi has recalled its Ivenix Large Volume Pump (LVP) because some units have mechanical issues with the fluid valve pins in the device’s internal housing, which can cause them to not move properly. Instead of working as they should, the pins may impact the side of a sensor,
Drugs
FDA has approved Merck’s Keytruda (pembrolizumab) with chemoradiotherapy (CRT) for treating patients with FIGO 2014 Stage III-IVA cervical cancer. Approval is based on data from the KEYNOTE-A18 (NCT04221945) trial that enrolled 1,060 patients with cervical cancer who had not previously received definitive surgery, radiation, or systemic
Drugs
The Government Accountability Office (GAO) says Congress should consider giving FDA more authority to oversee dietary supplements. The recommendation is in a GAO report that found that 11 of 12 prenatal supplements it tested had at least one nutrient above or below the levels noted on the labels. “This could
Drugs
FDA has accepted for review a Shorla Oncology NDA for SH-105 for treating breast and ovarian cancer. The agency has set a user fee review action target date of 6/29. SH-105 is described as a ready-to-dilute form of a well-established undisclosed drug that has
Drugs
Canadian federal health minister Mark Holland says the plan recently approved by FDA permitting Florida to import some drugs from Canada is a non-starter that will face Canadian government action to prevent any drug shortages for Canadians. The Canadian Broadcasting Corporation (CBC) says Holland said, “There is no way
Drugs
FDA has published the International Council for Harmonization’s Q5A(R2) guidance, Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin. The document describes the evaluation of the viral safety of biotechnology products including viral clearance and testing, and outlines what data should be
Drugs
FDA says it is continuing to evaluate the risk of suicidal thoughts or actions in patients taking glucagon-like peptide-1 receptor agonists (GLP-1 RAs) such as Novo Nordisk’s Ozempic and Wegovy and Lilly’s Mounjaro and Zepbound. An agency drug safety update says its preliminary evaluation does
Drugs
The Washington Legal Foundation (WLF) says an FDA draft guidance on communications from firms to healthcare providers about scientific information on unapproved uses (SIUU) of approved/cleared medical products “threatens to undermine public health” and also “disregards the Constitution.” The WLF comment letter says the draft would chill truthful, non-
Drugs
Busse Hospital Disposables has recalled its Tracheostomy Care Tray, Dressing Change Tray, and Tracheostomy Care Set in response to Nurse Assist’s 11/2023 recall of 0.9% sodium chloride irrigation USP and sterile water for irrigation USP due to sterility concerns. Busse says that the Nurse Assist saline is
Drugs
FDA says its review of records submitted by South Korea’s Woorilife & Health, registered with the agency as a manufacturer of over-the-counter drugs, identified significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 12/28/2023 Warning Letter says the specific violations were:
Drugs
A 9/23-10/12/23 FDA Bioresearch Monitoring Program inspection of two clinical trials led by Dr. Jeffrey Taub at Children’s Hospital of Michigan found “objectionable conditions,” according to a just-released 12/19/23 Warning Letter. The letter says it appears that Taub did not adhere to
Drugs
A California state appeals court has issued a split ruling in a case involving Gilead Life Sciences and 24,000 plaintiffs in a coordinated proceeding who say they suffered adverse effects from their use of the company’s tenofovir disoproxil fumarate (TDF) to treat HIV/AIDS. The decision says the
Drugs
FDA has published a draft guidance, Request for Reconsideration at the Division Level Under GDUFA, with recommendations on the procedures for ANDA applicants who want to pursue a request for reconsideration within the review discipline at the division level or original signatory authority. The document says that requests within its