Drugs
FDA has granted China-based Mabwell an orphan drug designation for its novel Nectin-4-targeting antibody-drug conjugate 9MW2821 for treating esophageal cancer. The therapy was previously given a fast-track designation for treating advanced, recurrent, or metastatic esophageal squamous cell carcinoma. NECTIN-4 is an adhesion molecule expressed
Drugs
Tandem Diabetes Care is recalling (Class 1) its t:connect mobile app (version 2.7 released 2/12) on the Apple iOS platform that is used with the company’s t:slim X2 insulin pump with Control-IQ technology. An agency recall notice says the recall is a device correction
Drugs
Three Winston & Strawn attorneys say the Supreme Court declined to hear an appeal of a 1st Circuit Court of Appeals decision upholding implied preemption of a putative class action suit against McNeil Nutritionals over its Lactaid dietary supplement. The attorneys write in an online post that the suit claimed
Drugs
Responding to an 8/30/2022 petition submitted by HBT Labs, FDA says it has determined that cancer drug paclitaxel particle bound particles for injectable suspension (albumin-bound) 100 mg/vial and Abraxane (paclitaxel protein bound particles for injectable suspension) are pharmaceutically equivalent and bioequivalent, and can be expected to
Drugs
A 12/5-12/16/2022 FDA Bioresearch Monitoring Program inspection at DBC Research in Tamarac, FL, operated by Dr. Kevin Bender, looked at the protocols for three clinical trials. A 5/2 Warning Letter says Bender failed to take adequate precautions to prevent theft or diversion of an investigational
Drugs
Endo Health Solutions has been ordered to pay $1.086 billion in criminal fines and an additional $450 million in criminal forfeitures related to distributing misbranded Opana ER, an opioid medication. In a statement, the Department of Justice says the company pleaded guilty on 4/18 to one count of
Drugs
The House Committee on Oversight and Accountability is stepping up pressure on FDA and its oversight imported Chinese active pharmaceutical ingredients and finished drugs. In a 5/6 letter to FDA commissioner Robert Califf, Committee chair James Comer (R-KY) calls on FDA to “do everything in its power to
Drugs
GlycoMimetics says its Phase 3 study of uproleselan combined with chemotherapy in relapsed/refractory acute myeloid leukemia (AML) patients “did not achieve a statistically significant improvement in overall survival in the intent to treat population versus chemotherapy alone.” The company says it is analyzing the data in collaboration with medical,
Drugs
FDA has released a draft guidance entitled “REMS Logic Model: A Framework to Link Program Design With Assessment. The document describes FDA’s risk evaluation and mitigation strategy (REMS) logic model, which it describes as a recommended framework to provide applicants with a systematic, structured approach to the design, implementation,
Drugs
CDER is announcing a new Quantitative Medicine (QM) Center of Excellence (CoE). “QM involves the development and application of exposure-based, biological, and quantitative modeling and simulation approaches derived from nonclinical, clinical, and real-world sources to inform drug development, regulatory decision-making, and patient care,” an agency notice says.
Drugs
FDA has announced an 8/16 public meeting on “Evaluating the Negative Symptoms of Schizophrenia in Clinical Trials” to discuss approaches to developing drugs to treat the negative symptoms of schizophrenia and disseminate important regulatory considerations for programs designed to evaluate such drugs. The hybrid meeting requires registration for attending
Drugs
A Eugia Pharma Specialities (an Aurobindo subsidiary) formulation manufacturing facility in Rajasthan, India has been issued a seven-observation FDA Form-483 after being inspected by the agency from 4/25 to 5/3. “The observations are procedural in nature and will be responded to within the stipulated time,” the
Drugs
The CDER Office of Translational Sciences 2023 annual report says it highlights achievements in the areas of drug regulatory review; inspections; science and research; advancing tools, technologies, and innovation; administrative operations; and outreach and communication efforts. Activities discussed in the report include: * promoting scientific collaboration and innovation in drug regulatory
Drugs
Sens. Richard Durbin (D-IL) and Richard Blumenthal (D-CT) have introduced legislation to prohibit tianeptine from being marketed to consumers. The Prohibiting Tianeptine and Other Dangerous Products Act would give FDA authority to prohibit the marketing of products such as tianeptine as dietary supplements. A statement issued by Durbin
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) says it strongly supports the flexible and innovative approach outlined in an FDA draft guidance on key information and facilitating understanding in informed consent. A PhRMA comment letter urges FDA and the HHS Office for Human Research Protections (OHRP) “to continue to embrace
Drugs
Writing in the open-source Journal of General Internal Medicine, CBER director Peter Marks and Brown University medical school professor Eli Adashi say that it appears that decentralized clinical trials (DCTs) are “a paradigm whose time has come, especially since by providing more broadly applicable results they may provide important
Drugs
FDA should use accelerated approval and other regulatory techniques to speed the development and approval of treatments. That’s the thesis in a Salon commentary written by the executive director of the National Mucopolysaccharidoses Society. The commentary says that to date, agency regulators have not used accelerated approval, even for
Drugs
Doctors for America (DFA) says FDA should finalize its draft guidance on the collection of race and ethnicity data in clinical trials and clinical studies for regulated products with strong recommendations for industry compliance and providing ongoing support and resources to facilitate the adoption of inclusive practices in clinical research.
Drugs
FDA has approved an Aquestive Therapeutics ANDA for Libervant (diazepam) Buccal Film for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) in patients with epilepsy between two to five years of age. Aquestive says it developed Libervant as an alternative
Drugs
AdvaMed says FDA should update its draft guidance on key information and facilitating understanding in informed consent “to be clear about what levels of reimbursement, compensation, and recruitment incentives are problematic for medical device studies.” The association’s comment letter also suggests that HHS modernize its human subject protection guidance,
Drugs
FDA has approved Boehringer Ingelheim’s high-concentration, citrate-free formulation of Cyltezo (adalimumab-adbm), an interchangeable biosimilar to Abbvie’s Humira (adalimumab) for treating multiple chronic inflammatory diseases. Boehringer’s low-concentration (50 mg/mL), citrate-free formulation of Cyltezo has been commercially available since 7/2023. “The availability
Drugs
The National Community Pharmacists Association (NCPA) says there are many comments it has submitted to FDA over the years that still have not been addressed by the agency. The comment is included in the NCPA statement submitted in advance of the agency’s 5/14 Drug Compounding Annual Listening Session.