Drugs
Researchers in the U.S. and Australia say that while there has been a substantial increase in individual participant data (IPD) sharing for industry-sponsored oncology trials in the past five years, much more needs to be done. An investigation published in JAMA Oncology found that of the 304 trials
Drugs
FDA has accepted for review a BLA from ImmunityBio for its N-803 antibody cytokine fusion protein to treat patients with BCG-unresponsive non-muscle-invasive bladder cancer (NMBIC) carcinoma in situ with or without Ta or T1 disease. The company says the submission is based on positive QUILT 3.
Drugs
FDA has accepted for review a Lexicon Pharmaceuticals NDA resubmission for sotagliflozin, an investigational dual SGLT1 and SGLT2 inhibitor for treating heart failure. The agency set a 5/2023 user fee review action date. The company says the submission seeks the following indications: * To reduce the risk of cardiovascular death,
Drugs
Five key Senate leaders have introduced the Cannabis Administration and Opportunity Act (CAOA) to “end the harmful and out-of-touch federal prohibition on cannabis by removing cannabis from the federal list of controlled substances and empowering states to implement their own cannabis laws.” In a statement, the senators say
Drugs
FDA has granted breakthrough therapy designation to Vertex Pharmaceuticals’ VX-548 to treat acute and neuropathic pain. The company says it has reached agreement with FDA on the design of a pivotal Phase 3 trial that will open in the fourth quarter of this year. The Phase 3 program will
Drugs
An 11/29-12/13/21 FDA inspection at the Goodman Eye Center, San Francisco, CA, conducted as part of the agency’s Bioresearch Monitoring Program, found objectionable conditions associated with a clinical trial conducted at the site. A 7/14 Warning Letter emphasized these issues: * failing to submit an
Drugs
FDA has published a guidance, General Clinical Pharmacology Considerations for Neonatal Studies for Drugs and Biological Products, to assist sponsors of INDs, NDAs, and BLAs and their supplements who are planning to conduct clinical studies in neonatal populations. The document has recommendations for neonatal clinical pharmacology studies, whether they are
Devices
FDA has issued a draft guidance to help ensure that information is available to patients and health care professionals about the benefits and risks of LASIK devices, which are used in vision correction (e.g., nearsightedness, farsightedness, and astigmatism) surgeries. Interested parties can comment on the guidance until 10/26.
FDA Policy/General
Federal Register notice: FDA withdraws the approval of Ivax Pharmaceuticals ANDA for chloramphenicol capsules (250 mg) after the company requested the withdrawal due to safety reasons. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has submitted to OMB a new information collection entitled “Pharmaceutical Voluntary Consensus Standard Recognition.” The collection supports CDER’s implementation of its “Program for the Recognition of Voluntary Consensus Standards Related to Pharmaceutical Quality.” It also supports a guidance that outlines procedures to submit requests for
Drugs
The Department of Justice has opened a criminal investigation into whether Cassava Sciences manipulated research results for its experimental Alzheimer’s drug simufilam, Reuters reports exclusively, based on information from two sources. The news service says it was told those doing the investigation specialize in examining whether companies or individuals
Biologics
FDA has approved Bavarian Nordic’s fill and finish facility in Denmark to manufacture its Jynneos smallpox/monkeypox vaccine. “With the approvals of the final drug production – the process by which the vaccine is formulated and filled into vials – the company is now allowed to deliver drug product manufactured at
Drugs
FDA has published a guidance, Cancer Clinical Trial Eligibility Criteria: Available Therapy in Non-Curative Settings, with recommendations for clinical investigators and sponsors about including patients who have not received available therapy for their cancer in clinical trials of drugs and biological products for the treatment of cancer in the
Devices
FDA has cleared a Viz.ai 510(k) for its Viz Subdural (SDH), an algorithm that uses artificial intelligence (AI) to automatically detect subdural hemorrhages. “Viz SDH is the only SDH-specific AI-powered detection and care coordination platform with the ability to identify acute and chronic subdural bleeds, then
Drugs
FDA has approved an additional indication for GlaxoSmithKline’s Benlysta (belimumab) to treat children age 5 to 17 with active lupus nephritis who are receiving standard therapy. The company says the approval extends the current U.S. indication to include both lupus and active lupus nephritis for the intravenous formulation
Drugs
A 13/15/21-1/14/22 FDA inspection at the Bi-Coastal Pharma International drug manufacturing facility in Shrewsbury, NJ, found significant violations of current good manufacturing practice regulations for finished drugs. A 6/30 Warning Letter says specific violations were: * failing to establish and follow adequate written procedures
Drugs
A 1/10-1/21 FDA inspection at the Jost Chemical drug manufacturing facility in St. Louis, MO, found significant deviations from current good manufacturing practice (CGMP) regulations for active pharmaceutical ingredients (APIs). A 7/18 Warning Letter says specific deviations were: * failure of the quality unit to ensure that
Drugs
Immuron says FDA has placed a clinical hold on an unidentified investigational drug being evaluated for treating campylobacter and enterotoxigenic escherichia coli. The Australian biopharmaceutical company, which is focused on developing and commercializing oral immunotherapeutic products for preventing and treating gut pathogens, says FDA has given feedback to the U.
Devices
FDA has cleared an iRhythm Technologies 510(k) for its ZEUS (Zio ECG Utilization Software) System for the Zio Watch. The artificial intelligence algorithm allows the sensor-based watch to provide long-term continuous monitoring for atrial fibrillation (AFib). ZEUS is being produced in partnership with Verily, an Alphabet precision
FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes the regulatory review period for Alkermes’ Vumerity (diroximel fumarate), indicated for treating certain relapsing forms of multiple sclerosis. The review period is 1,944 days, of which 1,623 days occurred during the testing phase and 321 days during the
FDA Policy/General
Federal Register notice: FDA has revoked the Emergency Use Authorization (EUA) issued to Gilead Sciences for Veklury (remdesivir) for treating Covid-19 in adults and pediatric patients. The revocation follows FDA approval of a supplemental NDA for Veklury, which expanded the approved indication to cover the EUA-intended population. To
Drugs
Avadel CNS Pharmaceuticals is suing FDA and HHS over an agency decision to require a patent statement for the company’s Lumryz NDA. The suit, filed in DC federal court, gives four reasons why FDA erred in requiring Avadel to file the statement for its REMS computerized system that FDA