Drugs
FDA has released a final guidance entitled “Nonclinical Evaluation of the Immunotoxic Potential of Pharmaceuticals.” The document is intended to assist sponsors in such evaluations of unintended immunosuppression or stimulation (including hypersensitivity), which can include adverse effects of exaggerated pharmacology of pharmaceuticals that are intended to act as immunomodulators. The
Drugs
FDA has published a draft guidance entitled “Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS): Establishing Drug Development Programs for Treatment.” The document provides recommendations for clinical drug development for such drugs and it includes advice FDA received at a 12/2017 advisory committee meeting on appropriate patient selection criteria and
Drugs
Roche/Genentech says an FDA draft guidance on developing drugs to treat neovascular age-related macular degeneration (nAMD) “is well constructed and helpful, outlining essential considerations for the design of clinical studies supporting the registration of therapies for the treatment of nAMD.” The companies provide points for further clarification or
Devices
CDRH is soliciting public comment on increasing patient access to at-home use medical technologies. The request for comment says access to medical devices outside a clinical care setting “may help bridge the gap by bringing healthcare directly to patients wherever they are….” The Center says it particularly wants public
Drugs
The Department of Justice says Anise Kachadourian of Towaco, NJ, pleaded guilty in a New Jersey federal court to using her medical license, and allowing others to use it, to purchase prescription oncology medicines under false pretenses to sell them for profit. A department statement says the oncologist was paid
Devices
FDA has cleared an Ezra 510(k) for its artificial intelligence-enabled Ezra Flash and its use in enhancing MR image quality and decreasing the time needed to complete a high quality scan. The company says it will use this technology to launch the “world’s first 30-minute full
FDA Policy/General
After serving at FDA for eight years, CDER Office of New Drug Policy director Maarika Kimbrell has left the agency to re-enter private legal practice at Morgan Lewis as a partner resident to counsel pharma/biotech companies on regulatory matters. Previously at FDA, she served as deputy chief of
FDA Policy/General
Federal Register notice: FDA is withdrawing approval of eight ANDAs from multiple applicants after they informed the agency that the products were no longer marketed and requested they be withdrawn. The withdrawn products are: * Hospira’s metoprolol tartrate injectable, * Tolmar’s calcipotriene solution * American Regent’s dorzolamide HCl solution/drops
Biologics
FDA has approved Pfizer’s Abrysvo (respiratory syncytial virus vaccine), a bivalent RSV (respiratory syncytial virus) prefusion F vaccine, to prevent lower respiratory tract diseases caused by RSV in people age 60 and older. A company statement says Abrysvo is unadjuvanted and is composed of two preF proteins selected to
Drugs
FDA has approved AstraZeneca and Merck’s Lynparza (olaparib) in combination with Janssen’s Zytiga (abiraterone) and prednisone or prednisolone for treating adult patients with deleterious or suspected deleterious BRCA-mutated metastatic castration-resistant prostate cancer. The approval follows a 4/28 advisory committee vote of 11 to 1 that
Drugs
FDA has published a draft guidance, Migraine: Developing Drugs for Preventive Treatment, to assist sponsors in the clinical development of these drugs. Specifically, the document addresses FDA’s current thinking about the overall development program and clinical trial designs to support the approval of drugs for the preventive treatment of
Drugs
AstraZeneca says it is discontinuing its brazikumab inflammatory bowel disease (IBD) development program. A company statement says brazikumab is a monoclonal antibody that binds to IL23, preventing the interaction with its receptor. It was in development for Crohn’s disease and ulcerative colitis. “The decision to discontinue brazikumab’s IBD
Drugs
FDA has issued a warning against using unapproved products that claim to treat molluscum, even if they say they are “FDA-approved” or “made in an FDA facility.” The agency notes that there are no FDA-approved products to treat molluscum. FDA says that any unapproved products marketed to treat
Drugs
FDA commissioner Robert Califf says artificial intelligence (AI), like many of the great innovations for humankind, can be used for tremendous good or tremendous harm. In a wide-ranging Medscape interview, Califf says it’s always good to have in the back of one’s mind that harm can be
Devices
CDRH is announcing a 9/6 Patient Engagement Advisory Committee meeting to discuss and make recommendations on “Advancing Health Equity in Medical Devices.” Panel members are scheduled to discuss using technology, including digital health technology, to help bridge gaps in health equity by extending access and bringing healthcare to patients
Drugs
Sanofi says data from a Phase 2 trial of frexalimab, a novel second-generation investigational anti-CD40L antibody, “significantly reduced disease activity” in patients with relapsing multiple sclerosis. “Following 12 weeks of therapy, the number of new gadolinium-enhancing (GdE) T1-lesions was reduced by 89% and 79% in the
Drugs
FDA is alerting patients and healthcare providers to concerns about compounded semaglutide that is being produced as an alternative to approved versions Ozempic, Rybelsus and Wegovy, which have been reported to be in short supply. The glucagon-like peptide-1 receptor agonists are used for treating diabetes and obesity. The
Drugs
CDER Office of Surveillance and Epidemiology (OSE) director Gerald Dal Pan says that in 2022 OSE responded to the Covid-19 and opioid public health emergencies and also detected and assessed risk across all of the drugs that CDER regulates. The OSE annual report says the risk detection and assessment
Drugs
FDA Oncology Center of Excellence director Richard Pazdur says the current shortage of most cancer drugs represents a market failure and FDA is limited in what it can do to manage shortages. Pazdur addressed the shortages in an extensive interview with The Cancer Letter. He says the shortages of cisplatin
FDA Policy/General
Federal Register notice: FDA is announcing that it intends to inactivate the registration of establishments that manufacture human cells, tissues, or cellular or tissue-based products (HCT/Ps) that have not updated their annual registration under the agency’s electronic human cell and tissue establishment registration system. Agency regulations require
Drugs
FDA is placing a clinical hold on a PepGen IND application to start a Phase 1 study of its PGN-EDODM1 in patients with myotonic dystrophy Type 1. A company statement says the agency indicated it would provide the reason for the clinical hold in an official notice within 30
Drugs
Based on positive results from the latest trial of Precision BioScience’s azercabtagene zapreleucel (azer-cel) as a potential first-in-class allogeneic CD 19 CAR T for the growing CAR T relapsed patient population with diffuse large B-cell lymphoma (DLBCL), the company has scheduled a June meeting with