Drugs
FDA has lifted a two-month-long partial clinical hold on a Molecular Templates (MTEM) Phase 1 multiple myeloma study of MT-0169 that was based on previously disclosed cardiac adverse events noted in two patients dosed at 50 mcg/kg, which prompted a dose reduction from 50 mcg/kg
Drugs
Senator Dick Durbin (D-IL) is urging FDA to take immediate action to improve supply shortages of critical cancer drugs. In a 6/1 letter to FDA commissioner Robert Califf, Durbin cited shortages with two chemotherapy drugs — carboplatin and cisplatin — that are used in treating hundreds of thousands of cancer
Drugs
FDA has posted a final guidance entitled “Drug-Drug Interaction Assessment for Therapeutic Proteins.” The document is intended to help sponsors determine the need for drug-drug interaction (DDI) studies for a therapeutic protein by providing recommendations for a systematic, risk-based approach. “Due to the evolving knowledge of novel
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FDA has published a draft guidance entitled “Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS): Establishing Drug Development Programs for Treatment.”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Roche/Genentech says an FDA draft guidance on developing drugs to treat neovascular age-related macular degeneration (nAMD) “is well constructed and helpful, outlining essential considerations for the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
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
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
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
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
Drugs
FDA continues to ramp up its return to face-to-face (FTF) meetings and beginning 6/12 CDER and CBER will expand in-person FTF industry meetings to include requests for Type B End-of-Phase 2 requests. The End-of-Phase 2 requests join the previously announced Type A,
Drugs
FDA is proposing to amend its Medication Guide regulation to require applicants to create a new one-page Patient Medication Information (PMI) for prescription drug products. A Federal Register notice says the PMI would have a standardized format and content that would be submitted to the agency for approval. The
Drugs
A 3/21-4/28/22 FDA inspection at New England Life Care, doing business as Advanced Compounding Solutions in Woburn, MA, found multiple violations of the Federal Food, Drug, and Cosmetic Act. A 5/16 Warning Letter says the investigators found serious deficiencies in the company’s practices for
Drugs
FDA has accepted for priority review a Bristol Myers Squibb NDA for repotrectinib, a next-generation tyrosine kinase inhibitor (TKI) for treating patients with ROS1-positive locally advanced or metastatic non-small cell lung cancer (NSCLC). The agency has set a review action target date of 11/27. The submission