Drugs
FDA has issued Mesoblast a second complete response letter on its BLA for remestemcel-L for treating pediatric steroid-refractory acute graft versus host disease (SR-aGVHD), requesting more data to support marketing approval. “To obtain the data required, Mesoblast will conduct a targeted, controlled study in the highest-risk
Drugs
After reporting two patient deaths, Regeneron says it has discontinued enrollment in a Phase 1 prostate cancer study of REGN5678, the company’s PSMAxCD38 costimulatory bispecific antibody, used in combination with a full-dose of its programmed death receptor-1 inhibitor Libtayo (cemiplimab-rwlc). The company says it plans to
Drugs
FDA has announced a new drug safety initiative that aims to develop artificial intelligence (AI) models for toxicological endpoints that are key to assessing drug safety and may help evaluate drug candidates before they are tested in human trials. Called SafetAI, the initiative involves FDA’s National Center for Toxicological
Drugs
FDA has posted a final guidance entitled “Recommended Acceptable Intake Limits for Nitrosamine Drug Substance-Related Impurities (NDSRIs).” The document provides manufacturers and applicants of drugs, including prescription and over-the-counter (OTC) drug products, with a recommended framework for predicting the mutagenic and carcinogenic potential NDSRIs that could be
Drugs
A bipartisan group of 28 members of the House of Representatives is warning FDA that the 11/27 deadline for implementing provisions of the Drug Supply Chain Security Act (DSCSA) could lead to disruptions to drug supply and patient care. The group is led by Reps. Troy Balderson (R-OH)
Drugs
FDA has published a guidance, Waivers, Exceptions, and Exemptions From the Requirements of Section 582 of the Federal Food, Drug, and Cosmetic Act, describing how an authorized trading partner or other stakeholder should request a waiver, exception, or exemption from the Drug Supply Chain Security Act (DSCSA). The document also
Drugs
Washington Legal Foundation (WLF) says the 2nd Circuit Court of Appeals affirmed 7/28 a federal district court’s grant of summary judgment to Forest Pharmaceuticals in a case involving the company’s antidepressant Lexapro (escitalopram). A WLF statement says the decision was a victory for the legal advocacy organization
Drugs
FDA says CDER staff have been conducting research to analyze different bispecific antibody (BsAb) molecular formats using physiochemical and biological approaches. An online paper says the studies are not intended to develop drugs, but rather to understand how different forms of BsAbs affect quality aspects such as product characterization, bioassay
Drugs
Regeneron says it will respond to a recent FDA complete response letter (CRL) on the company’s BLA for a higher dose of Eylea (aflibercept) 8 mg to treat patients with wet age-related macular degeneration, diabetic macular edema, and diabetic retinopathy. The agency has told Regeneron and contract vial
Drugs
A 1/30-2/8 FDA inspection at the Centaur Pharmaceuticals drug manufacturing facility in Maharashtra, India, found significant violations of current good manufacturing practice (CGMP) regulations in the production of finished drugs. A 7/25 Warning Letter says the specific violations were: * failing to clean, maintain, and, as appropriate
Drugs
FDA is reminding product sponsors that the deadline for the second submission cycle of its Advancing Real-World Evidence (RWE) program is 9/30. For selected sponsors, the program provides an opportunity to meet with staff from CDER, CBER, and the Oncology Center of Excellence, before protocol development or study
Drugs
FDA has published a draft guidance, Fixed-Combinations and Single-Entity Versions of Previously Approved Antiretrovirals for the Treatment or Prevention of HIV-1 Under PEPFAR, with recommendations for applications for these products. Specifically, the document addresses versions of previously approved single-entity (SE) and fixed-combination (FC) antiretroviral (ARV)
Drugs
FDA has revised form 356h: Application to Market a New or Abbreviated New Drug or Biologic for Human Use and form 1571: Investigational New Drug Application (IND) to align with new user fee requirements and to make data-quality improvements. To learn more about the specific revisions, click here.
Biologics
The Advanced Medical Technology Association (AdvaMed) says decentralized clinical trials can facilitate diversity in clinical trials. Commenting on an FDA draft guidance on decentralized clinical trials for drugs, biological products, or medical devices, AdvaMed says the document can facilitate recruitment of diverse populations in clinical trials and may help expedite
Drugs
FDA has approved Taiho Oncology’s Lonsurf (trifluridine and tipiracil) with bevacizumab for treating metastatic colorectal cancer (mCRC) patients previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild-type, an anti-EGFR therapy. In 2015, the agency approved single-agent Lonsurf
Drugs
FDA has granted fast-track designation to Invectys’ IVS-3001 for treating renal cell cancer. A company statement says the designation was based on data from an IND submission and the potential for meeting the unmet needs of patients with HLA-G positive locally advanced or metastatic clear cell renal
Drugs
Lupin Pharmaceuticals has recalled two lots of Tydemy (drospirenone, ethinyl estradiol and levomefolate calcium tablets 3mg/0.03mg/0.451 mg) due to out-of-specification test results at the 12-month stability time point. According to a recall notice, one lot tested low for ascorbic acid (an inactive ingredient)
Drugs
In an unusual 8/1 “Dear Americans” open letter, FDA commissioner Robert Califf and Drug Enforcement Administration (DEA) administrator Anne Milgram say the current shortage in prescription stimulants is not a problem the two agencies can solve on their own. “We are urging all stakeholders to work together to resolve
Drugs
FDA has granted Actuate Therapeutics an orphan drug designation for elraglusib for treating patients with pancreatic cancer. Elraglusib is described as a glycogen synthase kinase-3 beta (GSK-3β) inhibitor that targets molecular pathways in cancer that are involved in promoting tumor growth and resistance to conventional cancer drugs such
Drugs
A 7/28 Warning Letter cites Sanand, India-based Intas Pharmaceuticals for current good manufacturing practice (CGMP) violations found during an 11/22/22-12/2/22 FDA inspection. The letter says specific violations were: * failure of the firm’s quality control unit to exercise its responsibility to ensure drug
Drugs
A 1/30-2/10 FDA inspection at the Iso-Tex Diagnostics drug manufacturing facility in Alvin, TX, found significant violations of current good drug manufacturing (CGMP) regulations for finished drugs. A 7/20 Warning Letter says specific violations were: * failing to have buildings used in the manufacturing, processing, packing,
Drugs
A 1/19-1/27 FDA inspection at the Baxter Pharmaceuticals India drug manufacturing facility in Ahmedabad, India, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 7/25 Warning Letter says specific violations were: * failing to thoroughly investigate any unexplained discrepancy or failure of