Drugs
The FDA Science Advisory Board New Alternative Methods (NAMs) Subcommittee says the agency should create a centralized office to coordinate work on NAMs to evaluate regulated products while reducing dependence on animal testing. A Regulatory Affairs Professional Society (RAPS) report on the Science Board 10/7 meeting (includes links to
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FDA says six Baxter products are in shortage and may be further affected until the Baxter North Cove facility in Marion, North Carolina, resumes operations after being closed due to the effects of Hurricane Helene. The agency list includes two dextrose IV solutions, two sodium chloride products, and two sterile
Drugs
FDA has issued Zealand Pharma a complete response letter (CRL) on its NDA for dasiglucagon and its use in preventing and treating hypoglycemia in pediatric patients seven days of age and older with congenital hyperinsulinism (CHI) for up to three weeks of dosing. “The CRL is related to the timing
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FDA has accepted a Bayer NDA for elinzanetant, a non-hormonal investigational compound for treating moderate-to-severe vasomotor symptoms (VMS, also known as hot flashes) associated with menopause. The submission is based on the positive results from the OASIS Phase 3 studies evaluating elinzanetant versus placebo. Bayer says the
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FDA has issued an exemption from the enhanced drug distribution security requirements of the Drug Supply Chain Security Act for eligible trading partners. An agency notice says the exemption applies to any product transacted by eligible trading partners, trading partners who have successfully completed or made documented efforts to complete
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A 7/17-7/26/2023 FDA inspection at the Louisiana State University Health Science Center institutional review board (IRB), New Orleans, LA, conducted as part of the agency’s Bioresearch Monitoring Program, determined that the IRB “did not adhere to applicable statutory requirements….” A 9/27 Warning Letter emphasizes
Drugs
FDA has released the form FDA-483 issued following a 9/23-9/27 inspection at the Apitoria Pharma Private Limited active pharmaceutical ingredient manufacturing facility in Telangana, India. The 10 inspection observations were: * equipment used in the manufacturing of drug substances and intermediates is not of adequate upkeep to
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FDA has released the form FDA-483 issued following a 9/17-9/27 inspection at Biocon Sdn Bhd, a sterile drug product manufacturer in Johor, Malaysia. The eight inspection observations were: * failure to establish or follow written procedures designed to prevent microbiological contamination of drug products purporting to be
Drugs
The bipartisan leadership of the House Energy and Commerce Committee is asking FDA for a staff briefing about the presence of counterfeit copies of Novo Nordisk’s Ozempic (semaglutide) injection 1 mg in the U.S. drug supply chain (see earlier story). A 10/8 letter to FDA commissioner Robert
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Researchers representing several academic institutions worldwide say FDA’s Boxed Warning for youth antidepressants has not had the intended outcome of increased monitoring for suicidal thoughts and behaviors and instead is associated with unintended reductions in doctor visits for depression, depression diagnoses, antidepressant treatment and use, and psychotherapy visits, as
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FDA reviewers are questioning whether a Stealth BioTherapeutics NDA for elamipretide, a mitochondria-targeted therapy for treating Barth syndrome, contains adequate data to support approval. The ultra-rare genetic disease, which affects fewer than 130 individuals in the U.S., mostly occurs in males and is characterized by cardiac abnormalities
Drugs
Johnson & Johnson says that since an FDA draft guidance on Bacillus Calmette-Guerin-Unresponsive Nonmuscle Invasive Bladder Cancer treatment development will replace a 2/2018 guidance when it is finalized, and ongoing trials were designed based on recommendations in the 2018 version, it would be helpful for FDA to
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A 3/25-3/30 FDA inspection at the MMC Healthcare drug manufacturing facility in Chennai, Tamil Nadu, India, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 9/24 Warning Letter says specific violations were: * failure to establish an adequate quality control unit with
Drugs
The American Hospital Association is asking the Biden Administration to require FDA to take “immediate actions to increase the supply of intravenous (IV) solutions” in the wake of product shortages caused by Hurricane Helene, particularly the closure of Baxter’s manufacturing plant in Marion, NC. The facility is a key
Drugs
Former FDA principal deputy commissioner Janet Woodcock has joined the board of directors at Every Cure, a nonprofit organization that looks at repurposing existing drugs to treat rare diseases. Over the past 15 years, the group says it helped advance 28 repurposed drugs for multiple diseases. “Our approach democratizes biomedical
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FDA has placed a clinical hold on Kezar Life Sciences’ IND for zetomipzomib and its investigational use in treating lupus nephritis (LN). The agency action follows the company’s notification late last month that it was voluntarily suspending enrollment and dosing in its Phase 2b PALIZADE clinical trial of zetomipzomib
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FDA has granted a priority review for an Indivior prior approval supplement for Sublocade (buprenorphine) extended-release injection for treating moderate to severe opioid use disorder (OUD). The submission is seeking approval to expand treatment options under two proposed updates to the drug’s label, including: * Alternative Injection Sites: Expands
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FDA is requesting comments on a draft document about controlled terminology/vocabulary that applies to a set of coded quality attribute data elements and their categorization for therapeutic protein products. “Since the content of this chapter is part of the early thinking of CDER’s Office of Pharmaceutical Quality (OPQ)
Drugs
A Reuter’s look at Thermo Fisher's Greenville, NC drug contract manufacturing plant finds that it has been inspected twice this year by FDA. The most recent inspection was in May and documented manufacturing issues related to AstraZeneca/Sanofi’s respiratory syncytial virus drug Beyfortus for infants and
Drugs
New FDA research shows that 22% of new molecular entities (NMEs) approved between 2009 and 2023 required postmarketing requirements (PMRs) or postmarketing commitments (PMCs) to address “knowledge gaps” on drug–drug interaction (DDI) assessments not addressed during development. “We found that 22% of NMEs had at least one DDI-related
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Johnson & Johnson is discontinuing a Phase 2 study (NCT05201794) evaluating mosnodenvir for preventing dengue virus in adults aged 18-65 years. The move to discontinue the study is part of the company’s “strategic reprioritization” of its communicable diseases research and development portfolio, J&J says, adding that
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FDA says the shortage of tirzepatide injection (Lilly’s Mounjaro and Zepbound), a glucagon-like peptide 1 (GLP-1) medication that became in short supply in 2022 due to increased demand, has been resolved. An agency notice says it confirmed with Lilly that its stated product availability and manufacturing capacity