Drugs
Members of the FDA Cardiovascular and Renal Drugs Advisory Committee 11/16 voted 9-4 to back Ardelyx’ tenapanor as a monotherapy in kidney disease patients and 10-2-1 for its use in combination with phosphate binders. FDA medical reviewers had raised concerns about the drug’s treatment effect
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FDA Oncology Center of Excellence director Richard Pazdur says the agency wants to see multiregional trials in oncology submissions that represent the major International Conference for Harmonization (ICH) regions in the world. Speaking at the 2022 Friends of Cancer Research (FOCR) in Washington, DC 11/17, Pazdor expanded on a
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Worldwide academic medical center researchers led by Abass Alavi from the Hospital of the University of Pennsylvania Department of Radiology say FDA should pause its approval of Biogen’s Aduhelm (aducanumab) to treat Alzheimer’s disease. Writing in a Journal of Alzheimer’s Disease commentary, Alavi says the approval should
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The California Court of Appeal has upheld federal preemption in a case involving the heart drug amiodarone. Attorney Steven Boranian (Reed Smith) writes in a Drug & Device Law Blog post that the plaintiffs in the case alleged that they experienced severe effects after their doctors prescribed amiodarone off-label.
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Four Morrison Foerster attorneys say a panel on “Compliance and Cybersecurity Challenges in Clinical Trial Enforcement” held on 11/2 at a Food and Drug Law Institute conference featured a high-ranking attorney from the Department of Justice consumer protection branch and other regulatory compliance leaders to discuss key trends
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CBER has issued two new Standard Operating Policies and Procedures (SOPP) to guide Center staff in dealing with resubmissions to an application or supplement and actions on biological product licenses. SOPP 8405.1, Procedures for Resubmissions to an Application or Supplement, is a guide for the categorization and processing of
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GSK says a Phase 2a study showed that GSK3036656, an investigational antitubercular agent, was well tolerated and showed early bactericidal activity with a low, once-daily oral dose after 14 days of treatment in participants with drug-susceptible pulmonary tuberculosis (TB). “These results demonstrate the potential for GSK3036656 to be
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FDA has approved an expanded use for GE Healthcare’s DaTscan (ioflupane I 123 injection) for use in patients with suspected dementia with Lewy Bodies (DLB). Previously, the radiopharmaceutical was approved for use with single photon emission computed tomography (SPECT) imaging to visualize dopamine transporters (DaT) in the brains of
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FDA has issued a five-item Form FDA-483 after conducting a pre-approval inspection of Lupin’s Nagpur, India Unit-2 injectable manufacturing facility 10-17-29. “We are committed to addressing the observations at the earliest, and gaining approval for injectable manufacturing for the U.S.,” the company
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Some 165 organizations representing healthcare providers, public health professionals, scientists, patients, and the biotech and diagnostics industries are urging lawmakers to advance the Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act (H.R. 3932) before the 117th Congress ends 1/3/23. “With its power to jump-start the
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An analysis by the Germany-based ECA Academy of 42 FY 2022 FDA Warning Letters has identified the top 10 most frequently cited good manufacturing practice deficiencies. The 10 listed are: * responsibilities of the quality control unit (cited in 23 letters); * product record review (19 citations); * testing and release for
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FDA has published in the Federal Register a preliminary assessment indicating that certain naloxone products have the potential to be safe and effective for over-the-counter use to counteract opiod overdose. The notice is intended to help facilitate the development and approval of certain nonprescription naloxone drug products, an
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In a briefing document released in advance of an 11/16 meeting of the Cardiovascular and Renal Drugs Advisory Committee, FDA medical reviewers continue to raise questions about the Ardelyx NDA for tenapanor to control serum phosphorous in adults with chronic kidney disease on dialysis. The document says the agency
Drugs
FDA has released the form FDA-483 issued following a 9/8-9/16 inspection at Athenex Pharma Solutions, a Clarence, NY, outsourcing facility. The one inspection observation listed was the failure to thoroughly review the failure of a batch or any of its components to meet any of its
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Amazon Web Services says it supports the intent of an FDA draft guidance on computer software assurance for production and quality system software and makes several recommendations “to strengthen and accelerate the use of technology for quality improvement.” The company recommends: * reissuing the guidance to apply across the entire agency
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Roche says results from two Phase 3 studies evaluating Alzheimer’s therapy gantenerumab were not statistically significant in slowing clinical decline. “Study participants treated with gantenerumab showed a slowing of clinical decline in GRADUATE I and GRADUATE II of -0.31 (p=0.0954), and -0.19 (p=0.2998)
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Satsuma Pharmaceuticals says topline results from the STS101 SUMMIT Phase 3 efficacy trial showed numerical differences in favor of its migraine drug STS101 5.2 mg versus placebo, but they did not achieve statistical significance. It says the favorable differences were related to the pre-specified co-primary endpoints of
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GSK says it has complied with an FDA request to restrict the second-line maintenance indication for Zejula (niraparib) to only the patient population with deleterious or suspected deleterious germline BRCA mutations (gBRCAmut). The first-line indication remains unchanged for maintenance treatment of adult patients with advanced epithelial ovarian, fallopian
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The Federal Trade Commission has filed an amicus brief with the Delaware federal court in the case of Jazz Pharmaceuticals v. Avadel CNS Pharmaceuticals, taking issue with a Jazz patent for Xyrem (sodium oxybate) listed in FDA’s Orange Book that it says improperly blocks generic competition. The brief discusses
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FDA has approved AstraZeneca’s Imfinzi (durvalumab) in combination with Imjudo (tremelimumab) plus platinum-based chemotherapy for treating adult patients with Stage IV (metastatic) non-small cell lung cancer (NSCLC). The approval was based on data from the POSEIDON Phase 3 trial, which showed that patients treated with the combination
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FDA is seeking comments on a draft guidance entitled “Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin Q5A(R2).” The International Council for Harmonization document addresses the testing and evaluation of the viral safety of biotechnology products, and it outlines what data should
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The CDER Office of Pharmaceutical Quality (OPQ) has issued a Manual of Policies and Procedures, Quality Assessment for Products in Expedited Programs, outlining policies and procedures that are intended to facilitate and expedite the development, time to submission, assessment, and marketing approval of NDAs and BLAs for products that address