• Regulatory NewsRegulatory News

    FDA launches global Generic Drug Cluster

    In a new effort to boost alignment of scientific and regulatory approaches to generic drug development among global regulators, the US Food and Drug Administration is standing up a Generic Drug Cluster.   Described as “the first forum established for the world’s leading regulatory agencies to address generic drug development globally,” the new cluster, wrote FDA, is meant to help harmonize approaches global regulators take to generic drug development through a variety ...
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    Recon: Novavax COVID-19 vax 90%-plus effective; GSK pays big for Iteos' TIGIT-targeted immunotherapy

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Novavax Offers U.S. a Fourth Strong Covid-19 Vaccine ( NYT ) ( NPR ) ( Reuters ) Another Sad Coronavirus Pandemic Milestone Is Approaching ( NPR ) U.S. Not On Pace To Meet Biden's Vaccination Goal ( NPR ) Eight states see rise in new COVID-19 infections ( The Hill ) U.S. has administered over 309 million doses of Covid-19 vaccines, CDC says ( CNBC ) How did ...
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    Friends of Cancer Research project tracks early cancer therapy response

    The Friends of Cancer Research (FCR) has launched the next stage of a project that studies whether circulating tumor DNA changes can be used to track early response to cancer therapies.   The launch of Step 2 of the Circulating Tumor DNA for Monitoring Treatment Response (ctMoniTR) Project will involve data collection from over 3,000 cancer patients participating in more than 25 studies, said FCR in announcing the launch. Sixteen additional cancer treatments involving ...
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    FDA approves aducanumab for use in Alzheimer’s disease

    The U.S. Food and Drug Administration (FDA) on Monday announced the approval of Biogen’s human monoclonal antibody Aduhelm (aducanumab) for use in patients with Alzheimer’s disease under the agency’s accelerated approval pathway.   FDA’s approval of aducanumab is based on results from two Phase 3 clinical trials of patients with early Alzheimer’s disease (AD), EMERGE and ENGAGE . Both trials were stopped in March 2019 due to apparent futility by a data safety monito...
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    FDA provides draft guidance for enteral tube-administered drugs

    A new draft guidance from the US Food and Drug Administration (FDA) gives recommendations for how to test oral drug products’ suitability for enteral feeding tube administration.   Oral solutions are specifically excluded from the guidance, which identifies best practices for “consistent in vitro testing of oral drug products to demonstrate their suitability to be administered via enteral tube,” according to the Federal Register notice of the availability of the d...
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    Recon: CMS head confirmed; EU seeks breach-of-contract fine from AZ

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Biden's CMS head confirmed, but FDA pick remains elusive ( Axios/Yahoo ) BARDA Funding Freeze Risks Companies Abandoning COVID Therapeutic Work ( Pink Sheet ) CDC: Half of US adults now vaccinated against COVID-19 ( The Hill ) Pandemic creates 500-site backlog for FDA, despite decade of dwindling US inspections ( Pharma Tech ) The Vaccine Rollout Is Changing ...
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    Recon: ASCO 21 updates; Moderna goes for teen EUA

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Moderna says that its vaccine is effective for 12- to 17-year-olds and that it will seek F.D.A. authorization ( NYT ) ( NPR ) President Biden still hasn’t appointed a permanent FDA commissioner. That has big implications for upcoming drug approvals ( Fortune ) Bipartisan Legislation Introduced to Advance Biomedical Research Stalled by Pandemic ( Global Genes ) ...
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    Recon: NGM's NASH drug fails; Alzheimer's breakthrough?

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US U.S. Covid cases hit lowest level since June ( CNBC ) ( NPR ) Scott Gottlieb says vaccinations are not the only factor driving U.S. Covid cases down ( CNBC ) Passing the Buck: What the CDC Guidance on Masks Gets Wrong About Public Health (Harvard Law blog ) Covid vaccine passports: Everything we know so far ( CNBC ) White House says no plans to require vacci...
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    Cavazzoni paints CDER's post-pandemic future

    During an hour-long session at the annual meeting of the Food and Drug Law Institute (FDLI), the director of FDA’s Center for Drug Evaluation and Research (FDA’s CDER) went beyond a recap of the prior year’s challenges and wins, looking ahead to what CDER’s post-pandemic future will look like.   Summing up what she termed the “gestalt of the last 18 months,” CDER Director Patrizia Cavazzoni highlighted progress and trends in staffing, drug development and inspections t...
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    New guidance for developers of CINV prophylaxis shifts endpoints

    New draft guidance from the US Food and Drug Administration (FDA) updates which endpoint assessments and evidence are needed to show efficacy for medicines that treat chemotherapy-induced nausea and vomiting (CINV).   The guidance shifts away from the previous approach, where sponsors would choose a primary efficacy endpoint of complete response, which was defined as no vomiting and no use of rescue antiemetic medication. Direct evaluation of nausea severity and freque...
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    FDA calls for input on peptide evaluation

    The US Food and Drug Administration (FDA) is seeking comments on strategies for the pharmacological assessment of peptides, small polymers made up of 40 or fewer amino acids.   “For the purpose of this request, FDA is specifically interested in comments regarding the characterization of the effects of hepatic impairment, drug-drug interactions, and immunogenicity on the pharmacokinetics of peptides, as well as the effects of peptides on cardiac electrophysiology,” wrot...
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    Euro Convergence: EU pediatric medicines regulatory framework needs simplification, optimization

    Industry would like to see some “pragmatic” changes to the regulatory process for pediatric medicines in the EU, according to a recent presentation at RAPS Euro Convergence 2021.   These changes include incorporating scientific discussion throughout a product’s life cycle, comparable reporting requirements for pediatric trials to those for adult trials, and optimization and simplification of pediatric investigation plan (PIP) procedures and compliance checks, said Thom...