• ReconRecon

    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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    FDA updates guidance on covariate treatment in clinical trials

    In a revised draft guidance, the US Food and Drug Administration (FDA) has clarified how drug developers should adjust for covariates in certain clinical trials.   The revision provides “more detailed recommendations for the use of linear models for covariate adjustment and also includes recommendations for covariate adjustment using nonlinear models,” according to FDA’s Federal Register notice of the newly revised draft.   The updates to the April 2019 draft l...
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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    New draft guidance from the US Food and Drug Administration (FDA) updates which endpoint assessments and evidence are needed to show efficacy for medicines that treat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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    Euro Convergence Day 2: How to build a regulatory strategy, tackling IVDR and more

    The second day of RAPS Euro Convergence 2021 will bring attendees updates on challenges ahead for implementing the new In Vitro Diagnostic Regulations (IVDR), optimized strategies for drug development, why Europe may be lagging in medical technology and more.   Medical device strategies that span the Atlantic On 11 May, Chrisophe Amiel of Voisin Consulting Life Sciences (VCLS) will address how firms can build a strategy for medical devices and electronic health tec...
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    Global regulators issue call for clinical trial data transparency

    World regulatory authorities are calling for increased transparency from the pharmaceutical industry in how they report and give access to clinical trial data. In a joint statement, the World Health Organization (WHO) and the International Coalition of Medicines Regulatory Authorities (ICMRA) cited need for “wide access to clinical data for all new medicines and vaccines.”   Data related to a therapy or vaccine “must be published at the time of finalization of the regu...
  • ReconRecon

    Merck KGaA raises full-year forecast; Perlmutter's new gig tackles 'undruggable targets'

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Lilly hit by staff accusations, FDA scrutiny at COVID drug factories ( Reuters ) Pharma showers Menendez with rare, off-cycle burst of campaign cash as Democrats eye drug pricing reforms ( STAT ) Rising wholesale drug prices really do matter to half of all commercially insured Americans ( STAT ) Facing fresh pricing threats in D.C., pharma spent a record $92...
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    ODAC recommends pulling 2 of 6 accelerated approvals

    “Dangling” accelerated approvals of cancer immunotherapies were on the docket for a 3-day session of the US Food and Drug Administration’s oncology advisory committee that wrapped up on 29 April. After 2 days of relatively smooth sailing for the first half of the six indications on the docket, the final day saw two recommendations for withdrawal – and unexpected fireworks from FDA staff.   Of six indications put before ODAC, just two were recommended for withdrawal, de...
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    FDA adcomm declines to yank accelerated approvals for cancer immunotherapies

    At the halfway mark in its review of six “dangling” accelerated approvals for cancer immunotherapies, an advisory committee to the US Food and Drug Administration has declined to rescind approvals for any of the indications it has reviewed to date, citing immature data and ongoing unmet patient need.   FDA’s Oncologic Drugs Advisory Committee (ODAC), convening virtually, has thus far reviewed two indications for Genentech’s Tecentriq (azetolizumab) and one for Merck, S...
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    Pazdur: Oncology accelerated approvals under review by ODAC

    On 27 April, the US Food and Drug Administration’s Oncology Drugs Advisory Committee (ODAC) meets to consider the fate of a half-dozen oncology immunotherapy indications granted accelerated approval. The confirmatory trials of these drugs have not verified their clinical benefit in the indications for which they received approval.   The virtual meeting will take stock of the indications individually; committee members will engage in a “general discussion focused on nex...
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    ASCO-Friends meeting: NCI offers strategies to modernize cancer trials

    In a conversation hosted by the Friends of Cancer Research and the American Society of Clinical Oncology, cancer researchers spoke with regulators and industry to lay out ways to modernize cancer clinical trial eligibility criteria. Further, advances in use of real-world evidence and remote data collection may eventually reduce reliance on the classical clinical trial, according to some attendees.   During the 9 April webinar, attended by US Food and Drug Administratio...
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    Woodcock: Post-COVID, new flexibility could boost cancer trial diversity

    Though cancer clinical trials have taken a hard knock from COVID-19, preserving and extending pandemic flexibility may give oncology research broader reach than ever before, according to Janet Woodcock, MD, the acting commissioner of the US Food and Drug Administration (FDA). Woodcock spoke Friday at a webinar co-hosted by Friends of Cancer Research and the American Society of Clinical Oncology,   At the meeting, whose focus was how to improve patient access and repres...