• ReconRecon

    RECON: FDA halts Pepaxto trials; Pfizer nears $8B in vax sales for Q2

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Pfizer sells $7.8 billion in Covid shots in the second quarter, raises 2021 guidance on vaccine sales ( CNBC ) AstraZeneca castoff draws $123M wager on CXCR2 antagonist as Arena lines up a buyout option ( Endpoints ) Opinion: US FDA Should Take Its Time With COVID Vaccine BLAs ( Pink Sheet ) Biden Is Considering A Vaccine Or Testing Mandate For Federal Workers...
  • ReconRecon

    Recon: Biotech's 'coolers of cash;' Slipping pharma halo?

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Cavazzoni Begins Putting Her Mark On FDA Drug Center With New Principal Deputy Position ( Pink Sheet ) ( Biocentury ) The Delta Variant Is The Dominant Coronavirus Strain In The U.S. ( NPR ) ( Reuters ) COVID-19 cases up in nearly half of US states: analysis ( The Hill ) Maryland says 100 percent of COVID-19 deaths last month were among unvaccinated ( The Hill...
  • Regulatory NewsRegulatory News

    FDA finalizes guidance on studying CNS metastases in cancer trials

    A final guidance document from the US Food and Drug Association (FDA) provides recommendations for drug developers on how best to evaluate the safety and efficacy of cancer drugs in patients with central nervous system (CNS) metastases. The document finalizes a draft guidance issued in August 2020.   "There are few effective treatments for patients with central nervous system (CNS) metastases – a type of cancer that has spread from the original tumor to the CNS and is ...
  • Regulatory NewsRegulatory News

    Include cancer patients in COVID-19 vaccine trials, say ASCO and Friends of Cancer Research

    People with cancer should be included in COVID-19 vaccine clinical trials, according to a new joint position statement from the American Society of Clinical Oncology (ASCO) and the Friends of Cancer Research (FCR).   “We’ve learned that patients with cancer are especially vulnerable to severe illness, hospitalization, or death due to COVID-19,” said ASCO President Everett E. Vokes in a joint press release announcing the position statement. “It is critically important...
  • Regulatory NewsRegulatory News

    Regulatory science pilot floated in BsUFA III negotiations

    In the latest rounds of negotiations for the reauthorization of the Biosimilar User Fee Act (BsUFA III), industry and the US Food and Drug Administration (FDA) fine-tuned labeling and supplements language, sought to find new ways for developers to receive targeted feedback, and set the scope for future guidance documents.   In a series of three May 2021 meetings, the BsUFA III negotiation steering committee convened to work on these topics, and to hammer out an agreeme...
  • ReconRecon

    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 ...
  • Regulatory NewsRegulatory News

    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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    Industry and patient groups call for IVDR delay

    In the wake of the 26 May EU implementation of the new medical device Regulation (MDR), a trade group, a patient association and a data analytics firm have jointly called for a delay in implementation of the parallel In Vitro Diagnostics Regulation (IVDR), now slated for 26 May 2022. Without a course correction, the organizations cite the potential for serious disruptions in patient care, especially in targeted therapies for cancer patients.   With just a year to go ...
  • ReconRecon

    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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    Acceleron, under threat of fines, reports out a negative study

    The day after receiving a first-ever threat of civil penalties for failure to report clinical trial results to ClinicalTrials.gov, Acceleron Pharma fulfilled a legal mandate by posting summary results to the federal trials website.   Though the negative results for its trial of dalantercept and axitinib in patients with advanced renal cell carcinoma had been published elsewhere years earlier, Massachusetts-based Acceleron had not previously complied with federal report...
  • ReconRecon

    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 ) ...