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    House committee proposes $500M in COVID funding for FDA

    The House Energy and Commerce Committee will convene Thursday to markup its portions of the budget reconciliation bill that will contain President Joe Biden’s proposed $1.9 trillion COVID-19 relief package.   The budget reconciliation process was created under the Congressional Budget Act of 1974 and enables Congress to fast-track legislation related to taxes, spending and debt limits. Democrats have opted to use the process to allow them to pass the stimulus package...
  • EMA plans guidance on adapting vaccines for COVID variants

    The European Medicines Agency (EMA) on Wednesday said it will soon issue guidance explaining its expectations for adapting existing COVID-19 vaccines to protect against new and future variants of the virus.   The announcement comes just a week after the US Food and Drug Administration (FDA) said it is working on its own guidance to address these and other new variants of the virus. (Woodcock: FDA plans guidance to address new COVID-19 variants , Regulatory Focus 5...
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    Recon: FDA issues EUA for Lilly antibody combo; Federal court tosses ‘skinny labeling’ decision

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Gilead’s Galapagos deal falls apart, a black mark for CEO O’Day ( STAT ) ( Endpoints ) ( Reuters ) Eli Lilly's antibody combination receives FDA EUA for COVID-19 ( Reuters ) ( Endpoints ) ( FDA ) FDA panel admonishes Merck with a gentle — and rare — slapdown for rushing its pitch on an accelerated OK for adjuvant Keytruda in TNBC ( Endpoints ) ( Pink Sheet ) T...
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    Trump HHS advisor pressured FDA, says House subcommittee

    The House Select Subcommittee on the Coronavirus Crisis on Monday released nearly 100 pages of emails underscoring political pressure from a Trump administration official who pushed for the authorization of hydroxychloroquine and convalescent plasma to treat COVID-19.   Citing the emails, Subcommittee Chairman James Clyburn (D-SC) wrote to White House Chief of Staff Ronald Klain and Acting Health and Human Services Secretary Norris Cochran seeking additional docume...
  • Despite pandemic, CBER hit FY20 milestones

    The US Food and Drug Administration’s Center for Biologics Evaluation and Research (FDA’s CBER) met productivity milestones and continued product safety and biostatistics work, despite the pandemic disruptions of 2020. An annual report highlighting the fiscal year’s work, released 4 February, was accompanied by remarks from CBER director Peter Marks, MD, PhD.   Work plans for 2020 were upended as the COVID-19 pandemic swept the globe, said Marks. “This response has inv...
  • ReconRecon

    Recon: EU orders additional 300M doses of Pfizer-BioNTech vaccine; France steps up aid to boost pharma manufacturing

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Joe Biden’s big FDA decision ( Vox ) ( Politico ) Woodcock vs. Sharfstein: A head-to-head comparison of Biden’s top choices for FDA commissioner ( STAT ) Eli Lilly says CFO resigns after 'inappropriate communication' with staff ( NBC ) ( Endpoints ) Democratic lawmakers push FDA to lift restrictions on abortion pill ( Politico ) Democrats push temporary Obama...
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    Asia-Pacific Roundup: India rejects Comirnaty EUA

    Pfizer has withdrawn its application for emergency use authorization (EUA) in India for Comirnaty, its COVID-19 vaccine with partner BioNTech, after the country’s COVID-19 Subject Expert Committee (SEC) recommended against its authorization.   After reviewing data presented by Pfizer at an SEC meeting on 3 February, the committee did not recommend that an EUA be granted, citing serious adverse events including anaphylaxis and palsy as well as the companies’ lack of saf...
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    EU regulators expand use of remote source data verification in clinical trials

    The latest update to the European Commission and European Medicines Agency’s guidance on managing clinical trials conducted during the COVID-19 pandemic expands the use and scope of remote source data verification (rSDV) in clinical trials.   Previous versions of the guidance envisioned that rSDV would “only be considered necessary for very few trials” involving the treatment or prevention of COVID-19, “Or in the final data cleaning steps before database lock in pivota...
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    OCE year 4: Progress despite a pandemic

    Last year , the Oncology Center for Excellence laid out their vision for the future in the Project 2025 initiative, an ambitious effort to outline the future of cancer drug development and collaborate with stakeholders advance the field of oncology.   While the organization remains committed to Project 2025, they acknowledged efforts in 2020 soon shifted to address the needs of patients with cancer during the COVID-19 pandemic, according to Richard Pazdur, MD, directo...
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    EMA, MHRA update on COVID vaccine pharmacovigilance

    Regulators in Europe are beginning to give safety readouts from global experiences with vaccines against COVID-19, while the United Kingdom has issued a report delineating its multi-pronged safety surveillance approach.   The European Medicines Agency’s safety committee met at the end of January to review data from clinical use of the COVID-19 messenger RNA (mRNA) vaccine co-developed by Moderna and the US National Institutes of Health.   Following a 28 January mee...
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    Recon: China approves Sinovac vaccine for general public; Pfizer expects to speed vaccine production

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Pfizer expects to cut COVID-19 vaccine production time by close to 50% as production ramps up, efficiencies increase ( USA Today ) ( Fierce ) Fauci looking ahead to more vaccines in March, April ( Politico ) Virus Variant First Found in Britain Now Spreading Rapidly in US ( NYTimes ) White House says it is working to speed early production of J&J COVID-19 vacc...
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    J&J's COVID vaccine headed for VRBPAC on 26 February

    A third vaccine against COVID-19 is headed for review by the US Food and Drug Administration (FDA). On Thursday, the Janssen group of Johnson & Johnson submitted an application for emergency use authorization of its single-dose recombinant human adenovirus vaccine; FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) is meeting to review the application on 26 February.   “A public discussion by the advisory committee members about the data submitt...