• ReconRecon

    Recon: Evotec, Lilly team up on metabolic diseases; Gilead says counterfeiters sold $250M of spurious HIV drugs

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US US would seek global approach to updating Covid-19 vaccines, official says ( STAT ) FDA approves AbbVie, Pfizer drugs for eczema, creating competition for Sanofi ( BioPharmaDive ) ( Fierce ) With few remaining unapproved drugs, researchers tell FDA its Unapproved Drugs Initiative is no longer effective ( Endpoints ) FDA orders DMD trial halt, raising questions...
  • Regulatory NewsRegulatory News

    EU launches clinical trials transformation initiative

    The EU has just kicked off a new initiative meant to transform how clinical trials are initiated and run to promote clinical research in the region. The initiative is meant to address “a relative absence of EU impactful multi-state trials” prompted by the COVID-19 pandemic.   The initiative aims to “further develop the EU as a focal point for clinical research, further promote the development of high quality, safe and effective medicines, and to better integrate clinic...
  • Regulatory NewsRegulatory News

    Former commissioners, Woodcock dissect pandemic response, future challenges at FDA

    A panel of former US Food and Drug Administration (FDA) commissioners, as well as Acting FDA Commissioner Janet Woodcock, addressed the agency’s role in addressing the current and future pandemics, as well as their predictions for FDA’s near-term future.   The commissioners made their observations at the recent UCSF-Stanford Center of Excellence in Regulatory Science and Innovation (CERSI) Innovations in Regulatory Science Summit .   There was consensus among the ...
  • ReconRecon

    Recon: Pfizer to increase COVID-19 antiviral output with French deal; Unilever signals pursuit of GSK consumer arm

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA advises physicians to consider alternatives to Endologix AFX2 endovascular grafts ( MedTech Dive ) Moderna CEO says data for Omicron-specific shot likely available in March ( Reuters ) Martin Shkreli is ordered to pay $64 million and is banned from the pharma industry for life ( STAT ) ( Washington Post ) A $3B+ peak sales win? Pfizer thinks so, as FDA off...
  • Regulatory NewsRegulatory News

    WHO charts path to convergence on cell and gene therapies

    The World Health Organization (WHO) has issued a white paper for consultation that proposes a risk-based framework for regulating cell and gene therapy products (CGTPs) to promote global convergence among health authorities.   It proposes that autologous human cell and tissue (HCT) products for medical use be accorded a lower level of regulatory control than advanced therapy medical products (ATMPs), such as cell and gene therapies or tissue engineering products.  ...
  • ReconRecon

    Recon: Biogen wants dialogue with CMS over Aduhelm coverage decision; GSK, Vir seek authorization for COVID antibody shot

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Senate Panel OKs Califf Nomination for FDA Chief ( NYT ) ( Inside Health Policy ) US Supreme Court blocks Biden vaccine-or-test policy for large businesses ( Reuters ) ( STAT ) GSK, Vir seek US approval for COVID-19 antibody therapy as shot in arm ( Reuters ) FDA concerns at contractor Catalent site spurred on shortages of Novo Nordisk's semaglutide — report (...
  • Regulatory NewsRegulatory News

    Industry seeks delay for reporting manufacturing volume data

    Drugmakers and active pharmaceutical ingredient (API) suppliers say they need more time to set up the necessary systems to comply with the manufacturing volume reporting provisions in the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) to meet the February deadline set by the US Food and Drug Administration (FDA).   The Section 3112 of the CARES Act established new reporting requirements for manufacturers of finished dosage forms, API suppliers, over-t...
  • Regulatory NewsRegulatory News

    Chinese firm warned for making OTC eye drops without microbiological safeguards

    The US Food and Drug Administration (FDA) warned Chinese drugmaker Hubei Kangzheng for having inadequate microbiological controls to prevent contamination of its over-the-counter (OTC) eye drops. These violations partly stem from the firm’s misguided notion that the eye drops are non-sterile drugs, thus not to more stringent microbiological controls.   The warning letter was issued on 23 November 2021 and posted to FDA’s website on 11 January. It follows a nine-day ins...
  • ReconRecon

    Recon: CMS to restrict coverage of Aduhelm to only clinical trials; FDA warns of dental issues with buprenorphine

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Criticized by Senators, US Health Officials Defend Omicron Response ( NYTimes ) ( Endpoints ) Omnicron will infect ‘just about everybody,’ Fauci says ( Washington Post ) FDA flags risk of dental issues from use of opioid addiction drug buprenorphine ( Reuters ) ( FDA ) CMS to restrict coverage of Biogen’s controversial Alzheimer’s drug to only clinical trials ...
  • ReconRecon

    Recon: Pfizer to cut sales staff as provider meetings move virtual; US buys 600k more doses of GSK-Vir COVID therapy

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US US FDA Advisory Committees: Flipping FDAA Mandate on its Head ( Pink Sheet ) Pfizer to cut US sales staff as meetings with healthcare providers move to virtual ( Reuters ) CDC eyes recommending higher quality masks: report ( The Hill) Future of Biogen’s Aduhelm hinges on Medicare Alzheimer’s coverage ( Reuters ) Recall report: Another month, another issue wi...
  • Regulatory NewsRegulatory News

    Manufacturers object to provisions in FDA’s microbiological quality guidance

    An industry trade group and pharmaceutical manufacturers are calling for revisions to the US Food and Drug Administration’s (FDA) draft guidance on microbiological quality considerations for non-sterile drugs (NSDs), which they say proposes onerous new microbiological testing requirements.   The 24-page draft guidance was released for comment in September 2021 and is designed to help manufacturers control microbiological contamination of their non-sterile drugs and ste...
  • ReconRecon

    Recon: Bristol Myers buoys cell therapy interests with $3B Century deal; EMA could issue decision on Paxlovid within weeks

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Pfizer CEO unsure on need for fourth dose of COVID-19 vaccine ( Reuters ) Pfizer to pay Beam $300 million in gene-editing deal, amping up its mRNA ambitions ( STAT ) US breaks COVID-19 hospitalization record at over 132,000 as Omicron surges (Reuters) Starting later this week, some at-risk Americans become eligible for a 4th shot ( NYT ) FDA removes clinica...