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  • RoundupsRoundups

    FDA Approvals Roundup: Camzyos, Vivjoa, Epsolay

    New approvals  Camzyos gets go-ahead for adults with obstructive hypertrophic cardiomyopathy  Bristol Myers Squibb’s Camzyos ( mavacamten; capsules ) has been approved for treating adults with symptomatic New York Heart Association (NYHA) class II-III obstructive hypertrophic cardiomyopathy (HCM) to improve functional capacity and symptoms.    The approval of Camzyos was based on findings from the Phase 3 double-blind, placebo-controlled EXPLORER-HCM trial 2...
  • Regulatory NewsRegulatory News

    MedCon: CDRH plans return to normal pre-submission timelines

    The head of the US Food and Drug Administration’s (FDA) device center says the agency is planning to get back to normal pre-submission timelines soon. His office hit the pause button for certain pre-submission meetings and delayed others to conserve its resources during the COVID-19 pandemic.   Jeff Shuren, director of the Center for Devices and Radiological Health (CDRH), said, “Staring fairly soon,” FDA will reopen its pre-submission doors after the agency had to mak...
  • Regulatory NewsRegulatory News

    ICH plans model-informed drug development guideline in 3-4 years

    The International Council for Harmonisation (ICH) released a widely anticipated timetable detailing its plans to issue general guidance on model-informed drug development (MIDD) approaches in drug development.   The roadmap, developed by the recently formed ICH MIDD Discussion Group, lays out the harmonization body’s vision for an MIDD general principles guideline, additional MIDD-specific guidelines, and incorporating MIDD-principles and approaches into several of its...
  • Regulatory NewsRegulatory News

    Commission proposes European Health Data Space to unlock research opportunities

    The European Commission has proposed creating a European Health Data Space (EHDS) that will make it easier for developers and manufacturers of medicinal products to access data for research.   Currently, most health-related data held in the European Union is inaccessible to researchers and other stakeholders that could use it to inform the development of medicinal products. According to officials at the Commission, businesses “face important obstacles in accessing the ...
  • ReconRecon

    Recon: Moderna announces more than $6B in revenue in first quarter; Valneva to trial booster of its COVID vaccine

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US AstraZeneca poised to snag fast approval for a frontline use of Imfinzi, adding to its growing oncology portfolio ( Endpoints ) ( AstraZeneca ) FDA grants Prothena fast track designation for Alzheimer’s disease therapy ( Biopharma Reporter ) FDA hits Miami University in Ohio with a warning letter over falsified data ( Endpoints ) ( STAT ) FDA Approves Phathom’...
  • Regulatory NewsRegulatory News

    FDA officials: ‘New normal’ may include annual COVID vaccination

    In a new editorial, top officials at the US Food and Drug Administration (FDA) outlined some of the key considerations for an annual COVID-19 vaccination strategy that could occur alongside seasonal influenza vaccination. “Administering additional COVID-19 vaccine doses to appropriate individuals this fall around the time of the usual influenza vaccine campaign has the potential to protect susceptible individuals against hospitalization and death, and therefore will be ...
  • Regulatory NewsRegulatory News

    FDA's use of adcomms prior to drug approval decreased over the last decade

    Between 2011 and 2021, the US Food and Drug Administration (FDA) decreased the use of advisory committees before approving drugs from 59% to 6% per year, according to recent research published in Health Affairs .   “Advisory committees, if used consistently, can lend credibility to the FDA’s decision to allow a drug to market. But the decrease we found in advisory committee review of approved drugs since 2010 presents concerns about how FDA is choosing to use—or not u...
  • ReconRecon

    Recon: Biogen CEO to step down as drugmaker curbs spending on Alzheimer’s drug; FDA restructures device center, adding two health tech offices

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Another Pfizer gene therapy is free of FDA hold, but delay continues ( Fierce ) A year after CRL, Acadia is going back to bat for Nuplazid at the FDA ( Endpoints ) As expected, FDA spikes down Axsome migraine med, but issues are ‘addressable’ ( Fierce ) Shared First Interchangeable Biosimilar Exclusivity May Be Allowed Under US FDA User Fee Bill ( The Pink She...
  • RoundupsRoundups

    Asia-Pacific Roundup: TGA provisional determination for Moderna’s bivalent COVID vaccine

    Australia’s Therapeutic Goods Administration (TGA) has granted provisional determination to a bivalent Moderna COVID-19 vaccine that is designed to protect against the original, wild-type strain of SARS-CoV-2as well as the Omicron variant.   Moderna began developing bivalent vaccines as SARS-Cov-2 started taking hold in parts of the world. The vaccines use two pieces of mRNA, one encoding for the spike protein of the original strain, another encoding for the spike prot...
  • Regulatory NewsRegulatory News

    FDA’s Office of Compliance details enforcement actions in 2021

    The US Food and Drug Administration (FDA) Office of Compliance (OCC) issued numerous enforcement discretion decisions to increase supplies of critically needed medicines for treating COVID-19 and increasingly relied on the use of inspection alternatives, such as product sampling and reviewing firms’ written response to records, instead of traditional onsite inspections in 2021.   These are some of the areas highlighted in OCC’s latest annual report released 2 May, de...
  • Regulatory NewsRegulatory News

    FDA offers guidance on drug development for ulcerative colitis, Crohn’s disease

    The US Food and Drug Administration (FDA) issued draft guidance documents on drug development for ulcerative colitis (UC) and Crohn’s disease, outlining recommendations on clinical trial design. Both UC and Crohn’s disease are chronic inflammatory bowel diseases. In the current guidance documents, issued on 29 April 2022, agency officials outline their thinking on clinical trial populations, trial designs, efficacy considerations, and safety assessments. The guidance fo...
  • ReconRecon

    Recon: Pfizer’s Paxlovid fails to show benefit for COVID prevention; FDA places hold on Vertex’s diabetes study

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Pfizer says COVID treatment Paxlovid fails to prevent infection of household members ( Reuters ) ( STAT ) Vertex Falls After FDA Halts Diabetes Study in Surprise Move ( Endpoints ) ( STAT ) It’s CRL Day at the FDA as Axsome, Junshi and Coherus Get Bad News ( Biospace ) Human testing for Praxis’ lead epilepsy drug held up after FDA clinical hold ( Endpoints ) ...