• ReconRecon

    Recon: Canada authorizes J&J COVID vaccine; FDA cautions on fever scanner accuracy

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Woodcock Interview on COVID-19 Tests and Vaccines ( NPR ) What to look for in Lilly’s eagerly awaited Alzheimer’s data ( STAT ) Abbott's test to distinguish coronavirus and flu viruses gets US authorization ( Reuters ) FDA approves Roche’s Actemra/RoActemra treatment for rare lung disease ( Pharmafile ) San Diego Zoo apes get an experimental animal vaccine ag...
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    COVID-19: FDA offers guidance on container closure switches

    The COVID-19 pandemic has created unprecedented global demand for raw materials and components of products used in the response to the virus. Supply chains for critical materials such as reagents, test swabs and now the glass vials and stoppers used to hold vaccines and therapeutics have been impacted, necessitating workarounds to keep pace with demand.   With COVID-19 vaccines and several therapeutics using glass vials and stoppers for their container closure systems ...
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    Recon: Amgen buys Five Prime for $1.9B; EU investigating Teva over Copaxone practices

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Biden convenes bipartisan meeting on cancer research ( The Hill ) ( Reuters ) Amgen spends $1.9 billion on Five Prime, eyeing an expansion in Asia ( STAT ) The $14 million CEO: Drug distributor boosts executive’s pay despite historic opioid settlement ( Washington Post ) Pfizer’s Lorbrena scores expanded FDA approval for first-line NSCLC ( PMLive ) ( Endpoints...
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    FDA unveils data modernization plan

    A three-pronged plan to modernize the US Food and Drug Administration’s (FDA) approach to data was unveiled Wednesday, building on the agency’s previous technology modernization effort.   In a blog post announcing the new Data Modernization Action Plan (DMAP), Acting FDA Commissioner Janet Woodcock and Principal Deputy Commissioner Amy Abernethy write that data modernization is the “next step” for the agency after its 2019 Technology Modernization Action Plan (TMAP)...
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    Recon: Merck to conduct new trial of OncoImmune COVID drug; NIH halts convalescent plasma trial

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Biden says will have enough COVID-19 vaccine for every U.S. adult by May ( Reuters ) ( NYTimes ) Biden calls on states to prioritize vaccinations for teachers ( Reuters ) White House using Defense Production Act to equip Merck plants for J&J vaccine ( Reuters ) ( NPR ) ( Fierce ) White House taps insurers to boost vaccinations among vulnerable communities ( Po...
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    FDA warns COVID trial sponsor for failing to submit IND

    The US Food and Drug Administration (FDA) last month warned a clinical trial sponsor for failing to submit an investigational new drug (IND) application for a study of a product to treat COVID-19.   In its warning letter to KDunn and Associates, P.A. dba HealthQuilt, FDA said it observed “objectionable conditions” during an August inspection related to a trial the company sponsored titled “An Open-Label Pilot Study to Assess the Efficacy and Safety of [redacted] in Sub...
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    Recon: Merck to manufacture J&J COVID vaccine; Merck withdraws Keytruda for third-line SCLC

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Merck to help make Johnson & Johnson's COVID-19 vaccine: White House official ( Reuters ) ( Politico ) ( WaPo ) J&J COVID-19 vaccine shipping to US, but new deliveries hinge on regulators ( Reuters 1 , 2 ) US downplays possibility of sharing COVID-19 vaccines with Mexico ( Reuters ) Fauci says US must stick to two-shot strategy for Pfizer, Moderna vaccines: p...
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    MDCG issues guidance on Eudamed alternatives

    The European Commission’s Medical Device Coordination Group (MDCG) last week issued guidance on administrative practices and alternative technical solutions on the application of certain Medical Device Regulation (MDR) provisions in the absence of a fully functional Eudamed system.   While the first of six Eudamed modules was made available late last year, the remaining modules are expected to be rolled out by the database’s May 2022 date of application. Some modules, ...
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    Recon: Merck signs €900M deal for Debiopharm for cancer drug; Perrigo to sell generic business for $1.55B

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA authorizes Johnson & Johnson’s single-dose Covid-19 vaccine ( STAT ) ( Reuters ) ( Politico ) ( FDA ) Single-dose Covid vaccine recommended by CDC advisory panel ( Politico ) J&J CEO sees COVID-19 shots in American arms in 1-2 days as shipping starts ( Reuters 1 , 2 ) Johnson & Johnson has planned trials of its vaccine that will include infants ( NYTimes ...
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    MHRA awards first ‘innovation passport’ under new pathway

    MSD's (Merck Sharp & Dohme (UK) Limited) investigational drug belzutifan on Friday became the first drug to be awarded an “innovation passport” under the UK Medicines and Healthcare products Regulatory Agency’s (MHRA) innovative licensing and access pathway (ILAP).   Belzutifan is being developed to treat adults with von Hippel-Lindau disease, a rare cancer-causing genetic disorder, and has been granted orphan designation in the EU and both orphan designation and br...
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    Recon: FDA approves Sarepta’s third DMD drug; Health Canada authorizes AstraZeneca vaccine

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA advisory panel to review Johnson & Johnson COVID-19 vaccine with thumbs up expected ( Reuters ) ( STAT ) ( FT ) During COVID-19, FDA’s Vaccine Advisory Committee Has Worked To Boost Public Trust – It Can Still Do More ( Health Affairs ) Sarepta wins new drug approval for patients with Duchenne muscular dystrophy, its third marketed treatment ( STAT ) ( Endp...
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    FDA eases storage, transportation conditions for Pfizer-BioNTech vaccine

    The US Food and Drug Administration (FDA) on Thursday updated the emergency use authorization (EUA) for Pfizer and BioNTech’s COVID-19 vaccine to allow the vaccine to be transported and stored at temperatures found in conventional pharmaceutical freezers for up to two weeks.   The announcement comes one week after Pfizer and BioNTech disclosed they had submitted data demonstrating their vaccine’s stability at higher temperatures based on manufacturing data from the p...