Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA clears Covid booster shot for healthy kids ages 5 to 11 ( STAT ) ( Reuters ) ( FDA ) U.S. to allow baby formula imports amid nationwide shortage ( Reuters ) ( FDA ) Abbott, FDA reach agreement to reopen baby formula facility in Michigan ( Reuters ) ( FDA ) Baby formula makers ramp up U.S. supplies to tackle shortage ( Reuters ) U.S. Democrats unveil bill ...

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA approves Eli Lilly's treatment for type 2 diabetes ( Reuters ) ( Endpoints ) ( STAT ) FDA’s Real-World Evidence Project Finds That Pragmatic Clinical Trials Are Easier To DUPLICATE ( The Pink Sheet ) ( Endpoints ) Pediatric Cancer Studies: US FDA Eyes Waiver Framework For Same-In-Class Drugs ( The Pink Sheet ) Unpersuaded by the data, FDA rejects cheap, ge...

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Biden marks 1 million Americans dead from COVID ( Reuters ) Moderna completes FDA submission for use of COVID shot in adolescents, kids ( Reuters ) Moderna Vaccine Provokes Strong Immune Response in Children 6 to 11 ( NYTimes ) Lawmakers wade into a contentious battle over orphan drug monopolies ( STAT ) Is Paxlovid, the Covid pill, reaching those who most ne...

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Pfizer's $11.6 bln Biohaven buy could spark more biotech deals ( Reuters ) Arkansas sues drugmakers, pharmacy benefit managers over insulin costs ( Reuters ) Moderna CFO exits a day after taking charge as former employer launches probe ( Reuters ) J&J appoints consumer health head Thibaut Mongon to CEO of spun-off business ( Reuters ) Teva, Allergan Willing t...

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Cash-rich Pfizer to pay $11.6 bln for Biohaven in biggest deal since 2016 ( Reuters ) ( STAT ) ( FT ) Walgreens, CVS, Walmart begin $878 million opioid trial in Ohio ( Reuters ) Emergent's Covid vaccine problems more extensive than previously known ( Politico ) ( NYTimes ) Inside the sales machine of the ‘kingpin’ of opioid makers ( Washington Post ) Novavax ...

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA's Peter Marks to Congress: Youngest kids vaccine won't need to hit 50% efficacy mark ( Endpoints ) ( House Select Subcommittee on the Coronavirus Crisis ) U.S. elections may thwart Democratic effort to cap insulin cost ( Reuters ) Bausch + Lomb valued at $6.5 billion after stock ticks up in NYSE debut ( Reuters ) COVID shots made Moderna biotech’s biggest ...

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Congress mulls softer accelerated approval reforms as part of user fee reauthorizations ( Endpoints ) ( The Pink Sheet ) ( STAT ) Enhertu wins another breast cancer approval, as AstraZeneca and Daiichi Sankyo prepare to corner the market ( Endpoints ) ( Biospace ) BioCryst officially gets partial clinical hold on lead candidate after halting enrollment ( Endpoi...

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’...

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...

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 ) ...

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Moderna files for US authorization of COVID shot for kids under 6 ( Reuters ) ( Endpoints ) ( Biospace ) Pfizer can restart PhIII trial of Duchenne gene therapy, now on par for late-2023 FDA approval request  ( Endpoints ) ( Reuters ) ( Fierce ) ( BioSpace ) IRS seeks more than $7B in back taxes and penalties from Amgen for shifting profits to Puerto Rico ( End...

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Fauci: US no longer in ‘full-blown’ pandemic phase ( Washington Post ) Pfizer, BioNTech seek US authorization of COVID-19 booster shot for younger kids ( Reuters ) ( NPR ) Zolgensma for dementia? AviadoBio gains orphan tag for one-dose gene therapy ( Fierce ) Fennec looks for FDA approval for hearing loss drug haunted by manufacturing problems ( Endpoints ) E...