• ReconRecon

    Recon: Moderna to manufacture mRNA vaccines in Canada; Boston Scientific recalls 48,000 Ingenio pacemakers

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Boston Scientific recalls a decade's worth of Ingenio pacemakers over risk of unexpected system resets ( Fierce ) ( MedtechDive ) What full FDA approval could change about Covid vaccination ( NBC ) After leaving patients in limbo, Pfizer agrees to sell a discontinued glaucoma drug ( STAT ) A ‘frothy’ digital health market, Verily partners with Colgate, & a HIM...
  • ReconRecon

    Recon: Obamacare architect floated for FDA commissioner; Takeover battle for inhaler specialist Vectura may head to auction

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Obamacare architect floated for top FDA job ( Politico ) ( The Hill ) As White House mulls FDA commissioner job, a sign of industry backing for Woodcock surfaces ( STAT ) Pediatricians plead with FDA to move quickly on Covid vaccine for kids ( NBC ) FDA Aiming to Speed Extra Vaccine Doses for Immunocompromised Patients ( NYTimes ) Purdue’s bankruptcy deal shi...
  • ReconRecon

    Recon: Gilead warns of counterfeit HIV medicines in US; Novavax delays seeking approval for its COVID vaccine

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA Covid-19 Vaccine Booster Plan Could Be Ready Within Weeks ( WSJ ) Novavax again delays seeking U.S. approval for COVID-19 vaccine ( Reuters ) Novavax Says U.S. Will Pause Funding for Production of Its Vaccine ( NYTimes ) Medtronic to buy Intersect ENT in $1.1B deal targeting chronic rhinosinusitis market ( MedtechDive ) Gilead says aware of counterfeit HI...
  • ReconRecon

    Recon: Bayer to buy US biotech Vividion for up to $2B; South Korea pledges $1.9B for COVID-19 vaccine production

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Moderna says its COVID-19 shot 93% effective six months after second dose ( Reuters ) ( WSJ ) Moderna's Covid-19 vaccine sales to trail Pfizer's total significantly in 2021 and 2022 ( Endpoints ) White House says US can provide COVID-19 boosters if needed ( Reuters ) Bayer to buy US start-up Vividion for up to $2bn ( FT ) ( STAT ) ( BioPharmaDive ) CVS stops ...
  • ReconRecon

    Recon: Softbank builds $5B stake in Roche; FDA aiming to approve Pfizer vaccine in early September - NYT

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA Aims to Give Final Approval to Pfizer Vaccine by Early Next Month ( NYTimes ) ( Reuters ) ( Politico ) Amgen Disputes IRS Claim It Owes $3.6 Billion in Back Taxes ( WSJ ) Amgen, expecting higher demand for its medicines, to build plant in North Carolina ( BioPharmaDive ) ( Endpoints ) FDA classifies Philips ventilator recall due to low oxygen risk as most ...
  • ReconRecon

    Recon: Sanofi to acquire Translate Bio for $3.2B; BMS withdraws Istodax indication after confirmatory trial fails

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Abbott Labs to pay $160 mln over kickbacks, false diabetes claims to Medicare ( Reuters ) ( DoJ ) Sanofi bets on mRNA vaccines beyond COVID in $3.2 bln Translate Bio deal ( Reuters ) ( STAT ) ( Endpoints ) ( FT ) U.S. FDA gives priority review to Roche's Tecentriq lung cancer drug ( Reuters ) Rare disease drugmakers to Congress: Don't gut the accelerated appro...
  • ReconRecon

    Recon: Pfizer, Moderna raise EU vaccine prices; FDA approves AZ’s lupus drug Saphnelo

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA Under Pressure to Grant Full Approval to Covid-19 Vaccines ( WSJ ) ( STAT ) US Authorities Seek Documents From Troubled Covid Vaccine Manufacturer ( NYTimes ) Theranos Patients: The Emerging Wild Card in the Trial of Elizabeth Holmes ( WSJ ) FDA okays Regeneron COVID-19 antibody as preventive in high-risk settings ( Reuters ) How the biopharma industry is...
  • ReconRecon

    Recon: US authorities probing Emergent over vaccine issues; Japan authorizes AstraZeneca vaccine after delay

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Biden pushes cash reward to get vaccinated, new rules for federal workers ( Reuters ) US authorities probing Emergent BioSolutions over COVID-19 vaccine issues- filing ( Reuters ) Cavazzoni in the hot seat: House committee grills CDER director on neuro drugs ( Endpoints ) ( STAT ) States could get billions from opioid lawsuits. They have to decide how to spend...
  • ReconRecon

    Recon: Emergent to resume J&J vaccine production; Sanofi raises profit forecast

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Citing New Data, Pfizer Outlines Case for Booster Shots ( NYTimes ) J&J says US FDA agrees to extend shelf life of its COVID-19 vaccine ( Reuters ) Emergent to resume J&J COVID-19 vaccine production at Baltimore plant ( Reuters ) ( WSJ ) U.S. House panel seeks J&J documents on baby powder bankruptcy plans ( Reuters ) AstraZeneca CEO hopeful COVID-19 vaccine m...
  • ReconRecon

    RECON: FDA halts Pepaxto trials; Pfizer nears $8B in vax sales for Q2

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Pfizer sells $7.8 billion in Covid shots in the second quarter, raises 2021 guidance on vaccine sales ( CNBC ) AstraZeneca castoff draws $123M wager on CXCR2 antagonist as Arena lines up a buyout option ( Endpoints ) Opinion: US FDA Should Take Its Time With COVID Vaccine BLAs ( Pink Sheet ) Biden Is Considering A Vaccine Or Testing Mandate For Federal Workers...
  • ReconRecon

    Recon: Abbvie and Calico craft $1B deal; Purdue creditors sign deal to shield Sacklers

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US How Biogen found a believer: At the FDA, a hard-nosed regulator was won over on controversial Alzheimer’s drug ( STAT ) AbbVie hits go on $1B re-upped Calico deal as the Google life science spin-out continues I-O, neuro push ( Fierce ) Biden wants to bolster the pharma supply chain. A major generic plant closing may make that harder ( STAT ) CDC to reverse ind...
  • ReconRecon

    Recon: Shape Therapeutics' $112M gene therapy play; Incyte's cancer drug flops at FDA

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US At the FDA’s urging, Pfizer-BioNTech and Moderna are expanding their studies of children 5 to 11 ( NYT ) Bristol Myers withdraws Opdivo in liver cancer as fallout from FDA meeting continues ( Biopharma Dive ) Shelling out $5B+, PerkinElmer pays the big bucks for antibody and reagent player ( Endpoints ) House Democrats expand probe into political interference ...