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  • ReconRecon

    Recon: Pfizer, Voyager sign $630M gene therapy deal; WHO backs malaria vaccine for children in Africa

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Polarean Imaging says FDA rejects new drug application, shares slump ( Reuters ) FDA center directors on lessons from the EUA pathway: Flexibility serves us well ( Endpoints ) Troubled Voyager’s gene therapy relaunch gets a boost with $630M Pfizer deal ( Endpoints ) FDA offers support for Takeda's potential cytomegalovirus drug ahead of adcomm ( Endpoints ) A...
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    Recon: AstraZeneca seeks EUA for preventative COVID antibody; EMA considers rolling review for Merck's COVID drug

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Pfizer/BioNTech COVID-19 vaccine effectiveness drops after 6 months, study shows ( Reuters ) J&J files for authorization of COVID-19 vaccine booster ( Reuters ) AstraZeneca Submits Preventive Covid-19 Treatment for FDA Authorization ( WSJ ) ( Reuters ) Pharmacy chains failed to prevent opioid misuse, U.S. jury hears ( Reuters ) Henrietta Lacks' estate says ph...
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    Recon: J&J will reportedly seek authorization for boosters this week; Pfizer loses suit over copay assistance programs

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US McKinsey Never Told the FDA It Was Working for Opioid Makers While Also Working for the Agency ( ProPublica ) Gilead and Kite nab another approval for Tecartus, as leading CAR-T portfolio continues to grow ( Endpoints ) U.S. Supreme Court rejects challenge to New York tax on opioid companies ( Reuters ) Pharmacy chains face first trial over US opioid epidemic ...
  • ReconRecon

    Recon: Merck says COVID antiviral cut risk of hospitalization, death in Phase 3 trial; Appeals court rules FDA wrongly approved Jacobus' LEMS drug

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Merck's COVID-19 pill cuts risk of death, hospitalization by 50% in study ( Reuters ) ( STAT ) Appeals court rules FDA ‘arbitrarily and capriciously’ approved a rare disease drug ( STAT ) ( Endpoints ) Democrats struggle to reach deal in Congress on Biden's agenda ( Reuters ) Senate committee considers a carveout for small biotech cos in drug pricing reforms (...
  • ReconRecon

    Recon: Merck to buy Acceleron for $11.5B; AstraZeneca vaccine shows 74% efficacy in US trial

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Merck to buy Acceleron for about $11.5 bln in rare disease drug push ( Reuters ) ( WSJ ) AstraZeneca COVID-19 vaccine shows 74% efficacy in large U.S. trial ( Reuters ) ( NEJM ) US stem cell clinics boomed while FDA paused crackdown ( AP ) U.S. Congress seeks to ward off government shutdown as Biden agenda at risk ( Reuters ) U.S. House panel approves three b...
  • ReconRecon

    Recon: AstraZeneca buys rare disease drugmaker Caelum; FDA considering half-dose Moderna booster

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA misses GOP deadline on booster questions ( Politico ) FDA Leans Toward Authorizing Moderna Booster at a Half Dose ( Bloomberg ) ( Reuters ) FDA tells drug makers to redo studies run by two contract research firms due to data integrity issues ( STAT ) ( Endpoints ) Side effects from a third vaccine dose are similar to those from the second, a CDC report fin...
  • ReconRecon

    Recon: Marks takes over CBER's vaccines office; Pfizer submits data on COVID vaccine for children ages 5-11

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US A top FDA official moved on Monday to take over the agency’s vaccines office. ( NYTimes ) ( Endpoints ) Pfizer begins study of mRNA flu vaccine ( Reuters ) Pfizer submits data for COVID-19 vaccine use in younger kids ( Reuters ) Merck Nears Deal to Acquire Acceleron Pharma ( NYTimes ) Lilly to cut price of Lispro insulin injection by 40% from Jan. 1 ( Reuters...
  • ReconRecon

    Recon: Pfizer begins Phase 2/3 trial of oral drug for COVID prevention; Biohaven's multiple system atrophy candidate fails in Phase 3

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA approves add-on drug for ages 10 & up with rare forms of high cholesterol ( FDA ) Biohaven's drug candidate for neurological disorder fails study ( Reuters ) Pfizer begins study of oral drug for prevention of COVID-19 ( Reuters ) Acceleron Is in Advanced Talks for $11 Billion Sale ( Bloomberg ) ( Endpoints ) New ARIA cases dog Biogen's Aduhelm launch in a...
  • ReconRecon

    Recon: CDC chief overrules panel on boosters for at risk workers; GE drops $1.45B to buy imaging firm BK medical

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US GE Healthcare drops $1.45B to buy BK Medical, bringing its ultrasound franchise to the OR ( Fierce ) CDC Chief Overrules Agency Panel and Recommends Pfizer-BioNTech Boosters for Workers at Risk ( NYTimes ) ( Reuters ) Biden announces expanded booster rollout amid confusion over eligibility ( Politico ) ( STAT ) Boosters for Moderna and Johnson & Johnson vaccin...
  • ReconRecon

    Recon: FDA authorizes boosters for at-risk and older Americans; Novavax applies for WHO emergency listing

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA Authorizes Pfizer Booster Shots for Older and At-Risk Americans ( NYTimes ) ( Reuters ) ( STAT ) ( FDA ) Pfizer CEO rallies staff to fight Democrats’ drug price negotiation ( Politico ) Moderna chief executive sees pandemic over in a year ( Reuters ) Novavax applies to WHO for emergency listing of COVID-19 vaccine ( Reuters ) Biosimilar Drugs Are Cheaper ...
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    Recon: FDA approves Incyte's eczema cream with boxed warnings; Biden pledges 500M doses of Pfizer vaccine

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Biden pledges 500 mln more COVID-19 vaccine doses as U.S. pressured to do more ( Reuters ) A CDC panel is meeting to decide who should get Pfizer boosters. ( NYTimes ) ( Reuters ) FDA approves Seagen/Genmab’s antibody-drug conjugate Tivdak for women with advanced cervical cancer ( PMLive ) FDA approves Incyte's eczema cream with boxed warnings ( Reuters ) ( En...
  • ReconRecon

    Recon: J&J says second shot boosts protection against moderate to severe COVID; AZ to invest $360M in Irish manufacturing site

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US J&J says second shot boosts protection for moderate-severe COVID-19 to 94% ( Reuters ) ( STAT ) US lawmakers accuse patent office of weakening challenges and allowing drug prices to rise ( STAT ) Biosimilar drugs gain ground in U.S., but concerns linger about when patients can switch ( STAT ) Amgen scores Otezla patent win, protecting its blockbuster from Sand...