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...

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...

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...

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 ...

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...

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...

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US US to buy millions of Pfizer vaccine doses to donate to world ( Washington Post ) ( Reuters ) CDC study finds Moderna vaccine is best at preventing Covid-19 hospitalization ( Politico ) Pfizer/BioNTech say data show COVID-19 vaccine safe and protective in kids ( Reuters ) ( STAT ) Regulators expected to OK Pfizer boosters for older Americans this week ( Reuter...

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Moderna says COVID-19 vaccine protection wanes, makes case for booster ( Reuters ) U.S. Booster Policy Is in Flux as Studies Add to Dissent ( NYTimes ) U.S. FDA approves Takeda's lung cancer therapy ( Reuters ) ( FDA ) Drug Plan Fails, Signaling Thorny Path for Democrats’ $3.5 Trillion Bill ( NYTimes ) PhRMA launches 7-figure ad campaign against Democrats' dr...

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA staff say Pfizer COVID-19 boosters improve immunity but may not be needed ( Reuters ) Pfizer says third COVID-19 shot warranted in FDA document ( Reuters ) Biden to meet US CEOs in 'rallying cry' for vaccine mandates ( Reuters ) Centrists throw wrench in House Democrats’ drug pricing plans ( Politico ) ( STAT ) ( NYTimes ) Key senator opposes Democrats’ t...

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Biden Covid team sees vaccine efficacy waning in unpublished data from Israel ( Politico ) Pioneering Gene Therapy Freed Her of Sickle Cell. Is a Cure at Hand? ( NYTimes ) Emergent to make Providence Therapeutics potential COVID-19 vaccine ( Reuters ) US judge grants Purdue Pharma's $7M exec bonus plan, faces blunt criticism ( Reuters ) Fourth boy dies in Ast...

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA vaccine regulators argue against Covid-19 vaccine boosters in new international review ( STAT ) ( Endpoints ) ( NYTimes ) ( Politico ) GOP Seethes at Biden Mandate, Even in States Requiring Other Vaccines ( NYTimes ) Surgeon general: New vaccine policies neither illegal nor unusual ( Politico ) Novavax expects to make available at least 2 bln COVID-19 vacc...

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA says robust safety data needed before COVID-19 vaccine approval for kids ( Reuters ) ( FDA ) Attacking anti-vaccine movement, Biden mandates widespread COVID shots, tests ( Reuters ) ( NYTimes ) ( AP ) Senate considers pegging Medicare drug prices to deeply discounted Veterans Affairs rates ( STAT ) Martin Shkreli to go toe-to-toe with new FTC chair over D...