A handful of therapeutics have been approved specifically to treat COVID-19, reduce its severity, or prevent it entirely.   As of July 2022, those treatments include dexamethasone, Avigan (favilavir), Veklury (remdesivir) alone and in combination with Olumiant (baricitinib), Lagevrio (molnupiravir), Xevudy (sotrovimab), Regkirona (regdanvimab), Ronapreve (casirivimab and imdevimab), amubarvimab and romlusevimab (formerly BRII-196 and BRII-198), Actemra/RoActemra (tocil...

In March 2020, the Regulatory Focus editorial team was eager to find a way to meet the information needs of RAPS members and the regulatory community as the reality of a coronavirus pandemic set in. Guided by the RAPS Editorial Advisory Committee, the first iteration of this tracker was published on 21 March 2020.    What started as a running list containing one Phase I vaccine candidate (now known as Moderna’s Spikevax) and scores of preclinical possibilities evol...

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Regeneron to seek US OK for COVID-19 cocktail to be used for prevention ( Reuters ) ( STAT ) White House says J&J COVID-19 shot shipments to be low until U.S. vaccine plant cleared by regulators ( Reuters ) Eli Lilly to focus on selling COVID-19 antibody drug combination ( Reuters ) CEO at troubled vaccine plant received 51 percent compensation boost in 2020 (...

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Pfizer, BioNTech request expanded emergency use of Covid-19 vaccine for ages 12-15 ( CNBC ) Biden’s Orphaned AstraZeneca Stockpile Grows to 20 Million Doses ( Bloomberg ) Scientists work toward an elusive dream: a simple pill to treat Covid-19 ( STAT ) Biden pushes Congress to boost public health, pandemic preparedness funding ( STAT ) Inside the White House’...

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US US allotting 85% less J&J vaccines to states next week, data shows ( Reuters ) The world is watching the FDA's AstraZeneca decision ( Axios ) Eli Lilly's arthritis drug fails to prevent mechanical ventilation in COVID-19 patients ( Reuters ) The big hole in America's plan to fight Covid-19 variants ( Politico ) Gilead wins full approval for drug acquired in I...

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Moderna Vaccine Production Pace to Increase at CMO Catalent ( WSJ ) ( Endpoints ) Walgreens Not Following US Guidance on Pfizer Vaccine Spacing ( NYTimes ) Biden Tax Plan Seen Hitting Tech, Pharmaceutical Companies ( Bloomberg ) Biden to speed up eligibility for vaccine as US hits milestone ( Reuters ) Former USAID chief tapped to lead vaccine diplomacy effor...

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US US puts J&J in charge of plant that botched COVID vaccine, removes AstraZeneca ( Reuters ) ( CNN ) ( NYTimes ) US searches for new AstraZeneca vaccine producer after Emergent mix-up ( Politico ) Emergent gets $23 million additional order for vaccine production ( Reuters ) Acadia preps for battle as the FDA rejects a potential blockbuster application ( Endpoint...

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Fauci says US may not need AstraZeneca COVID-19 vaccine ( Reuters ) FDA allows Moderna to put more coronavirus vaccine doses in each vial ( Politico ) ( Reuters ) ( FDA ) FDA Probes Cause of Failed Johnson & Johnson Covid-19 Vaccine Batch ( WSJ ) Why the Biden administration might not want to be content with just an acting FDA commissioner ( Endpoints ) Johns...

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Factory Mix-Up Ruins Up to 15 Million Vaccine Doses From Johnson & Johnson ( NYTimes ) Company producing J&J vaccine had history of violations ( AP ) White House knew more than a week ago of J&J contractor vaccine-supply problems ( Politico ) An Accidental Disclosure Exposes a $1 Billion Tax Fight With Bristol Myers ( NYTimes ) ( Endpoints ) Pfizer shot 91% e...

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Biden faces first Covid surge as allies brush off warnings ( Politico ) Pfizer COVID-19 vaccine safe, effective on adolescents in trial, companies say ( Reuters ) ( Press ) Pfizer to Test Covid-19 Vaccine That Doesn’t Need Ultracold Storage ( WSJ ) FTC seeks to block Illumina from buying Grail, citing threats to competition ( STAT ) ( FT ) ( WSJ ) How Biden’s...

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US The operation formerly known as Warp Speed: Biden leans heavily on the flagship Trump-era initiative ( STAT ) Pfizer raise 2021 vaccine output goal to 2.5B doses ( Reuters ) ( Endpoints ) ( FT ) Johnson & Johnson vaccine partner Emergent still lacks FDA's manufacturing green light ( Fierce ) Biden urged to keep patent protections for Covid vaccines ( FT ) FDA...

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US Pfizer, Moderna vaccines reduce COVID-19 infection risk by 90% after second dose ( Reuters ) US vaccination campaign gains steam as White House speeds shipments ( Reuters ) Biden admin remakes vaccine strategy after mass vaccination sites fizzle ( Politico ) Moderna says shipped 100 million COVID-19 vaccine doses to United States ( Reuters ) U.S. FDA approves Br...