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Recon: FDA asked J&J to discard 60M vaccine doses made at Emergent plant; EMA adds rare blood condition as side effect of AZ shot

Posted 11 June 2021 | By Michael Mezher 

Recon: FDA asked J&J to discard 60M vaccine doses made at Emergent plant; EMA adds rare blood condition as side effect of AZ shot

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • FDA tells J&J that 60M doses made at Emergent plant cannot be used (NYTimes) (Reuters) (Politico)
  • J&J vaccine doses to be released, but many will be tossed (AP) (Axios) (FDA)
  • FDA faces mounting criticism over Alzheimer’s drug approval (Reuters)
  • Eli Lilly memo says firm did not make false statements to FDA (Reuters)
  • Controversial drug approval stokes concern about lack of a permanent FDA chief (Politico) (Endpoints)
  • Third member of FDA advisory panel resigns over Alzheimer’s approval (Reuters) (Endpoints) (STAT)
  • Advocates blast the FDA for not moving as fast on ALS as on Alzheimer’s (STAT)
In Focus: International
  • G7 leaders to pledge 1bn Covid-19 vaccine doses for poorer countries (FT)
  • EU adds another rare blood condition as side effect of AstraZeneca shot (Reuters) (EMA)
  • EU won't use J&J COVID shots from time of U.S. contamination issue (Reuters) (EMA)
  • COVID-19 vaccines: update on ongoing evaluation of myocarditis and pericarditis (EMA)
  • EU does not expect J&J will meet end of June vaccine target (Reuters)
  • UK medicine regulator looking at capillary leak syndrome precaution for AstraZeneca shot (Reuters)
  • Moderna COVID-19 vaccine plant in France gets approval (Reuters) (EMA)
Coronavirus Pandemic
  • The next generation Covid-19 vaccines seeking a slice of the market (FT)
  • ‘Extraordinary times, extraordinary measures’: US approach to vanquish pandemic (Reuters)
  • The CDC is investigating nearly 800 cases of rare heart problems following immunization. (NYTimes) (The Hill)
  • Widespread vaccination of adults helps protect unvaccinated children, according to a new Israeli study. (NYTimes)
  • Brazil approves Pfizer COVID-19 vaccine for children over 12 (Reuters)
  • International regulators and WHO address need to boost COVID-19 vaccine confidence (EMA)
Pharma & Biotech
  • Can Drug Trial Volunteers Get The Drug After Approval? Depends Where You Live (NPR)
  • The C.D.C. urges parents to get childhood vaccinations up to date following a steep decline last year. (NYTimes)
  • Eli Lilly, Roche's Alzheimer's prospects, including flops, boosted in light of FDA's Aduhelm approval: analysts (Fierce)
  • German psychedelic startup Atai targets valuation of $2.3 bln in U.S. IPO (Reuters)
  • The IPO 4-1-1: Four filings, a pricing and a withdrawal headline this week's Nasdaq action as raise approaches $7.5B (Endpoints)
  • Vertex shelves second drug for inherited lung disease, raising concerns about future growth (STAT) (Endpoints)
  • Vertex and CRISPR Therapeutics unveil more positive gene therapy data, but busulfan again casts a shadow over the field (Endpoints)
  • Verona signs China deal for PhIII COPD drug; Teva continues legal battle with Eli Lilly, alleging new patent infringements on migraine drug (Endpoints)
  • Months after FDA rejection, Sanofi touts pivotal win for rare disease drug sutimlimab as it preps to refile (Endpoints)
  • Fresh off $598M deal with Novo Nordisk, a Japanese stem cell company is on its way to the clinic with a different approach to treating heart failure (Endpoints)
  •  Autolus claims a CAR-T win at EHA; Imago touts two PhII trial wins for rare disease drug (Endpoints)
  • Novartis cuts jobs at Swiss plant as a UK facility sits in a holding pattern with 200 positions on the line — reports (Endpoints)
  • An API firm with a history of J&J funding scores a major loan to advance its portfolio (Endpoints)
  • NICE broadens access to treatments for rheumatoid arthritis (PharmaTimes)
  • MHRA approves Venclyxto for newly diagnosed AML (PharmaTimes)
  • Biogen reports new data backing long-term benefit of Spinraza (PMLive)
  • BMS, Acceleron’s Reblozyl shows new improvements for beta thalassemia patients (PMLive)
  • After 3 Years Of Work, FDA Says It Will Release Its Revamped Quality System Regulation This Month (MedtechInsight)
  • EU Drug And Device Authorities Take Steps Toward More Collaborative Working (MedtechInsight)
  • FDA Says SBOMs Are Key To Better Cybersecurity In NIST Report (MedtechInsight)
  • To RRA, Or Not To RRA? BD Talks Decision-Making Around FDA Requests For Remote Regulatory Assessments (MedtechInsight)
  • FDA greenlights Nuvo Group's uterine activity module (mobihealthnews)
Government, Regulatory & Legal
  • Sandoz Will Get To Search Rival CFO's Phone In Antitrust Row (Law360)
  • Teva Gets Judge To Nix Drug IP Inventorship Correction Order (Law360)
  • CVS Pricing Practice 'Cheated' Insured Drug Buyers, Jury Told (Law360)
  • Judge Slams Calif. For Discovery Violation In Generics MDL (Law360)
  • Calif. Counties Battle Drugmakers' Bid To Nuke Opioid Trial (Law360)
Regulatory Recon is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe.
A story's inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.


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