Regulatory Focus™ > News Articles > 2021 > 6 > Recon: AZ antibody cocktail fails to prevent COVID symptoms in large trial; Former FDA Commissioner

Recon: AZ antibody cocktail fails to prevent COVID symptoms in large trial; Former FDA Commissioner Hahn ventures on to Flagship

Posted 15 June 2021 | By Michael Mezher 

Recon: AZ antibody cocktail fails to prevent COVID symptoms in large trial; Former FDA Commissioner Hahn ventures on to Flagship

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • Novavax says efficacy preserved in participants receiving influenza, COVID-19 vaccines (Reuters)
  • Trump’s FDA commissioner takes job at Moderna backer (Washington Post) (Endpoints)
  • Divisive Drug Patent Proposal From Trump Era Is on Biden Agenda (Bloomberg) (Law360)
  • Sage's depression drug study results show improvement in symptoms (Reuters) (STAT)
  • New Alzheimer's drug could be 'devastating' for Medicare (Politico)
  • Biogen gene therapy deal has yet to bear fruit (BioPharmaDive) (Endpoints) (Press)
  • FDA’s Cavazzoni calls for adcomms to ‘get back to the substance’ (Endpoints)
  • Scientists CRISPR patients’ own immune cells in bid to shrink hard-to-treat GI tumors (STAT)
  • Mississippi becomes the first state to jointly sue drug makers and PBMs over the cost of insulin (STAT) (Endpoints)
In Focus: International
  • Governments need ‘portfolio of vaccines’ to beat Covid, says EMA head (FT)
  • Japan should have scrapped domestic trials to speed COVID shots - vaccine chief (Reuters)
  • Novavax's COVID-19 vaccine to be made in India soon - govt official (Reuters)
  • Astra antibody cocktail fails to prevent COVID-19 symptoms in large trial (Reuters) (FT)
  • Regulator begins probe into Pfizer’s anti-nicotine therapy for impurities (Korea Biomedical Review)
Coronavirus Pandemic
  • More evidence suggests Covid was in U.S. by Christmas 2019 (NBC) (NYTimes)
  • Many Post-Covid Patients Are Experiencing New Medical Problems, Study Finds (NYTimes)
  • Extra Covid vaccine may help protect transplant patients (STAT)
  • Brazil's Bolsonaro asks Pfizer to speed up COVID vaccine delivery (Reuters)
  • Pakistan allows AstraZeneca shot for under 40s to help its expatriates (Reuters)
  • Abbott's Panbio antigen test misses half of asymptomatic COVID-19 cases in Irish study (MedtechDive)
Pharma & Biotech
  • FDA’s Cavazzoni calls for adcomms to ‘get back to the substance’ (Endpoints)
  • ‘You have to get up on the podium’: Incoming BIO chair Paul Hastings on diversity, drug pricing and working with the FDA (Endpoints)
  • Bayer flushes money into the Nordics with $303M down payment on new Finnish plant, expansion (Endpoints)
  • Slashing 186 jobs, Novartis hands off U.S. sales, marketing duties for migraine med Aimovig to Amgen (Fierce)
  • Eli Lilly pins injectable migraine med Emgality against Biohaven's oral rival Nurtec ODT in head-to-head study (Fierce)
  • FDA pushes back Ascendis' PDUFA for long-acting hormone therapy; Debiopharm takes home a win in mid-stage test for ADC (Endpoints)
  • Why two scientific powerhouses are teaming up to tackle rare cancers long overlooked in research (STAT)
  • VectorY raises $38M to develop Alzheimer's, ALS gene therapies (Fierce)
  • The Next US FDA Center Of Excellence? Pazdur Thinks It Should Be (Surprise!) Biostatistics (Pink Sheet)
  • CRISPR Therapeutics takes a swing at ALS gene editing in discovery deal with AAV upstart Capsida (Endpoints)
  • Imbruvica/Venclyxto tops Gazyva plus chemo in first-line CLL/SLL (PharmaTimes)
  • J&J’s Darzalex shows ‘significant’ survival benefit in newly diagnosed multiple myeloma (PMLive)
  • Terns Pharmaceuticals touts safety data from an ex-Eli Lilly candidate in the hunt for NASH treatment (Endpoints)
  • Just shy of its 1-year anniversary, radiopharmaceuticals platform play RayzeBio bags another megaround (Endpoints)
  • Going after the phenomenon of 'regRNA,' Rick Young's Camp4 secures a launch round to push two programs forward (Endpoints)
  • Swiss-based upstart marches toward the clinic with a unique approach to fibrosis treatment (Endpoints)
  • SoftBank, Cormorant lead hefty $210M injection for Umoja's three-in-one cancer immunotherapy play (Endpoints)
  • Exscientia spends SoftBank's cash in bid to edge out AI rivals (Endpoints)
  • Recall report: Another drugmaker is pulling its version of metformin off shelves after a carcinogen scare (Endpoints)
  • Other OMUFA Fee-Related Questions (FDA)
  • With new data, Veracyte aims to expand prostate cancer test reach following Decipher acquisition (Fierce)
  • Twist Bioscience, Regeneron pitch global sequencing test to bring new diversity to large DNA studies (Fierce)
  • Novo's investment arm gains toehold in diagnostics with £400M deal for testing supplier BBI (Fierce)
  • EU Coordinates Market Surveillance For The First Time: Pilot Being Launched (MedtechInsight)
  • Polyurethane Foam Problems Nudge Philips To Recall Certain Sleep, Mechanical Ventilator Devices (MedtechInsight)
  • FDA advisory panel to review TransMedics' liver preservation device (MedtechDive)
  • Avita’s ReCell Wins FDA Approval For Pediatric Burn Patients (MedtechInsight)
  • One Drop poaches Sanofi’s head of diabetes innovation to bring CGM biosensor to market (Fierce)
  • Medical Devices; Exemption From Premarket Notification: Powered Patient Transport, All Other Powered Patient Transport (FDA)
  • The TGA response to ACCC safety and information standards (TGA)
Government, Regulatory & Legal
  • W.Va. State Opioid Claims Will Be Heard By A Jury (Law360)
  • CVS Overcharged Insured Drug Buyers $123.7M, Jury Told (Law360)
  • Glenmark, Teva In No Rush For January 2022 Criminal Trial (Law360)
  • Insulin Makers Blast Patients' 3rd Bid For RICO Claims (Law360)
  • Mallinckrodt Says Ch. 11 Disclosures Have Enough Info (Law360)
  • Purdue Hits Back At Creditor's Motion For Ch. 11 Examiner (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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