Recon: Biogen wins accelerated approval for aducanumab; FDA lifts hold on bluebird bio gene therapy trial

| 07 June 2021 | By Michael Mezher 

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • FDA Approves Alzheimer’s Drug Despite Fierce Debate Over Whether It Works (NYTimes) (Politico) (STAT) (FDA 1, 2)
  • Why Biogen may be sitting on the most lucrative product in pharmaceutical history (STAT)
  • FDA approves drug to treat smallpox (FDA)
  • J&J vaccine drive stalls out in US after safety pause (Reuters)
  • FDA approves Novo Nordisk's semaglutide as obesity treatment (Reuters) (FDA)
  • Under ‘threat’ of fines, Novartis sues HHS over drug pricing program (Endpoints)
  • FDA lets bluebird resume trials for sickle cell gene therapy after cancer scare, but big questions linger over field (Endpoints)
  • Rx Price Watch Report: Trends in Retail Prices of Brand Name Prescription Drugs Widely Used by Older Americans, 2006 to 2020 (AARP)
  • A New Type Of COVID-19 Vaccine Could Debut Soon (NPR)
In Focus: International
  • NetScientific's unit signs deal to sell AstraZeneca's COVID-19 test (Reuters)
  • In boost for Africa, Senegal aims to make COVID shots next year (Reuters)
  • Funding and vaccines sought from G20 nations for COVAX, says WHO (Reuters)
  • Covid: G7 vaccine decisions will 'define 21st Century' (BBC)
  • Moderna seeks EU, Canada approval for COVID-19 vaccine's use in teens (Reuters)
  • Astra and Glaxo in cancer battle (The Times)
  • Indemnity, disputes in US courts: Pfizer's demands before bringing vaccine to India (Business Today)
Coronavirus Pandemic
  • Biden’s vaccine push fails to gain traction with African Americans (Politico)
  • Indian PM Modi announces free COVID-19 vaccines for all adults (Reuters)
  • Venezuela to purchase and manufacture Russia's EpiVacCorona vaccine (Reuters)
  • Heart reaction probed as possible rare Covid-19 vaccine link in teens (STAT)
Pharma & Biotech
  • Will you accept this capital investment? Biotech and health startups bet on a strange new reality show for crowdfunding (STAT)
  • Pharma investors should brace for pricing and antitrust action (FT)
  • FDA Approves First Treatment for Patients with Plasminogen Deficiency, a Rare Genetic Disorder (FDA)
  • As head-to-head with Alexion heats up, Novartis flashes data for next wave of trials for star kidney molecule (Endpoints)
  • GlaxoSmithKline, AstraZeneca butt heads over licensing rights to key PARP inhibitor — report (Endpoints)
  • Onduo’s new exec on Google’s data skills, real-world evidence, and moving the needle on outcomes (STAT)
  • J&J breaks off alliance with argenx, dropping CD70 AML drug and axing $1.3B in biobucks (Endpoints)
  • With demand surging for lentiviral vectors, CDMO VIVEbiotech expands capacity 400% in cross-town move (Fierce)
  • Amgen’s KRAS inhibitor Lumakras scores positive overall survival data (PharmaTimes)
  • GSK’s PD-1 inhibitor Jemperli approved in the UK (PharmaTimes)
  • Kobayashi Kako’s 116-Day Suspension Over, but No Timeline for Resumption (PharmaJapan)
  • Dermavant engineers $160M deal to pay off GlaxoSmithKline milestones, gear up to launch psoriasis cream (Endpoints)
  • Elevation files for $100M IPO to fund tumor-agnostic candidate (Fierce)
  • A Celltrion-backed biotech is developing 'tunable' conjugates to crack solid tumors — and it has eyes on the clinic (Endpoints)
  • After a noose was found at NC plant, Merck launches internal investigation while decrying racist acts (Endpoints)
  • Blackstone, Carlyle and Hellman & Friedman to buy majority stake in medical supplier Medline (CNBC)
  • Cancer tech dominates FDA's latest batch of breakthrough devices (MedtechDive)
  • US FDA Panel Takes On Neurological Device Classification (MedtechInsight)
  • Theranos is history, but big blood testing breakthroughs are coming post-Covid (CNBC)
  • Grail launches long-awaited Galleri blood test, its groundbreaking multi-cancer screening diagnostic (Fierce)
  • Early research points to a single blood test for a range of neurodegenerative conditions (Fierce)
  • Dexcom shares clinical data on G7 CGM ahead of next-gen showdown with Abbott (MedtechDive)
  • ASCO: Agendia test spots ultra-low breast cancer recurrence risks, flagging women who could skip chemo (Fierce)
Government, Regulatory & Legal
  • Zofran Preemption Victory – Entire MDL To Be Dismissed (Drug & Device Law)
  • Antigua and Barbuda notified the WTO of their intent to import products using compulsory licenses (KEI)
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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