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

• 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)

• 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)

• 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)

• 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)

• 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)