Recon: Merck to buy Acceleron for $11.5B; AstraZeneca vaccine shows 74% efficacy in US trial

• Merck to buy Acceleron for about $11.5 bln in rare disease drug push (Reuters) (WSJ)
• AstraZeneca COVID-19 vaccine shows 74% efficacy in large U.S. trial (Reuters) (NEJM)
• US stem cell clinics boomed while FDA paused crackdown (AP)
• U.S. Congress seeks to ward off government shutdown as Biden agenda at risk (Reuters)
• U.S. House panel approves three bills aimed at tackling high drug prices (Reuters)
• Democrats dial back drug-pricing plans to win over moderates (Politico)
• Merck says research shows its COVID-19 pill works against variants (Reuters)
• FDA ruling on Pfizer's COVID jab for kids could come in November -Fauci (Reuters)
• Mirum's oral drug becomes first U.S. approved Alagille syndrome therapy (Reuters)
• Amicus, looking for a boost, sells its gene therapy work to a SPAC (BioPharmaDive)

• EU extends vaccine export control mechanism until year-end – official (Reuters)
• EU to decide on Pfizer booster on Oct. 4 (Reuters)
• Otsuka puts nearly $1 billion on the line for four neuropsychiatric candidates from Sunovion (Endpoints)
• GlaxoSmithKline, Merck KGaA officially call it quits on $4B partnership for flailing cancer drug (Endpoints)
• WHO's Covaxin Clearance Delayed Further Over Technical Queries: Sources (NDTV)
• Perrigo agrees €300m settlement of €1.64bn tax assessment (The Irish Times)

• U.S. CDC calls for more COVID-19 vaccinations among pregnant women (Reuters)
• FDA's top vaccine leader explains why Covid-19 'boosters' may really just be the 3rd shot in the primary series (Endpoints)
• REGEN-COV Antibody Combination and Outcomes in Outpatients with Covid-19 (NEJM)

• Covid has made biotech companies the hot new tech sector as investor demand drives record IPOs (CNBC)
• Major Massachusetts hospitals decide against using Biogen's Aduhelm, with the help of a former FDA adcomm member (Endpoints)
• The $165M immunology startup Sheila Gujrathi bet on after Receptos, Gossamer is shooting for an IPO (Endpoints)
• AbbVie, industry group push for international compromise on when trial investigators should receive unblinded data (Endpoints)
• A newly private Novartis partner bags a megaround on its first go to turbocharge CAR-T, cell therapy pipeline (Endpoints)
• Spero strikes $125M royalty deal for cUTI drug; French firm launches $100M early biotech fund (Endpoints)
• Continuing to chart post-Covid path, Moderna will build new science center near Massachusetts headquarters (Endpoints)
• NICE recommends life-extending urothelial cancer treatment (PharmaTimes)
• Lilly adds liver fat, CGM blood sugar data to mountain of evidence on hot diabetes prospect tirzepatide (Fierce)
• China’s Top Regulator Upholds Tough Stance Against 'Redundant' Clinical Trials (Pink Sheet)

• Bayer posts final analysis of Essure adverse events to FDA (MedtechDive)
• MedTech Europe director warns about EU's turbulent switch to IVDR (MedtechDive)
• Eudamed Temporarily Unavailable As ‘Major Upgrade’ Signals Two New Modules (MedtechInsight)
• CMS defends proposal to nix MCIT pathway, medtechs hold out hope (MedtechDive)
• TransMedics locks in 2nd FDA approval in a month with nod for donor liver preservation system (Fierce)
• FDA In Brief: FDA Warns Consumers of Risk of Exposure to Unsafe Levels of Radiation with Safe-T-Lite UV WAND (FDA)

• SEC charges ex-Goldman Sachs analyst with illegally profiting off biopharma mergers in insider trading scheme (Endpoints)
• Celgene Ended Theranos Deal Early Over Bad Data, Jury Told (Law360)
• Judge Orders Mallinckrodt Trial On Acthar Antitrust Claims (Law360)
• Sidley Austin Snags 3 Former FDA Attys From Hogan Lovells (Law360)
• Ex-Insys Sales Rep Admits Guilt On Day 4 Of Kickbacks Trial (Law360)
• Elizabeth Holmes wrote personal notes to herself about ‘becoming Steve Jobs’ as Theranos collapse began (CNBC)