Recon: Illumina closes Grail acquisition without go ahead from regulators; FDA approves Lilly, BI drug for heart failure

• Biden, first lady to get COVID-19 booster vaccine -ABC News interview (Reuters)
• Richard Sackler Says Family and Purdue Bear No Responsibility for Opioid Crisis (NYTimes)
• US states rush to meet deadline to join $26 billion opioid settlement (Reuters)
• FDA approves Lilly, Boehringer diabetes drug for heart failure (BioPharmaDive) (Endpoints)
• US officials’ decision on Covid-19 booster shots baffles — and upsets — some scientists (STAT)
• GOP governors embrace Covid cocktails over masks as cases surge (Politico)
• Biden will require vaccines for staff at federally funded nursing homes (Politico)
• A first-of-its-kind bet for an Alphabet spinout (STAT)
• Industry pitches FDA with 26% rise in user fee funding in MDUFA V negotiations (MedtechDive)

• Illumina purchases Grail without clearance from FTC or European Union (STAT)
• China's mRNA vaccine technology firm Abogen raises over $700 mln (Reuters)
• Rentschler ready to start commercial production of CureVac COVID-19 shot (Reuters)
• EU says import of J&J COVID vaccines from South Africa is temporary (Reuters)
• UK's cost-effectiveness gatekeeper wants to provide faster access to more new drugs (NICE)
• Ebola, other outbreaks, atop COVID-19, risk straining West Africa health systems -WHO (Reuters)
• GMed Designated Under EU IVD Regulation (MedtechInsight)

• Early data hint at a rise in breakthrough infections in the U.S. (NYTimes)
• Pan-Sarbecovirus Neutralizing Antibodies in BNT162b2-Immunized SARS-CoV-1 Survivors (NEJM)
• New EUA Allows More Home Collection Of Saliva Samples For COVID-19 Testing (MedtechInsight)
• What to Know About Boosters if You Got the Johnson & Johnson Vaccine (NYTimes)
• Another convalescent plasma trial for Covid-19 goes bust, but some experts are still holding out hope (Endpoints)

• Cell, gene therapy company funding reaches new heights, despite setbacks (BioPharmaDive)
• Pharma Pushes For Better Understanding Of Virtual Inspection Tools (Pink Sheet)
• Junshi, Coherus gun for major PD-(L)1 market with PhIII NSCLC results (Endpoints)
• Accelerated Approval, But Not Other Expedited Programs, Associated With More Postmarket Safety Changes (Pink Sheet)
• J&J hunts for a Rybrevant label add just months after rare lung cancer approval (Endpoints)
• CSL's Seqirus, spurred on by Covid-19 mRNA vaccines, props up new unit for 'self-amplifying' shot tech (Endpoints)
• Abiomed leads latest FDA breakthrough designations for heart disease devices (MedtechDive)
• Recall report: More Chantix lots pulled from shelves as nitrosamine woes continue (Endpoints)
• As demand for vaccines grow, an Alabama vial maker lands another federal contract (Endpoints)
• An EpiPen For Heart Attacks? Idorsia Launches Phase III Study Of Selatogrel (Scrip)

• FDA approval for Roche diagnostic solid tumour test (PMLive)
• Zimmer Biomet rounds out surgical robot lineup with FDA-cleared Rosa Hip system (Fierce)
• EchoNous scales up portable ultrasound platform with FDA OK for full-body probe (Fierce)

•  House members to urge FDA to remove in-person requirement for abortion medication (The Hill)
• House Democrats press insulin manufacturers for lower prices (The Hill)
• Teva Wants Eli Lilly Sanctioned In Migraine Drug Patent Fight (Law360)
• Pfizer Gets PTAB To Review Neulasta Patent In Amgen IP Row (Law360)