Recon: US authorities probing Emergent over vaccine issues; Japan authorizes AstraZeneca vaccine after delay

• Biden pushes cash reward to get vaccinated, new rules for federal workers (Reuters)
• US authorities probing Emergent BioSolutions over COVID-19 vaccine issues- filing (Reuters)
• Cavazzoni in the hot seat: House committee grills CDER director on neuro drugs (Endpoints) (STAT)
• States could get billions from opioid lawsuits. They have to decide how to spend it (STAT)
• Biogen launches Phase IV trial to see just how well Aduhelm works in the real world (Endpoints)
• Gilead's COVID-19 drug helps boost 2nd-quarter results as HIV sales dip (Reuters)
• Merck’s New CEO Promises Dealmaking, Investment in Research (WSJ)
• AbbVie expects Botox boom to power annual earnings (Reuters)
• FDA allows drugs without proven clinical benefit to languish for years on accelerated pathway (The BMJ)

• Japan OKs administration of AstraZeneca shots after delay – media (Reuters)
• CanSinoBIO to trial combining its COVID vaccine with Russia's Sputnik V dose (Reuters)
• Mixing Russia's Sputnik V, AstraZeneca shots proves safe in small trial -RDIF (Reuters)
• Increased manufacturing capacity and supply for Spikevax (EMA)
• In a win for struggling nations' vaccine supply, first African-produced doses of J&J shot hit arms (Endpoints)

• U.S. CDC internal report says Delta variant as contagious as chickenpox – report (Reuters) (NYTimes)
• India's Serum Institute ties up with industry in push to vaccinate rural areas (Reuters)
• COVID vaccine protection highly likely to wane over time - UK advisers say (Reuters)
• NICE publishes ‘rapid’ guideline on rare blood clots associated with COVID-19 jab (PharmaTimes)

• Takeda doubles down at California site as it looks to grow rare disease manufacturing base (Endpoints)
• The curious case of Eohilia: Takeda drug hit with mysterious FDA delay as company leans on launches for growth (Fierce)
• Ardelyx does 'not agree' with FDA's view after agency rejects blockbuster prospect Ibsrela—and one analyst is 'flummoxed' (Fierce)
• On the heels of Takeda pact, PeptiDream kicks off $2.2B deal to broaden Alnylam's siRNA delivery scope (Endpoints)
• Alzheimer’s scientists critique Cassava Sciences’ study results — overblown, inappropriate, uninterpretable (STAT)
• GlaxoSmithKline's Nucala beats AZ's Fasenra to the IL-5 punch in nasal polyps (Fierce)
• Charles River to expand Ireland manufacturing site to add Covid-19 vaccine capacity (Endpoints)
• Surprise! Pfizer jumps the queue and leaps into RSV vax contention as COVID helps turbo charge work (Fierce)
• Gilead lands in North Carolina with a plan to hire 300 for new center (Endpoints)
• BeiGene looks to carve out more space in the US market, setting up BTK drug for 2nd blood cancer nod (Endpoints)
• Takeda and Frazier team up again to launch a spinout — this time focused on a late-stage vaccine (Endpoints)
• To fill African manufacturing void, BioNTech will piggyback off plans for malaria mRNA vaccine with new manufacturing sites (Endpoints)
• Could a fourth lead drug finally bring Infinity an approval? (Endpoints)
• Royalty Pharma competitor stirs the pot with plans for $750M IPO (Endpoints)
• Gunning for Biogen’s multibillion dollar market, Eli Lilly cuts up another batch of Alzheimer’s data (Endpoints)
• Shooting straight for Venclexta, a seasoned Chinese CEO has global dreams for his startup (Endpoints)
• GMP Inspections to Be Conducted Unannounced as Basic Rule: MHLW (PharmaJapan)
• Clozapine Risk Evaluation and Mitigation Strategy (REMS) requirements will change on November 15, 2021 (FDA)
• Takeda Delivers Solid First Quarter FY2021 Results, Positioning Company to Accelerate Topline Growth and Continued Pipeline Progress (Press)

• Talk of Baxter-Hillrom tie-up grows as both companies focus on connected care (MedtechDive)
• NuVasive nabs FDA clearance amid global rollout of all-in-one spine surgery platform (Fierce)
• Siemens Healthineers' diagnostic sales soar on EU demand for COVID-19 tests (MedtechDive)
• Pent-up demand drives Edwards' TAVR sales past forecasts, but slowdown predicted (MedtechDive)
• Many Device-Related Deaths Are Not Being Accurately Reported To FDA, Study Claims (MedtechInsight)
• FDA Grants Labelers Of Lower-Risk Devices More Time To Comply With UDI Reg (MedtechInsight)
• Biofourmis nets FDA breakthrough label for digital heart failure treatment assistant (Fierce)
• Thermo Fisher continues its hot streak, but a dip in diagnostics sales could be trouble (Endpoints)
• Elon Musk’s brain computer start-up raises $205 million from Google Ventures and others (CNBC)

• McKinsey Opioid MDL Has A Need For Speed, Judge Says (Law360)
• Regeneron Investor Sues Execs, Alleging Kickback Scheme (Law360)
• Novartis Cancer Drug Suits Too Few To Centralize, JPML Told (Law360)
• JPML Urged To Consolidate Weight-Loss Drug Cancer Suits (Law360)
• Senate Panel OKs Antitrust Package Aimed At Drug Pricing (Law360)
• Bills To Speed Generic Entry Once Again Clear Senate Judiciary Committee (Pink Sheet)