Recon: FDA advisors vote 6-4 against Amylyx ALS drug; Vertex’s non-opioid pain reliever shows success in mid-stage studies

• Amylyx’s ALS Drug Should Wait For Phase III Results, US FDA Panel Says (The Pink Sheet) (Endpoints) (Fierce) (STAT)
• FDA Approves ViiV’s Triumeq PD for Children With HIV (Bloomberg)
• $35 monthly insulin cap: Republicans decry how White House, Dems plan to pay for it (Endpoints)
• US FDA’s Accelerated Approval Reforms Include Dispute Resolution For Withdrawals (The Pink Sheet)
• After an RTF and some stern warnings, FDA slaps CytoDyn with two clinical holds (Endpoints)
• Safety concerns lead FDA to reject Akebia's kidney drug (Endpoints)
• Senators Near Deal on Smaller Bill to Pay for Covid-19 Fight (Bloomberg)
• Second Booster Combos Tested by NIH as Future Variants Loom (Bloomberg)
• The Quality Lowdown: Stability Testing, OOS Findings, Major Quality Failures Cited (The Pink Sheet)

• Bayer to invest 2 bln euros in drug production over next 3 years (Reuters)
• France's Sanofi offers 1.5 billion euro bond linked to access to medicine (Reuters)
• Facing COVID Surge, China Revises Course To Support Imported mRNA Vaccines (Scrip)
• The Race Is On. When Will Korea Have Its Own Approved Gene Therapy? (Scrip)
• Mexico in talks to receive Indian vaccine and cancer drug technology (Reuters)
• WHO says most likely scenario shows COVID severity will decrease over time (Reuters)

• Analysis: Governments want COVID vaccine developers to aim higher in hunt for better shots (Reuters)
• U.K. Warned About Danger of Cutting Back on Covid Testing (Bloomberg)
• Ghana to start producing own Covid-19 vaccines in January 2024 (Reuters)
• Groups urge Biden to reject potential WTO 'concept' on COVID-19 vaccine barriers (Reuters)
• Pfizer/BioNTech COVID vaccine slashes pediatric hospitalization risk – U.S. study (Reuters)
• Omicron More Severe for Unvaccinated Children Than Other Strains (Bloomberg)
• Pregnant people at much higher risk of breakthrough covid, study shows (Washington Post)

• Vertex’s non-opioid painkiller meets goals in mid-stage studies (STAT) (Endpoints)
• COVID-19 Factor Wanes But Pharma’s R&D Pipeline Hits Record Heights (Scrip)
• Fresenius agrees two acquisitions to bolster Kabi drugs unit (Reuters)
• US FDA concluded inspection of Lupin’s Novel Laboratories (Bloomberg)
• Merck chopping 140-plus staffers out of Acceleron in wake of $11.5B buyout (Endpoints)
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• Bayer’s Koenen: Decentralized Trials For Pivotal Studies Not 'Black Or White Scenario' (Scrip)
• A team at Penn says it has slashed CAR-T cell therapy manufacturing timeframe to just 24 hours (Endpoints)
• ‘We’ll Be First With Off-The-Shelf CAR-T,’ Vows Precision Biosciences – And Hopes To Win Over Gene-Editing Skeptics (The Pink Sheet)
• Attention biotech history: Ginkgo pours $700M+ on just 2 execs (Endpoints)
• Taysha lays off 35% of staff, narrows R&D focus to keep fundings its top gene therapies (Fierce)
• As shares tank, Orchard once again restructures, shedding gene therapy programs and a large part of the staff (Endpoints)
• How a Seagen cancer drug with Nobel Prize science might also work in diabetes (Fierce)
• Innovative Purdue research leads to FDA-approved prostate cancer treatment (Outsourcing Pharma)

• FDA’s Shuren Grilled About Handling Of MDUFA V At House Hearing (MedTech Insight)
• Cytokine Storm: The Unmet Need Sigyn Hopes To Address (MedTech Insight)
• EU's 28th Notified Body Under The MDR Is Based In Slovenia (MedTech Insight)

• Hard-Hit W.Va. Eyes ‘Day of Fate” In Imminent Opioid Trial (Law360)
• Balwani 'Angry' At Quality Control Advice, Theranos Jury Told (Law360)