Recon: FDA advisors vote 6-4 against Amylyx ALS drug; Vertex’s non-opioid pain reliever shows success in mid-stage studies
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.In Focus: US
- 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)
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