Recon: Biden outlines plan to prepare for future pandemics; Lilly buys hearing loss gene therapy firm Akous for $487M
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.In Focus: US
- Coronavirus pandemic prompts Biden to focus on biological threats (Reuters) (STAT) (Bloomberg)
- FDA’s Fast Drug Approval Pathway Needs Revamp Soon, Califf Says (Bloomberg) (Pink Sheet)
- FDA wants to yank pregnancy drug. Firm argues Black women will suffer. (Washington Post)
- US FDA User Fee Staffing: The Objective Capacity Planning Adjuster Often Needs Subjective Review (Pink Sheet)
- With Increasing New Drug INDs Projected, How Much More Workload Can US FDA Handle? (Pink Sheet)
- FDA awards grants and contracts linked to rare diseases, including ALS (Biopharma Reporter)
- Despite its threats, PhRMA is still supporting Democrats who voted for Medicare negotiation (STAT)
- Biden officials search for backup for key Covid therapy for immunocompromised people (STAT)
- Prescription Drugs Eat Up Bigger Share of Spending by Medicare (Bloomberg)
- Trump’s CDC Changed Weekly Reports, House Covid Panel Finds (Bloomberg) (Washington Post)
- Streamlined European Pathway Needed For Biosimilars To Hit Smaller Targets (Pink Sheet)
- UK: Will Companies Remaining In Voluntary Payment Scheme End Up With A Bigger Bill? (Pink Sheet)
- WHO To Harmonize Reporting Of Summary Results In Clinical Trial Registries (Pink Sheet)
- Long Road Still Ahead For Decentralized Trials in Korea (Pink Sheet)
- Moderna signs deal on variant-adapted COVID shots for world's poorest (Reuters) (Bloomberg)
- XBB, BQ.1.1, BA.2.75.2 — a variant swarm could fuel a winter surge (Washington Post)
- Lilly Continues Foray into Gene Therapies with $487M Akouos Buyout (Biospace) (Endpoints) (Fierce) (Reuters)
- J&J looks at job cuts despite weathering inflation impact (Reuters) (STAT)
- J&J, flush with blood cancer assets, cuts one from the pipeline (Fierce)
- Korean buyer jumps into M&A game with $566M bid for Aveo Oncology (Endpoints)
- GSK expands AI partnership with Tempus, fronting $70M for access to 'multimodal data' (Endpoints) (Fierce)
- Salarius Stock Plunges 27% After Death in Sarcoma Trial (Biospace) (Fierce)
- Roche drops midphase hepatitis B and eye disease programs in quarterly pipeline clearout (Fierce) (Biospace)
- Mereo Cuts 40% of Staff to Drive Rare Disease Programs through the Clinic (Biospace)
- Things don’t look good for NGM’s Merck-partnered eye asset as phase 2 fail sends stock plummeting (Fierce)
- 10 Reasons to Keep an Eye on Chicago Biotech in 2023 (Biospace)
- Ginkgo Is Trying to Detect Future Man-Made Biological Threats (Bloomberg)
- Addiction drug shows promise lifting long COVID brain fog, fatigue (Reuters)
- Delayed Implementing Regulation On Annex XVI Common Specifications Finally Adopted (MedTech Insight)
- Coloplast told by FDA to keep transvaginal mesh off market after 36-month surveillance study (MedTech Dive)
- MHRA Says UK Approach To AI Regulation ‘Legislatively Light’, Unlike EU Proposals (MedTech Insight)
- Medtronic, in a first, secures expanded label for cardiac pacing lead (MedTech Dive)
- Industry Advocates Cautiously Optimistic About CMS Proposal For Coverage Of New Devices (MedTech Insight)
- Theranica aims to stretch FDA nod with study of neuromodulation device as preventive migraine treatment (Fierce)
- Patents for Human Genes, Diagnostic Tests Generate Policy Debate (Bloomberg)
- Sutter Health Settles False Claims Act Matter for $13 Million (Bloomberg)
- Sysmex, Danaher Settle Blood-Analyzer Patents Suit Before Trial (Bloomberg)
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