Recon: Biden outlines plan to prepare for future pandemics; Lilly buys hearing loss gene therapy firm Akous for $487M

ReconRecon | 18 October 2022 |  By 

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)
In Focus: International
  • 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)
Pharma & Biotech
  • 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)
Government, Regulatory & Legal
  • 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)
Regulatory Recon is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe.
A story’s inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.


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