Recon: Biden blacklists Chinese chip maker; Blackstone weighs options for $1B Ayumi Pharma
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.In Focus: US
- Biden Blacklists China’s YMTC, Crackdowns on AI Chip Sector (Reuters)
- U.S. Commerce removes Wuxi Biologics from unverified list (Reuters)
- Accelerated Approval Decline? Too Early To Overinterpret US FDA Trend (Pink Sheet)
- US set to pay nearly $2B for Pfizer's Covid-19 treatment Paxlovid in 2023 (Endpoints)
- Despite Import Alert, Sun Still Aims To Remediate Halol Rather Than Transfer Products (Pink Sheet)
- Leave Pfizer Copay Ruling as Is, Biden’s HHS Tells Supreme Court (Bloomberg)
- House Passes One-Week Spending Bill to Avert Dec. 17 Shutdown (Bloomberg)
- Generic Tiering Requirement, Enhanced Oversight On Chronic Meds Proposed For Marketplace Plans (Pink Sheet)
- Biden administration offers U.S. households more free COVID-19 tests for winter (Reuters)
- Science, Cell issue notices of concern on challenged papers co-authored by Stanford president (STAT)
- Aligning drug prices with ICER estimates could save tens of billions of dollars — JAMA paper (Endpoints)
In Focus: International
- New EU Fee System To Give Pharma Firms More Predictability (Pink Sheet)
- Expanding Hospital Exemptions For ATMPs Could Make Europe Less Attractive To Investors (Pink Sheet)
- Pfizer Adds to China Paxlovid Supply Amid Covid Case Surge (Bloomberg)
- India says samples taken from pharma firm linked to Gambia deaths meet required standards (Reuters)
- UK government takes measures to ease penicillin shortages (Reuters)
- China pushes vaccines as retreat from ‘zero-COVID’ turns messy (Reuters)
- China’s COVID scare sparks run on flu medicines, test kits as far away as Australia (Reuters)
- Spain passes pioneering sexual, reproductive health law (Reuters)
Pharma & Biotech
- Kintara Therapeutics Received Orphan Drug Designation for VAL-083 for Treatment of Diffuse Intrinsic Pontine Glioma (DIPG) (Biospace)
- AstraZeneca, Merck hit with 3-month delay for Lynparza’s FDA filing in first-line prostate cancer (Fierce)
- Blackstone Said to Weigh Options for $1 Billion Ayumi Pharma (DealStreetAsia) (Yahoo)
- Axcella axes NASH program, 85% of staff in last-ditch focus on long COVID (Fierce)
- Merck & Co. inks pact with Indonesia’s Bio Farma to make HPV vaccine (Fierce)
- Danish biotech seeking niche vaccine edge against Pfizer snags €72M for pivotal study (Endpoints)
- Novartis offloads five eye drugs in deal worth up to $175M (Endpoints)
- Sio confirms gene therapy company will be liquidated after tough year (Fierce) (Endpoints)
- Catalent to build a new $40M analytical services facility in North Carolina's Research Triangle (Endpoints)
- Avidity pushes phase 1/2 data as proof of first targeted RNA into muscle but FDA partial hold remains (Fierce)
- Two Ebola Vaccines Provide Lasting Immune Response in Big Study (Bloomberg)
- Enlaza launches with $61M, aims to take covalency into protein drugs (Endpoints)
Medtech
- Medtech Experts Voice Mixed Reactions To European Commission’s New MDR Proposals (MedTech Insight)
- Activists Push US Government To Investigate Animal Abuse Charges Against Neuralink and UC Davis (MedTech Insight)
- German Medtechs Say MDR Ball Is In EU’s Court, Plus DRG Changes and ESG Reactions (MedTech Insight)
- BARDA Plans Four-Pronged Approach To Future Pandemics (MedTech Insight)
- Detect Recalls Thousands Of COVID-19 Tests Due To Risk Of False Negative Results (MedTech Insight)
- Illumina defends Grail acquisition before FTC amid potential divestiture order in Europe
- (MedTech Dive)
- Axonics nabs Canadian nod for 20-year incontinence implant requiring fewer recharges (Fierce)
Government, Regulatory & Legal
- Mallinckrodt Released From ALS Drug Stock Suit Due to Bankruptcy (Bloomberg)
- LabSolutions CEO Convicted in $463 Million Genetic Testing Plot (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.
