Recon: Moderna sets COVID vax price at $130/shot; Bancel defends decision at Senate hearing
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.In Focus: US
- Moderna to Price Its Covid-19 Vaccine at $130 a Dose (Wall Street Journal)
- Delays in reporting led FDA to late cancer warning on breast implants, advocates say (Medtech Dive)
- Moderna CEO defends price of COVID shot at Senate hearing (Healthcare Dive)
- 'Banding together': 50 female biotech executives lay out plans for board diversity, new companies and mentoring founders (Endpoints News)
- Social media patient influencers ‘dancing in the gray’ of pharma marketing, more clarity needed, researcher says (Endpoints News)
- A Milestone Moment For Pharmacogenomics: US FDA Ready To Drop ‘Voluntary’ Program (Pink Sheet)
- Electronic Records: US FDA Updates Guidelines On Use In Clinical Investigations (Pink Sheet)
In Focus: International
- European Commission Proposes First “Master UDI-DI” - For Contact Lenses (Medtech Insight)
- Australia To Seek Stakeholder Input On Terms Of HTA Review (Pink Sheet)
- Switzerland: US FDA’s Medtech Can Bridge Innovation Gap Left By MDR (Medtech Insight)
- EU IVD Regulation Delaying Clinical Trials Using Diagnostics (Medtech Insight)
- China Grants First mRNA COVID Vaccine Approval To Homegrown Latecomer (Pink Sheet)
Pharma & Biotech
- Sanofi, Regeneron boast PhIII win with Dupixent in COPD, clearing first bar for expansion (Endpoints News) (Reuters)
- ‘In A Word, Complicated’ – AAM’s Burton Talks US Biosimilars (Pink Sheet)
- Three People Have Died From Bacteria Outbreak Linked to Eye Drops (Wall Street Journal)
- Roche, Lilly team on test for early detection of Alzheimer’s (Medtech Dive)
- FDA advisers support conditional clearance of Biogen’s ALS drug (Biopharma Dive)
- Biohaven strikes a deal to take TYK2 drugs in a new direction (Biopharma Dive)
- At EpiBiologics, a pair of Genentech alumni wants to make next-gen protein degraders (Biopharma Dive)
- A biotech stumbles in its bid to challenge Novo’s obesity drug (Biopharma Dive)
- Novo partners with Dewpoint to mine an emerging field for new drugs (Biopharma Dive)
- FDA warns Procter & Gamble over NyQuil label's ingredient listings (Endpoints News)
- Genentech to stop commercial manufacturing at California headquarters (Endpoints News)
- Drug developer 89Bio soars as NASH drug succeeds in mid-stage study (Reuters)
- US FDA grants accelerated approval for Incyte's skin cancer therapy (Reuters)
Medtech
- NuVasive shareholders expected to ‘begrudgingly’ back Globus’ $3.1B takeover amid lack of other bidders (Medtech Dive)
- Medtronic, NVIDIA to combine forces on AI devices, allowing users to create new software (Medtech Dive)
- FDA rejects AbbVie's infusion therapy for Parkinson's, requests more info on pump device (Endpoints News)
- Huma Secures EU MDR Approval For Medtech Software That Can Be Used In Any Disease (Medtech Insight)
- DOJ Files Preliminary Injunction Against Neoprene Manufacturer (Medtech Insight)
- How Innovative UTI Diagnostics Can Help Combat Antibiotic Resistance (Medtech Insight)
- Asensus Surgical Gets Pediatric Indication for Robotic Laparoscopic Device (FDAnews)
- FDA Updates its List of Medical Devices in Short Supply (FDAnews)
Government, Regulatory and Legal
- FTC wades into dispute between Supernus, generic competitor (Biopharma Dive) (Endpoints News)
- U.S. government again rejects call to seize Xtandi rights (Biopharma Dive)
- Rising Rate of Drug Shortages Is Framed as a National Security Threat (New York Times) (Endpoints News)
- PhRMA calls for more diverse infrastructure upgrades to US emergency trials framework (Endpoints News)
- J&J to seek U.S. Supreme Court review on unit's bankruptcy (Reuters)
- The much-maligned ‘quality-adjusted life year’ is a vital tool for health care policy (STAT+)
- Sanofi Tells Justices It Couldn't Give Away EpiPen Rival (Law360)
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.
