Recon: Judge dismisses Chantix cancer risk suit; Janssen and Remix agree to $1B licensing deal for RNA reprograming tech
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.In Focus: US
- A new analyst report spotlights 3 more deaths, ARIA among Alzheimer's patients taking Aduhelm (Endpoints)
- Lawsuit over Pfizer's disclosures before Chantix recall is dismissed (Reuters)
- '150 Billion Pills' Gaffe Imperils NY AG's Opioid Win Over Teva (Law360)
- Generic Firms Likely To Withdraw Drugs If US FDA’s Pursues ‘Disastrous’ PANDA Policy (The Pink Sheet)
- Biden’s new global vaccine push is running out of funds (Politico)
- Ex-NIH chief Collins returns as science advisor to Biden weeks into retirement (Fierce)
- NIH's top vaccine director retires, adding to the exodus of government vaccine expertise (Endpoints)
- AstraZeneca Wins Bid to Quash HHS’s Drug HHS’s Drug Discount Demand (Bloomberg) (STAT)
- Lawmakers ask Justice Department to explore criminal charges against Sacklers (STAT)
- WHO calls for strengthened role as US proposes new pandemic fund (Reuters)
- UK to Offer Pfizer’s Covid Shot to All Children Aged 5 to 11 (Bloomberg)
- Industry Skeptical Of EU Moves To Facilitate Compulsory Licensing (The Pink Sheet)
- PRIME: How The EU Scheme Is Delivering On Promise Of Faster Drug Approvals (The Pink Sheet)
- Generic Firms Resign Themselves To A Merger Drought As Regulators Tighten Up (The Pink Sheet)
- Putting its pivotal failure in the rearview mirror, AstraZeneca scores an EU nod for its lupus drug (Endpoints)
- EMA might deny Merck's molnupiravir conditional marketing authorization — report (Endpoints) (FT)
- Bill Gates visits Pakistan, says polio eradication possible in a few years (Reuters)
- Moderna patent application raises fears for Africa COVID vaccine hub (Reuters)
- Covid Patients May Have Increased Risk of Developing Mental Health Problems (NYT)
- As Omicron fears fade, pandemic restrictions are being dismantled. And that's a big deal for some biopharmas (Endpoints)
- Remix Therapeutics signs Janssen licensing deal that could top $1B (Fierce)
- Applying mRNA to healing broken bones (Fierce)
- Innovent’s phase 3 hits tee it up to challenge Amgen and Sanofi for Chinese PCSK9 market (Fierce)
- Yumanity's ugly demise continues with plans to axe 60% of staff in search for 'strategic alternatives' (Endpoints)
- Avalo Therapeutics shuffles leadership team as the flailing biotech searches for a port in the storm (Endpoints)
- Billionaire’s fund backs Heidelberg to carve out niche in busy BCMA space (Fierce)
- Innovent claims two PhIII wins for PCSK9 antibody, but non-China strategy remains unclear (Endpoints)
- Inspection-Challenged FDA Defies Odds By Issuing Most Quality-Related Warning Letters Since 2017 (MedTech Insight)
- How Notified Bodies Must Actively Monitor Legacy Products (MedTech Insight)
- Baxter begins integrating Hillrom, faces supply chain pressures (MedTech Dive)
- FDA clears Tandem’s smartphone app for programming insulin doses (Fierce)
- MindMaze Raises $105M To Advance Mixed-Reality Brain Health Tech (MedTech Insight)
- Purdue Pharma Mediator to Provide Settlement Update by Friday (Bloomberg)
- Drug Price Reporting Rules Foiled by Loopholes in Supply Chain (Bloomberg)
- OptumTx Wins Exit From Antitrust, RICO Case Over Insulin Prices (Bloomberg)
- Trump-era Medicare program under increased scrutiny (Politico)
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