Recon: Merck wagers $250M in circular RNA deal with Orna Therapeutics; US to send up to 442,000 Jynneos doses to states

| 16 August 2022 | By Michael Mezher 

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • FDA Clears Path for Hearing Aids to be Sold Over the Counter (NYTimes) (Reuters) (FDA)
  • US to provide states with up to 442,000 Jynneos doses to combat monkeypox (Reuters)
  • Elliott Management Has Large Position in Cardinal Health (WSJ)
  • Merck, a loser in the Covid vaccine race, reinvests in mRNA through a Cambridge startup (STAT)
  • Unpacking the drug pricing policies that Congress just approved (STAT)
  • Pregnancy tests are routine before many surgical procedures. But Dobbs has raised the stakes of a positive result (STAT)
  • New Hahn-era texts show the extent of the Trump White House's involvement in vaccine EUA process (Endpoints)
  • The Forgotten Virus: Zika Families and Researchers Struggle for Support (NYTimes)
  • Artificial intelligence was supposed to transform health care. It hasn’t. (Politico)
In Focus: International
  • UK's autumn COVID vaccination campaign buoyed by Omicron booster nod (Reuters)
  • Vibrant IVDs Innovation Climate At Risk From Poor UK Regulatory System Readiness (MedtechInsight)
  • AliveCor’s Smartphone-Linked ECG First Product Assessed Under UK’s Rapid HTA Pilot (MedtechInsight)
  • EU Allows Firms More Time To Make Nitrosamine-Related Manufacturing Changes (Pink Sheet)
  • Addendum to S1B reaches Step 4 of the ICH Process (ICH)
  • Langya: New virus infects 35 people in eastern China (BBC)
Pharma & Biotech
  • Opinion: As a pediatric cancer researcher, I admired the FDA. Then I got ALS (STAT)
  • Gilead's Trodelvy scores 'surprise' OS win in metastatic breast cancer, but data will wait for an upcoming conference (Endpoints)
  • Gilead doles out $280M upfront to regain Trodelvy rights in China, other regional territories (Endpoints)
  • Hepatitis C Treatment Restrictions In Spotlight After HHS Report (Pink Sheet)
  • Homology lays off staff, pauses rare metabolic disease trial despite clinical hold lift (Endpoints)
  • Positive readout? Public offering: Viridian plans to raise $175M on eye disease therapy data (Endpoints)
  • Roche’s Polivy continues its regulatory dance, will head to FDA for a form of blood cancer (Endpoints)
  • TYK2 heats up with Ventyx eyeing mid-stage trials; NexImmune cites competition in pipeline cull (Endpoints)
  • Resilience collaborates with the Mayo Clinic to manufacture rare and complex disease drugs (Endpoints)
  • Buying time to catch up on sales, ADC Therapeutics takes on $175M loan (Endpoints)
  • Two years post-merger, Flagship’s Senda refines pipeline and replenishes the bank (Endpoints)
  • De Oro Devices’ Nex(t)Stride To Help Freezing Gait Is Expand Into Other Diseases, Add Software (MedtechInsight)
  • Meditation app Calm lays off 20% of workforce (MobiHealthNews)
  • Outset lands VA contract for portable hemodialysis system in ‘modest’ boost for sales (MedtechDive)
  • Smartphone-linked blood pressure monitors fail to beat traditional devices, study finds (MedtechDive)
  • Philips CEO van Houten hands reins to head of beleaguered connected care business (Fierce)
  • AliveCor’s Smartphone-Linked ECG First Product Assessed Under UK’s Rapid HTA Pilot (MedtechInsight)
Government, Regulatory & Legal
  • Sales from controversial drug discount program rose to $44 billion last year (STAT)
  • Pain Management Physician Convicted of Unlawfully Distributing Opioids (DoJ)
  • After Regeneron filed PCSK9 antitrust suit, Amgen hits back with motion to dismiss (Fierce)
  • Covington Hires Former FDA Atty From Sidley (Law360)
  • Justices Told Generic Drugs At Risk From Skinny Label Ruling (Law360)
  • 1st Circ. Partially Resurrects Azurity's Beef With Edge Pharma (Law360)
  • McKesson Hid Sales Data In FCA Suit, Whistleblower Says (Law360)
  • Justices Urged To Reject Review Of Biogen MS Drug IP Ruling (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.


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