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

• 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)

• 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)

• 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)

• 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)