Recon: Merck seeks US authorization for COVID drug; EMA reviewing Regeneron, Roche COVID antibody

• Merck seeks first U.S. authorization for COVID-19 pill (Reuters)
• Roche says Alzheimer's therapy gets U.S. breakthrough designation (Reuters)
• U.S. CDC advisers to review Moderna, J&J COVID-19 booster shots this month (Reuters)
• Govt to control distribution of GSK/Vir COVID-19 antibody in U.S. – FDA (Reuters)
• Adamas, Flexion sell for $825M combined as dealmaking pace picks up (BioPharmaDive) (Endpoints)
• Democrats weigh changes to drug pricing measure to win over moderates (The Hill)
• CDC sets panel meetings for J&J, Moderna boosters, child vaccines (The Hill)
• After three decades and a surprise rejection, first treatment for babies born without a thymus secures FDA approval (Endpoints) (FDA)
• As Biden's vaccinate-or-test mandate approaches, questions arise over enforcement (NBC)
• Inside the Courtroom With Theranos’s Elizabeth Holmes (NYTimes)

• New Ebola case confirmed in eastern Congo (Reuters)
• Japan's Chugai files to expand use of COVID-19 antibody drug (Reuters)
• EU assesses Regeneron/Roche COVID-19 antibody cocktail for authorisation (Reuters) (EMA)
• AstraZeneca antibody cocktail study shows success treating COVID-19 (Reuters) (FT)
• African Medicines Agency To Be Established In 2022 (Pink Sheet)
• A global fight looms over Kratom, a possible opioid alternative (Politico)

• Moderna, Racing for Profits, Keeps Covid Vaccine Out of Reach of Poor (NYTimes)
• U.S. will accept WHO-approved COVID-19 vaccines for international visitors (Reuters)
• Lumen lands another DoD contract to treat Covid-related GI issues (Endpoints)

• Supernus bolsters Parkinson's portfolio with $400 mln deal for Adamas Pharma (Reuters)
• The Drug-Dosing Conundrum in Oncology — When Less Is More (NEJM)
• Researchers find a higher than expected risk of myocarditis in young men after full vaccination. (NYTimes)
• Mouse experiments with a decades-old drug suggest a new approach to Alzheimer’s treatment (STAT)
• Searching for the next 'big hairy goal,' BlueRock CEO Emile Nuwaysir jumps to in vivo cell therapy startup Ensoma (Endpoints)
• In quick turnaround, FDA lifts full clinical hold on Protagonist's blood cancer program (Endpoints)
• Post-split GSK to exit marquee world HQ, blueprinting smaller corporate digs (Endpoints)
• Sandoz completes acquisition of GSK’s cephalosporin business (PMLive)
• Ipsen poaches Novartis vet Mari Scheiffele to serve as president of its international specialty care team (Fierce)
• Some Dana-Farber Cancer Institute trustees stood to profit from their philanthropic role (STAT) (Endpoints)
• NICE approves treatment for rheumatoid arthritis (Pharmafile)
• Idorsia's Fabry disease program flops a PhIII study, leaving its future unclear (Endpoints)

• 5 health tech startups working to address chronic pain without opioids (STAT)
• What Does ‘Digital’ Mean For FDA’s Device Center? (MedtechInsight)
• 4 takeaways from a bumper year of M&A medtech activity (so far) (MedtechDive)
• Medtronic's surgical robot Hugo gains CE mark, setting up Intuitive faceoff (MedtechDive)
• Two New Modules Added To Eudamed For Use On Voluntary Basis (MedtechInsight)
• Mount Sinai unveils first-of-its-kind department to develop AI tools for healthcare (Fierce)
• Veracyte kicks off limited release of its nasal swab lung cancer test, as it gears up for full commercial launch (Fierce)

• AbbVie's Botox patent lawsuit is 'very unlikely to derail' Revance's rival launch: analysts (Fierce)
• New Trial Sought In CR Bard Hernia Mesh Bellwether (Law360)
• Canadian Creditors Seek Direct Appeal Of Purdue Ch. 11 Plan (Law360)