Recon: AbbVie’s CEO Gonzalez to depart company after 11 years; FDA halts two of Rapt’s mid-stage immunology trials

• AbbVie CEO Gonzalez to step down after a decade fiercely defending its top seller, Humira (STAT)
• FDA pauses RAPT Therapeutics’ immunology drug studies after patient experiences liver failure (Endpoints) (Reuters)
• Pink Sheet Podcast: Price Negotiation Suit Tossed, Drug Shortage Probe, FDA-Approved Marijuana (Pink Sheet)
• Senators Pressure US FDA To Issue New Guidance On Social Media Drug Promotion (Pink Sheet)
• New CMS rules will throttle access researchers need to Medicare, Medicaid data (STAT)
• Niacin has long been a public health darling. But an excess could be bad for the heart, study suggests (STAT)
• Obamacare plans don’t have to cover weight loss drugs. The government is considering changing that (STAT)
• Regulatory tracker: FDA fast tracks review of new indications for Merck's Keytruda, BMS' Krazati and argenx' Vyvgart (Fierce Pharma)

• More than half the world faces high measles risk, WHO says (Reuters)
• UK medical device reviewers form new association (MedTech Dive)
• English & Scottish HTAs Diverge On Sanofi’s Dupixent For Rare Skin Condition (Pink Sheet)
• French Agency Sets Up New Body To Advise On Biosimilar Substitution (Pink Sheet)
• Daiichi Sankyo plots €1B expansion to beef up antibody-drug conjugate production in Germany (Fierce Pharma)

• Bayer, short on cash, reaches into shareholders’ pockets (STAT)
• Another tough decision for Bayer as it plans to slash dividend by 95% to reduce debt (Fierce Pharma)
• Phage therapy: Researchers sharpen another arrow in the quiver against antibiotic resistance (STAT)
  The $100 billion club gets a shakeup, driven by biotech’s new blue-chip names (Endpoints)
• Resilience allocates $225M to expand manufacturing capacity in Cincinnati (Endpoints)
• WuXi AppTec subsidiary to manufacture Iovance’s solid tumor TIL therapy in US (Endpoints)
• Takeda readies next phase in corporate and R&D campaign to help boost US profile (Endpoints)
• Owkin launches new startup to ‘capture laws of biology’ with $35M seed round (Endpoints)
• AstraZeneca touts ‘overwhelming’ Tagrisso win among 3 lung cancer portfolio advancements (Fierce Pharma)
• National Resilience to drop $225M into Ohio facility, expand North Carolina operations (Fierce Pharma)

• Medtronic lifts annual profit forecast, exits ventilator business (Reuters)
• Neuralink's first human patient able to control mouse through thinking, Musk says (Reuters)
• FMC shares slide as analysts focus on weaker patient volumes outlook (Reuters)
• Medical device recall system ‘failing to meet the needs of public health,’ physicians find (MedTech Dive)
• Masimo’s MightySat Receives First FDA Clearance For OTC Pulse Oximeter (MedTech Insight)
• AAOS: Study Finds Robots Do Not Help Knee Revisions; Analysts Bullish On Ortho; More (MedTech Insight)
• News We're Watching: Accenture Expects 'More Human' Tech, Cardiac Genetic Tests In Walmart; And More (MedTech Insight)

• A lawsuit over a controversial Sanofi drug shortage is unexpectedly revived (STAT)
• As regulators play catch up with AI, tech startups say uncertainty is slowing them down (STAT)
• HP&M Welcomes Senior FDA Official, Ana Loloei, to the Firm (FDA Law Blog)
• CMS Expects Part D Plans To Go To Great Lengths Facilitating Participation In New Copay ‘Smoothing’ Option (Pink Sheet)