Recon: Sanofi, GKS report positive interim results for COVID shot; Regeneron resumes lymphoma trials after hold lifted

In Focus: US

• Covid-19 Drugmakers Take On Your Favorite TV Shows to Tackle Vaccine Hesitancy (WSJ)
• Trump tax law cut what US drugmakers owed. Now they fear an increase. (BioPharmaDive)
• Regeneron resumes enrollment in lymphoma drug trials (Reuters)
• Incyte's vitiligo treatment meets main goal in late-stage trial (Reuters)
• US Supreme Court denies Sandoz petition to review biosimilar Erelzi case (Press)
• At Illumina, the ‘era of the genome’ has arrived. But what role will the company play? (STAT)
• Apellis bags FDA nod for Soliris challenger with a different pathway to PNH (Endpoints) (Fierce)
• Administration lifts mask mandate for vaccinated people on federal property (The Hill)

In Focus: International

• Sanofi-GSK report positive interim results for their COVID-19 shot (Reuters) (STAT) (Press)
• China backs developing countries' call to waive IP rights on COVID-19 vaccines (Reuters)
• India says miniscule clotting cases after AstraZeneca vaccine (Reuters)
• G7 urged to donate ‘emergency’ supplies to vaccine-sharing scheme (Reuters)
• Big vaccine makers reject offers to help produce more jabs (Politico)
• Pfizer rejects calls to share vaccine formula (Sunday Times)
• More flexible storage conditions for BioNTech/Pfizer’s COVID-19 vaccine (EMA)

Coronavirus Pandemic

• How the United States Beat the Variants, for Now (NYTimes)
• Desperate for treatment, Covid 'long haulers' push for 9/11-style health registry (Politico)
• EU to back expansion of vaccine production capacity in Africa (FT)
• Japan, Pfizer Agree on 50 Million Extra Vaccine Doses by Sept-End (PharmaJapan)
• U.S. military offers J&J vaccines for South Korean troops (Reuters)
• Venezuela approves Russia's single-shot COVID-19 vaccine (Reuters)
• Indonesia pauses distribution of a batch of AstraZeneca vaccine (Reuters)
• Indian makers of Sputnik V may seek waiver for local Phase-3 trials (Economic Times)
• Eli Lilly buckles under pressure, offers voluntary licence to Natco Pharma (Economic Times)

Pharma & Biotech

• Abandoned Trump order on the bioeconomy highlights a path forward for Biden — but with mixed reviews (STAT)
• Sponsors Fail To Win US FDA Endorsement For Trimming Trials During Pandemic (Pink Sheet)
• Patient-Reported Outcomes In Pediatric Cancer Trials Endorsed By US FDA Advisory Committee (Pink sheet)
• Pfizer, Bristol Myers' Eliquis flops in post-heart surgery patients, spurring an 'unexplained signal' in certain deaths (Endpoints)
• Sanofi, touting new data, sees 'best-in-class' case for Dupixent in pediatric asthma (Fierce)
• Clinical trial strategies for rare neurodevelopmental disorders: challenges and opportunities (Nature)
• Bristol Myers backs up its case for heart drug mavacamten as FDA weighs app in cardiomyopathy (Endpoints)
• ACC 2021: J&J, Bayer pad case for Xarelto in post-surgery artery disease patients (Fierce)
• Novartis' Entresto takes its 2nd failure of the weekend at ACC, showing no benefit in most dire heart failure patients (Endpoints)
• Novartis whiffs on Entresto study after heart attacks — but that doesn't mean it's going down quietly (Endpoints)
• Keytruda wins NICE backing in MSI-H/dMMR colorectal cancer (PharmaTimes)
• No To Five, Yes To Three: NICE Decides On Funding For Drugs In England (Pink Sheet)
• Viatris Expects First “Interchangeable” Designation in July 2021 For Insulin Products (Big Molecule Watch)
• $DNA is once again on NYSE; FDA clears Soliris challenger for the market; Flagship’s thinking big again with eRNA; and more (Endpoints)
• AstraZeneca's Farxiga missed big on Covid-19 study, but it's taking SGLT2 safety data as a silver lining (Endpoints)
• Days ahead of Amgen split, Cytokinetics reads out post-hoc data suggesting heart drug works better in sicker patients — but can the CEO win over skeptics? (Endpoints)
• Regeneron's Evkeeza shows promise in curbing high triglycerides, but will genetic disparities limit use? (Endpoints)
• A T-cell player with backing from Roche takes next big step for BiTE drugs with 'on-off' switch to avoid toxicity (Endpoints)
• On the heels of a stinging Q1 setback, Esperion's longtime champion is exiting the helm and turning the wheel over to a marketing pro (Endpoints)
• Perceptive's China upstart LianBio continues swinging deals, teaming up with lead Xontogeny biotech Landos in IBD (Endpoints)
• Insider account of Roivant's SPAC deal — and that $7.3B valuation — reveals a few secrets as Matt Gline positions the company as the new ‘Big Pharma’ (Endpoints)
• Patrick Soon-Shiong's former chief scientist takes cancer company public in $155M reverse merger (Endpoints)

Medtech

• CMS again delays breakthrough device payment rule in nod to skeptics (MedtechDive)
• Blood pressure device maker CardieX launches Conneqt consumer venture to compete with Apple, Fitbit (Fierce)
• ACC 2021: Edwards' tricuspid valve replacement cuts leaks in 98% of patients (Fierce)
• ACC 2021: Large Medicare study finds no increased death risk with paclitaxel-coated balloons, stents (Fierce)
• PerkinElmer opens COVID-flush wallet for $155M immunodiagnostics buy (Fierce)
• Abbott nabs European approval for Navitor aortic heart valve replacement (Fierce)
• Boston Scientific's Watchman shows low stroke rate in large registry at ACC (MedtechDive)

Government, Regulatory & Legal

• EU Medical Device Regulation May Spur Litigation Uptick (Law360)
• AGs Say High Court Ruling Doesn't Weaken Drug Price Claims (Law360)
• DEA Opens Up Pot Research With Scientist Agreements (Law360)
• Philips Slaps MRI Repair 'Hacker' With Trade Secret Suit (Law360)
• PBMs Aren't Ready To Throw In Towel In Preemption Fight (Law360)
• Panacea Biotec files suit against Sanofi for patent infringement (Economic Times)