Recon: Roche Nabs Priority Review for Tecentriq in NSCLC; FDA Rejects 6-Week Dosing Schedule for Keytruda

• Trump's next health care move: Giving Silicon Valley your medical data (Politico)
• How the Drug Lobby Lost Its Mojo in Washington (WSJ)
• FDA sets June decision date for Tecentriq monotherapy in NSCLC (PMLive) (Press)
• FDA rejects Merck’s applications for 6-week Keytruda dosing schedule (Reuters) (Press)
• BMS’ Opdivo combo misses the mark in pancreatic cancer (PMLive) (Fierce) (Endpoints) (Press)
• Incyte hits endpoint in 2nd pivotal atopic dermatitis trial (Fierce) (Press)
• ITC Bans Bio-Rad DNA Product Imports In Patent Case (Law360-$)
• 'Oblivious' PixarBio CEO Gets 7 Years For $7.5M Stock Fraud (Law360-$) (STAT) (Pharmafile)
• Consumer groups and unions try again to block the AbbVie and Allergan merger (STAT)
• As bluebird makes commercial progress in Europe, US application for Zynteglo suffers delay (Endpoints) (BioPharmaDive) (Press)

• China HIV patients risk running out of AIDS drugs in days: UNAIDS (Reuters)
• In Fighting Outbreaks, Big Pharma Struggles to Get Out Front (Bloomberg)
• Coronavirus death toll rises above 2,000 worldwide (CNN)
• India's commerce minister: price cuts on medical devices, drugs here to stay (Economic Times)
• Israeli biotech NeoTX lands $45M series C for combo I-O cancer trials (Fierce) (Endpoints)
• UK’s NICE recommends Axonics’ device for overactive bladder treatment (MassDevice)
• Novacyt Gets CE Mark for Coronavirus Test (GenomeWeb)
• European Union proposes independent audits for high-risk AI systems (STAT)

• Priority Review Voucher Programs Poised For US Legislative Attention In 2020 (Pink Sheet-$)
• Pharma execs criticize a drug maker over pricing and claim orphan drug law is being misused (STAT)
• FDA Continues to Approve Biosimilars (Patent Docs)
• Audentes to build new gene therapy plant in North Carolina (BioPharmaDive) (Fierce)
• Imara Reveals IPO Plan as Sickle Cell Drug Advances in the Clinic (Xconomy)
• Astellas follows up $3B gene therapy buyout with $109M plan to accelerate a manufacturing boom (Endpoints)
• Could ICER Outreach To US FDA Lead To Better Cost Effectiveness Analyses? (Pink Sheet-$)
• GSK to shut down Pennsylvania plant, move production to Puerto Rico (PharmaManufacturing)
• For two decades, a new vaccine technology has been slowly approaching prime time. Now, can it stop a pandemic? (Endpoints)
• Cellectis boosts its coffers in revised off-the-shelf CAR-T deal with Servier (Endpoints)
• Specialty Pharmacy M&A in 2019: CVS, OptumRx, and Private Equity Highlight a Slowing Market (Drug Channels)
• DuPont makes another foray into drug R&D, throwing its name into the microbiome hat (Endpoints)
• 'Significant problems' at outsourcing sites prompt Trump to plan FDA budget boost (Outsourcing Pharma)
• Compounding Animal Drugs from Bulk Drug Substances; Draft Guidance (FDA)

• Seattle Genetics and Astellas Receive FDA Breakthrough Therapy Designation for PADCEV™ (enfortumab vedotin-ejfv) in Combination with Pembrolizumab in First-Line Advanced Bladder Cancer (Press)
• Terns Pharmaceuticals Announces Safety and Pharmacodynamic Results of a Phase 1 Clinical Trial of TERN-101, a Liver-Selective FXR Agonist in Development for the Treatment of NASH (Press)
• Palatin Technologies, Inc. Announces First Patient Enrolled in Dry Eye Disease Phase 2 Clinical Trial with PL9643 (Press)
• RIBOMIC Announces First Injection in the Phase 2 Clinical Trial of RBM-007 (TOFU Study) in Subjects with Wet Age-Related Macular Degeneration (Press)
• OrphoMed to Present Phase 1 Results of ORP-101 at Digestive Disease Week 2020 (Press)

• Why fixing security vulnerabilities in medical devices, IoT is so hard (Ars Technica)
• Baxter closes $350M acquisition of Sanofi's Seprafilm adhesion barrier (MedtechDive)
• Medtronic misses revenue estimates as TAVR position falters (MedtechDive)
• As CMS coverage decision nears, Abbott gears for MitraClip expansion (MedtechDive)
• Abbott And Insulet Partner To Integrate Next-Generation Glucose Sensing And Automated Insulin Delivery Technologies For Seamless Diabetes Care (Press)
• Abbott wins CE Mark for ICD device (MassDevice)
• Canon Medical Receives FDA Clearance for Aquilion ONE / PRISM Edition, Enabling Deep Learning Spectral Capabilities for Routine Use (Press)
• EndoClot Plus, Inc. Announces FDA Clearance of GI Submucosal Lifting Product (Press)

• What to watch in tonight's debate (Politico)
• States Rip Opioid Judge For Creating Class Action By 'Decree' (Law360-$)
• Amgen, Amneal Tell Fed. Circ. To Redo Sensipar IP Ruling (Law360-$)
• Ill. Consumers Say Walgreens Sold Toxic Blood Pressure Drug (Law360-$)
• Taxotere Court Finds that Distributor was Fraudulently Joined; Denies Remand (Drug & Device Law)
• FDA Releases Final Installment of FSMA Intentional Adulteration Guidance; Inspections Start (Gulp) Next Month (FDA Law Blog)
• New penalty, extended deadline drive increase in California health insurance sign-ups (Sacramento Bee)

• FDA Advisory Committee Calendar
• Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting – 21 April 2020
• Medical Imaging Drugs Advisory Committee; Notice of Meeting – 23 April 2020

• Innovation: MHRA’s speedy approval of high dose flu vaccine demonstrates flexibilities in national applications (MHRA)

• Aging Trend Helps New Billionaire Couple Emerge From China's Medical Industry (Forbes)

• Jawed Zia quits Abbott India (Economic Times)
• Coronavirus: Government panel recommends ban on export of 12 drug formulations, ingredients (Economic Times)
• Pharma cos don't see supply shortage, oppose exports ban (Economic Times)

• Medical device application processing times (TGA)

• Notice: Implementation of eCTD for clinical trial regulatory activities (Health Canada)

• China won't send officials to G20 meeting amid virus outbreak: sources (Reuters)
• Swiss postpone global patient safety summit amid coronavirus outbreak (Reuters)
• WHO reports 92 cases of human-to-human coronavirus cases outside China (Reuters)
• Passengers depart coronavirus cruise ship at last; Japan's effort under fire (Reuters)
• Coronavirus cases climb to 621 on Japan cruise liner as some passengers leave (Reuters)
• U.S. CDC places 14-day travel restriction on passengers from quarantined cruise ship (Reuters)
• South Korea reports 20 new coronavirus cases, church services at center of outbreak (Reuters)
• Second Hong Kong coronavirus death as it awaits stranded cruise passengers (Reuters)
• North Korea quarantines in place for coronavirus: envoy (Reuters)