Recon: Express Scripts Caps Out of Pocket Insulin Costs at $25 Per Month

• Cigna’s Express Scripts launches program to cap out-of-pocket insulin costs at $25/month (Reuters) (WSJ) (NYTimes) (CNBC)
• Roche says $4.3B offer for Spark is still on track for June completion (CNBC) (Endpoints) (Press)
• Generic-Drug Trends Squeeze Walgreens Profit (WSJ) (Financial Times) (Reuters)
• Startups Are Hawking Zoloft and Beta-Blockers for Off-Label Uses (Bloomberg) (NYTimes)
• Rx Drug Policy At The FDA: Looking Back At Gottlieb And Ahead To Sharpless (Health Affairs)
• McConnell told Trump: Senate won't do comprehensive healthcare bill (Reuters)
• How to save money on prescription drugs (NBC)
• A small drug maker accuses Soon-Shiong of masterminding a ‘catch-and-kill’ scheme (STAT)
• Overprescribed: High cost isn’t America’s only drug problem (STAT)
• Watch out Lilly, AbbVie & Biogen: 7 new blockbusters on the way to shake things up (Endpoints)
• Senate Passes First Drug-Pricing Bill Of Session, Next Stop Trump’s Desk (IHP-$) (Senate Finance)
• Progressive House Dems meet with Pelosi staffer to push for tough drug pricing bill (The Hill)
• Key House lawmakers reach bipartisan deal to advance long-stalled drug pricing bill (The Hill) (Politico)
• Insulin manufacturers to testify as part of House pricing probe (The Hill)
• A safety watchdog argues the FDA should reconsider approval of a Parkinson’s psychosis drug (STAT)
• Some drug companies are still imposing triple-digit price rises (Financial Times)

• The IVD industry is undergoing significant change. Join BSI experts at their In-Vitro Diagnostic Regulation Workshop to learn about the most significant changes to the European Regulatory and Compliance Expectations for CE marking. Topics such as an IVDR Overview including Classification and Grouping Devices, interacting with the Notified Body, Technical Documentation Requirements, New Requirements for Performance Evaluation and Using the Remaining Transition Period Effectively will be covered. Register here.

• Orphan Drugs, Antivirals Dominate China's Latest Fast Track List (Pink Sheet-$)
• Novartis’ Cosentyx beats J&J, Lilly to land first-in-class Chinese psoriasis nod (Fierce) (Endpoints)
• European players set up one-stop bacterial strain shop for microbiome-focused drug developers (Endpoints)
• After falling short on prelim OS data, EMA tells Aveo it wants to see something better on its long suffering tivo this summer — or else (Endpoints)
• Lyrica reclassified after being linked to 33 deaths (PharmaTimes)
• EMA accepts Takeda application for subcutaneous Entyvio (PharmaTimes)
• As Brexit delayed, wannabe next PM wants to slash trial regulations (Fierce)
• Study points to new antibody approach to tackling Ebola, other infections (Reuters)
• Timeline For EU GMP Annex 1 Revision Remains Unclear (Pink Sheet-$)

• Can CRISPR improve on nature’s own bacteria-killing phages? (STAT)
• The Challenge of Going Off Psychiatric Drugs (The New Yorker)
• Insulin Competition: FDA to Hold Public Meeting (Focus)
• Teva, Pfizer Seek Clarity on Tentative ANDA Approval Draft Guidance (Focus)
• Industry Seeks Cross-Center Alignment in FDA Proposal on Prescription Drug Software (Focus)
• The Gross-to-Net Bubble Reached a Record $166 Billion in 2018 (Drug Channels)
• Opioid addiction diagnosis and treatment climbs with Medicaid expansion (Reuters)
• IGBA Still Sees A Path To Change FDA’s Mind On Biologic Suffixes (Generics Bulletin)
• In a Parallel Universe: FDA Authorizes First REMS “Parallel System” (FDA Law Blog)
• Autolus’ next-gen CAR-T looks promising in ALL (PMLive)
• Accused: Surrogate Endpoints, Non-Inferiority Trials for Cancer Drugs (Medpage)
• Development of Antiviral Drugs for the Treatment of Adenoviral Infection in Immunocompromised Patients (FDA)
• Frequently Asked Questions (FAQ) - WHO Pilot Procedure for Prequalification of Biotherapeutic Products: rituximab and trastuzumab (WHO)
• FDA takes new steps to increase access to adverse event report data for medical products used in animals (FDA) (FDA)
• Under-fire Purdue hunts for ad agency to promote upcoming product: report (Fierce)
• Clovis Oncology's Rubraca shows promise in multiple pancreatic tumour mutations, interim data show (Pharmafile)
• Insulin Applications Intended For Biosimilar Pathway May Already Be At US FDA (Pink Sheet-$)
• CDMO Sterling burnishes its U.S. credentials with buyout of North Carolina facility (Fierce)
• Sandoz resubmission puts Amgen's Neulasta at further risk of competition (BioPharmaDive)
• Romesh Subramanian births a new biotech with $50M and a plan to steer toward the clinic with drugs for rare muscle diseases (Endpoints)
• AbbVie shareholder joins the growing ranks of critics, calling for an independent chairman (Endpoints)
• Editas and BlueRock join forces — and platform technologies — on a new wave of engineered cell therapies (Endpoints)
• Belgian biotech founded by University of Torino team nabs $23.5 million in Series A round (Endpoints)
• Agency Information Collection Activities; Proposed Collection; Comment Request;
• Guidance: Emergency Use Authorization of Medical Products and Related Authorities (FDA)

• Immunocore’s Lead Asset Tebentafusp Gains Fast Track Designation for Metastatic Uveal Melanoma (Press)
• NIH begins first-in-human trial of a universal influenza vaccine candidate (NIH)
• Gout treatment may help prevent obesity-related type 2 diabetes, suggests small NIH study (NIH)
• Bristol-Myers Squibb Announces Long-Term Survival Results from Pooled Analyses of Opdivo (nivolumab) in Previously-Treated Non-Small Cell Lung Cancer Patients (Press)
• Amylyx Pharmaceuticals Announces First Patients Dosed in PEGASUS Phase 2 Trial of AMX0035 in Alzheimer’s Disease and Expansion of the Trial (Press)
• New Glioblastoma Vaccine Shows Promising Results in Phase 1b Clinical Trial (Press)
• FDA Clears the IND for UCARTCS1, the First Allogeneic CAR-T to Treat Multiple Myeloma Patients (Press)
• VIZIMPRO® (dacomitinib) Receives Marketing Authorization in European Union (EU) for the First-Line Treatment of Adult Patients with EGFR-Mutated Non-Small Cell Lung Cancer (Press)
• Tetraphase Pharmaceuticals Presents Preclinical Data on TP-2846, a Novel Drug Candidate for Acute Myeloid Leukemia (Press)

• FDA Proposes Regulatory Framework for AI- and Machine Learning-Driven SaMD (Focus) (STAT)
• Emerging Product Liability Concerns for Medical 3D Printing (MDDI)
• J&J’s Ethicon warns EMEA docs on Intraluminal stapler issues (MassDevice)
• Silk Road Medical upsizes IPO (MassDevice)
• Obalon to lay off half its workforce in retail pivot (MassDevice)
• FDA accepts second application for Ocular Therapeutix’s drug-delivering implant (MassDevice)
• 5 burning questions for the DNA testing industry after the launch of the latest new disease risk test (STAT)
• Apyx Medical withdraws Renuvion FDA 510(k) app for dermal resurfacing indication (MassDevice)
• Mammography Facility Adverse Event and Action Report - April 02, 2019: DMI Clinic - Carl J. Kubek (FDA)
• Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device Accessories  (FDA)

• HHS Inspector General To Resign After 15 Years (Law360-$) (IHP-$)
• Six Lawsuits Target AbbVie’s Humira and its Patent Thicket (Focus)
• FDA Begins Plotting Pathway for Cannabis Product Approvals (Focus)
• FDA is investigating reports of seizures after vaping (STAT) (NBC) (FDA)
• Purdue's Sackler family fights 'inflammatory' Massachusetts opioid case (Reuters) (AP)
• Democrats mock Trump over healthcare delay ahead of 2020 election battle (Reuters)
• Some In The Beef Industry Are Bucking The Widespread Use Of Antibiotics. Here's How (NPR)
• Former FDA Official Joins Covington (Covington)
• E.D. Michigan Dismisses Hernia Mesh Case for Lack of Safer Alternative (Drug & Device Law)
• Novo Nordisk Investors Seek Cert. In Insulin Pricing Suit (Law360-$)
• Key Opioid Case On 'Untenable' Course, Teva Says (Law360-$)
• J&J, Other Drug Cos. Fail To Shake Fla. AG's Opioid Suit (Law360-$)
• Tribes Get Tentative Green Light In Opioid MDL (Law360-$)
• Insys Judge Unmoved So Far By Midnight Acquittal Bid (Law360-$)
• Pa. Counties Want Out Of Coordinated Opioid Litigation (Law360-$)

• FDA Advisory Committee Calendar

• MedTech Europe Flags MDR/IVDR ‘Burning Points’ (Focus)
• Webinars related to making submissions to the MHRA if the UK leaves the EU with no deal (MHRA)
• Guidance on substantial amendments to a clinical trial if the UK leaves the EU with no deal (MHRA)
• Decide if your product is a medicine or a medical device (MHRA)
• Apply to release a vaccine or a blood product to market (MHRA)

• Asia Regulatory Roundup: India Drops Interim Compensation Requirements From Proposed Clinical Trial Rules (Focus)

• US health officials alarmed by paralyzing illness in kids (AP)