Recon: Pfizer, Lilly and Merck Release First Quarter Results

• Big Pharma Puts the Price Squeeze on Itself (Bloomberg)
• Three major pharmaceutical companies just reported earnings — here’s how they did (CNBC)
• Pricing pressure weighs on revenue at drugmaker Eli Lilly (Financial Times) (Fierce) (Endpoints) (Press)
• Merck raises outlook on rising drugs sales (Financial Times) (Press)
• Pfizer nudges guidance higher amid strong drug sales (Financial Times) (Press)
• FDA lifts partial hold on Xencor leukemia study (Medcity) (Press)
• Novartis's Sandoz strikes deal for biosimilar of Herceptin (Reuters)
• They Want It to Be Secret: How a Common Blood Test Can Cost $11 or Almost $1,000 (NYTimes)
• Are You Ready for Drive-Thru Botox? (NYTimes)
• Health Firms Are Looking at Personal Data (WSJ)
• NIH Ends Gene Therapy Trial Reporting Requirements In Reg Streamlining Move (Pink Sheet-$)
• Whistleblowers: Company at heart of 97,000% drug price hike bribed doctors to boost sales (CNN)
• At gene therapy meeting, insurance execs grapple with expected cost (BioPharmaDive)
• Booming cannabis market puts pressure on FDA (The Hill)
• FTC Returns Almost $515,000 to Consumers Who Bought Deceptively Marketed “Amniotic Stem Cell Therapy” Between 2014 and 2017 (FTC)

• European universities fail to report results for 83% of trials (Fierce) (Endpoints) (STAT)
• Congo registers record of 27 new Ebola cases in one day (Reuters)
• Two Samsung employees arrested over alleged cover-up (Financial Times)
• ICH Updates: What’s Coming in 2019 and Beyond (Focus)
• The UK reaches a ‘first-of-its-kind’ deal with three drug makers for hepatitis C treatments (STAT) (Fierce) (PharmaTimes)
• Brexit clock ticking once again, UK heads for European elections (PMLive)
• European approval for Skyrizi, hot on the heels of US (PMLive) (Press)
• Kangmei’s $4bn accounting error highlights China risk (Financial Times) (Bloomberg)
• Top 5 Chinese players: What does Everest’s landmark deal with Immunomedics say about the flurry of in-licensing to China? (Endpoints)
• UN Issues Urgent Warning on the Growing Peril of Drug-Resistant Infections (NYTimes) (Focus)
• Childhood mortality declining globally but disability on the rise (Reuters)

• Maybe It’s Innate (LifeSciVC)
• PrEP vs. Privacy (Slate)
• Analyst pens a barbed note to Biogen: Shed caution, dump Alzheimer’s and retool at the top — go bold (Endpoints)
• Nearly all doctors can freely prescribe opioids. Now a new movement aims to vastly deregulate an addiction treatment (STAT)
• Drugmakers, EMA Comment on FDA Guidance on Assessing Food Effects on Drugs (Focus)
• Alentis raises series A round to advance drug against novel liver disease target (Fierce) (Endpoints)
• The bears and bulls are fighting over drug maker InflaRx. Here’s how to know who will come out on top (STAT)
• Incyte pulls away ‘damaged goods’ baricitinib to focus on internal pipeline (Endpoints)
• In-demand Zymeworks nabs Seattle Genetics R&D executive Josephson (Fierce)
• After beefy funding rounds, exosome-focused Codiak guns for $86M IPO (Fierce)
• FDA Flags Incidents of Excess Radiation Exposure to Patients (Focus)
• Patients highlight commonalities in rare diseases that could streamline drug development (BioCentury)
• Roche Spinout Nimble Therapeutics Bags $10M to Find New Peptide Drugs (Xconomy)
• Scientists say they're closer to possible blood test for chronic fatigue (Reuters)
• Takeda Unites San Diego Operations At New ‘Biotech-Style’ R&D Center (Xconomy)
• Peloton Therapeutics Plans IPO for Kidney Cancer Drug Clinical Trials (Xconomy)
• Bispecific Antibodies: US FDA May Require Comparison To Approved Monospecific Product (Pink Sheet-$)
• Vowing to spark a revolution in small molecule R&D, Vividion equips itself with an extra $82M for the final stretch to the clinic (Endpoints)
• Personalized Combination Therapies Yield Better Cancer Outcomes (NIH)
• NIH All of Us Research Program symposium to highlight progress and next steps in building largest, most diverse health research effort ever undertaken (NIH)
• The Medicines Co. CEO Timney On Selling Inclisiran And Why Big Pharma Is Still Interested In CV Disease (Scrip-$)
• Torrent Pharmaceuticals Limited Expands Voluntary Nationwide Recall of Losartan Potassium Tablets, USP (FDA)
• AmEx Pharmacy Issues Voluntary Nationwide Recall for one Lot of Bevacizumab 1.25mg/0.05mL 31 G Syringe Due to Reported Defective Delivery System (FDA)
• Teva Pharmaceuticals USA, Inc. Issues Voluntary Nationwide Recall of Losartan Potassium 25 mg and 100 mg Tablets USP, Sold Exclusively to Golden State Medical Supply (FDA)
• Legacy Pharmaceutical Packaging, LLC Issues Voluntary Nationwide Recall of Losartan Potassium Tablets (FDA)
• Jurox Incorporated is Voluntarily Recalling Two Lots of Alfaxan Unpreserved, an Intravenous Injectable Anaesthetic (FDA)

• FDA Approves KALYDECO® (ivacaftor) as First and Only CFTR Modulator to Treat Eligible Infants with CF as Early as Six Months of Age (Press)
• Dynacure Announces Approval of Clinical Trial Application for DYN101, an Antisense Medicine to Treat Rare Disease 'Centronuclear Myopathies' (Press)
• Daiichi Sankyo Announces Two Lancet Oncology Publications of Phase 1 Dose Expansion Results of [Fam-] Trastuzumab Deruxtecan in HER2 Positive Metastatic Breast and Gastric Cancer (Press)
• Cerevance Achieves Key Endpoints in Phase 1 Clinical Trial of Novel Parkinson’s Disease Drug CVN424 (Press)
• Beam Therapeutics Presents Data on Multiplex Base Editing for Engineered CAR-T Cells at American Society of Gene and Cell Therapy 22nd Annual Meeting (Press)

• Putting the 'Med' in MedTech: Three Tips For How Clinicians Can Succeed In Digital Health (Forbes)
• Medtronic Announces U.S. Commercial Launch of Solitaire(TM) X Revascularization Device (Press)
• Pfizer Inc. Issues A Voluntary Nationwide Consumer Level Recall of One Lot of ThermaCare® Back Pain Therapy HeatWraps (FDA)
• VivaQuant Receives FDA 510(k) Clearance for its RX-1 Rhythm ExpressTM Arrhythmia Device (Press)

• Maryland Takes Step Toward Capping Drug Prices (WSJ)
• Undocumented kids can get health care in California. Gavin Newsom wants it for young adults, too (Sac Bee)
• H.R. 965, the “CREATES Act”; H.R. 2375, the “Preserve Access to Affordable Generics and Biosimilars Act”; H.R. 2374, the “Stop Significant and Time-wasting Abuse Limiting Legitimate Innovation of New Generics Act”; and H.R. 2376, the “Prescription Pricing (House Judiciary)
• Hearing On “Prescription Drug Coverage In The Medicare Program” (House E&C)
• Why nurses are mobilizing behind Medicare for All (Politico)
• U.S. Trade Representative Releases 2019 Special 301 Report (Patent Docs)
• Drug-Injection Sites Are Battleground in Fight Against Opioid Overdoses (WSJ)
• Filing For Bankruptcy To Manage Opioid Suits Is No Magic Pill (Law360-$)
• NECC Pharmacists Not At Fault For Fake Orders, Jury Hears (Law360-$)
• Medtronic Can't Get Fed. Circ. Redo On $24M Spine IP Loss (Law360-$)
• When is a Period Not a Period? The Curious Case of Ivabradine and Pediatric Exclusivity (FDA Law Blog)
• Standing Corrected (Drug & Device Law)

• FDA Advisory Committee Calendar

• Asia Regulatory Roundup: WHO Seeks to Help Cambodia Strengthen Drug Regulation (Focus)
• Taiwan National Health Insurance Administration of the Ministry of Health and Welfare Approves Vemlidy(R) (tenofovir alafenamide) for Reimbursement (Press)

• Health ministry to upgrade manpower on priority as CDSCO plans to regulate all medical devices under D&C Act (Pharmabiz)
• Health ministry to amend D&C Rules to exempt drug makers holding product license from obtaining permission in Form 29 (Pharmabiz)

• Indoor tanning may trigger gene mutation that boosts melanoma risk (Reuters)
• Atrial fibrillation patients often overestimate risk of stroke, bleeding (Reuters)
• Harvard, MIT share $9 million gift to study marijuana’s health effects (STAT)