Recon: Teva Abandons Ajovy for Cluster Headaches After Missing Mark in Phase III Study

• Purdue’s Sackler family wants global opioids settlement: Sackler lawyer Mary Jo White (CNBC)
• For First Time, Pharmaceutical Distributor Faces Federal Criminal Charges Over Opioid Crisis (NYTimes) (Democrat & Chronicle)
• PBMs, under fire from the Trump administration, spend a record sum on lobbying (STAT) (The Hill)
• Elizabeth Holmes Gets Delay in Trial-Date Decision (WSJ) (STAT)
• With real estate deal, Sanofi Genzyme boosts its bottom line in hot market (STAT)
• Can We Afford to Be Cured? A Conversation With ICER’s Steve Pearson (Xconomy)
• In possible blueprint for other states, Ohio attorney general floats proposals to rein in PBMs (STAT)
• Insurer accuses J&J unit of using ‘sham’ patent litigation to extend monopoly on cancer drug (STAT)
• GSK punts a failed cardio drug to a biotech startup — which has a new development strategy in mind (Endpoints)
• The biotech era in late-stage drug R&D and marketing has arrived. And it looks like it’s here to stay (Endpoints) (Fierce) (IQVIA)
• Google Searches For Ways To Put Artificial Intelligence To Use In Health Care (NPR)

• Drug Regulators Look for Common Course on Gene-Therapy Reviews (Bloomberg)
• Lilly to sell legacy antibiotics, Ceclor and Vancocin, to China-based partner in $375M deal (Endpoints) (Fierce)
• Teva stops testing its migraine drug as cluster headache treatment (Reuters) (Press)
• Genentech backs UK accelerator to help pre-A round startups (Fierce) (PMLive)
• Landmark Malaria Vaccine Pilot Launches In Malawi (Pink Sheet-$) (WHO)
• China to Levy Heavier Fines for Fake Vaccines (FDA News-$)
• Overhaul In Store For Cambodia's ‘Fragmented’ Drug Rules (Pink Sheet-$)
• New Thai Rules To Impact Drug Approvals And Licenses (Pink Sheet-$)
• PAHO launches Vaccination Week in the Americas in Brazil, urging countries in the Region to unite to end measles (PAHO)
• Japanese regulators extend participation in Medical Device Single Audit Program (MDSAP) (Emergo)

• How Biopharma Companies Use NIH and Vice Versa (Focus)
• More NDAs, BLAs Filed in Q1 2019 Than Any Quarter in 2018 (Focus)
• U.S. biologics and biosimilars need distinguishable names (STAT)
• How patients can turn their medical data into money (Financial Times)
• Survey Finds Growing Interest In Continuous Manufacturing Of New Drugs (Pink Sheet-$)
• Will A Medicine Work For You? A Simple Test Might Tell – Pharmacogenetics (Forbes)
• Panel highlights need for further innovative research approaches to inform appropriate long-term use of osteoporosis drug therapies (NIH)
• Industry Seeks Clarity on CGT Draft Guidance (Focus)
• Bioclinica wants to move the needle in NASH (Fierce)
• FDA Reassures Public that MMR Vaccine is Safe and Effective (Focus)
• Pharmaceutical Industry Funding to Patient Advocacy Organizations: A Cross-National Comparison of Disclosure Codes and Regulation (Hastings)
• Association of Pharmaceutical Manufacturer Paymentsto Physicians and Prescribing Dosage of Opioid (Springer)
• Positive pivotal Lilly data set stage for Taltz approval in non-radiographic axial spondyloarthritis (Endpoints) (Fierce)
• Evenity's Postmarketing Requirement Includes Feasibility Component Familiar To Other Osteoporosis Drugs (Pink Sheet-$)
• Investors to AbbVie, J&J, Merck and more: Fork over info on pricing and exec pay (Fierce)
• Bayer, J&J's Xarelto scripts stagnate as discounts, competition pile up (Fierce)
• The Specialty Pharmacy Boom: Our Exclusive Update on the U.S. Market (Drug Channels)
• FDA Warns California Compounder for Unapproved Drugs Following Patient Death (FDA News-$)
• New Jersey Drugmaker Hit for Litany of Issues, Including OOS Management (FDA News-$)
• Modern drug launch: Consultancy promotes new go-to-market strategy for small-to-medium drugs (Fierce)
• As safety looms larger in CAR-T research, study highlights how small tweaks can make it easier to use (Endpoints)
• New breast cancer blood test could help spot relapse two years earlier (PharmaBiz)
• Can differences in genomic immune system signatures detect lung cancer before it takes hold? (Endpoints)
• What’s it take to recruit a top drug development exec out of Gilead? Stock options help, a lot (Endpoints)
• Long on ideas but short on experience? Start Codon has some cash and a place for you in the Golden Triangle (Endpoints)

• GlycoMimetics Announces Enrollment of First Patient in NCI-Sponsored Phase 3 Trial of Uproleselan in AML (Press)
• FDA Accepts BLA For Alder's Migraine Therapy For Infusion (BioCentury)
• Evofem Biosciences Announces Last Patient Enrolled for AMPREVENCE, the Phase 2b Sexually Transmitted Infections Trial of Amphora (Press)
• Mallinckrodt Lupus Phase 4 Clinical Study for Acthar® Gel (Repository Corticotropin Injection) Completes Enrollment in Difficult-to-Manage Population (Press)
• HEC TaiGen Initiates Phase III Trial of Combination of Furaprevir and Yimitasvir for the Treatment of Chronic Hepatitis C Patients in China (Press)
• Forbius Announces First Patient Dosed in Phase 2a EGFR-Overexpressing Triple Negative Breast Cancer (TNBC) Trial of AVID100, a Novel, Tumor-Specific Anti-EGFR ADC (Press)
• BerGenBio to Present NSCLC and AML Clinical Data From Phase II Development Programme With Selective AXL Inhibitor Bemcentinib at ASCO 2019 (Press)

• Sherlock Biosciences raises $31M to apply CRISPR technology to diagnostics (MedCity)
• FDA Approves First Pediatric ADHD Device (Focus)
• Surmodics Sublime™ Guide Sheath Receives FDA 510(k) Approval (Press)
• BaroNova wins FDA nod for TransPyloric Shuttle weight loss device (MassDevice)
• Veracyte Secures NY State Approval for Genomic Classifier Test for Lung Disease (GenomeWeb)
• Roche launches new VENTANA HER2 Dual ISH companion diagnostic test for breast and gastric cancer patients eligible for targeted therapy (Press)

• Get ready: Title X lawsuits hit three federal courts this week (Politico)
• ICT Report Highlights MedTech Positives in USMCA Agreement (Focus)
• US Patent Office Grants Charpentier/Doudna Key CRISPR Patent (Press)
• A Word To The Wise – Locate Your FDA-Mandated Agents With Care (Drug & Device Law)
• CT files new allegations against Purdue, Sacklers in opioid lawsuit (CT Mirror)
• Centene’s Obamacare Enrollment Soars As WellCare Deal Faces Regulators (Forbes)
• Alexander Statement on HHS Proposed Rule to Improve Electronic Health Records (Alexander)
• CMS launches new value-based payment models for primary care in 2020 (MedCity)
• New USPTO Guidance May Help Diagnostics Patents (Law360-$)
• J&J Settles Wash. AG's Pelvic Mesh Case Just Before Trial (Law360-$)

• FDA Advisory Committee Calendar

• UK Agency Tests Remote Inspections Program To Identify At-Risk GDP Sites (Pink Sheet-$)
• Field Safety Notice: 15-19 April 2019 (MHRA)
• Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 15-16 April 2019 (EMA)
• Transfer of health technology supervision duties from Valvira to Fimea proceeding as planned (Fimea)
• Why IMI PARADIGM? – The research foundation perspective (EFPIA)
• Catalent Invests $14 Million At Its Eberbach, Germany Softgel Facility (Catalent)

• Japan's Healios Progresses Novel Cell Therapy For ARDS (Scrip-$)
• Asia Regulatory Roundup: Korean Gene Therapy Probe Triggers Accusations of Data Fabrication, Lawsuit (Focus)

• CDSCO releases data of SQ drugs along with NSQ drugs to boost the image of Indian drug manufacturers (PharmaBiz)
• Cipla appoints Dr Raju Mistry as global chief people officer (Economic Times)
• Health ministry to amend Rule 66 of D&C Rules to authorise state DCs to issue stop sale order for non-compliance (Press)

• Labelling changes: information for health professionals (TGA)

• Updated pediatric blood pressure guidelines catch more kids at risk for heart disease (Reuters)