Recon: Bluebird Prices Gene Therapy Zynteglo at €1.575M Over 5 Years

• White House allies rally for looming rebate rule (Politico)
• Global Blood’s sickle cell disease drug heads to the FDA, but questions about benefit linger (STAT) (Endpoints)
• Facing progressive pressure, Pelosi could expand her drug pricing plan to negotiate prices for $118B worth of drugs (STAT)
• Allscripts is buying ZappRx, a prescription drug start-up (CNBC) (MedCity)
• ‘We Either Buy Insulin or We Die’ (NYTimes)
• Measles Outbreak: N.Y. Eliminates Religious Exemptions for Vaccinations (NYTimes)
• A Proposal To Make It Harder For Kids To Skip Vaccines Gives Powerful Voices Pause (KHN)
• Democratic Committee Leaders Question Secretary Azar About Damning Internal Memo From CMS Administrator (Ways & Means)
• #FreeThePill: Murray, Pressley, Ocasio-Cortez, Bera, Hill Introduce Legislation in Push for Affordable Over-the-Counter Birth Control (HELP)
• Enanta's lung infection therapy succeeds in mid-stage trial (Reuters)

• Bluebird prices gene therapy at 1.575 million euros over five years (Reuters) (Financial Times) (STAT) (Endpoints)
• WHO likely to declare Ebola an international emergency: experts (Reuters) (The Hill)
• May 2020 MDR Deadline is ‘Realistic and Achievable,’ EU Health Commissioner Says (Focus)
• BeiGene touts 'encouraging' response rates as the Chinese biotech mounts challenge to BTK, PD-1 leaders (Endpoints)
• Hansoh Pharma soars on Hong Kong stock market debut (Financial Times)
• Tessa forms JV with biohub to bring its cell therapies to China (BioCentury)
• Celgene says no to Mereo’s cancer drug etigilimab (PMLive)
• Scotland Greenlights More Rare Disease Treatments (Pink Sheet-$)
• EU Ruling Raises New Questions For Orphan Designation (Pink Sheet-$)

• Newsmakers at #EHA19: Regeneron, ArQule track progress on response rates (Endpoints)
• FDA Warns of One Death Linked to Fecal Transplants (Focus)
• Ensuring Innovation and Competition for Biologics Leads to More Timely Products for Patients (FDA)
• Gene therapy costs, manufacturing keeping CBER head 'up at night' (BioPharmaDive)
• GSK may be reviving incentive pay for sales reps, but it's not returning to its old ways: executive (Fierce)
• Pharmacies may not stock naloxone, despite statewide orders (Reuters)
• Route to lower drug prices is price transparency and drug manufacturer accountability (Nevada Independent)
• Many epinephrine self-injectors still potent long after expiration date (Reuters)
• Chi-Med cuts surufatinib PhIII short; FDA greenlights Herceptin copycat from Amgen, Allergan (Endpoints)
• Lawyer: FDA Compounding Move Represents Enforcement-First Approach (IHP)
• Merck, IBM, KPMG and Walmart Selected for FDA Blockchain Pilot (Focus)
• Under siege, investment manager Woodford faces another investment shock (Endpoints)
• FDA and BioCelerate Join Forces on Nonclinical Research (Focus)
• Antibiotic Incentives: Advocates Sounding The Alarm For DISARM (Pink Sheet-$)
• Tariq Kassum jumps from Obsidian to Celsius helm; Quell Therapeutics taps Iain McGill as new CEO (Endpoints)
• Hospira, Inc., et al.; Withdrawal of Approval of 12 Abbreviated New Drug Applications (FDA)

• Tolero Pharmaceuticals Presents Clinical Data from Ongoing Phase 1 Zella 101 Study Evaluating Investigational Agent Alvocidib in Combination with Cytarabine and Daunorubicin in Patients with Newly Diagnosed AML at EHA 2019 (Press)
• Regeneron CD20xCD3 Bispecific REGN1979 Shows Positive Results in Patients with Relapsed or Refractory B-cell Non-Hodgkin Lymphoma, including in CAR-T Failures (Press)
• Bristol-Myers Squibb Presents Updated Efficacy Data from Phase 2 Trial of Empliciti (elotuzumab) Plus Pomalidomide and Dexamethasone in Patients with Relapsed or Refractory Multiple Myeloma (RRMM) (Press)
• New Mechanistic Study Explores the Relationship Between a Key Genetic Marker and Clinical Efficacy of ORENCIA® (abatacept) or adalimumab in Moderate-to-Severe Early Rheumatoid Arthritis Patients (Press)
• bluebird bio Presents Long-Term Efficacy and Safety Data from Clinical Studies of LentiGlobin® Gene Therapy for Transfusion-Dependent β-Thalassemia (TDT) at 24th European Hematology Association (EHA) Congress (Press)
• Positive Phase 3 Extension Data for ULTOMIRIS® (ravulizumab) in Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) Presented at European Hematology Association (EHA) Congress (Press)
• BerGenBio posts updated data on trial of elderly AML patients (Fierce)
• Sun Pharma Announces Late-Breaking Phase 2 Data Showing Potential of ILUMYA™ (tildrakizumab-asmn) to Improve Joint and Skin Symptoms of Psoriatic Arthritis (Press)
• ArQule Announces Clinical Proof-of-Concept Data from Ongoing Phase 1 Study of Reversible BTK Inhibitor, ARQ 531, in Patients with Relapsed/Refractory Hematologic Malignancies at the 2019 EHA Annual Meeting (Press)
• Enanta Pharmaceuticals Announces Topline Results Showing EDP-938 Achieved its Primary and Secondary Endpoints in its Phase 2a Human Challenge Study in Healthy Adults Infected with Respiratory Syncytial Virus (RSV) (Press)
• Janssen reports top-line Phase 3 results for TREMFYA® (guselkumab) in adults with active psoriatic arthritis (Press)
• Aura Biosciences to Present Interim Phase 1b/2 Clinical Data for AU-011 at the European Society of Ophthalmology 2019 Congress (Press)
• Reistone Announces First Patient Dosed in Two Phase II Global Studies of SHR0302 JAK Inhibitor for Ulcerative Colitis and Crohn's Disease (Press)

• Experimental mobile app helps manage migraines (Reuters)
• DHS warns again on cybersecurity flaw in BD Alaris workstations (MassDevice)
• Mesh implants work for bladder leakage, long-term safety unclear (Reuters)
• FDA Draft Guidance Seeks to Mitigate Risk of Biotin Interference (Focus)
• FDA clears CorMatrix Cardiovascular’s Cor heart tissue patch (MassDevice)
• Bio-Techne Gets New York State Approval for Prostate Cancer Test (GenomeWeb)

• Architecture For Landmark Nationwide Opioid Settlement Unveiled (NPR)
• The Future Of US Biosimilars Litigation: Method-Of-Use Patents And ‘Dance’ Obligations (Pink Sheet-$)
• South Florida Pill Mill Owner Sentenced to Prison for Role in $2.2 Million Medicare Fraud Scheme (DoJ)
• Senators Seek Details on Sharing US Genomic Data With Companies Linked to China’s Government (Focus)
• J&J Loses Bid To Keep Talc Cancer Case Out Of Philly (Law360-$)
• 9th Circ. Breathes New Life Into CVS Drug Pricing Suit (Law360-$)
• Chamber, Drugmakers Back AbbVie In $448M FTC Fine Appeal (Law360-$)
• Sanders and Cummings, citing ‘polite f-u letters,’ urge feds to step up probes of generic makers (STAT)
• Guest Post − How Much Is Too Much Deference to FDA Warning Letters in Consumer Class Actions? (Drug & Device Law)

• FDA Advisory Committee Calendar

• Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 11-14 June 2019 (EMA)
• European Regulators Name UDI Issuing Agencies (Emergo)
• More than stockpiling needed to limit disruption of no-deal Brexit, warns generics manufacturers' body (Pharmaceutical Journal)
• Bottleneck of bottlenecks for notified body capacity (medicaldeviceslegal)
• Messy Rules For Non‐Biological Complex Drugs Under Fire (Pink Sheet-$)
• MHRA Inspectors are Advocating Data Mapping as a Key First Step on the Data Integrity Pilgrimage (IPQ)

• IDMA condemns USTR Report for making false allegation that 55% of global seizures of counterfeit drugs originated in India (PharmaBiz)

• ‘It felt like an ’80s criminal drama’: What happened when a biohacker met bureaucrats investigating him (STAT)
• Dr. Teruko Ishizaka, Who Advanced Allergy Treatment, Dies at 92 (NYTimes)
• Dr. Henry Lynch, 91, Dies; Found Hereditary Link in Cancer (NYTimes)