Recon: Teva Drops Chronic Cluster Headache Study

• Teva hit by another PhIII setback on CGRP pain drug fremanezumab, but there’s no pulling back now as rivals race ahead (Endpoints) (Reuters) (Fierce) (BioSpace)
• Mylan scores FDA approval of generic Suboxone for opioid addiction, but a strong launch is no sure bet (Fierce) (Reuters) (Medscape) (ABC News) (Pharmacy Times)
• $75M IPO: West Chester biopharm firm goes public (Philadelphia Business Journal-$) (Endpoints)
• Novartis touts effectiveness, safety of autoimmune drug copies (Reuters)
• Implantable defibrillators may cause dilemmas for older patients (Reuters)
• Pharma groups spy opportunity in rare diseases (Financial Times)

• Sirtex Medical goodbyes Varian, backs $1.9b Chinese offer from CDH (The Sydney Morning Herald) (Australian Financial Review) (Reuters)
• BlueBird Readies EU Filing for Gene Therapy (Forbes) (STAT) (Endpoints)
• A functional HIV cure? We have a long way to go, but Hong Kong investigators find a spotlight for their preclinical antibody (Endpoints) (Reuters)
• Govt’s Plans of Capping the Trade Margin of Medical Devices at 30% (BioSpectrum) (Times of India)
• UK start-up gets £2.2m funding boost for online mental health technology (The Telegraph) (PharmaTimes)
• MHRA to Move to New Canary Wharf Offices Next Week (MHRA)
• X-rays, soy on front lines of US-China trade spa (ABC News)
• This is why Chinese companies are paying $1.9 billion for Australian liver cancer treatment medtech Sirtex (Business Insider)
• Alphabet's DeepMind Should Clarify Profit Model, Panel Says (Bloomberg)
• US-focused pharma companies see 30% drop in FY18 earnings (Times of India)
• Suicide Isn't A U.S. Problem. It's A Global Health Epidemic (Forbes)
• Zambian health minister declares cholera epidemic over (Reuters)

• Eli Lilly CEO: 'It's time for a change' in the drug pricing system (CNBC)
• Winners and losers at #EHA18: Shares mostly slide as data from a range of prominent biotechs fail to wow investors (Endpoints)
• Calliditas files for $75M IPO to fund kidney disease phase 3 (Fierce)
• Current Prescription Drug Pricing Practices: Lessons In Obfuscation (Forbes)
• Why Kentucky Is Suing Walgreens Over the Opioid Crisis (Fortune)
• Pueblo sues big Pharma and grocery stores in opioid racketeering case (The Denver Post)
• Phase 2: Big Pharma expands its blockchain experiment (Supply Chain Dive)
• Hatch amendment to incentivize generic drug development (The Pharma Letter)
• New York doctors wrote more opioid prescriptions after pharma payments (CNN)

• As Treatments Await FDA Ruling, Researchers Discover ‘Key Players’ in Early-Onset Parkinson’s Disease (BioSpace)
• X4 targets year-end start for phase 3 WHIM trial after determining dose in midphase readout (Fierce)
• Selecta unveils more data on its gout treatment, commits to phase 3 study launch this year (Fierce)
• Despite FDA hold, Epizyme’s tazemetostat posts positive interim data (Fierce)
• ArQule Presents Results from Ongoing Phase 1 Dose Escalation Study of its Reversible BTK Inhibitor, ARQ 531 (Press)
• Amphivena Demonstrates at EHA First Human Proof-of-Concept For AMV564 in Relapsed/Refractory AML (Press)
• Epizyme Reports Positive Updated Interim Data from Phase 2 Study of Tazemetostat in Patients With Relapsed or Refractory Follicular Lymphoma at the Congress of the European Hematology Association (EHA) (Press)
• Selecta Biosciences Presents Data from Ongoing Phase 2 Trial of SEL-212, in Development for Chronic Severe Gout, at EULAR 2018 (Press)
• GBT Announces New Phase 2a Voxelotor Data in Adolescents with Sickle Cell Disease (SCD) at 23rd European Hematology Association (EHA) Congress (Press)
• Atara Biotherapeutics’ Tab-cel Achieves Positive Long-Term Outcomes in Phase 2 Studies of Patients with Epstein-Barr Virus Associated Post-Transplant Lymphomas (Press)
• BeiGene Provides Development Update and Presents Clinical Data on Zanubrutinib at the 23rd Congress of the European Hematology Association (Press)
• Affimed Announces Updated Data of AFM13 in Combination with Keytruda (Pembrolizumab) in Patients with Relapsed/Refractory Hodgkin Lymphoma Presented at EHA (Press)
• MorphoSys Presents Clinical Data with Blood Cancer Candidate MOR208 in Chronic Lymphocytic Leukemia at EHA 2018 Conference (Press)
• Aptose Presents New CG-806 Data at the 23rd Congress of the European Hematology Association (Press)
• MEI Pharma Presents Clinical Data on ME-401 at the European Hematology Association Congress (Press)
• Karyopharm Presents Updated Selinexor Phase 1b/2 STOMP Myeloma Data from Multiple Combinations at the European Hematology Association 2018 Annual Meeting (Press)
• Ra Pharmaceuticals Presents Data on Oral, Small Molecule Complement Inhibitors and Phase 2 RA101495 SC Program in PNH at the 23rd Congress of the European Hematology Association (Press)

• Certain rapid flu tests don't work half the time (Axios)
• A DNA testing start-up sent used kits filled with spit to some customers, an example of growing pains in a new industry (CNBC)
• Mental health app maker Mindstrong raises $15M in series B (Fierce)
• FDA advisory panel turns down PneumRx’s Elevair lung implant (Fierce)
• HealthPrize takes aim at medication nonadherence with habit-forming tech (DDBN)
• Insys Therapeutics reports positive preliminary data for allergy nasal spray (DDBN)
• Medtronic Receives FDA Approval for 200mm & 250mm IN.PACT(TM) Admiral(TM) Drug Coated Balloons (Press)
• Bluebee Achieves ISO 13485 Medical Device Quality Standard Certification (Press)

• Soaring costs, loss of benefits top Americans' healthcare worries: Reuters/Ipsos poll (Reuters)
• Congress needs to back legislation supporting disaster preparedness (STAT)
• A $2.3 billion tax gain for the Blues (Axios)
• Walgreens to move 1,800 jobs into new Chicago office (CNBC)
• These Are the Riskiest Cities and Counties For Infectious Disease Epidemics (Fortune)
• FDA to issue new guidance on Lasik risks (ABC)
• Dental Unit Waterlines (FDA)
• NIH to end funding for Moderate Alcohol and Cardiovascular Health trial (NIH)
• Early-stage Respiratory Syncytial Virus vaccine trial begins (NIH)
• House passes bill aimed at stemming international shipments of fentanyl (Washington Examiner)
• House appropriations bill puts focus on opioids, emergency preparedness (Fierce)

• FDA Advisory Committee Calendar

• Rare disease therapy Crysvita to be barred from NHS (PharmaTimes)
• NICE rejects adjuvant use of Perjeta post-surgery (PharmaTimes)
• Portugal's parliament legalizes cannabis-based medicines (Reuters)
• Northern Ireland confirms H5N6 bird flu case (Reuters)
• One-Stop Shop For Cancer Patients Raises $7 Million To Solve "Neglected" Issues From Skincare To Sex (Forbes)
• Don’t miss the boat on water management in pharma manufacturing (EPM)
• Orphan drugs dominate 2018 UK Prix Galien shortlist (pharmaphorum)

• Bristol-Myers wins the frenzied race to a first approval for a PD-1/L1 checkpoint in China as regulators hustle up a quick OK (Endpoints)
• Novotech inks MoU with China Medical University Hospital in Taiwan to offer enhanced services for global trials (Pharmabiz)
• Daiichi Sankyo launches generic of Fentos Tape (The Pharma Letter)

• Sensex posts fourth straight weekly gain; Infosys, TCS boost (Reuters)
• Odisha junks ‘Modicare’ for Biju health scheme (Times of India)
• Eight More States Agree to Implement Centre's Health Insurance Scheme (The Wire)
• Chemicals, pharma push Indian exports to 6-month high of $28 bn in May (Business Standard)

• NSW Budget: 'Bonanza' for paramedics and mental health projects (ABC News)
• WA minister riled by anti-vac billboard (Australian Associated Press)

• Health Canada Proposes Mandatory eCTD Formatted Master Files by 2019; Feedback Requested (Lexology-$)
• Information Update - Health Canada seized the unauthorized sexual enhancement product "Promatrix Yohim-B Active" from a Quebec store because it may pose serious health risks (Health Canada)

• Fewer US teens smoking, doing drugs ... and drinking milk (AP News)
• Using Harpoon-Like Appendages, Bacteria ‘Fish’ for New DNA (NYT)
• Kellogg issues massive Honey Smacks cereal recall over Salmonella risk (Reuters)