Regulatory Focus™ > News Articles > 6 > Recon: Teva Drops Chronic Cluster Headache Study

Recon: Teva Drops Chronic Cluster Headache Study

Posted 15 June 2018 | By Ana Mulero 

Recon: Teva Drops Chronic Cluster Headache Study

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

In Focus: US In Focus: International
  • 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)
Pharmaceuticals & Biotechnology
  • 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)
Pharmaceutical and Biotechnology: Study Results, Filings and Designations
  • 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)
Medical Devices
  • 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)
US: Assorted & Government
  • 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)
Upcoming Meetings & Events Europe
  • 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 $28 bn in May (Business Standard)
Australia Canada
  • Health Canada Proposes Mandatory eCTD Formatted Master Files by 2019; Feedback Requested (Lexology-$)
  • 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)
General Health & Other Interesting Articles
  • 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)
Regulatory Reconnaissance is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory news stories from around the globe. Each weekday morning, we aim to bring you the latest highlights of new approvals, meetings, legal and political developments, regulations and guidance, and the latest trends with the potential to impact regulatory affairs professionals and the industry in which they work.

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