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Regulatory Focus™ > News Articles > 2019 > 1 > Recon: Takeda's Dengue Vaccine Hit Primary Endpoint in Phase III Trial

Recon: Takeda's Dengue Vaccine Hit Primary Endpoint in Phase III Trial

Posted 29 January 2019 | By Michael Mezher 

Recon: Takeda's Dengue Vaccine Hit Primary Endpoint in Phase III Trial

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • America’s Love Affair With Cheap Drugs Has a Hidden Cost (Bloomberg)
  • Alex Azar: Why drug prices keep going up — and why they need to come down (STAT)
  • Pharma Stocks in Focus as Congress Kicks Off Drug Cost Hearings Tuesday (Bloomberg)
  • 'Greed' fueled Insys founder's opioid bribe scheme: prosecutor (Reuters)
  • Editorial: Should Scientists Toy With the Secret to Life? (NYTimes)
  • Pfizer's earnings outlook disappoints after Viagra loses patent protection and Lyrica faces same fate (CNBC)
  • Pfizer Results Hurt by Pricing Challenges (WSJ) (Financial Times) (Press)
  • Pfizer and Lilly’s tanezumab largely makes the efficacy cut in second PhIII study, but safety issues continue to blight anti-NGF drug (Endpoints) (Fierce) (Press)
  • Opioid drugmaker Purdue Pharma inks deal with Alivio over non-opioid inflammation drug (Pharmafile)
  • Apple and Aetna are teaming up on a new app to help track and reward healthy behavior (CNBC) (Reuters)
  • Lyndra Therapeutics raises $55 million from Gilead and Gates (STAT) (Xconomy)
  • Peer review could help smoke out the next Theranos (STAT)
  • A year after Trump touted ‘right to try,’ patients still aren’t getting treatment (STAT)
  • Vertex faces more pressure over pricing, but one analyst does not expect any movement (STAT)
  • Voyager bags a ‘transformational’ $1.8B gene therapy pact with Neurocrine (Endpoints) (Xconomy)
In Focus: International
  • Global medicine spend forecast to exceed $1.5 trillion by 2023 (PharmaTimes) (Drug Channels) (Scrip-$) (PhRMA) (Endpoints) (IQVIA)
  • US Nobel laureate knew about Chinese scientist's gene-edited babies (NBC)
  • Takeda’s Dengue Vaccine Works Safely, Company Says (WSJ) (Endpoints) (Reuters) (Press)
  • Celgene rolls along with another epigenetic preclinical deal featuring a Canadian biotech (Endpoints) (Fierce)
  • Medicines will take priority over food in no-deal Brexit (PMLive)
  • MPs pooh-pooh Tigger Hancock’s plans for the NHS after Brexit (The Guardian)
  • UK and Russia sign MoU on Regulatory Cooperation on Medicines (GOV.UK)
  • EMA cites Micro Labs plant in India (Fierce)
Pharmaceuticals & Biotechnology
  • Real-world evidence is changing the way we study drug safety and effectiveness (STAT)
  • A stem cell clinic touts its links with leading scientists. Some say they have no such connections (LA Times)
  • As Pfizer kills failed PhIII programs for Bavencio, where do they go from here in R&D? (Endpoints)
  • Study Offers Hint of Hope for Staving Off Dementia in Some People (NYTimes) (NBC) (NIH)
  • Fintech And Biotech Are Coming Together To Transform Drug Development (Forbes)
  • 2018 FDA Enforcement Review: Drugs, Biologics And Devices (Law360-$)
  • Q4 Pharma Earnings Preview: Roche, Celgene, Novo Nordisk, Merck, Gilead (Scrip-$)
  • How a healthcare company is pursuing agile transformation (McKinsey)
  • Takeda-backed Maverick promotes R&D staff for T-cell push (Fierce)
  • Moving Closer to a Stem Cell-Based Treatment for AMD (NIH)
  • FDA finds more issues at Lupin plant it spanked in warning letter (Fierce) (Lupin)
  • In Today's 24/7 World, Have Experts On Call For FDA Inspections, Eli Lilly's Quality Director Says (Pink Sheet-$)
  • Horizon taps academic partner to boost gene editing platform (PMLive)
  • The promise of ‘ingestibles’: In health care, the race is on to put sensors in your gut (STAT)
  • Lower Drug Costs Might End Perception US FDA Approval Standards Are Lower (Pink Sheet-$)
  • Overview of Original Subscription Model and Features of LA and WA Proposals (Drug Pricing Lab)
  • Washington takes 'Netflix' hep C drug pricing further with winner-take-all bidding (Fierce)
  • Edinburgh researchers genetically modify chickens to produce medicine filled eggs (Pharmafile)
  • Agenus touts blockchain tech to roll out new ‘digital security’ for its PD-1, but will it work? (Endpoints)
  • Trevena forges plan to take once-rejected opioid across finish line, after ‘productive’ FDA meeting (Endpoints)
  • Bayer gets with the program for Super Bowl LIII to kick off cancer testing awareness effort (Fierce)
  • Former Zavante Executive Tapped as Abide Therapeutics President (Xconomy)
Pharmaceuticals & Biotechnology: Study Results, Filings & Designations
  • AudioCure Pharma’s AC102 receives EMA orphan drug designation for the treatment of sudden sensorineural hearing loss (SSNHL) (Press)
  • Devonian Health Group Provides an Update on its Phase 2 Clinical Study in Atopic Dermatitis and Announces Plans for the First Photoprotection Product Issued From its Cosmeceutical R&D Program. (Press)
  • Alligator Bioscience Publishes Clinical Phase I Data for ADC-1013 in the International Journal of Cancer (Press)
  • CStone receives CTA approval in China to start Phase I trial for FGFR4 inhibitor BLU-554 (CS3008) (Press)
  • Allogene gets FDA go-ahead to start ‘off-the-shelf’ CAR-T study in lymphoma (MedCity)
Medical Devices
  • FDA sets approval record, lays out 2019 strategy (Medical Design & Outsourcing)
  • Hospitals to medtech: Clean up your cybersecurity act (MassDevice)
  • C2N Diagnostics Receives Breakthrough Device Designation from U.S. FDA for Blood Test to Screen for Alzheimer’s Disease Risk (Press)
  • Masimo receives FDA clearance for fingertip pulse oximeter measurement (Medical Design & Outsourcing)
  • 3M beats expectations, cuts outlook (MassDevice)
  • Cook Medical Collaboration with Zelegent, Inc., Receives FDA Clearance for Snoring Product (Press)
  • Interoperable artificial pancreas system reliably controls blood glucose levels in pilot trial (mobihealthnews)
  • Class 1 Device Recall Vial2Bag (FDA 1, 2, 3)
US: Assorted & Government
  • Grassley Presses HHS, CMS for Medicare Overpayments for Lab Services (Senate Finance)
  • Editorial: The Government Opioid Raid (WSJ)
  • German Co. Loses 3 Patents As Suit Against J&J Backfires (Law360-$)
  • Seventh Circuit Rejects Novel Causation Theory (Drug & Device Law)
  • Guest Post -- The Final Score: 2018 Drug & Biologic Patent Approvals (Patent Docs)
  • Petition to Bar Hydroponic Operations from Organic Certification (FDA Law Blog)
  • 15 Minutes With Bristol-Myers Squibb's General Counsel (Law360-$)
  • Can 'Bundle' Payment Plans Shield Against FCA Liability? (Law360-$)
  • Opioid Makers May Have To Pay For Prevention Costs Of 'Man-Made Plague,' Judge Suggests (Pink Sheet-$)
  • Bard wins surgical mesh case on appeal (MassDevice)
  • Mallinckrodt, Express Scripts Must Face Antitrust Suit In Ill. (Law360-$)
  • Judge accepts Medtronic plea deal in Ev3 off-label marketing case (MassDevice)
Upcoming Meetings & Events Europe
  • NICE links with EMIG (PharmaTimes)
  • Alert to users of FreeStyle Libre flash glucose monitoring system regarding skin reactions to sensor adhesive (MHRA)
  • Nellix Endovascular Aneurysm Sealing (EVAS) System - Device recall and enhanced patient surveillance (MDA/2019/002) (MHRA)
  • NMPA Releases Draft Good Manufacturing Practice Appendix on Standalone Software (Covington)
  • China's NMPA Grants Priority Review To Zai's PARP Inhibitor (BioCentury)
  • Has India’s Drug Pricing Authority Been Rendered Toothless? (Pink Sheet-$)
  • Consultation: Options for the regulation of Faecal Microbiota Transplantation materials (TGA)
General Health & Other Interesting Articles
  • Does The World Need A New Buzzword — 'Syndemic' — To Describe 3 Big Crises? (NPR)
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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