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

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• FDA Advisory Committee Calendar

• 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)

• Does The World Need A New Buzzword — 'Syndemic' — To Describe 3 Big Crises? (NPR)