Recon: Roche, AC Immune Halt Two Late-Stage Alzheimer's Trials

• How a Tainted Heart Drug Made in China Slipped Past the FDA (Bloomberg)
• Despite Raising Prices, Big Pharma Is Selling Drugs for Less (WSJ)
• Roche, AC Immune drop Alzheimer drug trials after setback (Reuters) (Endpoints) (Press)
• Biogen Slips as Roche Spikes Alzheimer's Trials on Weak Data (Bloomberg) (STAT)
• House, Senate Hearings Address Pharmaceutical Prices (Focus) (The Hill) (STAT) (Reuters)
• On Both Ends of Capitol, Both Parties Warn Big Pharma on Drug Prices (NYTimes)
• Wyden: Pharma Execs Must Come to Congress (Senate Finance)
• Trump ally Meadows says president wants to work with House Democrats to lower drug prices (CNBC)
• Novartis: Alternative payments will ‘reset the paradigm’ for covering gene, cell therapies (Fierce)
• Pharma Investors, Pick Your Poison (WSJ)
• Amgen falls 3% after 2019 outlook falls short (CNBC)
• Allergan worst performer on S&P 500 after weak outlook (Financial Times) (Reuters)
• Anthem To Launch PBM Earlier, Ending Express Scripts Deal In March (Forbes)
• Progressives gear up for 'Medicare for All' fight (Politico) (Reuters)
• Insys executive gave doctor lap dance while promoting drug, witness says (Reuters)
• Patients Suffer As Insurers And Big Health Systems Spar For Market Share (NPR)

• ABPI warns over skills shortages (PharmaTimes) (Pharmafile) (ABPI)
• Israeli company that claims cure for cancer would face years of testing ahead for US market — even if it works (CNBC) (Forbes) (Jerusalem Post)
• Undeterred by Sanofi's stumble, Takeda takes similar path with dengue shot (Reuters)
• Novartis aims for 10 blockbuster launches by 2020 (PMLive)
• Novartis forecasts mid-single digit sales growth in 2019 (Financial Times)
• If a Government Can’t Deliver Safe Vaccines for Children, Is It Fit to Rule? (NYTimes)
• Data Breaches Dent Singapore’s Image as a Tech Innovator (NYTimes)
• Natco dares Novartis with new heart drug (Economic Times)
• Strides to exit investment in Arrow for AUD 394 million (Economic Times)
• Swine flu outbreak kills 76 in India's desert state of Rajasthan (Reuters)
• Open-source drug discovery takes aim at malaria and neglected diseases (C&EN)
• Japan should put the brakes on stem-cell sales (Nature)
• Fexinidazole, the first all-oral treatment for sleeping sickness, approved in Democratic Republic of Congo (DNDi)

• These pricey new cancer therapies are custom-made. Can they ever be more mainstream? (STAT)
• Combating cancer around the world means keeping patients at the center (STAT)
• FDA Pushes Back eCTD Deadline for Type III DMFs Again (Focus)
• New blood thinners better than warfarin for atrial fibrillation (Reuters)
• Harvard Study Finds Older Insulins Are Safe as Well as Cheaper (Bloomberg)
• It’s time to get serious about the economics of expanded access (STAT)
• FDA Warns Chinese OTC Drugmaker, Florida Fertility Center (Focus)
• Right To Try Conversation Should Be Redirected Toward Reimbursement Of Unapproved Drugs, Experts Say (Pink Sheet-$)
• Hoping to brake a slow crash, Aduro’s Stephen Isaacs hits the reset button, axing staff in reorganization (Endpoints)
• Polaris’ Amir Nashat pulls together a $60M launch round to back the birth of a new biotech building a drug development platform from scratch (Endpoints)
• Path to the top: What kind of experience does it take to get tapped for the helm of a biotech? (Endpoints)
• Hit by trial setback, Aslan slashes staff and a study — hunkering down in wait for pivotal data (Endpoints)
• Novartis Translational Medicine Head Evan Beckman Talks Digital Endpoints (Pink Sheet-$)
• Biogen 4th-qtr beats expectations (PharmaLetter-$)
• An Unclear Path For Microbiome-Based Products At FDA (Law360-$)
• Commissioner Gottlieb and CBER Director Marks Deliver “State of Cell and Gene Therapy” Joint Statement (FDA Law Blog)

• J&J scores another PhIII win for Erleada as it continues to build a blockbuster franchise (Endpoints) (Press)
• Merck Receives Breakthrough Therapy Designation from FDA for V114, the Company’s Investigational 15-Valent Conjugate Vaccine for the Prevention of Invasive Pneumococcal Disease, in Infants, Children, and Adolescents (Press)
• BioInvent Receives FDA Orphan Designation for BI-1206 for Mantle Cell Lymphoma (Press)
• Aradigm Announces Submission of Responses to EMA Day 120 Questions and Meeting with FDA (Press)
• Eureka Therapeutics Announces US FDS Clearance of IND Application for Phase 1/2 Trial of ET140202 Artemis T-Cell Therapy, for the Treatment of Liver Cancer (Press)

• Experimental phone app works with insulin pumps to control diabetes (Reuters)
• Cybersecurity: FDA, Industry Groups Welcome Joint Plan (Focus)
• Gottlieb: Legacy Device Safety Is ‘Critical’ Cybersecurity Challenge (IHP-$)
• Philips faces $69m hit from Trump trade war (MassDevice)
• US gov’t shutdown again delays closing for Fresenius-NxStage merger (MassDevice)
• Stryker shares rise on Q4, FY2018 earnings Beat (MassDevice)
• Boston Scientific closes Millepede buyout (MassDevice)
• Medtronic Announces Positive Results from the Largest ENB Study to Aid in Lung Cancer Diagnosis, Staging, and Treatment Preparation in a Single Minimally Invasive Procedure (Press)
• Kurin, Inc. Receives FDA 510(k) Clearance for Its Novel Kurin Lock with Peripheral IV Infusion Set (Press)
• Qualigen Receives FDA Clearance for its FastPack® IP SHBG Assay (Press)

• Chinese national draws 27-month sentence in Medtronic, Edwards trade theft case (MassDevice)
• US senator asks J&J for documents on talc, baby powder safety (Reuters)
• NYC's Healthcare-for-All Collides With Hospital Woes (Bloomberg)
• Celgene Says Drug Buyers' Second Try For Cert. No Better (Law360-$)
• Investor Sues Drugmaker Over Lack Of Control Group In Trials (Law360-$)
• Bellwether Trial In Opioid MDL Delayed Another 7 Weeks (Law360-$)
• Miami Nice Personal Jurisdiction Decision (Drug & Device Law)
• Chinese Biotech Co. Says Gov't Bias Behind H-1B Visa Denials (Law360-$)
• High Court Outlook For False Claims Act Cases In 2019 (Law360-$)
• Reducing Patents Gets Attention From House Freedom Caucus At Pricing Hearing (Pink Sheet-$)
• Two South Texas Doctors Sentenced to Prison for Roles in Separate Multi-Million Dollar Medicare Fraud Schemes (DoJ)

• FDA Advisory Committee Calendar
• CTTI and FDA Convene Workshop on Including Patient Perspectives in Clinical Trials – 18 March  2019

• Fremanezumab Among Latest EU Drug Hopefuls While Patients Speak Up On Pacritinib (Pink Sheet-$)
• UK Inquiry Schedules Public Hearing On Availability Of Vertex’s Orkambi (Pink Sheet-$)
• A positive agenda for intellectual property in Switzerland (Guest blog) (EFPIA)

• China medical device control office issues new IVD classification (Pacific Bridge Medical)
• Patent protections bolstered in South Korea (Pacific Bridge Medical)
• Asia Regulatory Roundup: Leading Drugmakers Pressure Australian Government to Commit Resources to Regulatory Reforms (Focus)

• Why Couldn’t My Ebola Treatment Center Save This Baby? (NYTimes)

• GoFundMe CEO says one-third of all fundraisers are now for for medical reasons (The Hill)
• Searching for the Genetic Underpinnings of Morning Persons and Night Owls (NYTimes)