Recon: Lilly to Withdraw Lartruvo; Gilead NASH Drug Fails in Second Phase III Study

• Eli Lilly to Pull Cancer Drug From Market After Failed Study (WSJ) (BioPharmaDive) (Endpoints)
• Gilead experimental NASH drug fails another study (Reuters) (Endpoints) (Press)
• Amgen, Astellas Pay $125M to Settle DOJ Kickback Allegations (Focus)
• NIH Streamlines Gene Therapy Oversight and Charts a Course for Considering Emerging Technology (NIH)
• Former FDA, CMS heads commend importation, government negotiation to control drug prices (BioCentury) (JAMA) (Pink Sheet-$)
• Bristol-Myers raises forecasts on strong sales of stroke and cancer drugs (Financial Times) (Press)
• BMS' head and neck cancer hopes take a hit with Opdivo-Yervoy trial flop (Fierce) (Endpoints)
• AbbVie raises forecasts despite pressure on Humira (Financial Times) (STAT) (Press)
• Biogen dips as strategy post Alzheimer’s setback fails to impress (CNBC)
• House Dem chairmen to meet with progressives amid drug pricing divisions (The Hill)
• California vaccine rules advance over emotional opposition (AP) (The Hill) (Sac Bee)
• US measles cases hit highest level since eradication in 2000 (Reuters)
• Trump Declares Commitment to Ending Opioid Crisis ‘Once and for All’ (NYTimes) (Reuters)
• Majority Of Americans Say Drug Companies Should Be Held Responsible For Opioid Crisis (NPR)
• Relief For Pain Patients: CDC Makes Bold Clarification About Opioid Care In NEJM (Forbes) (NEJM)
• More millennials, Gen Z are dying of opioid overdoses, researchers say (CNBC)
• A decade of incentives to promote antibiotic development and still no viable route to commercial success (BioWorld)

• Bayer says it is looking into established drugs strategy (Reuters) (Press)
• Ebola first responders threaten strike if security not improved (Reuters)
• Technical Report on Pricing of cancer medicines and its impacts (WHO)
• Over 20 Million Children a Year Miss Out on First Dose of Measles Vaccine (NYTimes) (Reuters)
• EMA Guides Industry On How To Demonstrate Adequate Sterilization of New Drugs (Pink Sheet-$)
• EU Regulators Asked To Define 'Drug Shortages' Before Finalizing Notification Framework (Pink Sheet-$)
• Daiichi picks immuno-oncology bispecific, triggering payout to Zymeworks (Fierce)
• Novartis chief defends cell, gene therapy push (BioPharmaDive)
• New plant to make Merck KGaA drugs opens in Iran (Fierce)
• Novartis recruits GSK exec as new Sandoz CEO (PharmaTimes)
• ICR calls for faster access to innovative cancer drugs (Pharmafile)

• FDA hires Pew director to lead regulatory policy (STAT)
• FDA launches public education campaign to encourage safe removal of unused opioid pain medicines from homes (FDA)
• FDA Drafts Guidance on Adjusting for Covariates in Randomized Trials (Focus)
• Top 20 players: Everybody loves an orphan — especially when they come with blockbuster sales and a long run of exclusivity (Endpoints)
• Long-Term Use of Antibiotics Tied to Heart Risks (NYTimes)
• At a lively drug pricing debate, experts suggest killing off copays (STAT)
• FDA MAPP for Center for Drug Evaluation and Research Biopharmaceutics Council (FDA)
• Whale watching: What a decade of change at Big Pharma taught us about corporate phenotypes (Endpoints)
• FDA Finalizes Guidance on Extending Stockpiled Doxycycline Expiration Dates (Focus)
• Good year, bad year? Two biotech CEOs hit pay dirt in 2018 as compensation packages swell (Endpoints)
• Recalled blood pressure drugs linked to cancer risk OK to take short-term, FDA says (USA Today)
• Why Satsuma investors see room for another migraine therapy (BioCentury) (Endpoints)
• J&J's quest to detect lung cancer before it emerges (Fierce)
• LabCorp spends $485M as its CRO unit snaps up Envigo's nonclinical business (Fierce)
• Forge Therapeutics, Basilea Sign Deal to Pursue New Antibiotics (Xconomy)
• Price Hikes for Generics Just Media Hype? (Medpage)
• Salix grabs ex-Asia rights to Mitsubishi Tanabe autoimmune drug (Fierce)
• FDA approves Beximco's generic version of MSD's allergy drug Periactin (Pharmafile)
• The Quality Lowdown: What Happens When The Wrong Ingredients Are Used (Pink Sheet-$)
• Sobi shows strong growth despite haemophilia competition (PMLive)
• Legacy Pharmaceutical Packaging, LLC Expands Voluntary Nationwide Recall of Losartan Potassium Tablets, USP, 50mg Due to the Detection of Trace Amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) Impurity Found in the Active Pharmaceutical Ingredient (API) (FDA)
• Jurox Incorporated is Voluntarily Recalling Two Lots of Alfaxan Unpreserved, an Intravenous Injectable Anaesthetic (FDA)

• Bicycle Therapeutics and Oxurion Announce Full Enrollment in Phase I Trial for the Treatment of Diabetic Macular Edema (Press)
• Forbius: First Patient Dosed in a Phase 1b Myelofibrosis Trial of AVID200, a Novel TGF-beta 1 & 3 Inhibitor (Press)
• GenSight Biologics Announces Presentation of 72-Week Data from the REVERSE & RESCUE Phase III Trials of GS010 at the Annual Meeting of ARVO (Press)
• ACADIA Pharmaceuticals Initiates Phase 3 CLARITY Program with Pimavanserin as Adjunctive Treatment for Major Depressive Disorder (Press)
• CSL Behring Delivers on its Continued Commitment to Alpha 1 Patients with FDA Approval of Convenient Single-Vial Dosing for ZEMAIRA® [Alpha1-Proteinase Inhibitor (Human)] (Press)

• Digital Health: ‘Connecting the Dots’ Across FDA Centers (Focus)
• CMS Plots to Increase Breakthrough Device Payments (Focus)
• Insights from the FDA’s digital health lead Bakul Patel at MedCity INVEST (MedCity)
• Use of the Stryker Wingspan Stent System Outside of Approved Indications Leads to an Increased Risk of Stroke or Death: FDA Safety Communication (FDA)
• Is Boston Scientific Worried About Paclitaxel and Vaginal Mesh Headwinds? (MDDI)
• Scientists translate brain signals into speech sounds (NIH)

• If the states don’t treat pharma as a utility, it may be ‘lights out’ for too many patients (STAT)
• HHS moves to roll back transgender protections (Politico)
• Health apps may not disclose sharing your personal information (Reuters)
• Martin Shkreli gets a transfer to Brooklyn federal prison in wake of his latest rule-breaking escapades behind bars (Endpoints)
• FTC sues Surescripts, alleging it illegally monopolizes the e-prescribing market (STAT) (Law360-$)
• FDA Issues Draft Guidance Regarding Labeling of Allulose (the Monosaccharide That is Not a Sugar); More Guidance on Added Sugars to Follow (FDA Law Blog)

• FDA Advisory Committee Calendar

• EMA regrets to learn of the passing of Dr Eric Abadie, former CHMP Chair (EMA)
• EU Regulatory Roundup: France’s ANSM Warns About NSAIDs Following Safety Review (Focus)
• How SmPCs Can Affect Pricing Talks And Market Access (Pink Sheet-$)
• Ethicon Curved Intraluminal Staplers – risk of failure of staple lines (MHRA)

• Changes of Representative Director and Directors (Astellas)
• Asian health experts call for final push to wipe out deadliest form of malaria (Novartis)

• Canada Invests in Patient-Oriented Database (FDA News-$)

• Americans Are Among the Most Stressed People in the World, Poll Finds (NYTimes)