Recon: Sandoz Drops Plans for US Rituxan Biosimilar; Lilly Says Diabetes Drug Trulicity Cuts Heart Risks

• FDA Approves Powerful New Opioid Despite Warnings of Likely Abuse (NYTimes) (STAT) (Reuters) (The Hill) (WSJ) (Press) (Gottlieb)
• Trevena opioid painkiller fails to win FDA approval, shares plunge (Reuters)
• Lilly says diabetes drug Trulicity reduces heart risks in trial (Reuters) (Endpoints)
• Sandoz abandons effort for US approval of biosimilar rituximab (Reuters) (Endpoints) (Center for Biosimilars)
• FDA approves Pfizer's treatment for certain lung cancer patients (Reuters) (Fierce) (Press)
• FDA panel recommends Sage's postpartum depression treatment (Reuters) (Endpoints) (Xconomy) (Press)
• The FDA, but with guns: How far should a little-known office go to track down counterfeit drugs? (STAT)
• New rules could chill Chinese investment in biotech. Here’s what you need to know (STAT)
• FDA and DoD formalize collaboration to advance medical products in support of American military personnel (FDA)
• Priority Review Vouchers Revitalizing Neglected Disease Drug Development (Forbes)
• One number keeps me from taking part in cystic fibrosis trials. That’s wrong (STAT)
• Thousands of sickle cell and hemophilia patients are waiting for gene therapies. Can manufacturers keep up? (STAT)

• Whether you have decided to implement a new RIM system or are just considering making a change to your current solution, there are several things you can do to set yourself up for success.
• Join us to hear Steve Gens, managing partner at Gens and Associates, share five tips to start your RIM project off on the right foot. Register Today.

• Industry Picks Holes In UK Plans For Post-Brexit Drug Regulation (Pink Sheet-$)
• Novo Nordisk, Embark Seek Obesity Drugs That Boost Body's Energy Use (SCRIP-$)
• Takeda licenses Crescendo’s Humabodies (PharmaTimes)
• UK pharma Enesi links with Australian biotech Sementis (PharmaTimes)
• China Finalizes List Of Foreign Drugs Eligible For Priority Review (BioCentury)
• Novartis CEO Vas Narasimhan lines up his late-stage blockbuster contenders — mixing old favorites and add-ons (Endpoints) (Novartis)
• Comparable Overseas Reports (COR-A) pathway - First registration decision (TGA)
• Federal Council approves Swissmedic's strategic goals for 2019–22 (Swissmedic)
• Another Postponement Of Turkish Medical Device Tender Raises Eyebrows (Medtech Insight-$)
• Bulletin of the World Health Organization November 2018 (WHO)

• AbbVie/arthritis drugs: copycat flap (Financial Times)
• Digital R&D: The Next Frontier for Biopharmaceuticals (McKinsey)
• Coherus looks to disrupt Amgen’s $4B Neulasta franchise as analysts look for a deep discount on its copycat price (Endpoints)
• Blood Pressure Medication Recall: What Is In This That May Cause Cancer? (Forbes)
• Need alternative funding channels? Perceptive Advisors now has $675M devoted to those deals (Endpoints)
• Clearside slides as eye drug Xipere flunks combination study (Fierce) (Endpoints)
• In another try at lung cancer niche, J&J nabs a potential Tagrisso rival for $50M-plus (Endpoints)
• Win $2 Million to Solve Alzheimer’s: New Prize Will Reward Fresh Ideas (Xconomy)
• Abeona bags rights to Regenxbio AAV9 vector in rare lysosomal storage disorders (Fierce)
• AbbVie Gains Parkinson’s Pipeline From Bioarctic (BioCentury)
• Life sciences VC investment trends similar to tech, but there are differences (MedCity)
• Seres Therapeutics to Host Third Quarter 2018 Financial Results and Operational Progress Conference Call and Webcast on November 8, 2018 (Press)
• Mylan and Pfizer report new issues affecting some EpiPens that can delay treatment (Fierce)
• Aquestive wins FDA nod for seizure oral film (Drug Delivery)

• Bristol-Myers Squibb and Infinity Pharmaceuticals Announce a New Clinical Collaboration to Evaluate Opdivo (Nivolumab) in Combination with IPI-549 in Urothelial Cancer (Press)
• Seattle Genetics Submits Supplemental Biologics License Application for ADCETRIS® (Brentuximab Vedotin) in Frontline Treatment of CD30-Expressing Peripheral T-Cell Lymphomas (Press)
• SpringWorks Therapeutics Receives FDA Orphan Drug Designation for MEK Inhibitor (PD-0325901) for the Treatment of Neurofibromatosis Type 1 (Press)
• Genkyotex Meets Both Primary and Secondary Interim Efficacy Endpoints in Phase 2 Trial of GKT831 in Primary Biliary Cholangitis (Press)
• Onxeo Announces Positive Interim Results from Phase 1 Study of AsiDNATM, a First-In-Class DNA Damage Response Inhibitor (Press)
• Acesion Pharma Announces Positive Results for Novel Drug Targeting Atrial Fibrillation (Press)
• FLX Bio Announces Clinical Trial Collaboration Agreement With Merck for Ongoing Phase 1/2 Study of FLX475 (Press)

• FDA permits marketing of two devices that detect parathyroid tissue in real-time during surgery (FDA)
• Diabetics are hacking old insulin pumps to make them smarter — here's what happened when I tried it (CNBC)
• ResMed to pay $750m for MatrixCare (MassDevice)
• Axonics closes $120m IPO (MassDevice)
• McKesson CEO to retire in 2019 (MedCityNews)
• Halfway to the New European Medical Device Regulation, U.S. Manufacturers Feel the Pinch (MDDI)
• FDA issues Class I recall for Roche Diagnostics’ warfarin test strips (Drug Delivery)
• Illumina Shows That Big Medtech Deals Are Far from Over (MDDI)
• NinePoint Medical Announces FDA Clearance of an Artificial Intelligence Software Upgrade for the NvisionVLE® Imaging System (Press)
• Breaking Through the Bias: Debunking Common Misconceptions About Usability Studies (MDDI)

• Final polls: Democrats have commanding health care lead (Politico)
• 4 things you need to know about the administration’s latest Part B proposal (PhRMA)
• Pharmacies still blocking U.S. teens looking for emergency contraception (Reuters)
• Virginia facing high unexpected Medicaid costs (AP)
• Draft Report on Health Research and Development To Stem the Opioid Crisis: A Federal Roadmap; Request for Comments (Federal Register)
• Settlement Reached In Stryker Hip Replacement Suits (Law360-$)
• For pharma, a flipped House would be noisy, but real action? It's all about the Senate (Fierce)
• The Obesity Epidemic: FDA’s Waistline Continues to Expand! (FDA Law Blog)
• Updating Our Post-Bauman 50-State Survey on General Jurisdiction by Consent (Drug & Device Law)

• FDA Advisory Committee Calendar

• Ukraine Steps Up Plan For "Professional" Procurement Agency (Pink Sheet-$)

• Lupin recalls 6,752 bottles of Testosterone topical solution from US (Economic Times)
• Aurobindo recalls hypertensive drug in US citing cancer risk (Economic Times)
• Indian pharma companies maintaining good compliance standards: Frances Zipp, CEO, Lachman Consultants (Economic Times)

• Database of section 19A approvals to import and supply medicines to address medicine shortages (TGA)