Recon: FDA Expands Use of BMS’ Empliciti; AbbVie Sues NHS Over HCV Procurement

• Democrats' new health care math (Politico) (Forbes) (Law360-$) (STAT) (NYTimes)
• With a new Congress, a window opens to finally bring down drug prices (STAT)
• Pelosi sees possible 'common ground' with Trump on drug prices (The Hill)
• Bound to the hip with Trump, ex-Celgene chief Bob Hugin gets whipped in New Jersey Senate race (Endpoints)
• Indicted for biotech insider trading, Rep. Chris Collins keeps his seat (STAT)
• FDA approves new use for BMS’ Empliciti (PharmaTimes) (PharmaLetter) (Press)
• What if the Placebo Effect Isn’t a Trick? (NYTimes)
• Eli Lilly Raises 2018 Guidance after Strong 3Q (WSJ)
• Momenta Becomes the Latest to Settle With AbbVie Over Humira (Center for Biosimilars) (Press)
• AmerisourceBergen suffers another setback with its ‘real doozy’ of a compounding business (STAT)
• AMA delegates to consider a proposal for personal importation of drugs from Canada (STAT)
• Landmark RNAi drug gets off to a slow start in sales, but Alynylam calls for patience (STAT)
• Despite stepped-up scrutiny of patient assistance programs, pharma appears unprepared (STAT)
• Bristol-Myers lays off the last 63 staffers at ZymoGenetics, shutters Seattle operations (Endpoints)
• A star drug in Mallinckrodt’s $1.2B Sucampo buyout flops in pivotal trial (Endpoints)

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• Just $2 per person a year could halt deadly superbugs, OECD says (Reuters)
• EU Accelerated Assessment Tracker: Second Half Trumps First By Far (Pink Sheet-$)
• Endocrine disruptors: A strategy for the future that protects EU citizens and the environment (EC)
• Call on Harris to focus on supply of medicines after Brexit (The Irish Times)
• Greek minister: Effective health and pharma policy needs stronger EU Commission role (EurActiv)
• GSK among businesses wooed as Brexit reckoning nears (PMLive)
• AbbVie sues NHS England over hep C procurement (PMLive)
• Better Together: New Deal Adds Weight To China Biosimilar/Biobetter Swap (SCRIP-$)
• Ukrainian Draft Law Would Weaken IP Rights (Pink Sheet-$)
• EMA grants accelerated review for quizartinib (PharmaLetter-$)
• Uganda Vaccinates Front-line health-workers against Ebola (WHO)
• WHO guidelines: Management of physical health conditions in adults with severe mental disorders (WHO)

• Foamix's treatment for common skin condition meets late-stage trial goals (Reuters) (Endpoints)
• That generic Advair you've been expecting for months? It'll come, but let's talk other products, Mylan says (Fierce)
• Eylea crosses quarterly US blockbuster line for Regeneron as Dupixent nears new FDA expansion (Forbes)
• Consumers may not like health data sharing, but pharma sure does (Fierce)
• FDA’s Response to HHS’ Revised Common Rule: Four Things to Know (National Law Review)
• Which media reaches cancer patients? Depends on their diagnosis: report (Fierce)
• Why Pharma Risk Is Inherently Unpredictable And Why It Matters (Forbes)
• Eli Lilly's new launches step up in time to fill the growing Cialis gap (Fierce)
• Risk-Sharing Arrangements May Boost Fortunes Of Certain Prescription Drugs (Forbes)
• FDA Approves Elanco Cattle Drug, the First for Reducing Gas Emissions (Xconomy) (FDA)
• Moment of truth looms for Nektar, Bristol-Myers with a major update to NKTR-214 combo — and the latest snapshot is not promising (Endpoints)
• Families often share potentially dangerous antibiotics: study (Reuters)
• The changing biosimilar landscape: Lesser-known firms, blockbuster molecules (BioPharmaReporter)
• How Technology Fails Us In The Battle Against Opioid Addiction (Forbes)
• The resurrection of LUM001: Mike Grey gets his drug back from Shire — along with $120M to gamble on PhIII trials (Endpoints)
• Centrexion eyes $70M-$80M in IPO with big plans for PhIII non-opioid painkiller (Endpoints)
• Dana-Farber team identifies new ‘gene traffic control’ targets in two rare, aggressive cancers (Endpoints)
• Achaogen cuts costs again and puts up ‘for sale’ sign (Fierce)
• Jnana President Joanne Kotz to take on CEO role (Fierce)
• Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Postmarketing Adverse Drug and Biological Product Experience Reporting and Recordkeeping (Federal Register)
• Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution (Federal Register)

• Bone Therapeutics halts phase 3 for futility, sinking stock (Fierce)
• SpringWorks Therapeutics Receives FDA Fast Track Designation for Nirogacestat for the Treatment of Adult Patients with Desmoid Tumors (Press)
• Aridis Pharmaceuticals Announces Publication of Positive AR-301 Phase 1/2a Data in "Intensive Care Medicine" and "The Lancet Respiratory Medicine" (Press)
• Shionogi to Present Clinical Data on Mulpleta® (lusutrombopag) at the Liver Meeting® 2018 of the American Association for the Study of Liver Diseases (AASLD) (Press)
• Early Phase 1 Data from Merck’s Oncology Pipeline for Investigational Anti-LAG-3 Therapy (MK-4280) and Anti-TIGIT Therapy (MK-7684) to Be Presented at SITC’s 33rd Annual Meeting (Press)
• Rocket Pharmaceuticals Announces FDA Clearance of IND Application for RP-L102 Gene Therapy for Fanconi Anemia (Press)
• Karyopharm’s Selinexor Receives Fast Track Designation from FDA for the Treatment of Patients with Relapsed or Refractory Diffuse Large B-cell Lymphoma (Press)
• Lupin receives FDA green light for generic Hectorol (DSN)
• Elite, Glenmark launch generic methadone tablets (DSN)

• FDA clears Siemens Healthineers mobile 3D imaging arm (MedTechDive)
• Senseonics wins another FDA approval for its implantable CGM (Drug Delivery)
• Meet The Woman Behind 23andMe's Plan To Keep Your Data Safe (Forbes)
• K2M shareholders approve Stryker merger (MassDevice)
• Boston Scientific’s Eluvia drug-eluting stent succeeds in long lesions (Drug Delivery)
• Dexcom raises outlook after Q3 results top Wall Street estimates (Drug Delivery)
• FDA grants de novo clearance to AI Biomed, FluoOptics parathyroid tissue detection devices (MassDevice)
• Medtronic touts five-year data for In.Pact Admiral drug-coated balloon (Drug Delivery) (Press)
• Cybersecurity Vulnerability: Roche Point of Care Handheld Medical Devices (DHS)
• Spinal Elements® Announces FDA Clearance of Ti-Bond® Titanium Coating as a Macro-, Micro-, and Nano-Surface (Press)

• What Lawsuit to Gut Obamacare? Oh, That One (NYTimes)
• Endocyte's $2.1B Sale To Novartis 'Unfair' To Investors: Suit (Law360-$)
• Trump Administration Takes a Turn at Medicare Part B Payment Reform (FDA Law Blog)
• D. Colorado Applies Learned Intermediary Rule to Medical Devices (Drug & Device Law)
• CVS tops earnings, revenue estimates, says it expects Aetna acquisition to close before Thanksgiving (CNBC)
• Buffett-owned DaVita jumps 10% after voters reject cap on dialysis revenue (CNBC)
• Missouri Votes To Legalize Medical Marijuana (Forbes)
• Utah Voters Approve Medical Marijuana (Forbes)
• Idaho Medicaid Expansion Sails To Victory (Forbes) (The Hill)
• Utah voters approve ObamaCare's Medicaid expansion for low-income adults (The Hill)
• Nebraska Voters Approve Medicaid Expansion In Snub To Gov. Ricketts (Forbes) (The Hill)

• FDA Advisory Committee Calendar
• FDA Oncology Center of Excellence - Society for Immunotherapy of Cancer Public Workshop: Immune-modified Response Criteria in Cancer Immunotherapy Clinical Trials – 8 November 2018

• AEMS guidance for health professionals (TGA)
• AEMS guidance for sponsors (TGA)