Recon: Trump to Sign Opioid Bill

• Trump to sign sweeping opioid bill (Politico) (Bloomberg) (Reuters)
• Arkansas Wants Supreme Court Review of Drug Pricing Law (Bloomberg)
• Pfizer-Lilly non-opioid drug helps reduce osteoarthritis pain (Reuters) (Fierce) (Endpoints) (Press)
• Alexion buys RNAi therapies in Dicerna deal (Fierce) (Endpoints) (Press)
• Alexion Reports Third Quarter 2018 Results (Press)
• FDA and the FTC Won’t Get Fooled Again (FDA Law Blog)
• FDA Experts May Reconsider Diabetes Drug Safety Rules (Forbes)
• Centene Rolls Out RxAdvance PBM Promising Drug Cost Transparency (Forbes)
• NeoGenomics Buys Ex-Novartis Cancer Lab Genoptix for $125M, Stock (Xconomy)
• Aspirin May Be a Good Option to Prevent Blood Clots After Knee Surgery (NYTimes)
• FDA Dodges Death-Inspired Suit Over Study Volunteer Consent (Bloomberg)
• US regulators offer a helping hand to new nonprofit drug company (STAT) (The Conversation)
• Drug Companies, Not 'Middlemen', Are Responsible For High Drug Prices (Forbes)
• 9 things to know about Alkermes and its controversial drug for treatment-resistant depression (STAT)
• Teva Petitions FTC to Reopen and Modify Decision and Order in Case Involving Watson Pharmaceuticals Inc.’s Acquisition of Actavis Inc. (FTC)

• Fast-track flu vaccine raises hopes for quicker drugs approvals (Financial Times)
• Bayer, Orion drug shown to delay spread of prostate cancer (Reuters) (Fierce) (Endpoints) (Press)
• Patients 'may need to stockpile own drugs if no-deal Brexit looms' (The Guardian)
• Hong Kong IPO delivers $421M to Innovent as another one of China’s biotech unicorns hauls in big money (Endpoints)
• Pharma is getting away with lots of patent ‘evergreening’ in India (STAT)
• ESMO's not what it used to be—and that's a good thing, executives say (Fierce)
• UK Must Use Biosimilar Savings To Provide Earlier Access To Biologics (Pink Sheet-$)
• Dutch Plan To Boost EU Regulatory Network As Brexit Looms (Pink Sheet-$)
• Jitters Over Innovative Drug Pricing System Intensify In Korea As FTA Revision Deadline Nears (Pink Sheet-$)
• UK Biotech Orchard Primes $200M IPO Led By Goodwin (Law360-$)
• GSK boosts API manufacturing with £54m facility in Scotland (InPharmaTechnologist)
• MS and cholesterol drugs picked for new UK rapid uptake push (PMLive)
• Implementing the Falsified Medicines Directive: Safety Features (MHRA)

• Could precision medicine help women choose the contraceptive that works best for them? (STAT)
• Antisense startup Stoke Therapeutics secures another $90M in series B funding (Endpoints)
• Fresh from a $72M raise, Jeff Aronin’s new lead rare disease drug is flagged as a failure (Endpoints)
• Here’s a hypothesis: Lower doses of some cancer pills could save a lot of money (STAT)
• Mylan says Advair copy approval 'imminent,' but investors jittery (BioPharmaDive)
• How’s My Baby? (LifeSciVC)
• Biogen biosimilars and Spinraza fill MS void, but pipeline worries abound (Press)
• PARPs may be crushing it in the clinic, but half of doctors are still wary: executive (Fierce)
• Don't give decongestants to children for colds, experts say (Reuters)
• Real-World Evidence: US FDA’s Prucalopride Review Shows Datasets' Utility And Limitations (Pink Sheet-$)
• Cool it, analyst urges ‘overly punitive’ BMS investors after rough Opdivo week (Fierce)
• Former US FDA Chief Counsels Offer Advice For Navigating Thorny First Amendment Conundrum (Pink Sheet-$)
• Drugmakers Dispute Scope of Orphan Drug Exclusivity (FDA News-$)
• The New Zelnorm-al: US FDA’s Do-Over On Cardiovascular Safety (Pink Sheet-$)
• Pharmacovigilance and drug safety outsourcing worth $207.7M by 2024 (EPR)
• Public Citizen Calls on Florida Board of Medicine to Investigate Doctor Over use of Cesium to Treat Cancer (Citizen)

• Biogen sees two phase 2 failures: In sciatica and in its lupus collaboration with UCB (Fierce) (Pharmafile)
• vTv Therapeutics Presents Positive Data on the Effect of Azeliragon in Patients with Alzheimer’s and Diabetes at the 11th Clinical Trials on Alzheimer’s Disease (CTAD) Conference (Press)
• Oyster Point Announces Positive Results From Two Separate Phase 2b Clinical Trials of the Company’s Investigational Treatments for Dry Eye Disease (Press)
• JAMA Publishes Phase II recAP Data for Sepsis-Associated Acute Kidney Injury (Press)
• Context Therapeutics Reports Encouraging Phase 1 Safety and Efficacy Data of Apristor® in Progesterone Receptor Positive Cancers (Press)
• Cortexyme Announces Phase 1 Data Demonstrating COR388 is Safe and Well Tolerated in Healthy Older Volunteers and Alzheimer’s Patients (Press)
• SignPath Pharma Reports Extremely Beneficial Blood Level Results of Its Phase 1b Clinical Trials of Liposomal Curcumin in Advanced Cancer Patients as Published in the Cancer Research Journal “Cancer Chemotherapy and Pharmacology” (Press)
• Novaliq Announces Positive Topline Results for Its SEECASE Phase 2 Trial of NOV03 for the Treatment of Patients with Dry Eye Disease (Press)
• CStone Receives US FDA IND Approval for Recombinant PD-1 mAb CS1003 (Press)

• Boston Scientific slides on Q3 sales miss, lowered outlook (MassDevice)
• How To Protect Healthcare IoT Devices In A Zero Trust World (Forbes)
• Carl Zeiss Meditec buys cataract surgery device maker IanTech (MassDevice)
• Monteris wins FDA nod for NeuroBlate Optic laser probe (MassDevice)
• Novo Nordisk to launch two connected insulin pens, taps Flex to manage data (mobihealthnews)
• Siemens Healthineers, Healthy.io ink home kidney monitoring deal (MassDevice)
• Stryker closes $190m Invuity buyout (MassDevice)
• Consider the Most Probable Number Method for Bioburden Testing (MDDI)
• FDA to review Xeris’ glucagon rescue pen auto-injector (Drug Delivery)
• Orthocaps® Aligners Receive FDA Clearance (Press)
• Class 1 Device Recall CyPass MicroStent (FDA 1, 2, 3, 4)

• Amazon And NIH To Link Biomedical Data And Researchers (Forbes)
• Pharmalittle: West Virginia AG denies an opioid deal with McKesson is coming (STAT)
• Claire McCaskill is campaigning as pharma’s sworn enemy — and that’s the way she wants it (STAT)
• Obamacare could expand after the midterm elections, despite GOP efforts to undermine it (CNBC)
• Judicial Estoppel: Failing to Disclose MDL Lawsuit as Asset in Bankruptcy Prevents Plaintiff From Pursuing Case (Drug & Device Law)
• Johnson & Johnson inks last-minute Risperdal deal in boy-with-breasts case (Fierce)
• Takeda Tries Again To Shake Actos Antitrust Claims (Law360-$)
• Part B Payment Model Indexing Commercial Discounts Proposed By Genentech (Pink Sheet-$)

• FDA Advisory Committee Calendar
• Joint Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee – 17-18 December 2018

• UK seizes more than £2 million of fake medicines as part of international crackdown (MHRA)
• Large-scale production of APIs to be established in Russia (PharmaLetter-$)
• Serbia’s Galenika to invest $40 million in new pharma facility in Russia (PharmaLetter-$)

• Agena Biosciences MassArray System Cleared by China FDA (GenomeWeb)

• ICMR to launch research study to help govt formulate HIV-AIDS strategy to achieve global target of “90-90-90” by 2020 (PharmaBiz)

• Release of Draft (Step 2) ICH Guidance: S11: Nonclinical Safety Testing in Support of Development of Paediatric Medicines (Health Canada)

• Joint media release between Australian Border Force and Therapeutic Goods Administration (TGA)
• Submissions received and high level summary: Boxed Warning guidance (TGA)
• Provisional Determination: A step-by-step guide for prescription medicines (TGA)

• Death toll in New Jersey viral outbreak rises to seven children (Reuters)
• Start-up promising a revolutionary $1,000 breast pump has gone dark, leaving behind many unhappy customers (CNBC)