Recon: Alnylam Reports Positive Ph. III for Second Gene-Silencing Drug; GW Gets DEA Nod for Cannabis-Based Epidiolex

• Early approval of Alnylam's gene-silencing drug in question (Reuters) (Forbes) (STAT) (Endpoints) (Press)
• GW Pharma cannabis drug set to hit market following DEA nod (Reuters)
• Congress may soon require drug, device companies to disclose payments to nurse practitioners and other clinicians (STAT)
• J&J dumps its development deal on Geron’s imetelstat, shattering shares (Endpoints) (Xconomy)
• Nasdaq triple IPO play brings in $345M as the big biotech party rocks on (Endpoints)
• U.S.-Cuban biotech venture created to bring new cancer therapies to USA (Reuters) (Endpoints)
• Merck asks SCOTUS for its $200M in Gilead patent dues, never mind the misconduct (Fierce)
• Big Pharma's antibody drugs for asthma show benefits but cost 50% too much: ICER (Fierce)
• The murky world of disclosures (Nature)
• At least 80,000 people died of flu last winter in US, CDC says (NBC)
• Aetna, seeking antitrust nod, sells Medicare drug business to WellCare (Reuters) (CNBC)
• Defibrillator vest fails test because many heart attack survivors wouldn't wear it (Reuters)
• On the Trail of a Deadly Disease That Cuts Down Farmworkers in Their Prime (Bloomberg)
• HHS funding package en route to Trump's desk (Politico)
• Hologic to buy Focal Therapeutics for $125m (MassDevice)

• Countries pledge billions to fight tuberculosis worldwide (AP) (WHO) (WHO Director-General)
• Michael Bloomberg Reappointed as WHO Global Ambassador for NCDs and Injuries (WHO)
• Indivior cuts sales guidance sending shares down 15% (Financial Times)
• Draft NICE decision rejects Respreeza for incurable, genetic disorder (PharmaTimes)
• BIA and MHRA publish report ‘Collaborative Working in the UK, Driving Innovation Forward’ following their eighth annual joint conference (MHRA)
• French 2019 Budget A Mix Of Good And Bad News For Pharma (Pink Sheet-$)
• Norwegian-Danish Procurement Deal Targets Biogen’s Spinraza (Pink Sheet-$)
• Scathing short attack from an obscure source accuses Nanjing Legend of manipulating CAR-T data — Genscript shares nosedive (Endpoints)
• Novartis joins forces with GARDP for better, accessible infectious disease treatments in the developing world (Pharmafile)
• Lilly’s snaps up Chugai’s experimental diabetes drug (PharmaTimes)
• Call for genetic tests to bring personalised medicine to children with cancer (PMLive)
• Rare Diseases: What Makes China A Rising Star? (Pink Sheet-$)
• Fund gives J&J, Oxford experts $19 million to fight deadly viruses (Reuters) (Fierce)
• China issues guidance for use of new cancer medicines (PharmaLetter-$)
• Mandatory Drug Shortage Reporting In Australia Starts In January 2019 (Pink Sheet-$)

• Abolishing Drug Rebates May Push Consumer Drug Costs Higher (Forbes)
• Epidiolex Almost Didn't Get Proprietary Name Because Of Confusion With OTC Pedia-Lax (Pink Sheet-$)
• US FDA Gets Earful On Biologic ‘Umbrella’ Exclusivity, Patent Listings, Biosimilar Bridging Study Waivers (Pink Sheet-$)
• FDA announces new and expanded compounding research projects (FDA)
• Biotechnology Company Maps The Genome To Find The Dark Matter Of Infection (Forbes)
• NIH to build a detailed map of cells within the human body (NIH)
• AMAG exercises option on orphan drug candidate (PharmaLetter-$)
• Gene Therapy Play Logicbio Proposes IPO (BioCentury)
• Pharma execs talk challenges, opportunities of partnering with digital therapeutics (mobihealthnews)
• F-Prime, Atlas lead cancer startup Akrevia to $30M A round (Fierce)
• Antibody combo controls HIV for months (Fierce) (Reuters)
• Pharma advertising in 2018: TV, midterms and specialty drugs (BioPharmaDive)
• Eli Lilly picks up an oral GLP-1 diabetes drug from a big Roche sub for $50M in cash-plus deal — and it’s not a peptide (Endpoints)
• Vivus, diving into the cystic fibrosis sphere, backs stadium step-climbing fundraiser (Fierce)
• Atlas, F-Prime provide launch money for Akrevia — a little biotech with big plans to design better drugs (Endpoints)
• Goldacre Clashes With Pharma Over Trial Data Transparency (Pink Sheet-$)
• Fee for Using a Rare Pediatric Disease Priority Review Voucher in Fiscal Year 2019 (Federal Register)

• FDA accepts Allergan’s Vraylar for review (PharmaTimes)
• CytoSen Therapeutics Receives FDA’s Favorable Response to Pre-IND Meeting Package for Phase 2 Study in AML (Press)
• Cidara Therapeutics Initiates Phase 3 Trial of Lead Antifungal Rezafungin for Treatment of Invasive Candida Infections (Press)
• ImmusanT Announces First Patient Dosed in Phase 2 Trial of Therapeutic Vaccine for Celiac Disease (Press)
• Hansa Medical Reports Positive Final Top Line Results from Two Phase 2 Studies of Imlifidase for Kidney Transplantation (Press)
• Decibel Therapeutics and Oricula Therapeutics Announce Exclusive License for ORC-13661 in Phase 1 Development for Hearing and Balance Protection (Press)
• Targovax Announces Interim Results From Phase I Trial of ONCOS-102 in Checkpoint Inhibitor Refractory Melanoma (Press)

• FDA clears Baxter’s Altapore bone graft for spinal indications (MassDevice)
• Device Cybersecurity: For Better — and Worse? The Very Connected World of Medical Devices (MDDI)
• 2/3s of commercially available blood glucometers don't meet FDA accuracy standards, study finds (mobihealthnews)
• Effects of “No Deal” Brexit for Medical Device Sector (Emergo)

• Dozens of Doctors Who Screen Immigrants Have Record of ‘Egregious Infractions,’ Report Says (NYTimes)
• VA Adding Opioid Antidote To Defibrillator Cabinets For Quicker Overdose Response (NPR)
• Federal Courts Diverge On Bristol-Myers And Class Actions (Law360-$)
• Expert's Analyses Questioned In AbbVie Merger Cert. Row (Law360-$)
• Allergan Medicaid Rebate Suit Redo Denied At 3rd Circ. (Law360-$)
• McKesson Is Roped Into Generic-Drug Price-Fixing Row (Law360-$)
• J&J Fights $245M Faulty Hip Implant Judgment (Law360-$)
• 3rd Circ. Won't Revive Chinese Co.'s GSK Probe Suit (Law360-$)
• Plaintiffs’ Lead Counsel Off The Hook In Yaz MDL (Drug & Device Law)
• FDA Adopts New Policy on Release of Retailer Lists During Human and Animal Food Recalls (FDA Law Blog)
• GAO clears HHS of wrongdoing in ACA social media dispute (Modern Healthcare)
• New York regulator warns CVS-Aetna merger could raise prices, reduce consumer choice (HealthcareDive)

• FDA Advisory Committee Calendar
• Vaccines and Related Biological Products Advisory Committee; Notice of Meeting – 8 November 2018

• Life Sciences Scotland appoints two MSPs to their Industry Leadership Group (Pharmafile)
• Pharmacists face continued EpiPen shortages (Pharmaceutical Journal)

• Health Canada approves subcutaneous treatment for breast cancer (BioPharmaReporter)

• Avita Medical lands tax credit Down Under (MassDevice)

• Amazon basin DNA project aims to bolster indigenous people (Financial Times)