Recon: Sanofi, Denali Sign $125M Drug Development Deal; EC Approves Vertex’ CF Combo

• First FDA-approved cannabis-based drug now available in the US (CNN) (Endpoints)
• FDA announces recall of another heart medicine for possible cancer risk (CNN) (Focus)
• Industry group wants FDA to stop drug importation study (The Hill)
• FDA clears the first consumer genetic test for how well your medications may work — with caveats (STAT) (GenomeWeb) (FDA) (Shuren, Woodcock Statements) (Press)
• 6 months after arriving at Sanofi R&D, John Reed gambles $125M on Denali’s RIPK1 work (Endpoints) (Fierce) (Press)
• Magenta’s stem cell expansion therapy reveals hope and concern in first data look (STAT)
• Acceleron, Celgene reveal new clinical trial data on their blood disease drug (STAT)
• Protect the valuable work of the FDA by keeping it as part of HHS (STAT)
• How an IBM Watson Health rescue mission collapsed — and a top executive was ousted (STAT)
• Pricey Precision Medicine Often Financially Toxic For Cancer Patients (KHN)
• Lilly Buys Siga's Priority Review Voucher Gained Via Smallpox Approval (BioCentury)
• Esperion CEO: Our new cholesterol drug can help millions of patients (CNBC)
• HHS Reverses Course, Will Start 340B Fines Soon (Law360-$)
• Drug pricing goes local: State lawmakers around the country are pledging to take on pharma, too (STAT)

• Merck Pulls Out Of Agreement To Supply Life-Saving Vaccine To Millions Of Kids (NPR)
• EU approves Vertex’ cystic fibrosis combo (PharmaTimes) (Press)
• Warning ‘at red’ on no deal Brexit medicines chaos (PMLive)
• AbbVie offers up 80% Humira discount in EU tender market to hold off biosimilars: report (Fierce)
• Green light for Roche’s chemo-free CLL treatment combo (PharmaTimes) (Press)
• AbbVie, Roche combo treatment meets main goal of leukemia trial (Reuters) (Endpoints) (Press)
• WuXi Biologics breaks ground on $240m manufacturing site near Beijing (BioPharmaReporter)
• In Congo’s Ebola Outbreak, Experimental Treatments Are Proving Effective (NYTimes)
• Once Paralyzed, Three Men Take Steps Again With Spinal Implant (NYTimes) (Forbes)
• Update on the Australia-Canada Mutual Recognition Agreement (TGA)
• Innovent Biologics gains by a fifth on Hong Kong debut (Financial Times)
• What Might Brazil’s Divisive New President Bring Pharma? (Pink Sheet-$)

• Alliance for Regenerative Medicine Q3 2018 Data Report (ARM)
• Questions Raised About Invokana Label Expansion For CV Risk Reduction (Forbes) (Medpage)
• ViiV’s fostemsavir shows promise in ‘heavily pre-treated’ HIV patients (PharmaTimes)
• Astellas jumps into gene and cell therapy production with $255M investment (Fierce)
• USP Sparks Debate Over Rapid Sterility Testing For Cell And Gene Therapies (Pink Sheet-$)
• Novo Nordisk buys US and Canadian rights to Macrilen for $145 million (PharmaLetter-$)
• Hims Launches Hers, A Direct-To-Consumer Site Selling Birth Control And Other Drugs (Forbes)
• As rivals press in, Stanford spinout Forty Seven burnishes its prospects from an impressive PhIb (Endpoints) (Fierce)
• The New Anti-Flu Drug Xofluza's Value Proposition (Forbes)
• New National Strategy Aims To Up Participation In Alzheimer's Clinical Studies (Forbes)
• Ophthotech adds to pipeline again as climb back continues (Endpoints)
• Twist Bioscience IPO Hauls In $70M for DNA Synthesis Technology (Xconomy)
• FDA Reviewers: REMS Could Allay Safety Concerns For Sage's Brexanolone (BioCentury)
• Newly discovered link between the appendix and Parkinson’s disease could point to the way to treatments (Fierce)
• Intellia’s clinical head moves to CRISPR-focused Casebia to be its first CMO (Fierce)
• Ferring’s chief science officer to take over as executive board president in January (Fierce)
• Precision medicine means nobody is just ‘average’ (MedCity)

• Urovant’s overactive bladder drug scores in mid-stage trial (Endpoints) (Press)
• Acceleron Announces that Phase 3 Results from the MEDALIST and BELIEVE Trials of Luspatercept will be Presented at the 60th American Society of Hematology Annual Meeting (Press)
• Syros to Present Initial Clinical Data from Combination Cohorts in Its Ongoing Phase 2 Trial of SY-1425 at ASH Annual Meeting (Press)
• X4 Pharmaceuticals to Present Clinical Data Used to Determine Phase 3 Dose from Phase 2/3 Study of X4P-001-RD in WHIM Syndrome (Press)
• Bio-Thera Solutions Announces Initiation of Pivotal Phase III Study of BAT8001 for Patients with Metastatic Breast Cancer (Press)
• Ark Biosciences Reports Significant Progress of Phase 2 Clinical Trial of Ziresovir for Treatment of Hospitalized Respiratory Syncytial Virus (RSV) Infected Patients (Press)
• SanBio Announces Phase 2 STEMTRA Trial Using SB623 Cells for Treatment of Patients with Traumatic Brain Injury Met Primary Endpoint (Press)
• GlycoMimetics to Present Analyses from Phase 1/2 AML Trial of Uproleselan at 60th ASH Meeting (Press)

• US FDA Adds Details for Medical Device Conformity Assessment Accreditation Program Pilot (Emergo)
• FDA clears Zimmer Biomet’s Persona knee implant (MassDevice)
• TransEnterix closes Medical Surgery Technologies buyout (MassDevice)
• Assessing Innovations For Medical Device Development (Law360-$)
• Click-on bionic arm could help amputees do the simple things (Reuters)
• Smith & Nephew up on Q3 sales gain (MassDevice)
• OsteoRemedies wins FDA nod for Remedy Spectrum GV hip spacer and bone cement (MassDevice)
• StimWave wins FDA nod for Apple iOS-based WaveCrest mobile SCS patient controller (MassDevice)
• Abbott wins FDA nod for FreeStyle Libre’s mobile app (Drug Delivery)
• Medical device security gets a boost (mobihealthnews)
• Withdrawal of the Laser Products; Proposed Amendment to Performance Standard and the Electronic Submission of Labeling for Certain Home-Use Medical Devices (FDA)
• FDA Clears VITROS® XT 7600 Integrated System from Ortho Clinical Diagnostics, Bringing Innovative New Approach to Clinical Lab Management (Press)

• Welcome to ACA open enrollment (Politico)
• Pharma Co. Egalet Hits Ch. 11 With $129M Debt (Law360-$)
• Allergan, Generic Cos. Battle Over Restasis Launch Plans (Law360-$)
• Relief At Last? DC Circuit Rules on Rx PEG-3350 ANDAs (FDA Law Blog)
• Prescription Drug Prices: A Bitter Pill In The Midterm Elections (Forbes)
• Boston Says Opioid Suit Is Purely A State Law Matter (Law360-$)
• Fosamax in U.S. Supreme Court – Justice Alito Un-Recuses (Drug & Device Law) (Law360-$)
• Cigna CEO: Express Scripts Will Help Us Treat The 'Whole Person' (Forbes)
• Groundskeeper in Bayer in U.S. weed-killer case accepts reduced award (Reuters)
• PTAB Considers Allowing Claim Amendments During IPR Proceedings (BioCentury)

• FDA Advisory Committee Calendar

• Supply unlicensed medicinal products (specials) (MHRA)
• ‘Booming’ pharmaceutical industry in Scotland (EPR)
• Russia’s Nativa plans to start production of Novartis anticancer drug (PharmaLetter-$)

• A Wild CAR-T Race In China: The Hype, Reality And What Works (SCRIP-$)

• Dr. Reddy’s says FDA finds more issues at oncology drug plant (Fierce)

• Notice: Guidance Document - Data Requirements for Safety and Effectiveness of Subsequent Entry Inhaled Corticosteroid Products Used for the Treatment of Asthma (Health Canada)

• Annual Charge Exemption Scheme - entries declaring $0 turnover (TGA)

• Tenth child dies from viral outbreak at New Jersey facility (Reuters)
• Treating early signs of diabetes risk may stave off the disease (Reuters)
• Major Study Finds ‘Some Evidence’ of Link Between Cellphone Radiation and Brain Cancer (NYTimes)