Recon: Pharma Spends on Democrats; Achaogen Eyes Sale

• Lilly to consider more acquisitions like $1.6 billion Armo buy (Reuters)
• As Election Day neared, pharma spent more heavily on Democrats (STAT)
• Insys Looks to Sell Opioid-Related Assets, Including Subsys (WSJ)
• Lilly joins forces with NextCure to fuel immuno-oncology expansion (Fierce) (Endpoints) (GEN)
• 4 months after drug approval, Achaogen eyes fire sale (San Francisco Business Times-$) (Fierce)
• FDA Facilitates the Use of Surrogate Endpoints in Drug Development (FDA)
• No Matter What The FDA Decides, New Diabetes Drugs Will Still Require CV Outcomes Trials (Forbes)

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• AstraZeneca sells trio of respiratory drugs for $350m (Financial Times) (Reuters) (Endpoints)
• Novartis says SMA gene therapy is cost-effective at $4-5 mln per patient (Reuters) (STAT-$)
• Takeda CEO confident of investor backing for $62 billion Shire deal (Reuters) (Bloomberg)
• Samsung BioLogics to complete Biogen’s call option (Korea Biomedical Review)
• Celltrion Wins Japanese Trastuzumab Case (The Center for Biosimilars)
• Roche Chairman Predicts Swathe of China Drug Approvals (Bloomberg-$)
• Cochlear will appeal $377m US patent judgment as shares hit (Australian Financial Review)
• Attributable deaths and disability-adjusted life-years caused by infections with antibiotic-resistant bacteria in the EU and the European Economic Area in 2015: a population-level modelling analysis (The Lancet) (Reuters)

• How GDUFA II Impacts the Timing & Approval Process for Generic Drug Sponsors (The Weinberg Group)
• Amgen Files Cross-Appeal in Ongoing Battle Over Epoetin Alfa (The Center for Biosimilars)
• When Safe Drugs Become Risky: The Clinical Danger Zone (Forbes)
• Cancer drug pact gets MEI Pharma $10 million upfront, possibly $87.5 million and royalties (The San Diego Union-Tribune
• Arguments Heat Up in Opioid Multi-District Litigation (Bloomberg-$)
• Allergan nixes Texas plant expansion as Restasis generics loom (Fierce)
• Centrexion eyes $70M-$80M in IPO with big plans for PhIII non-opioid painkiller (Endpoints)
• Drug Safety Oversight Board Meeting - September 20, 2018 (FDA)
• Mylan Reports Third Quarter 2018 Results and Reaffirms 2018 Guidance (Press)

• Gene study reveals secrets of parasitic worms, possible treatments (Reuters)
• Clearside kills retinal vein occlusion program after phase III Sapphire trial failure (BioWorld)
• FDA Grants Priority Review for Dupixent (dupilumab) as Potential Treatment for Adolescents with Uncontrolled Moderate-to-Severe Atopic Dermatitis (Press)
• Fortis Therapeutics Receives FDA Clearance of Two IND Applications for Novel Anti-CD46 Therapeutic for Treatment of Late-Stage Prostate Cancer and Multiple Myeloma (Press)
• Iovance Biotherapeutics Announces Updated Phase 2 Clinical Data from the Lifileucel Metastatic Melanoma Trial at the Society for Immunotherapy of Cancer’s 33rd Annual Meeting (Press)

• San Diego's ResMed to buy health software firm MatrixCare for $750 million (The San Diego Union-Tribune)
• Invisalign Maker Says Rival Is Infringing Scanner Cover IP (Law360-$)
• AAMI Publishes Provisional Health IT Standard, Seeks Feedback (AAMI)
• 23andMe Can Appeal Patent Ruling in Dispute With Ancestry.com (Bloomberg-$)
• Becton Dickinson’s Q4 meets earnings expectations, beats on revenue (MassDevice)
• A deep learning approach to automate refinement of somatic variant calling from cancer sequencing data (Nature)
• Longitudinal personal DNA methylome dynamics in a human with a chronic condition (Nature)
• Siemens Healthineers Announces FDA Clearance of Cios Spin Mobile 3D C-Arm (Press)
• Shoulder Innovations Announces FDA 510(k) Clearance For Shoulder Technology (Press)
• Two Studies Measure Performance of ACUVUE OASYS with Transitions Light Intelligent Technology Contact Lenses in Simulated Sunlight, Day and Night Driving Conditions (Press)

• How the midterms could impact pharma (Politico)
• How Antivax PACs Helped Shape Midterm Ballots (Wired)
• Pharma Makes Lobbying Push to Roll Back Seniors' Drug Discounts (Bloomberg)
• Trump Trade Deal Spurs Fresh Criticism From Labor, Health Groups (Bloomberg-$)
• Cancer Society Executive Resigns Amid Upset Over Corporate Partnerships (NYT)
• The Future Of Healthcare Innovation And Why Government Matters (Forbes)
• The health industry bets on Republicans for the midterms (Axios)
• HRSA Releases Proposed Rule to Move Up Effective Date of 340B Final Rule (FDA Law Blog)
• CDC director warns that Congo’s Ebola outbreak may not be containable (The Washington Post)
• FDA approves Colorcon’s iron oxide petition to expand colour spectrum (Manufacturing Chemist)

• FDA Advisory Committee Calendar

• Draft agenda – EC/HMA/EMA workshop on electronic Product Information (EMA)
• Driving local excellence, delivering European results (Medicines for Europe)
• Celebrating 30 years of ABHI(MedTech Views)
• UK invests £50m to set up five new AI digital pathology and imaging centres (MobiHealthNews)
• Vicplas unit to invest in loss-making British medical device maker (Business Times)
• OcuMedic, Inc. Granted European Patent for Contact Lens Drug Delivery System (Press)
• Micro Medical Solutions' New MicroStent with 120 cm Delivery Catheter Receives CE Mark Approval (Press)

• Sanofi confirms continuous therapeutic benefits for relapsing-remitting multiple sclerosis treatment (Korea Biomedical Review)
• Janssen taps South Korea’s Yuhan for Tagrisso rival (Fierce)
• Teleflex’s NeoTract wins Japanese approval for UroLift BPH treatment system (MassDevice)
• Israel’s Mapi Pharma Receives $10 Million From China’s Zhejiang Jingxin (Business Times)

• Guidance Document on Free Sale Certificate of Notified Medical Devices in India (CDSCO)
• Cipla posts 11% YoY drop in Q2 profit at Rs 377 crore, misses Street estimates (Economic Times)

• Communication to stakeholders: Autologous human cells and tissues (HCT) products (TGA)
• 'It feels dodgy': parents bypass TGA to buy sleep drug from overseas (The Sydney Morning Herald)

• Ford PCs leave drug-company transparency law in limbo (The Globe and Mail)

• Why doctors hate their computers (New Yorker)
• Melinda Gates urges backing for 'human capital' of mother and child health (Reuters)
• The former CEO of the Cleveland Clinic has some surprising advice for Google's cloud team as it tries to break into health care (CNBC)
• A Billionaire's Dying Wish: A $10 Million Prize To Fight Brain Diseases (Forbes)
• Meet Tabula Rasa HealthCare, The Top Publicly-Traded Digital Health Company (Forbes)
• Learning From Patients’ Experiences Related To Diagnostic Errors Is Essential For Progress In Patient Safety (Health Affairs)