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Recon: Pharma Spends on Democrats; Achaogen Eyes Sale

Posted 06 November 2018 | By Ana Mulero 

Recon: Pharma Spends on Democrats; Achaogen Eyes Sale

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. 

In Focus: US
  • 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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In Focus: International Pharmaceuticals & Biotechnology
  • 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)
Pharmaceutical and Biotechnology: Study Results, Filings and Designations
  • 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)
Medical Devices
  • 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 (Bloomberg-$)
  • Becton Dickinson’s Q4 meets earnings expectations, beats on revenue (MassDevice)
  • A deep learning approach to automate refinement of somatic variant calling from cancer sequencing data (Nature)
  • Longitudinal personal DNA methylome dynamics in a human with a chronic condition (Nature)
  • Siemens Healthineers Announces FDA Clearance of Cios Spin Mobile 3D C-Arm (Press)
  • Shoulder Innovations Announces FDA 510(k) Clearance For Shoulder Technology (Press)
  • Two Studies Measure Performance of ACUVUE OASYS with Transitions Light Intelligent Technology Contact Lenses in Simulated Sunlight, Day and Night Driving Conditions (Press)
US: Assorted & Government
  • How the midterms could impact pharma (Politico)
  • How Antivax PACs Helped Shape Midterm Ballots (Wired)
  • Pharma Makes Lobbying Push to Roll Back Seniors' Drug Discounts (Bloomberg)
  • Trump Trade Deal Spurs Fresh Criticism From Labor, Health Groups (Bloomberg-$)
  • 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)
Upcoming Meetings & Events Europe
  • 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)
Canada General Health & Other Interesting Articles
  • 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)
Regulatory Reconnaissance is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory news stories from around the globe. Each weekday morning, we aim to bring you the latest highlights of new approvals, meetings, legal and political developments, regulations and guidance, and the latest trends with the potential to impact regulatory affairs professionals and the industry in which they work.

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