Regulatory Focus™ > News Articles > Regulatory Recon: Big Ruling Against Sanofi and Regeneron; Obama on Repealing Obamacare (6 January 2

Regulatory Recon: Big Ruling Against Sanofi and Regeneron Obama on Repealing Obamacare (6 January 2017)

Posted 06 January 2017 | By Zachary Brennan 

Regulatory Recon: Big Ruling Against Sanofi and Regeneron Obama on Repealing Obamacare (6 January 2017)

Welcome to Regulatory Recon, a daily regulatory news and intelligence briefing.

In Focus: US                                      

  • Obama: Repealing the ACA without a Replacement — The Risks to American Health Care (NEJM)
  • Regeneron Cholesterol-Lowering Drug Banned From U.S. Market in Stunning Loss to Amgen in Patent Case (TheStreet) (Reuters) (Wall Street Journal-$) (Endpoints) (In the Pipeline) (Harvard’s Bill of Health) (Decision)
  • Leaving Biogen, CEO Scangos To Head New Firm That Battles Germs (Forbes) (Endpoints)
  • Republicans Face Pressure for Push to Repeal Affordable Care Act (Wall Street Journal-$) (Bloomberg)
  • New “21st Century Cures” Legislation: Speed and Ease vs Science (JAMA)
  • Crystal Ball Gazing: Biotech Predictions for 2017 (LifeSci VC)
  • What Biotech Investors Can Expect From the J.P. Morgan Health Care Conference 2017 (TheStreet)
  • Botox: The Drug Treating Everything (Time-$)
  • Mylan’s EpiPen Sales Plan: Schools Today, Everywhere Tomorrow (Bloomberg)
  • Japanese Drugmaker Eisai Handed 483 Due to Data Integrity, Quality Concerns (FDANews-$)
  • Merck’s Vaccine Won’t Be the End of Ebola (MIT Tech Review)
  • Pfizer’s Humira biosimilar hits efficacy target (PharmaTimes)
  • Company Will Raise $1 Billion To Create Blood Test To Detect Cancer (Forbes) (Xconomy) (Press)
  • US clears fifths indication for Roche eye drug (PharmaTimes)
  • Enforcement delays as critical as approval times (BioWorld)
  • Mammogram Record Retention: FDA Offers Guidance (Focus)
  • Drugs to Which FDA has Granted Pediatric Exclusivity for Pediatric Studies (FDA)
  • Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding “Intended Uses” (Federal Register)
  • Submission of Quality Metrics Data; Revised Draft Guidance for Industry; Extension of Comment Period (Federal Register)
  • Generic Drug User Fee Amendments II Program Fee (Federal Register)

In Focus: International

  • China’s Airpocalypse Paves a Path for New Cancer Medicines (Bloomberg)
  • J&J, Actelion approach Swiss takeover board over deal structure (Reuters)
  • NICE backs use of UCB’s Cimzia, Novartis’ Cosentyx for psoriatic arthritis (PharmaTimes)
  • Toronto’s plan to open supervised-injection sites stuck in limbo (Globe and Mail)
  • European Commission Clears up Questions on Orphan Drug Regulation (Focus)
  • South Korea court convicts ex-Reckitt Benckiser unit chief in sterilizer case (Reuters)
  • Ducks gassed in thousands as France fights bird flu virus (Reuters)
  • Hong Kong confirms second bird flu death this winter (Reuters)
  • India's Community Approach To Depression Tackles Treatment Shortage (NPR)
  • The Doctors Aren't In At Kenya's Public Hospitals (NPR)

US: Pharmaceuticals and Biotechnology

  • The man who kicked off the biotech revolution (Nautilus)
  • Cheating Death Can Cost $200,000 as Cancer Tops Pharma Sales (Bloomberg)
  • Dynavax axes 38% of staff, focuses on I/O after FDA setback (FierceBiotech)
  • Momenta Pharma gets $50M upfront for CSL drug development pact (FierceBiotech)
  • Otonomy close to filing Otiprio for swimmer's ear (FierceBiotech)
  • Lilly management shakeup brings Novartis vet Shaw in, moves Conterno up and puts U.S. chief out (FiercePharma)
  • Novel targets podcast: Episode 16: Controversies in Hematology (Podcast)
  • Top 10 pipeline blowups, setbacks and snafus in H2 2016 (Endpoints)
  • Another Langer-backed biotech breaks out of stealth mode, aims for the clinic with hearing loss therapy (Endpoints) (Xconomy)
  • J&J grabs an option to buy a NASH drug in latest string of biotech deals (Endpoints)
  • Gilead tosses $100M milestone chip in its fast-growing gamble on new NASH drugs (Endpoints)
  • New Alzheimer’s Treatments Offer Hope Despite Recent Drug Failures (Scientific American)
  • Genentech Presses For Cancer Drug Patent's Invalidation (Law360-$)
  • J&J Denied Delay Request In Talc Cancer Missouri Trials (Law360-$)
  • MD Anderson Cancer Center to Lay Off Roughly 5% of Workforce (WSJ-$)
  • OncoBreak: Fewer Cancer Deaths; Hot Anticancer Protein; War and Cancer (MedPage Today)
  • Cryoport to deliver Gradalis autologous immuno-onc therapies across US (BioPharma-Reporter)
  • Synpromics to develop synthetic promotors for GE’s CHO platform (BioPharma-Reporter)
  • Pfizer licenses cell lines from preclinical CRO (Outsourcing-Pharma)
  • Appili Therapeutics Inc. Appoints Industry Veteran Stephen Nicolle to its Board (Press)
  • Sangamo BioSciences Changes Name To Sangamo Therapeutics (Press)

US: Pharmaceuticals and Biotechnology: Study Results, Filings and Designations

  • Teva cuts 2017 forecast, shares fall in pre-market trade (Financial Times-$)
  • What Passes For Positive Data (In the Pipeline) (CNBC) (Press)
  • Data Lacking on Prednisone Use in RA (MedPage Today)
  • FDA Grants Orphan Drug Designation to ALXN1210 for the Treatment of Patients with Paroxysmal Nocturnal Hemoglobinuria (Press)
  • Ionis and Akcea Enter into Strategic Collaboration (PharmaLetter-$) (Press)
  • Viamet Reports Positive Results from RENOVATE Phase 2b Trial of Oral VT-1161 in Onychomycosis (Press)
  • Xenetic Biosciences Receives $3 Million Milestone Payment from Shire (Press)
  • Rgenix Announces Treatment of First Patient in Phase 1 Trial of RGX-104, its Lead Immuno-Oncology Therapeutic (Press)
  • AACR Project GENIE Publicly Releases Large Cancer Genomic Data Set (Press)
  • KaloBios Announces Positive Guidance from FDA for Benznidazole (Press)
  • Acceleron Outlines Corporate Goals and Priorities for 2017 (Press)

Medical Devices

  • Bristol-Myers Squibb and GeneCentric Diagnostics Announce Exploratory Biomarker Research Collaboration (Press)
  • Roche gains FDA Clearance for 18-Minute Anti-Müllerian Hormone Test to Assess Ovarian Reserve (Press)
  • Cancer Diagnostic Startup Capio Moves to Wisconsin, Raises $2.9M (Xconomy)
  • Graphene Sensor Detects Individual Brain Cancer Cells (MedGadget)
  • Boston Sci giving lift to new erectile dysfunction device (Mass Device)
  • Lombard wins Japanese clearance for IntelliFlex LP delivery device for Aorfix stent graft (Mass Device)
  • Mazor Robotics gains on Street-beating Q4 outlook (Mass Device)
  • Obstetrical and Gynecological Devices; Reclassification of Surgical Instrumentation for Use With Urogynecologic Surgical Mesh (Federal Register)
  • Insomnia Device Maker Cerêve Raises $38M From KKR, Others (Law360-$)
  • Top 10 Medical Device Regulatory Stories of 2016 (Emergo)
  • Authorization of Emergency Use of an In Vitro Diagnostic Device for Detection of Zika Virus; Availability (Federal Register)

US: Assorted and Government

  • H.R.242 - To amend part D of title XVIII of the Social Security Act to require the Secretary of Health and Human Services to negotiate covered part D drug prices on behalf of Medicare beneficiaries (Bill)
  • Botanical drug development guidance undergoes its first revision (Lachman Consultants)
  • 21st Century Cures: Three Notable Provisions (FDA Law Blog)
  • Doctors, Nurses Still Divided on Tom Price (MedPage Today)
  • FDA issues 2 guidances on nutrition facts (Natural Products Insider)

Upcoming Meetings and Events             


  • No further time concession to radiopharmaceutical importers for non-compliance: DCGI (PharmaBiz)

General Health and Other Interesting Articles

  • Inside a killer drug epidemic (NY Times-$)

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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