Regulatory Recon: Obama Signs 21st Century Cures Act (14 December 2016)

Posted 14 December 2016 | By Zachary Brennan 

Regulatory Recon: Obama Signs 21st Century Cures Act (14 December 2016)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @RAPSorg on Twitter.

In Focus: US

  •  21st Century Cures Act: Making Progress on Shared Goals for Patients (FDA)
  • Obama signs widely popular 21st Century Cures Act (FDA Law Blog) (Endpoints) (Modern Healthcare) (SNL) (White House) (Washington Post-$) (Obama and Biden Remarks) (Device Overview)
  • The 21st Century Cures Act — A View from the NIH (NEJM)
  • Let's work with Trump to reduce drug prices: Sen. Klobuchar (USA Today)
  • Grassley to Trump: Agencies Must Regulate Rx Drug Prices (InsideHealthPolicy-$)
  • Exclusive: If Trump skews science, researchers must raise the alarm - Obama official (Reuters)
  • Sanofi Is in Talks for Deal With Actelion Pharmaceuticals (WSJ-$) (Endpoints)
  • Payer and Policy Maker Steps to Support Value-Based Pricing for Drugs (JAMA)
  • All Eyes on Sandoz Biosimilar Case After High Court Denies Apotex Review (Bloomberg)
  • New drug OKs fell off a cliff in 2016 and the FDA wants you to know why (Endpoints)
  • FDA to Publicly Disclose ‘Emerging Signals’ Info for Medical Devices (Focus)
  • FDA approves first autologous cellularized scaffold for the repair of cartilage defects of the knee (FDA)

In Focus: International

  • EU-USA strategic meeting on the future of paediatric medicines (EMA)
  • Adaptation of formal requirements for marking/highlighting changes in manuscripts of medicinal product information (Swissmedic)
  • Intercept Pharma's liver drug wins conditional EU approval (Reuters)
  • Five pharmas fall foul of ABPI Code of Practice (PharmaTimes)
  • EU Pharma Patent Settlements Still Limiting Entry of Generics (Focus)
  • Endologix AFX CE Mark suspended over endoleak issues (Mass Device)
  • Indian pharmaceutical generics majors' growth will be driven by M&As (PharmaLetter-$)
  • Choosing the new WHO director general (BMJ)
  • NICE recommends old-fashioned temperature check over other methods (Onmedica)

US: Pharmaceuticals and Biotechnology

  • Year-over-year price growth up for 6th straight month; drug price growth at 24-year high (Altarum)
  • Bristol-Myers outlines a big R&D overhaul covering East, West Coast operations (Endpoints)
  • CRISPR Patent Outcome Won’t Slow Innovation (MIT Tech Review)
  • Month 2 of GDUFA Year Five Statistics Now Available (Lachman Consultants)
  • USP Creates New Global Health Standard to Help Fight Fatal Newborn Infections (USP)
  • Third Rock Startup, Goldfinch, Collects $55M to Dig Into the Genetics of Kidney Disease (Forbes)
  • Moderna's Mysterious Medicines (Forbes)
  • Three top Valeant execs jump ship after grabbing $1M retention bonuses (FiercePharma)
  • GSK opens new vaccines plant in Rockville, planning 200 fresh hires (FierceBiotech)
  • J&J incubator alumnus Ab Initio inks GPCR antibody deal with Pfizer (FierceBiotech)
  • New York in $500 million de Blasio-backed biotech boost (Pharmafile)
  • Ethics award for pharma giant Johnson & Johnson raises some eyebrows (STAT-$)
  • The Worst Biopharma CEOs of 2016 Are ... (TheStreet)
  • Analysts track a payer revolt against Sarepta’s controversial Duchenne drug (Endpoints)
  • Men to sue over drug that made them grow breasts (CNN)
  • Watson and Pfizer (In the Pipeline)
  • In a quest for a non-addictive pain drug, ex-Pfizer CEO turns to chili peppers (STAT-$)
  • US FDA Clears Akorn Plant After Re-Inspection (In-PharmaTechnologist)
  • CMO Evonik acquires silica business for $630m (Outsourcing-Pharma)
  • INC Research to move HQ from Raleigh to Morrisville, create 550 jobs (Triangle Business Journal)

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

  • Personal-genome cancer-risk profile may not inspire lifestyle changes (Reuters)
  • Pulmagen med passes phase 2 asthma test, seeks partner for late-stage trials (FierceBiotech)
  • bluebird bio Announces First Patient Treated with LentiGlobinTM Drug Product in Northstar-2 (HGB-207) Phase 3 Trial of Patients with Transfusion-Dependent β-Thalassemia (Press)
  • Syndax Pharmaceuticals Announces Collaboration with the National Cancer Institute to Develop Entinostat and SNDX-6352 for the Treatment of Cancer (Press)
  • VistaGen Therapeutics Grants Exclusive Sublicense of Cardiac Stem Cell Technologies to BlueRock Therapeutics (Press)
  • In-Depth Analyses Presented at International Symposium on ALS/MND Suggest Strong Biological Effect for NurOwn; Evidence of Halting of Disease Progression (Press)
  • Protalix BioTherapeutics Receives Letter Detailing Intended Purchases of Approximately $24 Million of alfataliglicerase to Treat Gaucher Patients in Brazil (Press)
  • Concert Pharmaceuticals Announces CTP-543 Positive Top-Line Phase 1 Results (Press)

US: Medical Devices                        

  • Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Devices; Third-Party Review Under the Food and Drug Administration Modernization Act (Federal Register)
  • Quest Diagnostics Reports Data Breach (WSJ-$)
  • Boston Scientific closes $75m Neovasc deal (Mass Device)
  • FDA Efforts to Mitigate Contact Lens Discomfort (Study)
  • FTC’s settlement with blood pressure app developer echoes frustration with misleading claims (MedCity News)
  • Intuitive Surgical boosts share repurchasing program to $3B (Mass Device)
  • Zimmer-Biomet prices $1B senior debt offering (Mass Device)
  • BodyCap to bring space wearables to consumers in 2017 (PharmaPhorum)

US: Assorted and Government

  • How Fast Could GOP Congress Get Obamacare Repeal To Trump's Desk? (Kaiser Health News)
  • Merry Xmas NIH—Here's your 0.1% additional raise (Modern Healthcare)
  • HHS Report Suggests That Patient Health Continues to Take a Back Seat to Medical Companies’ Pursuit of Maximum Profits (Public Citizen)

Upcoming Meetings and Events               


  • Count down to Christmas with the FakeMeds advent calendar (MHRA)
  • EU researchers join forces in search for Zika vaccine (PharmaLetter-$) (GEN)


  • Korean Drug Ministry releases more biosimilar approval results in English (Korea Herald)
  • India committed to adopt advanced technology to drive supply chain integrity of medicines: SM Mudda (PharmaBiz)
  • Class 1-3 in-house IVDs: using the online application form (Australia’s TGA)

Other International

  • 35% of all imported medicine in Guyana is fake, investigation finds (Pharmafile)
  • Extensive Brain Defects Seen in Babies of Mothers With Zika (NY Times-$) (Forbes) (JAMA)
  • Mexican Senate passes medical marijuana bill (Reuters)
  • Full impact of devastated health services in north-eastern Nigeria revealed by WHO report (WHO)

General Health and Other Interesting Articles

  • Gates launches $1 billion clean energy fund (C&EN)
  • DePinho Accepts Responsibility As MD Anderson’s Losses Grow (Cancer Letter)
  • Why Doctors Still Worry About Measles (NY Times-$)
  • Rolling Back Abortion Rights After Donald Trump’s Election (NY Times-$)
  • Oklahoma abortion restrictions blocked (Washington Post-$)

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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