Regulatory Recon: US Supreme Court Sends Obamacare Contraceptive Challenge to Lower Court Pfizer Acquires Anacor for $5.2B (16 May 2016)

Posted 16 May 2016 | By Zachary Brennan 

Regulatory Recon: US Supreme Court Sends Obamacare Contraceptive Challenge to Lower Court Pfizer Acquires Anacor for $5.2B (16 May 2016)

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

In Focus: US

  • Supreme Court sidesteps major ruling on Obamacare contraception coverage (Politico) (NPR) (Reuters) (TPM)
  • Pfizer to Buy Anacor for $5.2 Billion (PR) (WSJ-$) (NY Times-$) (Fierce) (Reuters)
  • As prices soar, US drugmakers say they bear an unfair burden (FT-$)
  • Vermont to require drug makers to explain price increases (AP)
  • Price spikes for life-saving drug (Politico)
  • Scientists Talk Privately About Creating a Synthetic Human Genome (NY Times-$)
  • In major shift, medical journal to publish protocols along with clinical trials (Retraction Watch)
  • FDA Finalizes Guidance on Postmarket Device Surveillance (Focus)
  • Why an FDA plan to find compassionate-use drugs may be a Band-Aid (STAT)
  • Valeant Outlines Heart Drug Discounts After Heavy Scrutiny (WSJ-$) (Bloomberg) (Reuters) (House Oversight)
  • Eisai's Lenvima approved in the US for kidney cancer (Pharma Times)
  • Custom Ultrasonics' AERs to Remain in Field (PR)
  • Medicare Payment Demo Would Put Often-Prescribed Cancer Drugs ‘Underwater’ (Pink Sheet-$)

In Focus: International

  • EMA's PRIME: Helpful But Not A Panacea (Pink Sheet-$)
  • Generic drug market in Central Europe to develop by 3%-6% pa between 2016 and 2021 (PharmaLetter-$)
  • Scheduling delegate's final decisions: Paracetamol / Ibuprofen, May 2016 (TGA)
  • Dying Infants and No Medicine: Inside Venezuela’s Failing Hospitals (NY Times-$)
  • EU regulators approve Biogen/Sobi's Alprolix (Pharma Times)
  • European Commission Publishes New Harmonized Standards for Devices, Implants, IVDs (Focus)
  • Summary Safety Review - SGLT2 Inhibitors (canagliflozin, dapagliflozin, empagliflozin) - Assessing the Risk of the Body Producing High Levels of Acids in the Blood (Health Canada)
  • Health Canada to propose regulatory change to allow access to diacetylmorphine (PharmaLetter-$)
  • Counterfeit Viagra seizures triple, says MHRA (Securing Industry

Drug Approval – Speed your time to market with FDA’s Expedited Programs

·          The FDA’s Expedited Programs – fast track designation, breakthrough therapy designation, accelerated approval pathway, priority review designation – reduce the time spent on the development and review processes and provide a faster way to market for your products that treat serious or life-threatening conditions.

·           Read this Cardinal Health white paper to learn how to leverage the benefits of each program and speed your time to market.

US: Pharmaceuticals and Biotechnology

  • Editorial: Congress Wakes Up to the Opioid Epidemic (NY Times-$)
  • Choice Of Regulatory Pathway Is Key Inflection Point In Drug Reviews (Pink Sheet-$)
  • Electronic Medical Records May Play Bigger Role In Future REMS Assessments (Pink Sheet-$)
  • REMS Assessment Challenges Shine Through In Opioids Review (Pink Sheet-$)
  • Wal-Mart expands generics procurement with McKesson (Reuters) (PR)
  • Amgen Sues Sandoz Over Biosimilar Version of Neulasta (Big Molecule Watch Blog) (Law360-$)
  • Sanofi Says Evidence Doesn't Justify Verdict In Patent Suit (Law360-$)
  • Pfizer Blocks the Use of Its Drugs in Executions (NY Times-$)
  • C&EN talking with Jay Bradner, physician-scientist turned R&D chief (C&EN-$)
  • New Scheduling Schedule: DEA Meets 90-Day Deadline For UCB’s Briviact (RPM Report-$)
  • There's A Pharma Waiting In The Sky: Lilly In Space (SCRIP-$)
  • Biogen enlists gene therapy stars, adds vectors for eye disease pipeline (Fierce) (PR)
  • UPS teams with Zipline, Gavi to deliver medical supplies using drones (Fierce)
  • ISSCR Releases Updated Guidelines on Stem Cell Research (ISSCR)
  • George Church has a wild idea to upend evolution. Here’s your guide
  • Will new gene editing tech NgAgo challenge CRISPR? (IPSCell)
  • Katrine Bosley's Race To Make Gene Editing A Medical Reality (Fast Company)
  • Will Smith to Deliver Keynote at 2016 BIO International Convention (BIO)

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

  • Aduro's pancreatic cancer drug fails in mid-stage study (Reuters) (Fierce)
  • New findings expand potential of cancer drug cetuximab (PharmaLetter-$)
  • Mundipharma and Purdue reach new deal to in-licence product from Esteve (PharmaLetter-$)
  • Merck to present new data on Keytruda at ASCO 2016 (PharmaLetter-$) (PR)
  • Teligent Announces FDA Approval Of Triamcinolone Acetonide Ointment USP, 0.1% (PR)
  • Gene editing player Caribou raises $30M B round (Fierce) (PR)
  • Trevena flubs heart failure trial, will now focus on ‘Breakthrough’ pain candidate (Fierce)
  • Sarepta's AdCom Needs FDA's Permission To Speak Freely (Forbes)
  • Weighing The Risks And Benefits Of A Drug Prescribed To Pregnant Women For Extreme Morning Sickness (Forbes)

Medical Devices

  • Theranos Is Wrong: We Don’t Need More Blood Tests (538)
  • AdvaMed Supports House Legislation to Preserve Medicare Patient DME Access (AdvaMed) (Bill)
  • Allergan’s Occuleve on track for FDA submission this year (Mass Device)
  • Impulse Dynamics secures $30m for novel heart implant (PharmaPhorum) (Mass Device)
  • Bone Index Receives FDA 510(k) Clearance for the Bindex Point-of-care Instrument to Help Physicians in Diagnosing Osteoporosis (PR)
  • First Ray Receives FDA 510(k) Clearance for CortiClamp Small Bone Fixation System (PR)

US: Assorted and Government

  • FDA Issues Final Guidance for Medical Foods Largely Ignoring Comments (FDA Law Blog)

Upcoming Meetings and Events              


  • Slight increase in sales of veterinary antimicrobials (Fimea)
  • Report: ConvaTec preps $1B IPO (Mass Device)


  • India's New IPR Policy (SCRIP-$)
  • A strange project to ‘revive’ the brain dead (The Hindu)
  • Government’s Patent Grant to Gilead Challenged (Economic Times)
  • Roche looks to block copies of Avastin in India (Economic Times)
  • Govt should improve health infrastructure to ensure access to quality medicines rather than controlling drug prices: OPPI (PharmaBiz)
  • Government implements polio immune strategy despite IPV shortage in India (PharmaBiz)


  • Senate reaches deal on Zika funding; House Republicans ready proposal (Boston Globe) (AP) (CNN)
  • Puerto Rico Reports First Microcephaly Case Linked to Zika (NY Times-$)
  • Yes, Zika will soon spread in the United States. But it won’t be a disaster (Science)
  • Tracing Zika Back to Patient Zero (Atlantic)

General Health and Other Interesting Articles

  • ‘Swine flu’, H1N2v reported in Minnesota (Outbreak News)
  • Q&A: Universal Health CEO believes Obamacare is here to stay (Modern Healthcare)
  • Study of Telemedicine Finds Misdiagnoses of Skin Problems (WSJ-$)
  • First penis transplant surgery in the US carried out in Boston (STAT)
  • Defective ‘breast cancer’ genes aren’t just dangerous for women. They’re also linked to aggressive cancer in men. (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.

Need to contact the editor of Regulatory Reconnaissance? Send him an email at

A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.

Categories: Recon, Regulatory News

Regulatory Focus newsletters

All the biggest regulatory news and happenings.


Most Viewed Articles