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Regulatory Recon: Six Former FDA Commissioners Call for HHS-Independent FDA Supreme Court Strikes Down Texas Abortion Clinic Rules (27 June 2016)

Posted 27 June 2016 | By Michael Mezher 

Regulatory Recon: Six Former FDA Commissioners Call for HHS-Independent FDA Supreme Court Strikes Down Texas Abortion Clinic Rules (27 June 2016)

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

In Focus: US

  • High drug prices a bitter pill to swallow for sick Americans (CBS 1, 2)
  • Biotech Labs Birth New Drugs—and New Fortunes (WSJ-$)
  • Empagliflozin May Be Poised To Gain CV Indication (Cardiobrief) (BioCentury)
  • Senators Hatch and Wyden: Do your jobs and release the sealed opioids report (STAT)
  • GW Pharma says cannabis-based epilepsy drug meets main goal (Reuters) (The Street)
  • Quality Metrics: FDA Outlines What Data to Submit (Focus)
  • Six former commissioners say FDA should be independent agency (STAT) (Politico) (SCRIP-$)
  • Manufactured stem cells to advance clinical research (NIH)
  • Senate to Take Up House Bill on Zika Funding, Barbs and All (NYTimes) (Politico)
  • Inside A Secret Government Warehouse Prepped For Health Catastrophes (NPR)
  • Supreme Court strikes down Texas abortion clinic regulations (STAT)

In Focus: International

  • MHRA Mulling Brexit Implications as UK's BSI Says it Will Remain an EU Notified Body (Focus) (Medical Devices Legal)
  • Brexit: I woke up this morning and the world had changed (Harvard Bill of Health)
  • Brexit Will Be Bad For Pharma (Forbes) (EP Vantage)
  • Why Brexit Is So Bad for the Global Economy (The Atlantic)
  • Bayer CEO Takes Risk in Bid for Monsanto (WSJ-$)
  • Circassia's blemishes are a reminder of the risks in biotech (Financial Times)
  • Sanofi, Boehringer Ingelheim Agree to $25 Billion Asset Swap (Bloomberg)
  • Global Pharma Spending May Reach $1.4 Trillion by 2020: Chart (Bloomberg)
  • EMA Recommends Suspending Alkem Drug Over Flawed Studies (Focus)
  • Bangladesh gets $150 million from World Bank for health (Reuters)
  • Brexit sparks competition for EMA headquarters (BioCentury)
  • EMA Begins Review of US CMO Pharmaceutics international (EMA) (PharmaLetter-$)

US: Pharmaceuticals & Biotechnology

  • Clinical-Development Company Medpace Files for IPO (WSJ-$)
  • Researchers pinpoint best meds to treat migraine in the ED (Reuters)
  • Game-based drug adherence app startup HealthPrize nabs Series B (Fierce)
  • FDA's Biosimilar Suffix 'Error': Molehill Withdrawn But Mountain Coming? (Pink Sheet-$)
  • With Selecta, total raised by Mass. biotechs so far this year hits $376M (Boston Biz Journal)
  • KaloBios, Shkreli Deal Gets Final OK In Bankruptcy Court (Law360-$)
  • Sometimes Even A Breakthrough Discovery Is Not Enough, You Also Need The Strength To See It Through (Forbes)
  • Allergan Is Primed for Increase After a Big Decline (The Street)
  • FDA Oncology Office Looks To Get Better INFORMED Through Big Data (Pink Sheet-$)
  • Growing Established Pharma Products: Three Strategic Imperatives (In Vivo-$)
  • ICER Review Of NSCLC Drugs To Include Roche's Pending Indication For Tecentriq (Pink Sheet-$)
  • Creating A Partial Solution To Delayed Generic Competition (Law360-$)
  • FDA, PD-1 Inhibitor Sponsors Discussing Real-World Study (Pink Sheet-$)
  • Clinical Trial Endpoints May Not Fit Real-World Studies (Pink Sheet-$)
  • Real-World Evidence May Find A Home On Breakthrough Pathway (Pink Sheet-$)
  • Four Strategies For Creating Value In Life Sciences (Forbes)
  • Unforced Error: Pharma Supporter Attacks The Wrong Paper (Cardiobrief)
  • Merck Oncology Strategy: With First-Line Lung Data, A New Day Dawns For Keytruda (Pink Sheet-$)
  • Engineering Roche's Next Big Thing: Bispecific Antibodies And Beyond (Pink Sheet 1, 2-$)
  • Senators Send FDA Letter with Concerns Over Draft Guidance Documents (Policy and Medicine)
  • Healthcare providers do not fully understand cancer risk from CT scans (MNT)
  • Cancer immunotherapy may increase risk of developing rheumatologic disorders: Johns Hopkins study (Fierce)
  • Allergy Therapeutics says study fails to find hay fever therapy dose range (Reuters) (Fierce)
  • Pfizer Completes Acquisition of Anacor (Press)

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

  • Bristol-Myers Squibb's Opdivo (nivolumab) Receives Breakthrough Therapy Designation from U.S. Food and Drug Administration for Advanced Form of Bladder Cancer (Press)
  • Oncobiologics announced first CTA approvals for global Phase 3 clinical program for ONS-3010 (Biosimilar News)
  • SanBio Presents Interim Results of Chronic Stroke Phase 1/2a Clinical Trial at International Society of Stem Cell Research Annual Meeting (Press)
  • The Medicines Company Announces Positive Top- Line Results for Phase 3 TANGO 1 Clinical Trial of CARBAVANCE (Press)
  • Santalis Pharmaceuticals Announces Positive Results From a Study Using 10% East Indian Sandalwood Oil (EISO) Serum Formulation for the Treatment of Mild-to-Moderate Plaque Psoriasis (Press)
  • FDA Grants Napabucasin Orphan Drug Status for Gastric Cancer (MPR)
  • Singapore's ASLAN gets second U.S. FDA orphan designation for ASLAN001 (Fierce)

US: Medical Devices

  • Medtronic to put up $1.1B for HeartWare (MassDevice) (Press)
  • Global Medical Device Industry Prepares to Transition to New ISO Standard (MDDI)
  • Fresenius touts 10-year dialysis mortality reduction (MassDevice)
  • Johns Hopkins team diagnoses brain infections using next-gen sequencing (Fierce)            
  • Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 043 (FDA)
  • InVivo Therapeutics touts case study in 1st spine scaffold implant (MassDevice)
  • Why Is It So Hard to Innovate at Big Medical Device Companies? (MDDI)
  • NDS receives FDA clearance for embedded wireless video receiver in Radiance Ultra displays (Press)
  • Accuray Receives 510(k) FDA Clearance for the Radixact Image-Guided Radiation Therapy Platform and Integrated Software (Press)

US: Assorted & Government

  • Arizona says it has run out of drugs for executions (Reuters)
  • Sorry, Paul Ryan: Obamacare's Not Hurting Doctors But Making Them Rich (Forbes)
  • Flint children's blood lead levels rose in water crisis: US officials (Reuters)
  • Florida Appellate Court Applies State Daubert Test Retroactively to Exclude Expert and Dismiss Case (Drug and Device Law)
  • Suit Challenges U.S. Over Abortions and Birth Control for Immigrant Minors (NYTimes)
  • GE Unit Diluted Cell Growth Serum, Stole Buyers, Suit Says (Law360-$)

Upcoming Meetings & Events


  • EU officials to decide on Roundup herbicide after political impasse (Reuters)
  • Brexit To Leave Most Of European Pharma Outside EU (SCRIP-$)
  • Jimenez: "Huge Sense Of Urgency" To Implement Outcomes-Based Systems In Europe (SCRIP-$)
  • British watchdogs suspend Astellas UK after investigations, audits, and a crackdown from Japanese HQ (Fierce)
  • EMA reviewing veterinary medicine Velactis following serious adverse events in cattle (EMA)
  • MolMed gains European conditional nod for 'suicide gene' drug (Fierce)
  • Merck Receives CHMP Positive Opinion for KEYTRUDA (pembrolizumab) for the Treatment of Advanced Non-Small Cell Lung Cancer (NSCLC) (Press)
  • Reflection paper on viral safety of plasma-derived medicinal products with respect to Hepatitis E virus (EMA)
  • UK launches study of Dune Medical's MarginProbe breast cancer device (MassDevice)
  • Ferring Pharmaceuticals announces approval of new tailored dosing regimen in the PICOPREP (sodium picosulfate, magnesium oxide, citric acid) label in MRP countries in Europe (Press)


  • Takeda ends Japan deal for two Amgen candidates (BioCentury)
  • Cytori Cell Therapy Receives Limited Approval for Osteoarthritis in Japan (Press)
  • Taiwan Liposome PhI/II trial on acupuncture-type arthritis candidate fully enrolled (Fierce)
  • 'Sea Turtles' Give China's Drug Startups a Shot in the Arm (Bloomberg)
  • INTERVIEW: Korea Initiative Aims To Create Global Clinical Trial Hub (PharmAsiaNews-$)


  • CDSCO renews WC certificate to API units to ease export to EU countries (PharmaBiz)
  • Dr. Reddy's Laboratories, GSK end tie-up in emerging markets (LiveMint)
  • Brexit – Indian Pharma's Diversified Play A Buffer? (PharmAsiaNews-$)
  • PvPI needs to include pharmacy colleges to expand patient safety reporting: Dr Shobha Rani Hiremath (PharmaBiz)


  • Servier Canada to sell Daiichi Sankyo's Factor Xa Inhibitor Edoxaban in Canada BioSpectrum)

Other International

  • Sickle Cell Partnership Creates Demonstration Project to Treat Children in Angola (Press)

General Health & Other Interesting Articles

  • Demand for 'Himalayan Viagra' Fungus Heats Up, Maybe Too Much (NYTimes)

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? Find him on Twitter at @Michael_Mezher or send him an email at

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

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