Regulatory Focus™ > News Articles > Regulatory Recon: NIH Refuses to 'March-In' on Xtandi; Billionaire Sean Parker Funds First In-Human

Regulatory Recon: NIH Refuses to 'March-In' on Xtandi Billionaire Sean Parker Funds First In-Human CRISPR Trial (21 June 2016)

Posted 21 June 2016 | By Michael Mezher 

Regulatory Recon: NIH Refuses to 'March-In' on Xtandi Billionaire Sean Parker Funds First In-Human CRISPR Trial (21 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

  • Drug company-sponsored meals tied to more prescriptions (Reuters) (ProPublica) (WSJ-$) (CardioBrief)
  • CBER Laboratories in the Life Sciences-Biodefense Complex (FDA Voice)
  • NIH refuses Xtandi march-in request (BioCentury)
  • Government Appropriation Of Breakthrough Drug Patent Rights Would Deter Biopharmaceutical R&D And Innovation (Health Affairs Blog) (Harvard Bill of Health)
  • Money Behind First CRISPR Test? It's from Internet Billionaire Sean Parker (MIT Technology Review)
  • NIH Finalizes Single IRB Policy to Reduce Redundancies (Focus) (NIH)
  • A new way to cut drug prices? Make Big Pharma show what it spends to bring drugs to market (LA Times)
  • Results Wire: US FDA Advisory Committee Hears Updates About Research at CBER– JUN 20, 2016 (BPAC) (Tarius)
  • Visium's Valvani Found Dead in Apparent Suicide Amid Charges (Bloomberg)
  • Biosimilars in the US: Panel Discusses Tricky Balance of Building the Market With Necessary Precautions (Focus)
  • Landmark effort to speed drug approvals nears critical phase in Congress (STAT)
  • FDA Finalizes Guidance on Extrapolating Data for Pediatric Medical Devices (Focus)
  • FDA Issues Interim Response to PhRMA/BIO Joint Citizen Petition on Biosimilar Labeling (Big Molecule Watch) (FDA Letter)
  • The Migraine Race (In the Pipeline)
  • House Chair Fred Upton Demands Meeting With HHS: I Wanna Be In The Room Where It Happens (Forbes)

In Focus: International

  • Pharma biggies like Cipla, Pfizer among 200 under lens for poor drugs (Economic Times)
  • Takeda Cements Norovirus Lead Through Vaccine Trial Start (PharmAsiaNews-$) (PMLive)
  • Colombia Ministry of Health Ignores Corporate Threats and Possible US Interference, Improves Affordable Access to Cancer Treatment (Public Citizen)
  • CFDA Vice Minister Wu Zhen meets the delegation of Ministry of Health of the Federal Republic of Germany (CFDA)
  • Biosimilars in the EU: Lower Costs, Increased Patient Access, IMS Report Finds (Focus)
  • Asia Regulatory Roundup: CFDA Offers Guidance on Revised Vaccine Distribution Regulations (Focus)
  • Japan's MHLW names Tomonori Nakayama to key reimbursement post (Fierce)
  • UK biotech holds its breath as voters decide whether to split from EU (Fierce)
  • China's Regulatory Review on New Drugs and Oncology Market (PharmaceuticalComplianceMonitor)

US: Pharmaceuticals & Biotechnology

  • Two Out Of Three Ain't Bad: Biosimilar User Fee Talks Completed (Pink Sheet-$)
  • Life In The Trenches Of A Biotech LLC (LiveSciVC)
  • FDA Announces Minor Use/Minor Species (MUMS) Grant Application Open Period Due August 12, 2016 (FDA)
  • Fireside with Califf (BioCentury-$)
  • Therapy focus – Thawing conditions for PD-1s in colorectal cancer (EP Vantage)
  • Q&A: Roche's Dan Chen Talks Immuno-Oncology Combinations (Pink Sheet-$)
  • Lilly's Older Drugs Face More Price Pressure Than Newer Ones (Bloomberg)
  • Study Questions 'Lower Is Better' For Cholesterol (CardioBrief)
  • Interview – Cell Medica will drive a CAR to its next cash raise (EP Vantage)
  • On-Label HCV Treatment Works Better Than Off-Label, Analysis Shows (Pink Sheet-$)
  • Cheryl Laboratories added to US FDA "Red List" after refusing to allow inspection (In-PharmaTechnologist)
  • An innovative approach to collecting Real World Data (EPR)
  • Determination of Regulatory Review Period for Purposes of Patent Extension; XOFIGO (FDA)
  • Takeaways From Our Twitter Chat With PCORI (Health Affairs Blog)
  • Amgen Poised For Another Steep Drop (The Street)
  • Genetics company Counsyl targets oncologists in bid to boost patient screening (MedCityNews)

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

  • Mitsubishi Tanabe seeks US approval for Edaravone to Treat ALS (BioSpectrum) (Fierce)
  • FDA Approves New Drug Application for RAYALDEE® to Treat Secondary Hyperparathyroidism Associated with Vitamin D Insufficiency in Stage 3-4 Chronic Kidney Disease (Press)
  • Results of Phase 2 Study of Merck's Investigational Beta-Lactamase Inhibitor Relebactam in Combination with Imipenem/Cilastatin Presented at ASM Microbe (Press)
  • Breakthrough Designation Affirms Ocrelizumab Blockbuster Potential and Sets Ocrelizumab up for Approval and Launch by the End of 2017 - Research and Markets (Press)
  • Oncternal Receives Fast Track Designation for TK216 in Relapsed or Refractory Ewing Sarcoma (Press)
  • Cellectis Announces First Patient Treated in Phase 1 Trial of UCART19 in Pediatric Acute B Lymphoblastic Leukemia (B-ALL) (Press)
  • Results of Phase 2 Study of Merck's Investigational Beta-Lactamase Inhibitor Relebactam in Combination with Imipenem/Cilastatin Presented at ASM Microbe (Press)
  • Savolitinib Global Phase II Trial Initiated in EGFR Mutant Non-Small Cell Lung Cancer (Press)
  • WAVE Life Sciences Receives Orphan Drug Designation from FDA for its Lead Candidate Designed to Treat Huntington's Disease (Press)
  • Auris Medical initiates Phase III trial for sudden deafness treatment (Pharmafile)
  • Amgen's denosumab may help check breast cancer in women with BRCA1 gene – Study (Pharmafile)

US: Medical Devices

  • J&J's Ethicon recalls Physiomesh flexible composite hernia mesh (MassDevice)
  • Dexcom expands in Phoenix with new manufacturing facility (MassDevice)
  • Stryker initiates voluntary recall on select Target Nano neuro coils (MassDevice)
  • Valcare touts 1st-in-human use of Amend annulplasty ring (MassDevice)
  • Philips acquires Irish digital pathology firm PathXL (MassDevice)
  • Novartis-backed app provides social support for chronic hives patients (MobiHealthNews)
  • How the FDA Is Doing with Medical Devices and the Medical Device Industry (Policy and Medicine)

US: Assorted & Government

  • FDA Targets High-Risk Firms for Dietary Supplement GMP Reinspections (Natural Products Insider)
  • Labs Get Extra Year To Adjust To Diagnostics Reimbursement Revamp (Gray Sheet-$)
  • Can Plaintiffs Sue a "Celebrity Spokesperson"? (Drug and Device Law)
  • A New and Improved (Updated) List of Pending DESI Program Proceedings (FDA Law Blog)
  • Department Of Labor Awakening Could Have Greater Impact On Healthcare Than Obamacare Did (Forbes)
  • Teen marijuana use in Colorado found lower than national average (Reuters)
  • Shareholders Lose Suit Over Glaucoma Drug Trial (Law360-$)
  • Medical Device Maker Must Arbitrate Dispute, NJ Court Says (Law360-$)
  • California Regulator Signs Off On $37 Billion Aetna-Humana Insurance Merger (KHN)

Upcoming Meetings & Events


  • Inhaled-Drug Maker Savara Buys European Biotech With Two Candidates (Xconomy)
  • Nomenclature For Eudamed Could Be Free With New EU Regs: Impact On GMDN? (Clinica-$)
  • Advertising investigations: May 2016 (MHRA)
  • Half Of The UK Living With Chronic Pain, Study Finds (Forbes)
  • ABPI BMAG says new insights into biologic medicines market present a "win-win" for the NHS (ABPI)
  • Lombard Medical wins CE Mark for Aorfix AAA stent graft delivery device (MassDevice)
  • Murdo Gordon Appointed Executive Vice President and Chief Commercial Officer (Press)
  • Therapix Biosciences Signed a Binding MOU With a Swiss Pharmaceutical Development Company, to Receive a License to Use a Formulation for Ultralow-Dosage Administration (Press)


  • Eisai launches dementia registry (BioCentury)
  • China formally approves marketing authorization pilot and pharma contract manufacturing (PharmaLetter-$)
  • Malaysia's New Reg System Is Coming – And No More Extension This Time (Clinica-$)
  • Carlyle Group Hires Former J&J Executive to Advise Asia Buyout Fund (WSJ-$)
  • MSD Accesses Korea Oncology Innovation Through State Fund (PharmAsiaNews-$)
  • China rolls out sops for investments to Indian pharma companies (Economic Times)


  • CIPMMA urges DCGI to provide prior information to industry about listing of drugs under 'banned category' (PharmaBiz)
  • India ups direct foreign investment cap in drug companies to 74% from 49% (Fierce)
  • Expensive R&D, slow drug discovery lead startups to accelerate out-licensing opportunities: Prof Murthy (PharmaBiz)
  • Indian E-Chemists Decry Regulatory 'Witch Hunt' Amid Offline Rival Opposition (PharmAsiaNews-$)


  • Annual Charge Exemption (ACE) scheme forms (TGA)


  • NIH launches large study of pregnant women in areas affected by Zika virus (NIH)
  • US to help fund technology to eliminate Zika in blood supply (Reuters) (Fierce)
  • Zika's impact on children will require new medical approach: expert (Reuters)

General Health& Other Interesting Articles

  • Tech Companies Mull Storing Data in DNA (IEEE Spectrum)
  • Parkinson disease may be getting more common (Reuters)
  • Many patients at risk for stroke get wrong medicine (Reuters)
  • Many surgical readmissions can't be blamed on hospitals (Reuters)
  • The Evolving World Of 'Money Is No Object' Medical Tourism (Forbes)

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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