Regulatory Recon: Criteria for New EMA Host Coming Saturday Concerns Raised About Integrity of International Trials (27 April 2017)

Posted 27 April 2017 | By Michael Mezher 

Regulatory Recon: Criteria for New EMA Host Coming Saturday Concerns Raised About Integrity of International Trials (27 April 2017)

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

In Focus: US

  • Senate Committee Advances Gottlieb Nomination as FDA Commissioner (Focus)
  • GOP looks short on repeal vote (Politico)
  • Hard-Line Republican Caucus Backs Revised Bill to Repeal Obamacare (NYTimes 1, 2) (Reuters)
  • Supreme Court Weighs Biosimilar Patent Dance (Focus) (Reuters) (Patent Docs) (BioCentury) (Transcript)
  • Widespread Hype Gives False Hope To Many Cancer Patients (KHN)
  • Negotiating Drug Prices: Should State Agencies Band Together? (KHN)
  • How low can you go? US pharma already shoulders light tax burden (EP Vantage) (Fierce)
  • If The NIH's Budget Gets Slashed, Don't Expect Biopharma To Make Up The Difference (Forbes)
  • The top 10 pharma R&D budgets in 2016 (Fierce)
  • Novartis, Pfizer and Amgen top pharma's lobby spending in eventful Q1 (Fierce)
  • Bristol-Myers beats Wall St estimates, helped by Cancer drug Opdivo (Reuters) (Press)
  • Celgene quarterly sales misses on soft demand for psoriasis drug (Reuters)
  • Drugmaker AbbVie's profit, revenue beat as Humira sales rise (Reuters)
  • Cost controls help offset lower Amgen first-quarter drug sales (Reuters) (BioCentury) (The Street)
  • Ahead Of Vote, Gottlieb Advocates For Public CRLs (BioCentury)

Sponsored Content: Trying to Map Out the Transition to Comply with IDMP Standards?

In Focus: International

  • Criteria for EMA, EBA hosts coming Saturday (Politico)
  • Serious Questions Raised About Integrity Of International Trials (CardioBrief) (In The Pipeline)
  • Drugs firms call for phased transition of regulation after Brexit (Reuters)
  • South Korea fines Novartis $49 million over kickbacks, suspends insurance payment (Reuters)
  • Cheap blood drug could prevent thousands of maternal deaths in developing world (NYTimes) (NPR) (Reuters)
  • Synairgen loses half its value as AstraZeneca dumps drug (Reuters) (Fierce)
  • Negative NICE draft guidance for Ninlaro (PharmaLetter-$) (PharmaTimes)
  • Ocalvia gets NHS green light for rare chronic liver disease (PharmaTimes)
  • Swiss drugmaker Roche confident sales growth will overcome generic threat (Reuters) (Press)
  • EMA Should Clarify Role in Collaboration on Non-EU Drugs, Officials Say (FDANews-$)
  • TGA Scraps 15-Day GMP Clearance Timeline, Expands to 30 Days (FDANews-$)
  • ABPI unveils its post-election wish-list (PharmaTimes)
  • New conductor, old tune from U.K. pharma lobby as ABPI threatens exodus (Fierce)
  • Finance chief quits drugmaker Teva, leaving another gap at top (Reuters) (Pharmafile)
  • Neurocrine goes high—$60K-plus high—with price for new movement drug Ingrezza (Fierce)
  • Bayer CFO Dietsch to leave company in May 2018 (Reuters)

US: Pharmaceuticals & Biotechnology

  • America's Other Drug Problem (ProPublica)
  • Apotex Petitons FDA on Biosimilar NEULASTA; Wants Comparative Clinical Efficacy Studies in at Least One Patient Population (FDA Law Blog)
  • Merck cholesterol drug Vytorin faces competition from Impax, Teva generics (Reuters)
  • Beyond Genes and Molecules — A Precision Delivery Initiative for Precision Medicine (NEJM)
  • Whose Data Are They Anyway? Can a Patient Perspective Advance the Data-Sharing Debate? (NEJM)
  • Pharma boss, facing 30 years in prison, battles US extradition (Securing Industry)
  • Spreading Plan C to End Pregnancy (NYTimes)
  • Roche dumps lead asset from its $725M Seragon buy (Fierce)
  • FDA Looks to License Technology for Purifying Synthetic DNA Sequences (Federal Register)
  • Mark Zuckerberg And Priscilla Chan's Philanthropy Backs Effort To Change Scientific Publishing (Forbes)
  • Gates Foundation Leads Arsanis' $45.5m Series D (BioCentury)
  • Antidepressant may enhance drug delivery to the brain (NIH)
  • DiCE Places Bets On Tomorrow's Small Molecules (SCRIP-$)
  • FDA Patient Feedback Meetings: External Model Ramping Up In 2017 (Pink Sheet-$)
  • CPhI expert says quicker approvals for ANDA's would lower drug costs (EPR)
  • SMA Patient Meeting Showcases FDA Flexibility – And Appreciation From Advocates (Pink Sheet-$)
  • Akebia Surges but is Still Undervalued, Making Takeover a Potential Remedy (The Street)

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

  • Pfizer's Next-Generation ALK/ROS1 Inhibitor, Lorlatinib, Granted Breakthrough Therapy Designation from FDA for ALK-Positive Metastatic Non-Small Cell Lung Cancer (Press)
  • Sage Therapeutics Announces Initiation of Phase 1 Development and First Dosing of SAGE-718 (Press)
  • Amazentis SA Announces Successful Phase 1A/1B Study Results in Healthy Elderly Subjects with the Food Metabolite Urolithin A (Press)
  • Bonti Announces Inaugural Presentation of Phase 2a Clinical Data for Its Lead Product EB-001 (Press)

US: Medical Devices

  • Underwriters Laboratories acquires Emergo Group (MedicalDesign&Outsourcing)
  • Let's Design for People as Consumers, Not Patients (MDDI)
  • Edwards shares rise on Beat-and-Raise Q1 (MassDevice)
  • Stryker shares steady on Street-topping Q1 earnings (MassDevice)
  • Boston Scientific's Q1 sales top Wall Street, earnings miss by a penny (MassDevice)
  • Mercator enrolls first patient in BTK vascular disease trial (Drug Delivery)
  • Medtronic touts 5-year Endurant II AAA registry data (MassDevice)
  • Medtronic touts long-term data from VenaSeal studies (MassDevice)
  • LimFlow wins FDA IDE to launch end-stage CLI treatment trial (MassDevice)
  • Braeburn's risperidone implant meets primary endpoint in schizophrenia trial (MassDevice)
  • Samsung GC70 Digital Radiography System Receives FDA 510(k) Clearance (Press)

US: Assorted & Government

  • House to Consider MDUFA Add-Ons (Focus)
  • White House to keep paying Obamacare subsidies for now: official (Reuters)
  • Anthem Threatens to Leave Health Exchanges if Subsidies Are Halted (NYTimes)
  • Senate User Fee Bill S.934 Posted, Awaiting Summary and Text (
  • House Bill Would Require Doctors to Report Certain Device Adverse Events (
  • Availability, Outcomes, and Federal Support Related to Pediatric Trauma Care (GAO)
  • Supreme Court 4/25 Personal Jurisdiction Argument (Drug & Device Law)
  • J&J, Bayer face first jury trial over blockbuster Xarelto's bleeding risks (Fierce)
  • Bayer Fights En Banc Review Of Dow's $455M Patent Loss (Law360-$)

Upcoming Meetings & Events


  • Celltrion's Truxima launched in Europe (Biosimilar News)
  • Realising the benefits of health data (EFPIA)
  • SAB Biotherapeutics moves to bolster board (Pharmafile)
  • Intuitive Surgical wins CE Mark for da Vinci X system (MassDevice)
  • Clinigen to run managed access program for Onxeo's belinostat in Europe (Fierce)


  • CFDA issues Provisions for Medical Device Standards (CFDA)
  • Astellas Reports Full Year FY2016 Financial Results (Press)
  • China Drugmaker Drops Paper-Based Documentation (PharmaceuticalManufacturing)


  • Indian pharma to maximise quality, timelines & budgets to market drug products via digital platforms (PharmaBiz)
  • Health ministry to give final touches to norms on GMPs to align with global regulations (PharmaBiz)
  • MRPA urges CDSCO reconsider health ministry move to allow pharmacists to dispense generics equivalent to branded drugs (PharmaBiz)
  • Zydus Cadila gets USFDA nod for anti-cholesterol drug (Economic Times)


  • Generics Firms Don't Infringe Patents Just By Applying For Reimbursement, Australian Court Confirms (Pink Sheet-$)

Other International

  • Injured Venezuela protesters face another woe: finding medicine (Reuters)
  • Meningitis outbreak in Nigeria has killed 813 people: minister (Reuters)
  • WHO says Liberia taking precautions after mystery deaths (Reuters)

General Health & Other Interesting Articles

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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