Regulatory Recon: Roche's Tecentriq Fails in Phase III PhRMA Cuts 22 Members (10 May 2017)

Posted 10 May 2017 | By Michael Mezher 

Regulatory Recon: Roche's Tecentriq Fails in Phase III PhRMA Cuts 22 Members (10 May 2017)

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

In Focus: US

  • Senate Confirms Gottlieb as Next FDA Commissioner (Focus) (NYTimes) (STAT)
  • How Much Change Does a Commissioner Make? (Eye on FDA)
  • Pharma Lobby Ousts 22 Drugmakers Amid U.S. Pricing Debate (Bloomberg) (BioCentury)
  • Billions saved because FDA didn't rush approval of Alzheimer's drug (Reuters)
  • Pfizer, German Merck immuno-oncology drug wins FDA approval for bladder cancer (Reuters) (PharmaTimes) (PMLive) (Press)
  • Roche's star cancer drug stumbles in study, raising doubts about future (Reuters) (Pharmafile) (PharmaTimes) (The Street) (Endpoints) (Press)
  • FDA Science Board Weighs Plan for 'Cures' Funds (Focus)
  • Does the White House need its own drug policy office? A former insider offers a resounding 'yes' (STAT)
  • Senate's Help To Hold Drug Price Hearing (BioCentury)
  • GOP report says health bill could be 'mild negative' at worst (Politico)
  • Examining the "Drug Innovation Paradox": Should the Length of Exclusivity Reflect the Time it Takes to Develop a Drug? (FDA Law Blog)
  • Significant Safety Events Found in a Third of FDA-Approved Drugs, Study Finds (Focus)
  • Marathon's Bad News May Help Industry In Pricing Debate (Pink Sheet-$)
  • FDA Warns Indian Firm for Impeding Inspection (Focus)
  • Critics at Town Halls Confront Republicans Over Health Care (NYTimes)
  • Sen. Manchin Bill Proposes One In, One Out for Opioid Approvals (Congress)
  • Turing is considering a $100M cash offer for the drug that triggered a national scandal over drug pricing (Endpoints)

In Focus: International

  • With Macron Elected, 10 Insights Into US-France Trade—From Brandy To Insulin (Forbes)
  • Eurasian Medical Device Regulatory System Advances (Emergo)
  • India government panel rejects Boston Scientific plea on stent price caps (Reuters)
  • Biosimilars in the EU: New IMS Report Shows Savings Through Competition (Focus)
  • AstraZeneca asthma drug fails, after similar setback at Roche (Reuters) (Pharmafile) (Fierce) (Endpoints)
  • New Korean President Set To Maintain Pharma Policy Support (Pink Sheet-$)
  • Valeant shares jump as it lifts full-year earnings guidance (Financial Times)
  • Behind the numbers: The pharmaceutical industry and global health (EPR)
  • Asia Regulatory Roundup: TGA Plans to Bolster its Punishment Powers (Focus)
  • Stability At Last For Drug Innovators And Pricing In Australia (Pink Sheet-$)
  • EU approves first immunotherapy for neuroblastoma (PharmaTimes)
  • EUSA Pharma wins accelerated approval for rare cancer drug (PharmaLetter-$)
  • Pharma Firms Told To 'Keep Your Distance' When Patients Come To EU CHMP Meetings (Pink Sheet-$)
  • Turkey Spinraza Access Scheme Falls Far Short Of Demand (Pink Sheet-$)
  • Factors for manufacturers to consider as they enter the biosimilars space (PharmaLetter-$)

US: Pharmaceuticals & Biotechnology

  • Modernizing the Way Drugs Are Made: A Transition to Continuous Manufacturing (FDA)
  • Accelerating Pace of Approvals and a Strong Development Pipeline Indicate Vigorous Growth for New Biotech Products (Tufts)
  • New study points to a double-digit hike in branded drug prices, spotlighting a growing national debate (Endpoints)
  • Avastin as effective as Eylea for treating central retinal vein occlusion (NIH)
  • Patient Voices: Crohn's Disease (NYTimes)
  • Are Statin Side Effects 'All in Our Heads'? (NYTimes)
  • Pain Relievers Tied to Immediate Heart Risks (NYTimes)
  • FDA Warns Lonza's Class II Device Manufacturing Site (Focus)
  • FDA Blueprint for Opioid Education Shifts Focus to Pain Patients (Focus)
  • FDA Official Offers Advice In Absence Of DSCSA Waiver Guidance (RxTrace)
  • Why pharma needs help dealing with the 'wicked problem' of vaccine shortages (PharmaLetter-$)
  • Allergan says it had a good start to 2017 (PharmaLetter-$)
  • Trump administration appoints new AHRQ director (Modern Healthcare)

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

  • Bristol-Myers Squibb and Calithera Biosciences Expand Collaboration Evaluating Opdivo (nivolumab) in Combination with CB-839 into Non-Small Cell Lung Cancer and Melanoma (Press)
  • Agilis Biotherapeutics Announces Presentation of Data from Phase I/II Trial for Treatment of AADC Deficiency (Press)
  • Experimental drug reduces thyroid-associated 'Graves' eyes' (Reuters)

US: Medical Devices

  • How Consumer Technology Is Driving Innovation in Medical Devices (MDDI)
  • Biotronik wins FDA nod for CRT-D Multi-Pole Pacing tech (MassDevice)
  • Robotic surgery is taking off: Here's what you need to know (MedicalDesign&Outsourcing)
  • CurveBeam wins FDA 510(k) for InReach extremity cone beam CT (MassDevice)
  • Allergan, Medicines360 tout 4-year pivotal data for Liletta intrauterine contraceptive (MassDevice)
  • Initial Pre-Emergency Use Authorization Submission Made to U.S. FDA for Use of ReCell® in a Mass Casualty Scenario (Press)
  • Insightec wins FDA nod for Exablate Neuro for use with 1.5T MRI (MassDevice)

US: Assorted & Government

  • Grassley, Chaffetz rebuke HHS secretary for muzzling agency employees (Washington Post)
  • SDNY Rejects Innovator Liability (Drug & Device Law)
  • Bristol-Myers, Pfizer Escape Suit Alleging Eliquis Risks (Law360-$)
  • Obamacare spared some families from medical financial catastrophe (Reuters)
  • US court rules in favour of Zydus Cadila in patent case (Economic Times)
  • Par Pharmaceutical, Inc. v. Luitpold Pharmaceuticals, Inc. (D.N.J. 2017) (Patent Docs)
  • AdvaMed president Whitaker talks Trumpcare and tax reform (MassDevice)
  • Appeals court upholds Boston Scientific win in pelvic mesh case (MassDevice)
  • Four Lessons In The Adoption Of Machine Learning In Health Care (Health Affairs Blog)

Upcoming Meetings & Events


  • 2016 MHRA GMP Inspections yields 50% more deficiencies in key areas (FDAZilla)
  • Cancer drug pricing: the truth and the rhetoric (ABPI)
  • Glenmark adds 1,000L line at Swiss plant and eyes further capacity (BioPharmaReporter)
  • Selexis' Swiss investment in mammalian cell lines (BioPharmaReporter)
  • Early access to medicines scheme (EAMS) scientific opinion: Glecaprevir/Pibrentasvir for the treatment of chronic hepatitis C (HCV) infection in adults (MHRA)


  • CFDA releases 2016 Annual Report for National Medical Device Adverse Event Monitoring (CFDA)
  • Fosun Investing In Partners Innovation Fund (BioCentury)
  • Rotavirus vaccine will have an impact in Asia (PLOS)
  • WuXi using Thermo Fisher to equip 28,000L single-use site in China (BioPharmaReporter)
  • Adimmune's Quadrivalent Flu Vaccine Approved by TFDA (Press)


  • Indian pharma market posts 8.3% growth in April 2017 to Rs. 9,474 crore (PharmaBiz)
  • Natco Pharma launches generic hepatitis C drug in India (Economic Times)
  • Natco Pharma launches generic blood cancer drug in India (Economic Times)


  • New Canadian clinical guideline for physicians to reduce use of opioids (EPR)

Other International

  • Private providers sense opportunity in Africa healthcare (Financial Times)
  • Infant mortality and malaria soar in Venezuela, according to government data (Reuters)

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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