Regulatory Recon: Google's Verily to Launch 10,000 Patient 'Baseline' Study; WHO, Gates Underscore Progress Against NTDs (19 April 2017)

Posted 19 April 2017 By Michael Mezher

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

In Focus: US

  • Alphabet seeks 10,000 volunteers — and their health data — for a massive medical study (The Verge) (Financial Times) (Forbes 1, 2) (Bloomberg)
  • Senate HELP Committee to Vote on Gottlieb as FDA Commissioner on 26 April
  • Trump era strengthens the vaccine doubters' resolve (Financial Times)
  • 'Holy grail' of universal cancer cure remains a distant prospect (Financial Times)
  • Johnson & Johnson's Weak Pharma Revenue Could Spell Doom for Rest of Sector (The Street)
  • J&J's Remicade sees 'very little' biosim erosion, but payers are sticking it to Xarelto (Fierce)
  • Flexible 'Menu' Of Antibacterial Development Options Suggested By US FDA Panel (Pink Sheet-$)
  • Can Big Data Match Up To The Big Promise? (Pink Sheet-$)
  • FDA Warns LA-Based Medical Food Company for Clinical Trial Without an IND (Focus)
  • Theranos Agrees to Two Year Ban, Refunds Every Arizonan Who Purchased a Blood Test (Focus)
  • FDA User Fee Bills: Is It Possible For Reauthorization To Be Too Clean? (Pink Sheet-$)
  • An open source pharma roadmap (PLOS)
  • Hackers hit 320% more healthcare providers in 2016 than in 2015, per HHS data (HealthcareITNews)
  • Cardinal Health's dull forecast drags along rivals' shares (Reuters)
  • Allergan, Argentum settle patent dispute over eye drug Restasis (Reuters)
  • A New Act for Health Care Coverage (NYTimes)
  • Health Insurers Make Case for Subsidies, but Get Little Assurance From Administration (NYTimes)
  • Secret Hospital Inspections May Become Public at Last (ProPublica) ( NPR)
  • Vaping Venture Poses Potential Conflict for Trump's FDA Nominee (Bloomberg)

In Focus: International

  • Anglo-Japanese JV announces Shingrix submission in Japan (PharmaLetter-$)
  • Unprecedented progress against neglected tropical diseases (WHO)
  • Gates backs Big Pharma push to wipe out tropical diseases (Reuters)
  • Asia Regulatory Roundup: India Looks to Reform Drug Pricing Legislation (Focus)
  • NICE nod for Novartis' Cosentyx in PsA (PharmaTimes)
  • MHRA Investigates GMP Deficiency Trends From 2016 (Focus)
  • TGA to Move Forward With Orphan Drug Revamp (Focus)
  • Malaysian Regulators Sets Deadlines for Combination Product Regulatory Policy (Emergo)
  • With new online tool, MSF invites Pfizer, GSK investors to weigh in on vaccine pricing (Fierce)
  • Cancer Research UK, NCI Funding Ras Research (BioCentury)
  • Amid vaccine debate, Italy faces return of eradicable diseases (Financial Times)
  • Fake Clinical Data No More: China To Criminalize Forgery (Pink Sheet-$)
  • China's push on innovation nourishes cross-border collaborations (PharmaLetter-$)
  • Ionis looks east, teaming up with Ribo to bring RNA drugs to China (Fierce)
  • Galapagos Eyes Rare European Biotech Heavyweight Title, Launches $338m Offering (SCRIP-$)
  • UK firms should look to global opportunities to offset Brexit woes, says biotech CEO (InPharmaTechnologist)
  • HPRA to host the WHO International Conference of Drug Regulatory Authorities (ICDRA) in 2018 (HPRA)

US: Pharmaceuticals & Biotechnology

  • Pfizer launches Healthcare Hub to support healthtech startups (Pharmafile)
  • Sharing R&D Risk in Healthcare via FDA Hedges (SSRN)
  • Alpine bags Nivalis, making Gold a public biotech CEO again (Fierce)
  • BRIEF-Cytrx says FDA agreement on regulatory pathway for Aldoxorubicin (Reuters)
  • Science looks to nucleic acids to create right genetic vaccine recipe (Financial Times)
  • Clinical decision tools are needed to identify HIV-positive patients at high risk for poor outcomes after initiation of antiretroviral therapy (PLOS)
  • FDA Panel To Review Emmaus' Sickle Cell Therapy (BioCentury)
  • Opioid use common even after minor surgery (Reuters)
  • Arena, Galapagos Price Follow-Ons (BioCentury)
  • Researchers discover mitochondrial "circuit breaker" that protects heart from damage (NIH)
  • Demands of disease drive vaccine science (Financial Times)
  • Merck's Keytruda sticks to TV ad spree, but BMS slashes March Opdivo spend (Fierce)
  • Amarantus Bioscience forms two new companies in restructuring operation (PharmaLetter-$)
  • Partnership of nations set to combat pandemic health threats (Financial Times)
  • Investors bet on Incyte cancer drug success (Financial Times)
  • Cannabidiol reduces seizures by half in severe epilepsy, study suggests (Pharmafile)
  • Frog mucus may offer protection against flu virus (Pharmafile)

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

  • Ultragenyx's Burosumab Hits Mark In Phase III XLH Study (BioCentury)
  • Roche to present new data at AAN reinforcing efficacy and safety of newly FDA-approved OCREVUS™ (ocrelizumab) in two types of multiple sclerosis (Press)

US: Medical Devices

  • Medtronic updates on HVAD recall, FDA labels as Class I (MassDevice) (Press)
  • Medtronic updates 2011 warning on Synchromed II implantable drug pumps (MassDevice)
  • Becton Dickinson warns customers about injury reports from Eclipse needle (Drug Delivery)
  • Cardiovascular Systems recalls saline pumps (MassDevice)
  • FDA approves electroCore's treatment for cluster headaches (Reuters) (Medpage)
  • Bringing Voice Services to the Patient Bedside (MDDI)
  • MTI gets FDA clearance for connected spirometer (mobihealthnews)
  • What does FDA really mean when something is 510(k) exempt? (Medical Design & Outsourcing)
  • Life Spine Announces FDA Clearance of PLATEAU-C Ti Cervical Spacer System (Press)

US: Assorted & Government

  • Divided Infringement After Eli Lilly V. Teva (Law360-$)
  • Sen. Grassley Demands Scrutiny Of Medicare Advantage Plans (KHN)
  • Opinion analysis: Justices reject Missouri's push to expand insurance benefits for federal employees (SCOTUS Blog)
  • States push back deadlines for health-insurance rates amid uncertainty (CNBC)
  • Democrat Jon Ossoff Advances To Runoff For Tom Price's Georgia House Seat (Forbes)
  • Disputes Continue over Foundational Patents for Gene Editing (Genomics Law Report)
  • California Hospitals Lose Ground In Quality Of Care, Report Card Shows (KHN)
  • Cardinal Health's Unhappy Profit Surprise: The Coevolution of Pharmacy Buying Groups and Wholesaler Economics (Drug Channels)
  • Formulary Oversight For Obamacare Plans Will Be Deferred In Some States (Pink Sheet-$)
  • 'Right To Try' Unapproved Drug Measure Passes Pa. House (Law360-$)
  • So . . . About That Guilty Plea: The Government Responds to the Decosters' Petition for Cert (FDA Law Blog)
  • WDNY Holds that Tysabri Warnings are Adequate as Matter of Law and that Product Liability Claims are Preempted (Drug & Device Law)

Upcoming Meetings & Events

Europe

Asia

  • Effectiveness of a live oral human rotavirus vaccine after programmatic introduction in Bangladesh: A cluster-randomized trial (PLOS)

India

  • PM Narendra Modi's push for generic drugs to shift focus to chemists, says pharma industry body (Economic Times)
  • Cases pile up as three State FDA labs hit by staff crunch (Times of India)
  • Enforcing generic drugs hints at new public health framework (Economic Times)
  • Retail margin on generic drugs may be as high as 1,000%, claims study (Economic Times)
  • TN DCA prosecutes 6 cos for producing spurious drugs, 65 retailers for selling drugs without pharmacists (PharmaBiz)
  • IDMA seeks key changes in health ministry's plan to regulate sale of drugs with e-portal (PharmaBiz)

Australia

  • Zydelig - Safety advisory - change to indications and addition of warnings (TGA)
  • TGA presentations: RACI Supply and Use of Medicinal Cannabis Seminar, 28 March 2017 (TGA)

Other International

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 news@raps.org.

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

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