Regulatory Recon: Neurocrine Biosciences' Ingrezza Approved for Tardive Dyskinesia; FDA's Pazdur Discusses New Oncology Center (12 April 2017)

Posted 12 April 2017 By Michael Mezher

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

In Focus: US

  • Neurocrine Biosciences gets FDA's OK for movement disorder drug (Reuters) (FDA) (Medpage) (Press)
  • FDA's revolving door sweeps top regulators into pharma consulting firm (STAT)
  • California Presses Forward In Fight To Regulate Pharma (KHN)
  • Trump ends hiring freeze, but aims to restructure government (SNL) (NYTimes)
  • Enforcing unmet trade obligations protects US innovation (PhRMA)
  • Should the FDA Relax Rules on Compassionate Access to New Drugs? (WSJ)
  • Oncology Center of Excellence Open For Business: Podcast With US FDA's Richard Pazdur (Pink Sheet-$) (Audio)
  • What They Said – Press Releases 1st Quarter 2017 (Eye on FDA)
  • Price restraint talks hit reality bump (EP Vantage)
  • Pharmaceutical Theft (FBI)
  • FDA Extends Deadline for Comments on Gene Edited Plants and Animals Guidances (FDA)
  • Scientific Research Needs Better Oversight, Report Says (Medpage)
  • To boost diversity in clinical trials, researchers seek out allies — starting with black pastors (STAT)
  • ACMG Guidelines at Odds With FDA Green Light for 23andMe Health Risk Tests (GenomeWeb)
  • In 'Stealth Move,' Mich. Refines Vaccine Waivers, Improves Rate Among Kids (KHN)
  • Democrats Propose A $2 Billion Prize Fund For New Antibiotics (Forbes)
  • FDA Warns Mylan Over Quality System Failures (Focus)
  • Release of New FDA Guidance Declines Sharply Following Trump's Inauguration (Focus)
  • AdvaMed CEO Confident of Device Tax Repeal This Year (Focus)
  • PhRMA Seeks More Transparency on FDA Inspections to Speed First-Cycle Approvals (Focus)
  • SV Health closes $400M early biotech, med dev and digital health fund (Fierce)
  • How Patent Trolls Sparked a Failed Assault on High Drug Prices (Bloomberg)
  • What Trump Can Do Without Congress to Dismantle Obamacare (NYTimes) (Forbes)
  • The number of Americans without health insurance rose in first quarter 2017 (CNBC)
  • Antibacterial Drugs: FDA Panel To Explore Approval Path For Single-Species Agents (Pink Sheet-$)
  • Real-world evidence for medtech: what you need to know (Medical Design & Outsourcing)

In Focus: International

  • Update of EMA recommendations for 2017/2018 seasonal flu vaccine composition (EMA)
  • India's Strand Life Sciences launches blood test to detect cancer (Reuters)
  • Asia Regulatory Roundup: CFDA Increases Drug Regulation Budget by 31% (Focus)
  • UK starts handing out £4.7B boost to science funding (Fierce)
  • Indian regulator clears first autologous dendritic cell-based I-O product (BioWorld)
  • Multinationals, Patients Benefit From New Approvals As China Speeds Reviews (SCRIP-$)
  • Japan automakers look to robots to keep elderly on the move (Reuters)
  • Samsung Bioepis's Biosimilar Enbrel 'Substitutable' In Australia As Pfizer Patent Case Is Rebuffed (Pink Sheet-$)
  • Malaysia calls for phase 4 Dengvaxia study before considering full approval (Fierce)
  • Mexican regulator undermines Teva's Rimsa fraud claims with 'all clear' memorandum (Fierce)
  • GSK vaccine R&D exec: Get to work now on the next emerging disease outbreak (Fierce)
  • Cellular Biomedicine, GE in China Cell Manufacturing Deal (BioCentury) (BioPharmaReporter)

US: Pharmaceuticals & Biotechnology

  • Discovery of predictive protein signature births new leukaemia treatment hopes (Pharmafile)
  • Sanfilippo syndrome gene therapy could be filed in US next year, Abeona (BioPharmaReporter)
  • US biosimilars: Quality trumps manufacturing location, say physicians (BioPharmaReporter)
  • Smithfield makes move on market for pig-human transplants (Reuters)
  • Pfizer's Prevnar conundrum: How to convince 'invincible' baby boomers they need a shot? (Fierce)
  • Study finds genetic basis for drug response in childhood absence epilepsy (NIH)
  • Could organs-on-a-chip one day replace animals in medical testing? (STAT)
  • JLabs's Tom Luby Talks About Houston's Potential as a Biotech Hub (Xconomy)
  • With Ovid IPO, Ex-Teva CEO Levin Pitches Neuro Drug Plan to Wall Street (Xconomy)
  • Komodo dragon blood could hold secret to new antibiotic (Pharmafile)
  • CRISPR uncovers drug compounds in bacterial genome (Drug Delivery)
  • Generic Drug Puzzle: Why Did ANDA Submissions Spike Again? (Pink Sheet-$)
  • Can Drugs Really Treat Sarcopenia? Some Patients Are Doubtful (Pink Sheet-$)
  • Emerging Pharmaco's dilemma: 'Go it alone' or partner? (PharmaLetter-$)
  • Cirius Suspects Insulin Resistance Is Underlying Key To NASH (SCRIP-$)
  • Marinus Pharmaceuticals appoints Lorianne Masuoka as chief medical officer (PharmaLetter-$)

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

  • Synergy Pharmaceuticals Announces Issuance of Three New Patents Expected to Extend TRULANCE (Plecanatide) Patent Protection Until 2032 (Press)
  • FluGen Raises $2M More, Provides Update on Phase 1 Trial (Xconomy)
  • Ironshore Pharmaceuticals Announces Positive HLD100 Results from Open-Label Tolerability Study in Pediatric ADHD Patients (Press)

US: Medical Devices

  • Why Medtech Needs to Get out of the ′80s (MDDI)
  • Digital Health: Moving from Big Ideas to the Practical Issues of Adoption (MDDI)
  • Roche warns on bolus advisor issues with Accu-Check Connect app (MassDevice)
  • FDA Authorizes Nanobiosym Zika Test (GenomeWeb)
  • This is why modern device engineers need a new approach to medical training (MedCityNews)
  • FDA clears Mazor X Align spinal surgical planning software (MassDevice) (Press)
  • Adgero touts data for photodynamic drug-device combo (MassDevice)
  • United Orthopedic Corporation Receives U.S. FDA Clearance For Company's Polyethylene Knee Insert (Press)
  • Ventec Life Systems Receives FDA 510(k) Clearance of VOCSN, the First Portable Unified Respiratory System for Patients on a Ventilator (Press)

US: Assorted & Government

  • Bristol-Myers, Pfizer Sue To Halt Generic Blood Thinner (Law360-$)
  • Medicaid Responds To The Opioid Epidemic: Regulating Prescribing And Finding Ways To Expand Treatment Access (Health Affairs Blog)
  • Opportunities to Comment Closing - April 2017 (FDA)
  • When Precedents Collide (Drug & Device Law)
  • DEA Administrative Decisions Update: Sex, Drugs, and . . . Rocky Agency Precedent (FDA Law Blog)
  • PTAB Life Sciences Report -- Part IV (Patent Docs)
  • Shire, Actavis Say Intuniv Settlement Not Reverse Payment (Law360-$)

Upcoming Meetings & Events

Europe

  • The evaluation of new scientific information on the safety of PIP breast implants and on The state of scientific knowledge on a possible association between breast implants and anaplastic large cell lymphoma (EC)
  • Sotio Picks Up Rights To Cancer Metabolism Program (BioCentury)
  • NICE says new prisoners should be tested for infections (OnMedica)
  • Draft guideline on good -clinical -practice compliance in relation to trial master file (paper and/or electronic) for content, management, archiving, audit and inspection of clinical trials (EMA)
  • List of centrally authorised products requiring a notification of a change for update of annexes (EMA)
  • Harnessing AI For Drug Development – UK's BenevolentAI And MRCT Link (SCRIP-$)

Asia

  • China's H7N9 bird flu death toll at 47 in March: government data (Reuters)
  • Sumitomo Dainippon buys cell therapy processing tech from Hitachi (InPharmaTechnologist)
  • ShangPharma Innovation appoints new CEO (BioSpectrum)
  • DHL strengthens in China (BioSpectrum)
  • PMDA-ATC GMP Inspection Seminar 2017 (PMDA)

India

  • Torrent Pharma to buy certain generic drugs from Novartis (LiveMint)
  • Taking steps to discourage import of bulk drugs: Government (Economic Times)
  • Drug to treat MDRTB to be made available across the country: Government (Economic Times)
  • DCGI begins registration of notified bodies to carry out audit of mfg sites of Class A & Class B medical devices (PharmaBiz)
  • US FDA hands Neuland Laboratories with Form 483 after plant inspection (InPharmaTechnologist)
  • US FDA OKs Cadila Healthcare topicals plant (InPharmaTechnologist)
  • Centre's move to merge NPPA & DoP with health ministry receives mixed response (PharmaBiz)
  • Indian pharma market clocks growth of 9.6% in March 2017 (PharmaBiz)

Australia

  • Stimwave wins Australian regulatory nod for Freedom SCS (MassDevice)

Other International

  • Caribbean-wide drug regulatory system 'will help fight fakes' (Securing Industry)
  • A new cascade of HIV care for the era of "treat all" (PLOS)
  • Community-based strategies to strengthen men's engagement in the HIV care cascade in sub-Saharan Africa (PLOS)

General Health & Other Interesting Articles

  • Risk factors for heart disease and stroke also tied to Alzheimer's (Reuters)
  • NIH researchers trace origin of blood-brain barrier 'sentry cells' (NIH)
  • Seeing Outside the Disability Box (NYTimes)
  • Spine manipulation might help with low back pain (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 news@raps.org.

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

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