Regulatory Recon: Editas Delays CRISPR Cas9 Human Study; AstraZeneca Sues Former Exec After Leaving for GSK (16 May 2017)

Posted 16 May 2017 By Michael Mezher

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

In Focus: US

  • International Cyberattack Affects Some Corners of US Health Care, Including Medical Devices (WSJ) (MassDevice) (Forbes)
  • When the Immune System Thwarts Lifesaving Drugs (NYTimes)
  • Lobbyists stay quiet as health bill moves forward (Politico)
  • Editas delays IND for Allergan-partnered CRISPR program (Fierce) (Endpoints)
  • Gottlieb to FDA Staff: Immediate Challenge is Opioid Abuse (Focus)
  • FDA Launches New ORA Structure to Align Inspections With Expertise (Focus)
  • Trump taking aim at drug pricing (The Hill)
  • Congress to Trump: Let's Tackle Drug Pricing in User Fee Reauthorizations (Focus) (BioCentury)
  • Senate Democrats to Trump: HHS Cuts Will Impede 'Cures' Implementation (Focus)
  • FDA Officials Discuss Modernizing the Regulation of Combo Products (Focus)
  • Nurturing the biomedical ecosystem (Boston Globe)
  • Why Most Regenerative Therapy Applications for US RMAT Designation Fail to Make The Grade (Pink Sheet-$)
  • USPTO Files Response Brief in In re Janssen Biotech, Inc. & New York University (Patent Docs)
  • Pfizer shares hit by Citi downgrade (Financial Times)
  • Pharma and biotech rebound in annual trust study, but there's still room for improvement (Fierce) (Edelman)
  • AdvaMed unveils new tools to assess medical device value (Medical Design & Outsourcing) (AdvaMed)
  • US FDA Planning Another Patient Group To Boost Involvement (Pink Sheet-$)
  • Can Biosimilar Studies Be Conducted Solely In Healthy Volunteers? (Pink Sheet-$)
  • Financing and Distribution of Pharmaceuticals in the United States (JAMA)

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In Focus: International

  • Novartis Compliance Head Discusses Korea, Building Integrity (WSJ) (Fierce)
  • Samsung Looks Beyond Smartphones to Next-Gen Biologics (Bloomberg)
  • AstraZeneca Sues Executive After Rival Glaxo Lures Him Away (Bloomberg)
  • Indian drug makers wary as US FDA sharpens focus on quality control (Live Mint)
  • WHO preparing authorization, logistics for Ebola vaccination in Congo if needed (Reuters)
  • Relocating the EMA: An open letter from EFPIA and Pharma Heads of Research (EPR)
  • An end to pandemics is within reach, but we must redouble efforts now (STAT)
  • More than 1.2 million adolescents die every year, nearly all preventable (WHO)
  • EU Health Tech Assessments: Majority Favor Continuing Beyond 2020 (Focus)
  • CDSCO Touts its Achievements From 2015-2017 (CDSCO)
  • China's latest Western-style FDA tweak puts orphan drug approvals in the fast lane (Fierce)
  • South Africa Proposes Requirements For Registering Co-Packaged Medicines (Pink Sheet-$)
  • India Pushing Ahead With Rare Disease Policy Plan (Pink Sheet-$)
  • China FDA Proposes Sweeping Reforms To Incentivize Innovation (Pink Sheet-$)
  • ABPI responds to news of European Commission investigation into Aspen Pharmacare (ABPI)

US: Pharmaceuticals & Biotechnology

  • FDA Reviewing Aerie's Resubmitted NDA (BioCentury)
  • FDA Posts New Infographic on Approval Process (FDA)
  • Early phase clinical trials of anticancer agents in children and adolescents — an ITCC perspective (Nature)
  • Sarepta Trial Protocol Changes May Ignite Debate On Placebo Design (Pink Sheet-$)
  • Texas leans into unproven stem cell treatments, to the dismay of scientists (STAT)
  • MedImmune's Bahija Jallal On Changing The Diversity Narrative (SCRIP-$)
  • Duke-Margolis Forms Value-Based Payment Consortium (BioCentury)
  • Real World Evidence is Critical to Pharma's Future: Can we Agree on What it is? (SCRIP-$)
  • Overwrought Marketing? Ads, Not Research, Create Some Pharma Best-Sellers (KHN)
  • RSV Vaccine Trials In Infants Might Become Easier To Conduct (Pink Sheet-$)
  • With Latest Deal, Biogen Bets $120M on Remedy Pharma Stroke Drug (Xconomy) (Fierce)
  • FDA's OTC Naloxone Study Is A Starting Point For Other Switches, Not A Roadmap (Pink Sheet-$)
  • FiercePharma readers didn't just pick a new Valeant moniker. They have some advice, too (Fierce)
  • Yelp for drugs? Sermo debuts drug-rating tool for doctors featuring reviews, ratings and comments (Fierce)
  • Amgen adds online cancer team narratives to Neulasta Onpro push (Fierce)
  • Common treatment for MS revealed to have potential adverse reactions (Pharmafile)
  • CardioBrief: Study Fuels Debate Over When to Start Cholesterol Screening (Medpage)
  • Many U.S. travelers don't get recommended measles vaccine (Reuters)
  • Prolific dealmakers Akebia and Vifor pen anemia drug pact (Fierce) (The Street)

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

  • Sangamo Receives Fast Track Designation From The FDA For SB-525 Investigational Hemophilia A Gene Therapy (Press)
  • Merck to Present New Phase 3 Data on Investigational Ertugliflozin, Additional Analyses of Studies of JANUVIA (sitagliptin), and Real-World Evidence Research at the 77th Scientific Sessions of the American Diabetes Association (Press)

US: Medical Devices

  • Siemens sees first results of ultrasound turnaround (Reuters)
  • BD, Roche Weigh FDA's Proposed Exemptions for Class II Devices (Focus)
  • Report: Layoffs ahead for Medtronic Spine in Memphis (MassDevice)
  • Artificial pancreas partnerships aim to compete with Medtronic (EP Vantage)
  • Abbott Initiates Voluntarily Recall of Specific Lots of Three Coronary Catheters (FDA) (MassDevice)
  • Boston Scientific closes $435m Symetis buyout (MassDevice)
  • Bos Sci's Leadless Pacer Proves Feasibility (MDDI)
  • Boston Scientific's Lotus beats Medtronic's CoreValve in head-to-head study (MassDevice)
  • HRS 2017 Roundup: Study pinpoints battery issue in Abbott's Nanostim leadless pacer (MassDevice)
  • Body Vision Medical Receives FDA Clearance for the LungVision Navigation System, Revolutionizing the Areas of Lung Cancer Detection and Treatment (Press)
  • Cook Medical wins FDA nod for Flourish pediatric surgery device (MassDevice)
  • Novocure wins humanitarian use designation for TTFields system (MassDevice)

US: Assorted & Government

  • Indicators Associated With WannaCry Ransomware (ICS-CERT)
  • Trump administration vastly expands global anti-abortion policy (Reuters) (Washington Post)
  • Trump and Christie's First Steps to Solving the Opioid Crisis (WSJ)
  • New York county sues Purdue, J&J over opioid marketing (Reuters)
  • Preexisting Conditions And Continuous Coverage: Key Elements Of GOP Bill (KHN)
  • Texas Seeks Medicaid Money It Gave Up Over Planned Parenthood Ban (NYTimes)
  • E-Cig Summit: Does FDA Regulation Go Too Far? (Medpage)
  • DEA Administrative Decisions Update: What's Prescribed in Vegas . . . Has Got to Stay in Vegas (FDA Law Blog)
  • N.D. Alabama Issues Mixed Bag of Branded Preemption Rulings (Drug & Device Law)
  • Justices Reject Sheller Appeal Over Risperdal FDA Petition (Law360-$)
  • 'Pre-Approval' Design Defects? There's No Such Thing (Law360-$)
  • Sanofi Fights Bid To Combine EpiPen Suits Against Mylan (Law360-$)
  • Medtronic Settles Heart Valve Patent Suit After Venue Fight (Law360-$)
  • 1st Circ. Upholds Biogen's Win In Drug Sales Forecast Suit (Law360-$)
  • Why Florida Pharmaceutical Compounders Should Be Wary (Law360-$)

Upcoming Meetings & Events

Europe

  • J&J starts measuring the drapes in Actelion boardroom (PharmaLetter-$) (Press)
  • NHS could save £67 million a year if smoking rates cut (PharmaTimes)
  • GW Pharmaceuticals makes two senior research appointments (PharmaLetter-$)
  • Committee for Medicinal Products for Veterinary Use (CVMP) Meeting of 10-12 May 2017 (EMA)
  • Agilent Opdivo CDx Approved for Expanded Use in Europe (GenomeWeb)
  • Shockwave wins CE Mark for coronary Lithoplasty device (MassDevice)
  • Aptar Pharma's nasal spray compliance device wins EMA nod (Drug Delivery)

Asia

  • Boehringer Ingelheim Inaugurates World-Class Biopharmaceutical Manufacturing Facility in China (Press)
  • China Embracing Microbiome Research Through Programs, Partnerships (SCRIP-$)

India

  • Glenmark anti-myeloma drug gets clinical trial nod from USFDA (Economic Times)
  • Advance licensing scheme for pharma exporters to be abolished (PharmaBiz)
  • NPPA revises ceiling prices of 5 scheduled drug formulations (Economic Times)
  • Pharmexcil calls on industry to explore business opportunities in Colombia and Ecuador (PharmaBiz)
  • Dr. Reddy's Warns US Market 'Unpredictable' As Q4 Profit Below Expectations (SCRIP-$)
  • Maharashtra FDA asks blood banks to address issues related to inadequate staff urgently (PharmaBiz)

Australia

  • Suspension - Philips IntelliVue MX40 wearable patient monitor (TGA)

Canada

  • Notice to Stakeholders: Release of the Product Monograph Template - Schedule D - Biosimilar Biologic Drug (Health Canada)

Other International

  • Pharma serialization snapshot: Saudi Arabia (SecuringIndustry)
  • Cholera outbreak death toll in Yemen rises to 180: ICRC (Reuters)
  • Ceaseless Middle East wars forcing change in approach to medical care (Reuters)

General Health & Other Interesting Articles

  • Tuberculosis Crisis in Alabama's Black Belt (EJI)

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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