Regulatory Recon: Former FDA Commissioner Califf Gets New Role at Verily; FDA Puts Hold on Concert Hair Loss Drug Study (17 May 2017)

Posted 17 May 2017 By Michael Mezher

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

In Focus: US

  • Trump's new FDA commissioner has a huge decision to make (Washington Post)
  • As States Wage Battles on High Drug Prices, Drugmakers Fight Back (WSJ)
  • Former FDA Commissioner Robert Califf to Start New Roles at Verily, Standford University (Verily) (STAT) (CNBC)
  • HHS Secretary Pushes to Cut FDA Appropriations, Replace With More Industry Fees (Focus)
  • E&C Subcommittee Schedules Reauthorization Markup (BioCentury) (E&C)
  • FDA places clinical hold on Concert Pharma's hair loss drug (Reuters) (Press)
  • Califf calls for marketers to develop off-label 'code of ethics' (MM&M)
  • FDA Seeks Input on Device Accreditation Pilot (Focus)
  • FDA Adds Boxed Warning to Janssen's Type 2 Diabetes Drug Label (Focus) (Reuters) (Medpage)
  • AbbVie shares dip after it loses round in Humira patent fight (Financial Times)
  • Bayer gets FDA priority review for blood cancer drug (Reuters) (Fierce) (Press)
  • A deluge of new cancer research data hits at 5 pm ET: Here's what to watch (CNBC)
  • Amazon is hiring people to break into the multibillion-dollar pharmacy market (CNBC)
  • Sanofi rejects US Army request for 'fair' pricing for a Zika vaccine (STAT)
  • Congressional Ethics Office Probing Rep. Chris Collins' Aussie Biotech Investment (KHN) (Buffalo News)
  • Merck, Upsher-Smith to pay $60 million in 'pay-for-delay' drug case (Reuters) (Law360-$)
  • J&J, steering through a rough patch, draws blockbuster roadmap with 10 new meds (Fierce) (Press)
  • Health Groups Petition HHS Secretary to Support Fogarty International Center (Center for Global Health Policy)

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In Focus: International

  • Big pharma hopes rule change will ease China sales pain (Financial Times)
  • The 5 most overpaid pharma CEOs in the world (STAT)
  • More than half of world's deaths still have no recorded cause: WHO (Reuters) (WHO)
  • Rasi On Brexit: 'EMA Is Well-Oiled Machine That We Cannot Afford To Start Stuttering' (Pink Sheet-$)
  • Quest For 'It Factor' Continues In Competition For EMA After Brexit (Pink Sheet-$)
  • Results Of Danish Infliximab Biosimilar Switching Study Published (Big Molecule Watch)
  • EMA Releases Report on Personalized Medicines (EMA)
  • Scientific Advice for medicinal products in ANSM  (ANSM)
  • Asia Regulatory Roundup: CFDA Offers New Drug, Device Draft Guidance (Focus)
  • Novelion CEO quits Novo Nordisk board due to NASH conflict (Reuters)
  • India's drugmakers need more time to meet international standards: industry group (Reuters)
  • Sanofi to bulldoze small-molecule plant it never used (Fierce)
  • IQWiG finds hint of 'considerable added benefit' for Keytruda in NSCLC (PharmaLetter-$) (IQWiG)
  • US, Mexico bolster efforts to combat deadly tide of fentanyl (Reuters)
  • Novartis invites scrutiny of effort to improve access to medicine (Novartis)
  • Merck KGaA eyes options for splitting-out divisions (PharmaLetter-$)
  • AstraZeneca sets out post-Brexit wish list for UK politicians (Fierce)
  • 500 jobs to go as Teva exits troubled Hungary plant (InPharmaTechnologist)

US: Pharmaceuticals & Biotechnology

  • Reducing Preventable Harm from Medications: Too Big for FDA to Do Alone (FDA)
  • FDA Extends Comment Period on Delay to Intended Use Rule (FDA)
  • Testimony on the Transformative Power of Biomedical Research (NIH)
  • T cells found to 'acquire knowledge' to take fight to metastatic cancer (Pharmafile)
  • The Competition Prescription: A Market-Based Plan for Making Innovative Medicines Affordable (Campaign for Sustainable Rx Pricing)
  • Prescriptions for Competition, Value, and Innovation (Council for Affordable Health Coverage)
  • Generic Drug Sponsors Seek Advance Notice Of Approvals From US FDA (Pink Sheet-$)
  • FDA Issues New and Revised Guidance for Generic Drugs (Focus)
  • Interview With J&J's CMO Dr Joanne Waldstreicher On Internal And External Challenges To Sharing Clinical Trial Data (Pink Sheet-$)
  • Treating multiple myeloma: An interview with Janssen (EPR)
  • Pfizer's Oncology Strategy Centers On Three Anchors To Steady The Ship (SCRIP-$)
  • Pfizer On Lung Cancer: "We Need To Have Single-Agent Avelumab" (SCRIP-$)
  • Ipsen's New CEO Targets At Least One New Drug Annually 'Forever' (SCRIP-$)
  • Event – Gilead needs to best Glaxo with bictegravir (EPVantage)
  • FDA Issues 483 to Florida Drugmaker (FDA)
  • Do Best-Selling Drugs That Calm Stomachs Damage Kidneys? The Answer's Unclear. (KHN)
  • New Technologies In Focus At ASGCT (BioCentury)
  • Patient Voices: Sickle Cell Anemia (NYTimes)
  • Limited domestic vaccine manufacturing endangers U.S. flu prep, GAO report says (Fierce)
  • Consolidated vaccine sector urgently needs a workforce booster shot, Sanofi (BioPharmaReporter)
  • OTC Topicals Firm's Regulatory Problems More Than Skin Deep (Pink Sheet-$)
  • Sarepta Meets FDA Again; Praise for Valbenazine Trials (Medpage)

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

  • Pharmadax Receives FDA Approval for a Generic Version of Seroquel XR® (Press)
  • Tenax Meets with FDA to Discuss Positive Mortality Data and Potential Levosimendan NDA Submission (Press)

US: Medical Devices

  • Do You Subject Your Packaging to Human Factors Studies? (MDDI)
  • Coronary Catheters by Abbott: Recall - Difficulty in Removing Balloon Sheath (FDA)
  • Rep. Walters Proposes Bill to Provide Alternative to Substantial Equivalence Determinations (Congress)
  • Integra LifeSciences, Johnson & Johnson pass papers on $1B Codman Neuro buy (MassDevice)
  • R.I.P. – Scanadu Scout – 01/30/15-05/15/17 (medGadget)
  • Here's How to Make an IoT Medical Device Useful (MDDI)
  • 10 innovative diagnostic tests to combat diseases (MassDevice)
  • Smith & Nephew touts lowered infection rate in Pico wound therapy trial (MassDevice)
  • FDA clears Oxitone's wrist-worn pulse ox for remote patient monitoring (mobihealthnews)
  • Smart Meter wins FDA nod, CE Mark for iGlucose monitoring system (MassDevice)
  • MindMaze receives FDA clearance to bring VR rehab platform to the US (mobihealthnews)
  • New Data on CoreValve(TM) and Evolut(TM) R Self-Expanding TAVI Systems Show Excellent Clinical Outcomes in Routine Clinical Practice (Press)
  • Alucent Medical Receives FDA Approval to Begin Clinical Trials of Novel Therapy for Vascular Disease (Press)

US: Assorted & Government

  • Hatch, Wyden Announce Mark-Up of CHRONIC Care Act (Senate Finance)
  • Group Protests at FDA for Not Banning Electrical Stimulation Devices (ADAPT)
  • BIO Submits Comments Re: 340 B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties (CMP) Regulation Interim Final Rule (BIO)
  • Trump's health chief pushes 'waivers' for states from Obamacare rules, as HHS says program in 'death spiral' (CNBC)
  • Medicaid: What Happens Now? (Health Affairs Blog)
  • Diffusion Of Innovations In Health Care—Obtaining Evidence To Move Faster (Health Affairs Blog)
  • U.S. sues UnitedHealth again for mischarging Medicare Advantage (Reuters)
  • CVS's Omnicare to pay $8 million to settle U.S. probe (Reuters)
  • Cigna's Value-Based Approach To Opioid Abuse Makes Progress (Forbes)
  • FDA Extends the Future Compliance Deadlines for Newly Deemed Tobacco Products by 90 Days (FDA Law Blog)
  • No Ifs, Ands Or Butts – Preemption Gutts, Rebutts, and Shutts Down Utts (Drug & Device Law)
  • Medtronic looks to settle TAVR patent spat with doc inventor (MassDevice)
  • ResMed withdraws US trade complaint against Fisher & Paykel Healthcare (Reuters)

Upcoming Meetings & Events

Europe

  • EFPIA/CPIA joint China/EU Pharmaceutical Industry Forum Workshop to Scrutinise a Variety of Regulatory and Legal Issues (EFPIA)
  • Abbott's TactiCath Contact Force Ablation Catheter, Sensor Enabled Cleared in Europe (Medgadget)
  • Elixir Medical Corporation Announces Outstanding 5-Year Clinical Data for CE Mark-approved DESolve® Novolimus Eluting Bioresorbable Coronary Scaffold System (Press)

Asia

  • Astellas Completes Acquisition of Ogeda SA (Press)
  • Boehringer Ingelheim opens Shanghai contract biomanufacturing plant (BioPharmaReporter)

India

  • Govt plans new pharma policy that may bring down prices (Economic Times)
  • Single-use making its mark in India as Stelis teams with MilliporeSigma (BioPharmaReporter)
  • Submission of BE data to be made mandatory for grant of license for all drugs including those in market (PharmaBiz)
  • Jubilant gets USFDA nod for generic hypertension drug (Economic Times)
  • Dr. Reddy's Laboratories Announces USFDA Approval for the Launch of Doxorubicin Hydrochloride Liposome Injection in the US Market (Press)

Australia

  • Scheduling delegate's interim decisions and invitation for further comment: ACCS/ACMS, March 2017 (TGA)
  • Consultation: Proposed Amendments to the Poisons Standard - ACCS, ACMS and Joint ACCS/ACMS meetings, July 2017 (TGA)

Other International

  • WHO members urged to delink R&D from cancer medicine (FIGO)
  • Ebola exposure, illness experience, and Ebola antibody prevalence in international responders to the West African Ebola epidemic 2014–2016: A cross-sectional study (PLOS)

General Health & Other Interesting Articles

  • Widening Gap in U.S. Life Expectancy (NIH)
  • Jerry Canterbury, Whose Paralysis Led to Informed Consent Laws, Is Dead at 78 (NYTimes)
  • Even with free sunscreen, most people don't use enough (Reuters)
  • Babies From Skin Cells? Prospect Is Unsettling to Some Experts (NYTimes)

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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