Regulatory Recon: Drugmakers Upped Political Contributions After Trump Drug Pricing Comments; Japan Approves Maviret, Benlysta and Darzalex (27 September 2017)

Posted 27 September 2017 By Michael Mezher

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

In Focus: US

  • Right After Trump Blamed High Drug Prices On Campaign Cash, Drugmakers Gave More (KHN)
  • FDA Works To Encourage Office-Use Compounding In Advance Of Legislation (Pink Sheet-$) (FDA)
  • Industry Wants FDA Help, Guidance on New Drug Tracking System (Bloomberg)
  • 3 hurdles to bringing medical devices to the US market (STAT)
  • No time for formalities, Acorda scraps FDA meeting in scramble to re-file CVT-301 (Endpoints)
  • Prescription drug pricing is totally broken, even for generics—here's what happened (Quartz)
  • AbbVie insists it's keeping its pricing pledge, calling earlier reports 'incorrect' (STAT) (Endpoints) (Press)
  • Real-World Evidence Complements Randomized Controlled Trials In Clinical Decision Making (Health Affairs Blog)
  • Apple, Verily and J&J Among 9 Selected for FDA Digital Health Pilot (Focus)
  • FDA Finalizes Combination Product Classification Guidance (Focus)
  • Revival of Gilead Whistleblower's Lawsuit Should Stoke Fear In Big Pharma (Forbes)
  • As Obamacare Repeal Fails Again, Device Makers See Three Paths To Tax Relief (Forbes)
  • Pfizer confirms Puerto Rico plants damaged by hurricane Maria (InPharmaTechnologist) (BioPharmaDive)
  • These Volunteers Are Swallowing E. Coli Pills to Help Medicine (MIT Technology Review)

In Focus: International

  • EMA warns HQ move may cause major turmoil, seriously delaying new drug approvals (Endpoints/Focus)
  • EMA staff favor move to Amsterdam: Politico (Reuters) (Politico)
  • China's Revenue-Free Drug Trip (Bloomberg)
  • GSK spinout NeRRe splits the pipeline, creates its own spinout (Endpoints)
  • Pregnant women still unaware of epilepsy drug risks: EMA hearing (Reuters) (The Guardian)
  • Asia Regulatory Roundup: TGA Shares Guidance, Tool to Help Companies Navigate GMP Clearance Process (Focus)
  • India's Draft Plan To End API Reliance On China 'Needs Work' (Pink Sheet-$)
  • AdvaMed inks cooperation agreement with China's medtech association (MassDevice) (MDDI)
  • Microsoft has a new digital health research initiative in the UK (Medical Design & Outsourcing)
  • AstraZeneca's latest respiratory win could spur Bevespi approvals in China, Japan (Fierce)
  • Abbive's Maviret Approved in Japan to Treat HCV (Press)
  • GSK's Benlysta Approved in Japan to Treat Systemic Lupus Erythematosus (Press)
  • Japan's MHWL Approves Darzalex for Relapsed or Refractory Multiple Myeloma (Press)

Pharmaceuticals & Biotechnology

  • Pharma's R&D brain drain continues as GSK's Chris Carpenter jumps to upstart Rubius (Endpoints)
  • Making Advances Against Sickle Cell Disease (FDA Voice)
  • Introducing the USP Quality Institute (USP)
  • Can Heart Disease Shed Light on Cancer? (NYTimes)
  • Next-gen CAR-T firm Autolus takes funding tally to $173M (Fierce)
  • As Loyal Blood Donors Age, Industry Is Out For Young Blood (KHN)
  • Is FDA Most Science-Based and Less patient Centric Now that Gottlieb is in Charge? (PharmaMarketingBlog)
  • Encouraging Young Innovators To Join American Manufacturing (Pfizer/Forbes)
  • Newron Seeks New Assets To Grow Pipeline (SCRIP-$)
  • Convening Experts to Examine the Critical Underpinnings of Antimicrobial Resistance Strategies (USP)
  • Repligen In Precarious Waters After GE Launches In-House Resin (BioCentury)
  • The Emergent Microbiome: A Revolution for the Life Sciences Part XII: Taking Stock of Livestock (Patent Docs)

Pharmaceutical and Biotechnology: Study Results, Filings and Designations

  • Sinovac's chickenpox vaccine shows 87% efficacy in topline phase 3 (Fierce)
  • FDA Accepts Supplemental New Drug Application for Eisai's Lenvatinib for the Treatment of Liver Cancer (Press)
  • Vitruvias Therapeutics and Sunny Pharmtech Receive First FDA Generic Drug Approval (Press)
  • Lannett Receives FDA Approval For Oxycodone And Acetaminophen Tablets USP, 5 mg/325 mg And 10 mg/325 mg (Press)
  • Immune Pharmaceuticals Announces Positive Results from Ongoing Phase 2 Trial of Bertilimumab in Bullous Pemphigoid (Press)

Medical Devices

  • FDA's Scott Gottlieb: LDTs are no longer a "mom-and-pop" industry and need legislative approach (MedCityNews)
  • Clinical labs on track to lose $670 million next year (Modern Healthcare)
  • NCI-funded TMIST study compares 2-D and 3-D mammography for finding breast cancers (NIH)
  • Advisory Committee; National Mammography Quality Assurance Advisory Committee; Renewal (FDA)
  • Defense Dept. awards DePuy $33m deal for surgical products (MassDevice)
  • Japan's Murata Manufacturing puts up $102m for Vios Medical (MassDevice)
  • FDA adds coronary indication to Reflow Medical's Wingman14C clearance (MassDevice)
  • Hologic Receives FDA 510(k) Clearance to Market SculpSure for Non-Invasive Body Contouring (Lipolysis) of the Submental Area (Under the Chin) (Press)
  • FDA Gives Guardant Health IDE Approval for Clinical Trial of Merck KGaA Cancer Drug (GenomeWeb)

US: Assorted & Government

  • Senator Calls on Insurers to Improve Access to Non-Opioid Pain Treatments (ProPublica)
  • Pfizer, J&J Antitrust Suit Is Next Big Pharma Fight (Bloomberg) (Fierce)
  • Court Deals Blow to Mysteriously Named Whistleblower, and Blows off Precedent (FDA Law Blog)
  • New STD cases in U.S. set record high in 2016: CDC report (Reuters)
  • N.Y. Court Holds that Manufacturer Cannot be Responsible for Medical Malpractice (Drug & Device Law)
  • Former Zacks biotech analyst Napodano charged with fraud after settling with SEC on insider trading cases (Endpoints)
  • Forest Labs Must Produce Mylan Docs In Antitrust Suit (Law360-$)
  • Judge Dismisses Price-Fixing Claims Against Generic Drugmakers (FDANews-$)

Upcoming Meetings & Events

Europe

  • BD launches fully-automated diagnostic to fight antimicrobial resistance in Europe (Drug Delivery)

Asia

  • GSK, Gilead, Shire Gain RDPAC Membership (BioCentury)
  • FDA Warns Chinese Drugmaker Over Fake Test Results, Blocking Access to Inspectors (Focus)
  • Daiichi Sankyo announces TaNeDS Global 2018 collaborative drug discovery program (PharmaNews)

India

  • Speciality segment to be a key growth driver for Sun Pharma (Economic Times)
  • Knee Implant Price Cap: Firms Asked To Maintain Supplies in India (Bloomberg)
  • Govt to amend Schedule V of Drugs and Cosmetics Act to clear confusion between vitamins and drugs (PharmaBiz)
  • Pharmaceutical exports poised to grow 3-5 per cent this year: Pharmexcil (PharmaBiz)

Australia

  • Consultation: Business process improvements supporting complementary medicines assessment pathways (TGA)

Canada

  • Health Canada Approves Visbiome® Probiotic for Irritable Bowel Syndrome (Press)

General Health & Other Interesting Articles

  • The Staggering Prices Of Long-Term Care 2017 (Forbes)
  • One in five US adolescents has sustained a concussion (Reuters)
  • Newly discovered protein could help diagnose chronic brain disease: study (Reuters) (NBC)
  • Survey: Millenials more likely to ignore recall notifications than boomers (MassDevice)

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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