Regulatory Recon: Medicare Spent $1.5B to Replace Faulty Heart Devices; FDA Approves Novo's Fast-Acting Insulin Fiasp (2 October 2017)

Posted 02 October 2017 By Michael Mezher

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

In Focus: US

  • Do Pharma's Claims on Drug Prices Pass the Smell Test? We Found 5 Stinkers. (KHN)
  • Heart Device Failure: Medicare Spent $1.5B Over 10 Years To Replace Defective Implants (KHN) (NYTimes) (HHS OIG)
  • US invests $170 million in late-stage Ebola vaccines, drugs (Reuters)
  • California Takes On Drug Pricing: Real Progress Or Illusion? (Health Affairs Blog) (KQED)
  • Judge: Maryland can act against drug price-gouging, for now (AP) (Reuters)
  • Absent Federal Action, States Take The Lead On Curbing Drug Costs (KHN)
  • FDA approves Novo Nordisk fast-acting insulin Fiasp (Reuters) (Press)
  • Does FDARA Open the Door to Third-Party Reviews of Implantable Devices? Lawyer Discusses (Focus)
  • FDA Launches Searchable Adverse Event Database for Drugs and Biologics (Focus)
  • Medicine Nobel awarded for work on circadian clocks (Nature) (Reuters) (NPR)
  • Biopharma valuations—onward and upward? (McKinsey)
  • VC-Backed Biotech Financings: Boom Or Bubble? (LifeSciVC)
  • Price resigns from HHS after facing fire for travel (Politico) (Focus)
  • Trump's Next Move on Health Care? Choice for Secretary May Offer Clue (NYTimes)
  • FDA, industry step up efforts to avert drug shortages after Puerto Rico hurricane (Washington Post)

Sponsored Content: Georgetown Master of Professional Studies in Project Management

In Focus: International

  • Belgian biotech Ablynx scores big hit with blood disease drug (Reuters) (Endpoints) (Fierce)
  • Drugs firm AstraZeneca wants three-year Brexit transition (Reuters)
  • After Gland, Chinese pharma giant Fosun eyes API maker Symbiotec (Economic Times)
  • Francis Crick Institute looks to turn discoveries into treatments (Financial Times)
  • CHMP endorses Tresiba label update in the EU (PharmaTimes)
  • ICH Plans Work on Clinical Trials Guideline Revision, Pediatric Extrapolation (Focus)
  • Generics prices 'unsustainably low' in Europe, industry group says (PharmaLetter-$)
  • WHO scales up response to plague in Madagascar (WHO)
  • One million unvaccinated Venezuelan kids vulnerable in measles outbreak: doctors (Reuters)
  • Chinese scientists fix genetic disorder in cloned human embryos (Nature)
  • Saudi Arabian Regulators May Exempt Some Low-Risk Medical Devices from MDMA Registration (Emergo)

Pharmaceuticals & Biotechnology

  • The Wrong Pill Can Play With Your Mind (NYTimes)
  • Cancer-fighting power couple tackles mysteries of the immune system (Washington Post)
  • With an FDA decision looming, Dynavax is shopping a deal on Heplisav — report (Endpoints) (Reuters)
  • Endocyte starts renaissance by licensing 'billion-dollar' prostate cancer drug (Fierce)
  • Rigel Rises on Update on FDA Review of Bleeding Disorder Treatment (The Street)
  • Is Pharma's Focus On The Patient All Wrong? (Forbes)
  • Sanofi's key to bridging the gap between lab and real-world results? Behavioral science, it says (Fierce)
  • Stopping aspirin therapy may raise heart attack, stroke risk (Reuters)
  • Sam Kulkarni takes the helm at CRISPR Therapeutics as founding CEO steps down (Endpoints)
  • Genzyme vet David Meeker takes helm at stealthy KSQ with $76M and a new map for drug discovery (Endpoints)
  • Top trend #4: We're coming to a tipping point on cancer R&D, and it may not be pretty (Endpoints)
  • In the wake of a drubbing, Vivek Ramaswamy gambles $116M on Arbutus' hep B work (Endpoints)
  • Lupus Community Shares Views with FDA at Historic Patient-Focused Drug Development Meeting (Lupus Foundation)
  • Appointments: Lilly, Kiadis, Pliant, Alma, NeuroVia and Nektar Therapeutics (SCRIP-$)

Pharmaceutical and Biotechnology: Study Results, Filings and Designations

  • Seattle Genetics receives FDA breakthrough therapy designation for lymphoma drug (Reuters) (Press)
  • Seres Therapeutics Reports Positive Topline Results from SER-287 Phase 1b Study in Patients with Ulcerative Colitis (Press)
  • Biohaven skunked by a placebo in PhII/III flop for ataxia drug, shares slide (Endpoints)
  • Indivior says submitted NDA to FDA for schizophrenia​ treatment (Reuters)
  • Mylan Launches Generic Gleevec® Tablets (Press)
  • FDA Accepts Supplemental New Drug Application (sNDA) filing for AVYCAZ® (ceftazidime and avibactam) (Press)
  • Lannett Receives Two FDA Approvals For Lansoprazole Delayed-Release Capsules USP, One Each For Full Prescription And OTC (Press)
  • Kitov Pharma (KTOV) Reports FDA Filing for New Drug Application for KIT-302 (StreetInsider)
  • Janssen Submits Supplemental New Drug Application (sNDA) to U.S. FDA Seeking New Indication for INVOKANA® (canagliflozin) to Reduce the Risk of Major Adverse Cardiovascular Events (MACE) Based on Landmark CANVAS Program (Press)
  • Avexis Gets Nod From FDA To Start Pivotal SMA Trial (BioCentury)

Medical Devices

  • FDA Releases 5 Medical Device Guidance Documents (Focus)
  • CardioBrief: FDA's Gottlieb Preparing To Lower The Bar To Approval (Medpage)
  • Abbott's $5B acquisition of Alere set to close tomorrow (MassDevice)
  • The Human Experience: How Patients Inspire Innovation and Why Medtech Should Listen (MDDI)
  • Alere Receives FDA Clearance for Alere™ i Influenza A & B 2 Rapid Molecular Test (Press)

US: Assorted & Government

  • Celgene Hit With Expansive Antitrust Suit Over Thalomid (Law360-$)
  • Massachusetts AG launches probe of addiction treatment fraud (STAT)
  • Mother who refuses to follow court order to vaccinate son: 'Most likely, I'll be going to jail' (Washington Post)
  • Medicare patients face high costs for newer injected cholesterol drugs (Reuters)
  • Company founded by Shkreli off the hook in $43 million lawsuit: judge (Reuters)
  • Does the Federal Circuit's In re Cray Decision Suggest a New Business Model for Savvy Infringers? (Patent Docs)
  • Fraud on the FDA? If Not Preempted, It Is Trumpery (Drug & Device Law)
  • FDA Proposes Jan. 1, 2020 as New Compliance Date for Nutrition Labeling (FDA Law Blog) (Reuters)

Upcoming Meetings & Events

Europe

  • EU MDR / IVDR Regulatory Cassandra (MedicalDevicesLegal)
  • Information on changes to the guidance document (formerly Information sheet) on the Fast-track authorisation procedure (SwissMedic)
  • Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 25-29 September 2017 (EMA)
  • Closing the gap on metastatic breast cancer (EurActiv)

Asia

  • What Makes Singapore's Health Care So Cheap? (NYTimes)

India

  • Health ministry places order for 3.8 mn does of rotavirus vaccine under UIP to combat severe gastroenteritis (PharmaBiz)
  • Overuse of antibiotics in animals to worsen India's AMR problem (Economic Times)

Australia

  • Special Access Scheme (TGA)

General Health & Other Interesting Articles

  • In the US, 110 Million STD Infections (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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