Regulatory Recon: Grail Sees Hope for Liquid Biopsy; Study Finds Heart Drug Prescribing Slashed After Price Hikes (10 August 2017)

Posted 10 August 2017 By Michael Mezher

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

In Focus: US

  • Silicon Valley Startup Grail Sees Hope for Cancer Blood Test (Bloomberg) (STAT) (NEJM)
  • Melinta will beef up its antibiotics pipeline after a merger with troubled Cempra (Endpoints) (Fierce)
  • Eyeing an IPO, Sutro retools its $1B I/O deal with Celgene but stays focused on BCMA (Endpoints) (Fierce)
  • Hospitals Slashed Use Of Two Heart Drugs After Huge Price Hikes (KHN) (NPR) (Medpage) (NEJM)
  • Study: Doctors received more than $46 million from drug companies marketing opioids (Washington Post) (NBC) (STAT)
  • The price of uncertainty could mean new double-digit health insurance rate hikes (CNBC)
  • Three Ways President Trump Can Make Good On His Promise To Bring Down Drug Prices (Health Affairs Blog)
  • Drug Review Profiles: Behind The Scenes At US FDA (Pink Sheet-$)
  • Do Drugs Approved Via Expedited Pathways Offer Greater Benefits? Study and Doctors Debate (Focus)
  • FDA Offers More Details on Digital Health Precertification Pilot (Focus)
  • Qualifying Medical Device Development Tools: FDA Finalizes 2013 Guidance (Focus)
  • FDA Warns of Bacterial Contamination in PharmaTech Liquid Drugs (Focus)
  • United Therapeutics Sues FDA After Agency Denies Orphan Drug Exclusivity for ORENITRAM (FDA Law Blog)

Sponsored Content: FDA Recommendations for Cybersecurity in Life Sciences

In Focus: International

  • Mexico watchdog finds big pharma faces no competition on some drugs (Reuters) (Cofece)
  • CRUK, Biotecnol team up for T-cell engager trial (Fierce) (PharmaTimes)
  • More European Countries Agree To Swap Pricing Info And Negotiate Prices (Pink Sheet-$)
  • NICE approves Bayer's Nexavar for primary liver cancer (PharmaTimes) (PMLive)
  • Biggest challenges of multi-region clinical trials identified (EPR)
  • Positive outlook for EU biotech M&A and funding, says report (PharmaTimes)
  • News from Abroad: Briefing on Supplementary Protection Certificates for Medicinal Products (Patent Docs)
  • UK Supreme Court Broadens Scope Of Patent Protection (Law360-$)
  • EMA Guide Outlines Steps Taken by Multinational Review Team Leaders (FDANews-$)
  • Case Study: Sourcing Medical Supplies in India and Vietnam (Pacific Bridge Medical)
  • TÜV SÜD Extends Compliance Deadlines for State-of-the-Art Requirements of Meddev 2.7/1 Rev. 4 (Emergo)

Pharmaceuticals & Biotechnology

  • Citing a 'conflict,' GSK vet Slaoui abruptly quits Intellia board (Endpoints)
  • Class I drug recalls soared in Q2 according to new research (InPharmaTechnologist)
  • Bristol-Myers Squibb nixes 58 marketing jobs as HIV medications near patent cliff (Fierce)
  • Generic Deflation Roils the Channel—And Will Get Worse (Drug Channels)
  • Biotech to drive biggest cancer advancements in decades – report (PharmaTimes)
  • Continuous manufacturing: Upgrading the supply chain to meet rising demand (Pharmafile)
  • Testing the safety of immunotherapy in diabetes (Fierce)
  • Insurers can profit while improving the lives of people with type 1 diabetes (STAT)
  • Pfizer chooses Sanford, North Carolina site for $100m gene therapy plant (BioPharmaReporter)
  • Can Novo's blockbuster push on obesity drug semaglutide succeed where others failed? (Endpoints)
  • Drugmakers test out Tumblr, to tap specific audiences (MM&M)
  • The hunt for behavioral health biomarkers is harnessing digital health at the research stage (MedCityNews)
  • Shire strikes bi-specific antibody deal with Novimmune (PMLive)
  • Cambrex investing $24m in API manufacturing capabilities (Outsourcing Pharma)
  • Galapagos spotlights an 'exciting' round of PoC data for IPF drug, shares surge (Endpoints)
  • Ocular's new CEO to 'aggressively' seek partnerships (Drug Delivery)

Pharmaceuticals and Biotechnology: Study Results, Filings and Designations

  • Heron Therapeutics Announces Initiation of Phase 3 Program for HTX-011 in Postoperative Pain Following Successful End-of-Phase 2 Meeting with FDA (Press)
  • InDex Pharmaceuticals Receives Orphan-drug Designation for Pediatric Ulcerative Colitis in the US (Press)
  • Bonti Announces Topline Results of EB-001 Phase 2A Clinical Study in Glabellar Lines (Press)

Medical Devices

  • Abbott launches trial of transcatheter tricuspid repair device, eyes CE Mark (MassDevice)
  • Analyst: Johnson & Johnson tables cardiology M&A – for now (MassDevice)
  • This 3D printed implant replaces skull bone (Medical Design & Outsourcing)
  • Heart and Asthma Monitors? There's an App for That (NYTimes)
  • Can new tool make cervical biopsy more efficient, less painful? (Reuters)

US: Assorted & Government

  • Senate Democrats Delay HHS Nominee Over Women's Health Funding (KHN)
  • Making The Exchanges More Competitive By Bringing Medicare Into The Fold (Health Affairs Blog)
  • Shire Beats Contract Suit Seeking $425M From Dry-Eye Drug (Law360-$)
  • 3rd Circ. Affirms Win For GSK In Wellbutrin Antitrust Case (Law360-$)
  • A Tale as Old as Time … A Beauty and a Beast (Drug & Device Law)

Upcoming Meetings & Events

Asia

  • Announcement: The 22nd AHWP Annual Meeting will be held in New Delhi, India, 4-8 December 2017 (AHWP)

India

  • IPC to suggest for setting up ADR monitoring centres at corporate hospitals across the country: Dr V Kalaiselvan (PharmaBiz)
  • Gujarat government upgrades stock of swine flu drug to ensure consistent supply of medicines (PharmaBiz)
  • FDA approves Lupin's Livalo generic Nikita (DSN)
  • Implants in repeat knee surgeries can cost as much as Rs 9 lakh: Pricing Regulator (Economic Times)

General Health & Other Interesting Articles

  • Scientists Hack a Computer Using DNA (MIT Technology Review)
  • Video Games May Affect The Brain Differently, Depending On What You Play (NPR)

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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