Regulatory Focus™ > News Articles > 2019 > 5 > Recon: Grail Gets FDA Breakthrough Device Designation for Multi-Cancer Early Detection Test

Recon: Grail Gets FDA Breakthrough Device Designation for Multi-Cancer Early Detection Test

Posted 13 May 2019 | By Michael Mezher 

Recon: Grail Gets FDA Breakthrough Device Designation for Multi-Cancer Early Detection Test

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • Grail, the liquid biopsy startup, picks an approach for its cancer test (STAT) (Press)
  • ElevateBio launches to help other cell, gene therapy companies lift off (STAT) (Xconomy)
  • Following Opioid Suits, Family Behind Deadly OxyContin Squabbles (Reuters)
  • The inside story of why Amazon bought PillPack in its effort to crack the $500 billion prescription market (CNBC)
  • FDA questions credibility of Daiichi data ahead of AdComm (Fierce) (Endpoints)
  • Novartis pitches discounts on pricey gene therapy for deadly muscle disorder (Reuters)
  • Lilly's Cyramza approved in US for hepatocellular carcinoma sub-population (Pharmafile) (Press)
  • Lilly's new migraine drug pulls ahead of Amgen in fierce battle for new prescriptions (Reuters)
  • US records 75 new measles cases, 9.8% increase, as outbreak grows (Reuters)
In Focus: International
  • German ethics council expresses openness to eventual embryo editing (STAT)
  • Top vaccine makers Merck and Pfizer target China and older adults next (CNBC)
  • Italian cancer startup Philogen gets off an impressive $70M funding round (Fierce) (Endpoints)
  • New data backs Merck’s segue into MS with BTK inhibitor (PMLive) (Press)
  • Threats By Text, A Mob Outside The Door: What Health Workers Face In The Ebola Zone (NPR)
  • ICH Plans Revamp Of Guidance On Clinical Trial Data Quality (Pink Sheet-$)
  • Tax credit changes could put a ‘hard brake’ on UK biotech (PMLive)
  • Drug prices: we need to talk about Nirmal (Financial Times)
Pharmaceuticals & Biotechnology
  • Drug lawsuit ads are scaring seniors to death (STAT)
  • Getting Clinical On New Drug Launches (LifeSciVC)
  • Updated: Interchangeable Biosimilars: FDA Finalizes Guidance (Focus)
  • Pharma, late to digital game, rushes to catch up (BioPharmaDive)
  • Two words to help Ned Sharpless revolutionize clinical trials: data standards (STAT)
  • $10 Billion In Annual U.S. DTC Healthcare Advertising Indicates Merging Of Patient And Consumer (Forbes)
  • MAPP Describes the Work of CDER’s Biopharmaceutics Council (Focus)
  • Getting Clinical On New Drug Launches (Forbes)
  • US Reforms Could Be $35bn Drag On Drug Prices By 2023 (Pink Sheet-$)
  • How Viagra revolutionized the erectile dysfunction market (CNBC)
  • ADMA Biologics returning Bivigam to market after 3-year absence (Fierce)
  • AZ, Forty Seven to test triple immunotherapy combo for lymphoma (PharmaTimes)
  • DSCSA: Historic Change To Commerce (RxTrace)
  • Safety, Efficacy, and Quality Remain Top Priorities as We Continue Our Work to Expand Access to Cost-Saving Generic Drugs for the American Public (FDA)
  • Gottlieb Shifts From Regulatory To Reimbursement Focus In One Of First Post-Commissioner Appearances (Pink Sheet-$)
  • Major Upgrades In Store For The US FDA's Inactive Ingredients Database (Pink Sheet-$)
  • French drug maker Servier sets up U.S. headquarters in Boston’s Seaport (STAT)
  • The unsung public policy innovators paving the path to cures (BioCentury)
  • Reagan-Udall Annual Meeting: 4 Takeaways From US FDA Center Directors (Pink Sheet-$)
  • Now grown up, independent biotechs bulk up their platforms with more modalities (BioCentury)
  • Microbiome upstart Vedanta gets an extra $18.5M in the bank, wrapping up $45.5 Series C round (Endpoints)
  • Researchers hope new vaccine could improve odds for pancreatic cancer (CBS)
  • They got bounced out of Alexion. Now David Hallal and Vikas Sinha are back with $150M and a focus on cell and gene therapies (Endpoints)
Pharmaceuticals & Biotechnology: Study Results, Filings & Designations
  • Minerva claims ‘positive’ PhII data on depression drug while skeptics push stock down (Endpoints)
  • Celgene Corporation Announces POMALYST® Granted Breakthrough Therapy Designation from FDA for HIV-Positive and Negative Kaposi Sarcoma (Press)
  • Medtronic Reveals Results of First-In-Human Study for Investigational Extravascular ICD System (Press)
  • Polyphor hits the brakes on their PhIII pivotal for a lead antibiotic as investigators track a high rate of kidney injuries (Endpoints)
  • FDA Approves Broadened Indication for XEOMIN® (IncobotulinumtoxinA) as First-Line Treatment for Blepharospasm (Involuntary Blinking) in Adult Patients (Press)
  • Vifor Pharma’s Phase-II AMBER Study Meets Primary Endpoint (Press)
  • FDA Grants Orphan Drug Designation to Ayala’s AL101 for Potential Treatment of Adenoid Cystic Carcinoma (ACC) (Press)
  • Sesen Bio Reports First Quarter 2019 Financial Results and Updated, Preliminary Primary and Additional Secondary Endpoint Data from Phase 3 VISTA Trial for High-Risk Non-Muscle Invasive Bladder Cancer (Press)
  • ORIC Pharmaceuticals Announces Initiation of Phase 1b Study with ORIC-101 in Patients with Cancer (Press)
  • First Patient Enrolled in RegeneRx JV Phase 3 Dry Eye Trial (Press)
Medical Devices
  • Experts Raise Concerns with FDA Draft Guidance on Combo Product Reviews (Focus)
  • Israel's Zebra Medical gets FDA ok for AI chest X-ray product (Reuters)
  • FDA clears AliveCor's six-lead smartphone ECG (mobihealthnews) (Press)
  • FDA Draft Guidance On Medical Device Inspections Is Limited (Law360-$)
  • FDA Approves Impella 5.0 and Impella LD Extended Duration of Use to 14 Days for Cardiogenic Shock Derived from AMI or Cardiomyopathy (Press)
US: Assorted & Government
  • Two More States Seek to Establish Prescription Drug Importation Programs (FDA Law Blog)
  • Amgen Inc. v. Sandoz Inc. (Fed. Cir. 2019) (Patent Docs)
  • Yes, Virginia (Utah, Actually), There Is §510(k) Medical Device Preemption (Drug & Device Law)
  • Engulfed in legal trouble, bankruptcy could be the answer for opioid drugmaker Insys (Endpoints)
  • Turning Question Marks Into Check Marks: HHS Blueprint One Year Later (Pink Sheet-$)
  • SEC Won't Take Action Against Ocular Over Eye Drug (Law360-$)
Upcoming Meetings & Events Europe
  • IVDR, in-house developed tests and the state of MDR/IVDR implementation (MedicalDevicesLegal)
  • National MDR and IVDR implementation news – Netherlands implementation decree consultation (MedicalDevicesLegal)
  • The interplay between the GDPR and the EU Clinical Trials Regulation (Pharmafile)
  • Marketing authorisations granted in April 2019 (MHRA)
  • Parallel import licenses granted in April 2019 (MHRA)
  • Class 2 Medicines Recall: Co-amoxiclav 125 mg/31.25 mg/5 ml and 25 mg/62.5 mg/5 ml Powder for Oral Suspension (MDR 24-05/19) (MHRA)
  • Global drugmakers find fault with quality of clinical trials conducted in Russia (PharmaLetter-$)
  • Maha FDA asks DCGI to include balloon catheters and guiding catheters under NLEM (PharmaBiz)
  • Consultation - Draft Guidance Document for Industry and Practitioners on the Special Access Program (SAP) for Drugs (Health Canada)
  • Consultation on the Draft Guidance: Public or Canadian Armed Forces Health Emergencies - Drugs for Immediate Use or Stockpiling (Health Canada)
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.
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