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

• 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)

• 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)

• 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)

• 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)

• 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)

• 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-$)
• SEC Won't Take Action Against Ocular Over Eye Drug (Law360-$)

• FDA Advisory Committee Calendar

• 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)