With Revlimid and Pomalyst price increases, could Celgene be next on Trump’s to-call list? (Fierce)
3 Key Lessons From Trump's Drug Price Feud With Pfizer (Fortune)
What Pfizer, Trump, and consumers got out of a surprising deal — and what they didn’t (STAT)
U.S. ended value-based pricing plan for cancer drug because of doubts it would work (STAT-$)
U.S. Insurers Say the Opioid Crisis Might Be Declining (Fortune)
Patient Experience: The Future Of Big Pharma Is Software (Forbes)
Drug Prices Keep Climbing Even as Trump Steps Up Twitter Threats (Bloomberg-$)
Celgene’s Otezla Drug Patent Dispute Swells N.J. Court Docket (Bloomberg-$)
Tackling pharma’s predatory research problem (PharmaTimes)
VC money booms in Q2, with mega-deals hitting record levels (Endpoints)
Pharmaceutical and Biotechnology: Study Results, Filings and Designations
Parker Institute scientists herald a cell therapy breakthrough in the lab, using next-gen CRISPR tech to engineer T cells (Endpoints)
Common Chemotherapy Drug Is More Effective When Given With Dietary Supplement In Mice (Forbes)
Virus-free CRISPR could mean faster, more precise gene editing for T-cell therapies (Fierce)
Roche’s Venclexta filed in the US for acute myeloid leukemia (PharmaTimes)
Zynerba Pharmaceuticals Announces New FAB-C Phase 2 Open-Label Data in Patients with Fragile X Syndrome (Press)
Medical Devices
New Research Provides More Reasons to Repeal the Medical Device Tax (Tax Foundation)
NAMSA Launches “Uniquely IVD” Development Services to Expedite In Vitro Diagnostic Technology Commercialization Efforts for Global Manufacturers (NAMSA)
Abbott Receives FDA Approval for Next-Generation MitraClip Device to Treat People with Leaky Heart Valves (Press)
Medtronic Wins Expanded Indication for SelectSecure MRI SureScan Pacing Lead for His Bundle Site Stimulation (Press)
Cutting Edge Spine Announces FDA 510(K) Clearance of its New HA Enhanced PEEK Interbody for the Cervical Spine, the EVOL ha-C (Press)
US: Assorted & Government
The Trump Administration Is Making Immigrant Parents Pay $800 for DNA Tests to Get Their Kids Back (NPR)
TGA presentations: The new Code - where are we at? 12 & 13 June 2018 (TGA)
Canada
Thousands of local patients affected by recall of contaminated heart drug (Windsor Star)
Protecting Patents in Canada • Common Rule Recommendations (Bloomberg-$)
Updated: Application Form for Custom-Made Devices and Medical Devices for Special Access (Health Canada)
Notice of intent to amend: Prescription Drug List (PDL): Phytocannabinoids (Health Canada)
General Health & Other Interesting Articles
Few U.S. women have serious complications after abortions (Reuters)
Everyone deserves a holistic, patient-centric health care system (STAT)
How Bundling Care Hurts The Patients Who Need It The Most (Forbes)
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? Email us at [email protected].
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