The FDA is sounding the alarm on the next group of drugs that could be abused (Business Insider)
Bayer and MD Anderson collaborate on novel targeted cancer treatments (pharmaphorum)
Leading oncology group wary of Trump drug price proposals (Reuters)
Drug costs prompt fears of ‘financial toxicity’ in cancer care (Financial Times)
Opinion: Putting Patients First in Drug-Pricing Decisions (Morning Consult)
Drug makers push back on cost-effectiveness research for Medicare drugs (STAT-$)
FDA wants brand and generic drug makers to get along (Axios)
Sanofi tweaks pricing policies, discloses 8.4% net price decline in 2017 (Fierce)
Amgen is the latest drugmaker to have a Herceptin biosim sidelined by a CRL (Fierce)
Dova reveals $9K to $13.5K Doptelet price, stock sags (BioPharma Dive) (Press)
Pharmaceutical and Biotechnology: Study Results, Filings and Designations
The difficult search for the right recipe in cancer immunotherapy (C&EN)
Next-Generation Therapies in Focus at Year's Top Cancer Meeting (Bloomberg)
Microbiome, Herbal Medicine, and Probiotics Combine to Extend Lifespan (GEN News)
Ahead of ASCO, BMS' Opdivo leads Merck's Keytruda in U.S. sales—but not for long, analyst predicts (Fierce) (Press)
Small molecule silences cancer-driving RNA, opens up previously undruggable targets (Fierce)
Samsung Bioepis Announces Results of Additional One-Year Follow-up Study on SB3 Trastuzumab Biosimilar Candidate at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting (Press)
Aratana Therapeutics Files for FDA Approval of NOCITA (bupivacaine liposome injectable suspension) Label Expansion (Press)
Halozyme Identifies Plasma Biomarkers As Potential Predictors Of Survival In Pancreatic Cancer (Press)
SELLAS Life Sciences Provides Clinical Update on Phase 2b NeuVax (nelipepimut-S) Study in Combination with Trastuzumab in HER2 1+/2+ Breast Cancer Patients (Press)
Exelixis Announces Further Expansion to Clinical Research Protocol for Phase 1b COSMIC-021 Trial of Cabozantinib in Combination with Anti-PD-L1 Immunotherapy in Patients with Locally Advanced or Metastatic Solid Tumors (Press)
Immunomedics Announces Pivotal Study of Sacituzumab Govitecan in Patients With Locally Advanced or Metastatic Urothelial Cancer (Press)
Data Highlighting Advaxis’ ADXS-PSA Presented at ASCO Annual Meeting (Press)
Tonix Pharmaceuticals Presented New Data Related to Suicidal Ideation and Behaviors in Military-Related PTSD from the Phase 2 AtEase Study at the American Society of Clinical Psychopharmacology (Press)
Lilly to Showcase New Data at Digestive Disease Week 2018 for Mirikizumab in Moderate-to-Severe Ulcerative Colitis (Press)
Medical Devices
Blood test offers hope of finding cancers before symptoms develop (CNN)
As FDA signals wider AI approval, hospitals have a role to play (Healthcare IT News)
Virgo’s technology enables video recording of colonoscopies (MedCity News)
Telemedicine services appear to drive genetic testing (MobiHealthNews)
Artificial Sensory Nerves May One Day Provide Prosthetic Limbs with Sense of Touch (GEN News)
Korea’s IntroMedic wins FDA nod for MiroCam capsule endoscope, inks U.S. distro deal (MassDevice)
Startup debuts with plan to map gene signaling pathways for new targets (Fierce)
GE Healthcare Introduces Virtual Reality Training for Healthcare Technology Management Professionals (Press)
Philips provides AEDs for New Cardiac Arrest Response System (Press)
Branchpoint Technologies announces FDA 510(k) for its AURA Intracranial Pressure Monitoring System (Press)
US: Assorted & Government
FDA’s Ninth Annual Report to Congress on 505(q) Citizen Petitions: New Numbers and a New Tone (FDA Law Blog)
Mergers between health insurers and pharmacy benefit managers could be bad for your health (STAT)
Alphabet's Verily has hired top execs to bring its science research into hospitals and homes (CNBC)
Jamie Dimon says after health venture with Amazon and Berkshire was announced insurers were 'pissed off' (CNBC)
CVS donated to pro-Trump "dark money" group (Axios)
Doctors are being more careful on opioid prescriptions (Axios)
A More Egalitarian Hospital Culture Is Better for Everyone (NYT)
A 'wake-up call' about what's killing America's young people (CNN)
Drug Use Rankings Show Big Surprises And Even Bigger Problems (Forbes)
When Scientists Develop Products From Personal Medical Data, Who Gets To Profit? (NPR)
Skyping the doctor? Poll shows it’s not just for the young (AP News)
Digital Health: "It's Not About the App" (PharmExec)
The key to weight loss may be right in the palm of your hand (CNBC)
Humans' Big Brains May Be Partly Due to Three Newly Found Genes (GEN News)
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]. A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.
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