Regulatory Focus™ > News Articles > 3 > Recon: Trump Urges Opioid Action

Recon: Trump Urges Opioid Action

Posted 02 March 2018 | By Ana Mulero 

Recon: Trump Urges Opioid Action

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

In Focus: US In Focus: International
  • Asian investor commits $15M to launch new protein degradation biotech startup Cullgen out of UNC (Endpoints News)
  • Pfizer, Merck KGaA nab NICE's favor for Bavencio in Merkel cell carcinoma (Fierce)
  • Lilly underlines what's at stake in Brexit talks (The Pharma Letter-$)
  • Overwhelmed health system to blame for Kenya hospital mix-up: doctors (Reuters)
  • Indonesia's first biomedicine factory opens (Nikkei Asian Review) (FiercePharma)
  • Why Oppenheimer Global fund is focusing on biotech as rates rise (Reuters)
  • EU-US FDA mutual recognition of inspections of medicines manufacturers enters operational phase (EC) (Focus)
Pharmaceuticals & Biotechnology
  • Remarks by Dr. Gottlieb on Enhancing Drug Distribution Security (FDA)
  • Advocates protest Novartis ‘bullying tactics’ over access to medicines in poor countries (Stat News-$)
  • Valeant settles Solodyn pay-for-delay litigation for $58 million (Reuters) (Law360-$)
  • McCaskill seeks to end tax breaks for consumer drug ads (Stat News-$)
  • Amid a boisterous fundraising week, BioMedPartners airs $107M biotech fund (Endpoints News)
  • Despite ‘responsible’ price, Regeneron drug kept out of many patients’ hands by payers (Stat News-$)
  • Express Scripts Turns To Dogs And Cats Amid Flat Prescription Growth (Forbes)
  • Beacon and Takeda initiate multi-year drug discovery collaboration (The Pharma Letter-$)
  • Oregon Drug Price Transparency Bill Heads to Senate (BioCentury)
Pharmaceutical and Biotechnology: Study Results, Filings and Designations
  • Roche, Ionis herald a big win in early-stage Huntington’s disease trial, demonstrate disease modifying potential (Endpoints News)
  • Verona jumps as midphase cystic fibrosis data dial up hopes (FierceBiotech)
  • Roche, Ionis hail Huntington's success, plan pivotal trial (FierceBiotech)
  • Reata Announces Top-Line Data from the Dose-Escalation Cohorts of the Phase 2 Motor Study of Omaveloxolone in Patients With Mitochondrial Myopathies (Press)
  • Verona Pharma Reports Positive Top-Line Data from Phase 2a Trial with RPL554 in Cystic Fibrosis Patients (Press)
  • Nightingale Health announces strategic collaboration with PerkinElmer (The Daily Telescope)
  • Hisamitsu totes positive Phase III data for transdermal PD therapy (The Pharma Letter-$)
  • Stem cells shed light on potential anti-Alzheimer’s compound (FierceBiotech)
  • A 25-Year Experience of US Food and Drug Administration Accelerated Approval of Malignant Hematology and Oncology Drugs and Biologics (JAMA)
  • FDA to review Dupixent sBLA in asthma (The Pharma Letter-$)
  • IONIS-HTT Rx (RG6042) Top-Line Data Demonstrate Significant Reductions of Disease-Causing Mutant Huntingtin Protein in People with Huntington's Disease (Press)
  • CTTI continues to address barriers to single IRB adoption: latest expert meeting summary (CTTI)
Medical Devices
  • Zimmer Biomet loses Pa. state appeal in $16m knee implant loss (MassDevice)
  • 3rd Circ. Nixes Part Of 'Hybrid' Medical Device Suit (Law360-$)
  • PTAB Upholds Eye Treatment Tool Patent (Law360-$)
  • InterSystems and Rhode Island Quality Institute Deliver Designee Alerts for Patient Empowerment (Press)
  • Gelesis raises $30M to gear up for weight loss launch (FierceBiotech)
  • Philips, Hologic ink mammography deal (MassDevice) (Press)
  • Covance Enters into Strategic Technology Agreement with GSK (Press)
  • Biocartis grabs lab space, staff from Johnson & Johnson to fuel U.S. expansion (FierceBiotech) (Press)
  • ALFA receives another US FDA 510(k) clearance for Simple Cup multi-drug test with Driven Flow (Press)
  • How LensCrafters is using iPads to reinvent the eye exam (MobiHealthNews)
  • Precision Health AI Launches Eureka HealthTM Oncology AI Platform, First of Its Kind “System of Intelligence” Which Delivers Data-Driven Insights to the Cancer Care Community (Press)
  • Samsung Presents its Latest Medical Equipment and Healthcare Solutions at the 2018 European Congress of Radiology (Press)
  • FDA approves BD Onclarity HPV Assay (FDA)
US: Assorted & Government
  • Alphabet Loses Top AI Researcher at Anti-Aging Unit Calico (Bloomberg-$) (Endpoints News)
  • 'Revolving Door' At DEA Faces Scrutiny In Opioid MDL (Law360-$)
  • Travis Kalanick joins board of medical software company (Axios) (Bloomberg)
  • How the U.S. military might help answer a critical question about the flu vaccine (Stat News-$)
  • Express Scripts Needs to Get Vertical (Bloomberg)
  • Senate plans 340B oversight hearings as transparency push mounts (Modern Healthcare)
  • FDA seeks comment on Post-Marketing Pediatric-Focused Product Safety Reviews (FDA)
Upcoming Meetings & Events Europe
  • Science Says: Why Europe still has so many measles outbreaks (AP News)
  • Supply chain commitment to tackling problem of medicine shortages (Press)
India Australia
  • Third death in rockmelon listeria outbreak (The West Australian)
  • Endometriosis research allocated $2.5 million in Government funding (ABC News)
Canada
  • They cost us billions and they can kill: Counterfeit drugs are invading Canada (Financial Post)
  • WeedMD to Secure Dealer’s License from Health Canada as a Next Step in its R&D Strategy (Press)
  • Canada's Pharmascience Renews Agreement With CDMO Saneca Pharma (Pharmaceutical Processing)
  • Cipher Pharmaceuticals Acquires Exclusive Canadian Rights to FDA-Approved Trulance from Synergy Pharmaceuticals (Press)
  • Innovus Pharma’s AllerVarx Receives Commercial Approval by Health Canada for the Reduction in Symptoms of Seasonal Allergic Rhinitis (Press)
General Health & Other Interesting Articles
  • How a society gala was used to sell young-blood transfusions to baby boomers desperate to cheat death (Stat News)
  • As Surgery Centers Boom, Patients Are Paying With Their Lives (Kaiser Health News)
  • The Challenge of Doctor-Patient Relations in the Internet Age (The New York Times)
  • Worst of bad US flu season is over as illnesses decline (AP News)
  • We need to rethink mental health laws. But not because of mass shootings. (The Washington Post)
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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