Regulatory Focus™ > News Articles > 2 > Recon: FDA to Expand Medication-Assisted Therapy for Opioid Addicts

Recon: FDA to Expand Medication-Assisted Therapy for Opioid Addicts

Posted 26 February 2018 | By Ana Mulero 

Recon: FDA to Expand Medication-Assisted Therapy for Opioid Addicts

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

In Focus: US
  • FDA to Expand Medication-Assisted Therapy for Opioid Addicts (The New York Times)
  • A New Regulatory Threat to Cancer Patients (The Wall Street Journal)
  • Drug price hikes spark investor demand for socially responsible innovation (S&P Global)
  • Allergan is dealt another setback as patent board shoots down Mohawk patent deal (Stat News)  (Press) (Patent Law Weblog)
  • Buffett-Dimon Health Venture to Go Beyond Just Squeezing the Middlemen (Bloomberg)
  • Patients Eagerly Awaited a Generic Drug. Then They Saw the Price. (The New York Times)
  • Why Your Pharmacist Can’t Tell You That $20 Prescription Could Cost Only $8 (The New York Times)
  • Medtronic wins FDA nod for smallest drug-eluting stent on U.S. market (MassDevice)
  • Hidden Profits In the Prescription Drug Supply Chain (The Wall Street Journal)
  • FDA Implements FDARA Provision on Orphan Drug Clinical Superiority Determinations (FDA Law Blog)
  • Vertex Appoints Reshma Kewalramani, M.D., as Chief Medical Officer (Press) (Fierce)
In Focus: International
  • Reva gets CE mark for bioresorbable scaffold with thin struts (FierceBiotech)
  • Italy’s vaccine debate shows anti-establishment sway (AP News)
  • EMA’s CHMP recommends 5 new medicines for approval (Focus)
  • Interview – Zimmer Biomet sees a tricky European future (EP Vantage)
  • Response to announcement of Baroness Cumberlege's review into patient safety (ABPI)
  • Canada’s health-care system is a point of national pride. But a study shows it’s at risk of becoming outdated. (The Washington Post)
  • Health Sector Payment Transparency Act, 2017 - New Regulation (Ontario)
Pharmaceuticals & Biotechnology
  • Esperion Targets $10 a Day for Heart Pill to Undercut Rivals (Bloomberg)
  • Amgen Fears 'Staggering Loss' After FDA Exclusivity Denial (Law360-$)
  • Hospira Issues A Voluntary Nationwide Recall For Labetalol Hydrochloride Injection, USP, Due To The Potential Of Cracked Glass At The Rim Surface Of The Vials (Press)
  • Obseva still faces hard labour with fertility therapy (EP Vantage)
  • Proximagen buy creates first AI firm capable of entire drug R&D: BenevolentAI (FierceBiotech)
  • AstraZeneca taps Pelago for drug-protein interaction assay (FierceBiotech)
  • Transitioning Teva revamps branding to emphasize brand-generic unity (Fierce)
  • Recipharm CFO Resigns (Contract Pharma)
  • Bavarian Nordic, AstraZeneca, & Georgetown Team Up (Contract Pharma)
  • Catalyst Biosciences Announces Manufacturing Agreement with AGC Biologics for Subcutaneous Factor IX Product CB 2679d (Press)
  • Xencor Signs Four Commercial License Agreements with Selexis SA to Advance its Pipeline of XmAb Bispecific Antibody Drug Candidates (Press)
  • Clearside Biomedical Announces Organizational Changes Designed to Support Transition to a Commercial-Stage Company (Press)
  • Neos Therapeutics Launches Adzenys ER (amphetamine) Extended-Release Oral Suspension in U.S. for the Treatment of ADHD in Patients 6 Years and Older (Press)
Pharmaceutical and Biotechnology: Study Results, Filings and Designations
  • Medical Researchers Look to Enlist Patients as Partners (The Wall Street Journal)
  • A new app wants you to swab your cheek to match with a genetically compatible date (Stat News)
  • Biosensorix pens pact to develop rapid dengue, stroke tests (FierceBiotech)
  • New Data Show Lilly's Trulicity (dulaglutide) in Combination with an SGLT-2 Inhibitor Improves Blood Sugar Control in People with Type 2 Diabetes (Press)
  • Adverum Biotechnologies Announces Completion of Dosing of First Cohort of Patients in the Phase 1/2 Clinical Trial of ADVM-043 Gene Therapy for A1AT Deficiency (Press)
  • Bioventus to Co-Develop Next Generation Bone Allograft with LifeLink (Press)
Medical Devices
  • Medtronic wins sensor nod from FDA for MiniMed 670G auto insulin tech (MassDevice)
  • Medical Devices; Hematology and Pathology Devices; Classification of Lynch Syndrome Test Systems (FDA final order)
  • MD Anderson, RaySearch ally to take adaptive radiation therapy mainstream (FierceBiotech)
  • More than 1 Million Screened for Colorectal Cancer with Cologuard (Press)
US: Assorted & Government
  • When Public Policy and Medical Science Are Misaligned (Eye on FDA)
  • 2017 Draft Report to Congress on the Benefits and Costs of Federal Regulations and Agency Compliance with the Unfunded Mandates Reform Act (White House)
  • Industry Input in Policymaking: Evidence from Medicare (NBER)
  • Academics: Challenges To Maryland, Nevada Drug Pricing Laws Likely To Fail (InsideHealthPolicy)
  • Buffett: The JPMorgan-Amazon-Berkshire Hathaway healthcare venture 'is looking for something bigger' than shaving a few percent off costs (Business Insider)
  • Arizona could face fines in lawsuit over prison health care (AP News)
Upcoming Meetings & Events India
  • Big claims, little evidence (The Hindu)
  • ‘Syringe, needle makers’ move to self-regulate prices hits roadblock as 4 MNCs play spoilsport (PharmaBiz)
Australia
  • Australia awarded A$1.3 million contract for next generation secure wireless devices (OpenGov)
  • Global Digital Health Partnership launched in Australia with participants from 13 countries, Hong Kong SAR and WHO (OpenGov)
  • TMCx builds bridges to Australia's health tech sector (Houston Chronicle)
Canada
  • Health Canada approves Fasenra (benralizumab injection) for patients with severe eosinophilic asthma Français  (Press)
General Health & Other Interesting Articles
  • One man’s fight to wife HPV off the face of the earth (CBS News)
  • U.S. Supreme Court rejects challenge to EPA water regulation (Reuters)
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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