Recon: FDA Approves New HIV Treatment for Patients With Limited Options

Posted 06 March 2018 | By Ana Mulero 

Recon: FDA Approves New HIV Treatment for Patients With Limited Options

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

In Focus: US In Focus: International
  • Australia could become first country to eradicate cervical cancer (The Guardian) (New Scientist)
  • Opdivo Faces 23.8% Price Cut as Slew of Reduction Rules Apply; Nexium Down 16.1% on Huge Seller Slash (Pharma Japan) (Japan News)
  • European Parliament Working Group expresses “strong condemnation of the request” from PhRMA to add the EU to the USTR "Special 301" watch list (Statement)
  • 16th Invitation to manufacturers of antituberculosis medicines to submit an expression of interest (EOI) for product evaluation to the WHO Prequalification Team: medicines (WHO)
  • Second international awareness session for international regulators, academia and non-governmental organisations (EMA)
Pharmaceuticals & Biotechnology
  • How will biotech’s latest bubble go pop? We asked some experts (Stat News-$)
  • FierceBiotech’s rotten tomatoes and ripening fruit 2017 (Fierce)
  • Quiet and confidential IPO registration? Who needs it. Autolus shouts about its next big raise (Endpoints News) (Fierce)
  • Big Pharma's lobbyists are losing despite their 'pass the buck' campaigns (The Hill)
  • Why can’t the drug industry solve its gender diversity problem? (c&en)
  • ViewPoint Therapeutics gets $35M to advance non-surgical alternative for cataracts, presbyopia (Endpoints News) (Press)
  • After bagging Shire’s cell therapy castoff, Caladrius stock climbs (Endpoints News) (Fierce)
  • Cell therapy flotations could follow Kite and Juno buyouts (EP Vantage)
  • Daiichi Sankyo makes another big whack at U.S. sales operations, cutting 280 jobs (Fierce)
  • As CVS-Aetna Looms, Retail Pharmacy Clinic Growth Stalls (Drug Channels)
  • Opioid Maker Insys Still Has Fans on Wall Street (The Wall Street Journal)
  • Hospira Issues a Voluntary Nationwide Recall for Hydromorphone HCL Injection, USP CII Due to The Potential for Empty or Cracked Glass Vials (FDA)
  • Dan R. Littman Elected to Pfizer’s Board of Directors (Press)
  • Newly Approved Treatment for Impetigo to be Commercialized by Cutanea Life Sciences, Inc. (Press)
  • Novartis' Xolair recommended in new global chronic urticaria guideline (Press)
Pharmaceutical and Biotechnology: Study Results, Filings and Designations Medical Devices
  • GUDID Analytics March 2018 (FDA)
  • J&J Unit Can't Shake $15M Pelvic Mesh Verdict In NJ (Law360-$)
  • Class OK'd In Background Check Suit Versus Medical Supplier (Law360-$)
  • RenovoDerm Receives FDA Clearance for Proprietary Product (Press)
  • Medtronic criticized for lax response to hacking vulnerability (Minneapolis Star Tribune)
  • WellDoc’s Digital Platform for Type 2 Diabetes Powers “Diabetes Wellness Program” Within Samsung Health (Press)
  • Focus Universal Inc. Receives USPTO Issue Notification for Patent Covering its Universal Smart Device (Press)
  • Elliquence, LLC Expands Endoscopic Spine Product Line to Accommodate Growing Demand for High Quality Solutions (Press)
  • Cerner Announces New Collaboration with Salesforce to Extend Care Beyond the Exam Room (Press)
  • 71% of IoT medical device ransomware infections caused by user practice issues (Healthcare IT News)
  • Smiths Medical inks distro deal for infusion therapy products (Drug Delivery Business News)
  • Siemens launches industrial PCs for medical equipment market (Medical Design & Outsourcing)
US: Assorted & Government
  • Remarks on Value-Based Transformation to the Federation of American Hospitals (HHS)
  • Comment Request; Reclassification Petitions for Medical Devices (FDA)
  • Medical Devices; General and Plastic Surgery Devices; Classification of the Extracorporeal Shock Wave Device for Treatment of Chronic Wounds (FDA)
  • FDA Can Build on Existing Efforts to Measure Progress and Implement Key Activities (GAO)
  • Flu the Coop! (Lachman Consultants)
  • State Obamacare Changes Could Hurt Medicaid Programs (Bloomberg)
  • DEA Agrees To Large Data Release In Opioid MDL (Law360-$)
  • Junk insurance plan proves Trump doesn't care about your health (USA Today)
  • Collaborating to Combat the Opioid Epidemic (US Chamber of Commerce)
  • Manchin unveils bill to change controversial opioid enforcement law (The Hill)
  • Bill Would Boost Tribes’ Access To Opioid Treatment Funds (Law360-$)
  • Jared Kushner says 'Trump administration has a new plan for interoperability' (Healthcare IT News)
Upcoming Meetings & Events Europe
  • Electronic transmission of individual case safety reports (ICSRs) with ANSM (ANSM)
  • Delivering new services to put our customers first (MHRA)
  • NHS-funded nursing care rate announced for 2018 to 2019 (MHRA)
  • Innovatus closes buyout of Bayer’s European imaging device service biz (Medical Design & Outsourcing)
  • New Guidance from China FDA on 3D Printed Medical Device Registration Rules (Emergo Group)
  • China Approves First Device through Marketing Authorization Holder Program, Green Lights Contract Manufacturing (China Med Device)
  • Chinese Vaccine Co. Sues 'Dissident' Shareholders Over Coup (Law360-$)
India Australia
  • Consultation: Proposal to change the current good manufacturing practice (GMP) fees and charges (TGA)
  • News from Abroad -- Australia Remains a Gene-Patent Friendly Jurisdiction (Patent Docs)
  • Notice: Release of Draft (Step 2) ICH Guidance: Q12: Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management (Health Canada)
  • Over 500 Canadian doctors protest raises, say they're being paid too much (yes, too much) (CNBC)
  • Taiho Pharma Canada, Inc. announces Health Canada approval of Lonsurf (trifluridine and tipiracil tablets) for metastatic colorectal cancer (Press)
General Health & Other Interesting Articles
  • Halfway to Zero Serious Safety Events (NEJM)
  • Survey: 93 percent of hospital patients can view EHR online (Health Data Management)
  • Ochsner Health System uses AI to detect early warning signs in patients (MedCity 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.

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