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

• Judgment day is coming: Federal judge orders Martin Shkreli to forfeit a small fortune following felony convictions (Endpoints News) (Bloomberg) (Law360-$) (The Hill)
• FDA approves new HIV treatment for patients who have limited treatment options (FDA)
• Trump's health chief warns hospital execs about health care costs: 'Change is coming' (The Hill) (MedPage Today) (Fierce) (Healthcare Dive) (Washington Examiner)
• UnitedHealth Group Will Pass Drug Maker Rebates Directly To Customers (Forbes) (NYT) (BioPharma Dive) (Fierce)
• Numbers show drugmakers are keeping RTFs under wraps (BioPharma Dive)
• FDA approves new dosing for Bristol-Myers Squibb's Opdivo (Reuters) (Endpoints News) (BioPharma Dive)
• Searching for HIV cure, Gilead’s new ‘shock and kill’ combo swats back lethal virus in monkeys (Endpoints News) (BioPharma Dive)
• Democratic Sen. Claire McCaskill says drug giant is "stonewalling" her opioid investigation (USA Today) (Washington Examiner)
• Fujifilm Sues Hologic For Mammography Patent Infringement (Law360-$) (MassDevice)

• 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)

• 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)

• Magenta inks deal with Heidelberg to add new ADCs to its transplant palette (Fierce) (Endpoints News)
• Alzheimer’s researchers win world’s top brain research prize (Medical Research Council)
• Adamis Pharma’s EpiPen alternative succeeds in human factors study (Drug Delivery Business News)
• Clearside Biomedical enrolls first patient in Ph3 macular edema trial (Drug Delivery Business News)
• Endologix launches study of second-gen Nellix endovascular aneurysm sealing system (MassDevice) (Press)
• Cleaning products tied to faster lung function decline in women (Reuters) (Fox News)

• 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)

• 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)

• FDA Advisory Committee Calendar

• Electronic transmission of individual case safety reports (ICSRs) with ANSM (ANSM)
• Delivering new services to put our customers first (MHRA)
• U.K. PARLIAMENT TO DEBATE NHS ACCESS FOR VERTEX'S ORKAMBI (BioCentury)
• 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-$)

• The tightrope walk of India's drug-price regulator (Economic Times)
• Spotlight on health — Changing India’s sanitation practices (Hindustan Times)
• India to offer free health services to half a billion people (Global Government Forum)

• 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)

• 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)