Recon: US Indicts Indivior Over Suboxone Marketing Tactics

• Sanofi to cut US insulin costs for some patients to $99 per month (Reuters) (STAT) (CNBC) (Endpoints) (Press)
• US indicts Indivior over Suboxone opioid treatment marketing (Reuters) (STAT) (Endpoints) (DoJ)
• Amgen's postmenopausal osteoporosis drug gets FDA greenlight (Reuters) (Endpoints) (NYTimes) (FDA)
• 5 names to know at Verily: Players to watch at Alphabet’s life sciences unit (STAT)
• PBMs sidestep the Senate’s tough questions — but lawmakers hint at legislation (STAT)
• Invisible Middlemen Are Slowing Down American Health Care (The Atlantic)
• ‘He calls me, I call him’: Alex Azar on his relationship with President Trump, drug pricing, and winning over skeptical conservatives (STAT)
• Sanders set to unveil 'Medicare for All' legislation (Politico)
• FDA Expands RWE Demonstration Project (Focus) (Endpoints)
• New York City Parents Held "Measles Parties" To Infect Unvaccinated Children As Officials Battle An Outbreak (Buzzfeed)
• Bill Requiring Justification For Rx Price Hikes Clears House Cmte. (Pink Sheet-$) (Ways & Means Committee)
• Why I Am Stockpiling Insulin in My Fridge (NYTimes)
• Student loan borrowers with cancer are supposed to be able to pause their payments. They’re hitting a wall (CNBC)

• WHO asks panel to weigh whether Ebola outbreak is global emergency (STAT)
• Congo Ebola outbreak 'far from contained,' US aid chief says (Reuters)
• Chinese player joins a growing group of biotechs buying into Synaffix’s ADC linker tech (Endpoints)
• No-deal Brexit fears over medication supplies (The Guardian)
• Brexit causing ‘significant’ generic drug shortages (PMLive)
• Lynparza set for further expansion with EU approval in breast cancer (PMLive)
• Novartis’ Kisqali hit with NICE rejection (PharmaTimes)
• UK stem-cell specialist ReNeuron agrees China deal (Financial Times)
• Inaugural WHO Partners Forum launches new push for collaboration on global health (WHO)
• WHO airlifts medical supplies for flood response in Islamic Republic of Iran (WHO)

• The Biopharmaceutical Cartel And High Drug Prices (Forbes)
• Medical Countermeasures: FDA Reports on FY2018 Achievements (Focus)
• Inozyme brings $67M to the bank to build up its calcification-focused rare disease pipeline (Endpoints)
• Two more Big Pharma CEOs enjoyed hefty raises in 2018, leaving the industry’s only major league female chief in firm control of last place (Endpoints)
• Fresenius moves forward with two US expansions after killing Akorn deal (Fierce)
• NIH researchers make progress toward Epstein-Barr virus vaccine (NIH)
• Lupin launches generic antidepressant tablets in US (Economic Times)
• FDA new drug approvals in Q1 2019 (Nature)
• Loyalty pays: Merck CEO Ken Frazier scores 19% raise as he stays past retirement age (Endpoints)
• Shire R&D chief Andy Busch jumps ship to Ironwood spin-out amid Takeda megamerger (Fierce)
• Admedus deals vaccines biz to Constellation Therapeutics (MassDevice)
• J&J pens Children's National deal to bring JLABS to D.C. (Fierce)
• Therapeutic targeting of trained immunity (Press)
• Compared to avoidance, Aimmune’s peanut allergy treatment an improvement over DBV’s product — ICER (Endpoints)
• Gene therapies for the cats and dogs you love? Penn-partnered Scout Bio just raised $20M to make it a reality (Endpoints)
• March on: AbbVie, Pfizer hold their places atop pharma's TV ad spender list (Fierce)

• Sound Biologics Announces FDA Allowance of its IND Application for PSB205, an Anti-PD-1/CTLA-4 MabPair, in Relapsed and Refractory Solid Tumors (Press)
• Can-Fite Announces Late-Breaking Abstract Presentation on Namodenoson™ Phase II Results at the American Association of Clinical Oncology (ASCO) Annual Meeting (Press)
• Concert Pharmaceuticals Initiates Phase 1 Multiple-Ascending Dose Trial of CTP-692 as an Adjunctive Treatment for Schizophrenia (Press)

• Medical Devices For Assessing Head Injury (FDA)
• FTC grants final approval for Fresenius’s $2B buyout of NxStage (MassDevice)
• Angel Medical’s Guardian implantable heart monitor fails on efficacy endpoint (MassDevice)
• Avinger wins FDA nod for Pantheris SV small vessel atherectomy device (MassDevcie)
• Synchron’s thought-to-text tech starts clinical trial (MassDevice)
• Varian Medical joins embolic therapy tech dev ABK Biomedical’s $30m Series B (MassDevice)

• GAO Identifies Gaps in FDA's Office of International Programs (Focus)
• In final hours, Maryland lawmakers pass prescription drug, UMMS reform, clean energy bills (WTOP)
• How the Trump tax cuts to Big Pharma widen inequality and undermine the health of women and girls (Oxfam)
• U.S. charges 24 in $1.2 billion Medicare orthotic brace fraud (Reuters) (DoJ)
• PTAB Axes Hair Loss Treatment Patent In Incyte Challenge (Law360-$)
• Ill. AG Is Latest To Sue Purdue Over Opioid Crisis (Law360-$)
• Medical Cannabis Research Act Stirs DEA Marijuana Registration Pot (FDA Law Blog)
• The CMS DTC Drug Pricing Rule – FDA v. Brown & Williamson All Over Again? (Drug & Device Law)

• FDA Advisory Committee Calendar

• UK Moves To Fill GCP Guide Gaps On Unblinding (Pink Sheet-$)
• Making submissions to the MHRA in a no deal scenario (MHRA)

• Asia Regulatory Roundup: China Adds 30 Drugs to Fast Track for Products Approved Overseas (Focus)
• Positive Phase III Data Set Stage For Japan Imeglimin Filing (Scrip-$)

• CDSCO to scrutinise claims made by manufacturers of malaria rapid diagnostic tests for accuracy in test results (PharmaBiz)

• Therapeutic Goods Advertising Consultative Committee, 21 March 2019 (TGA)

• Notice of Intent: Transitioning Product Monographs to a Structured Format (Health Canada)