Recon: Boehringer to Cut 300 Jobs in France

• The Year Ahead: Drug pricing efforts to test bipartisanship (The Hill)
• GlaxoSmithKline's Shingrix shortage expected to persist 'throughout 2019' (Fierce)
• Lawsuit alleges NIH, FDA let clinical trial sponsors off the hook (STAT) (Law360-$)
• One Implant, Two Prices. It Depends On Who’s Paying. (KHN)
• Scientists say freeze on fetal tissue acquisition puts HIV study in 'limbo' (Politico)
• FDA approves first prescription mobile app for opioid use disorder, courtesy of Sandoz and Pear Therapeutics (Pharmafile) (mobihealthnews) (FDA) (Press)
• Gottlieb blasts high insulin prices, touts far-off new rules he says will spur competition in that market (STAT)
• The military pushed it for the battlefield. The FDA went along. Is the newest opioid any better? (STAT)
• New documents shed light on secretive ElevateBio, next step for former Alexion execs (STAT)
• Dozens of groups attack Trump plan to peg drug prices to what other countries pay (STAT)

• As May delays, industry warns again of ‘no-deal’ Brexit (PMLive)
• Boehringer's France restructure will cull over 300 jobs (Pharmafile)
• UK Pharmas Shrug Off Brexit Vote Delay (BioCentury)
• UK Government Says Orkambi Must Go Through Proper NICE Channels (BioCentury)
• Health secretary orders review overprescribing (PharmaTimes)
• SMC accepts four medicines for NHS use (PharmaTimes)
• Amgen teams with Entera to develop oral biologics (Fierce) (Press)
• Pfizer announces new UK Managing Director (Pharmafile)
• Lonza bets on China biotech market with plans for new plant (BioPharmaDive)
• WHO confirm Tanzania FDA as Africa's first well-functioning regulatory body (Pharmafile)
• Years before CRISPR babies, this man was the first to edit human embryos (MIT Technology Review)
• Will Mexico's COFEPRIS Dissolve Under New Presidency? (Pink Sheet-$)
• In Remote Villages, Surprising New Measures Save Children With Malaria (NYTimes)

• Research Gaps Leave Doctors Guessing About Treatments For Pregnant Women (NPR)
• Did Free Pens Cause the Opioid Crisis? (The Atlantic)
• Lessons From The Biggest Pharma Drug Launches Of All Time (Forbes)
• Gene Therapy’s Next Big Challenge: Manufacturing (Scrip-$)
• Counter-Intuitive Thinking To Combat Drug Shortages (Pink Sheet-$)
• Proposed FDA Drug Software Rules Strict On Pharma Cos. (Law360-$)
• Four years after mega IPO, Circassia set for small-cap exchange (Fierce)
• Pfizer's palbociclib most commonly used breast cancer drug in clinical trials (Pharmafile)
• Too much success? A booming biotech pipeline will spur intense rivalries — analyst (Endpoints)
• Targeting CD47? UCLA joins bandwagon, with gel to stem tumors from resurfacing (Endpoints)
• Benefits of statins far outweigh risks (Reuters)
• Sue Dillon, Karyn O’Neil steer fledgling Aro Biotherapeutics to $13M debut — with J&J’s blessing (Endpoints)
• Black Diamond turns down an open stretch of R&D highway, headed to a showdown with oncogenes (Endpoints) (Xconomy)
• Novo taps e-therapeutics for diabetes target discovery drive (Fierce)
• CRISPR-based heart test pinpoints genetic risk for severe cardiomyopathy (Fierce)
• David J. Fishman: Debarment Order (FDA)
• Su-Chiao Kuo: Debarment Order (FDA)

• Non–Cystic Fibrosis Bronchiectasis (NCFB) FDA Grants “Fast-Track” and “QIPD” to Zambon for Colistimethate Sodium Powder for Nebulizer Solution Delivered by the I-neb AAD System (Press)
• Karuna Pharmaceuticals to Present Results of KarXT Phase 1 Study at American College of Neuropsychopharmacology Annual Meeting (Press)
• Acerus Announces Results of Phase 1 Clinical Trial with a Proprietary Intranasal Formulation of a Tetrahydrocannabinol-Rich Cannabis Oil (Press)
• Marinus Claims Phase 2 Postpartum Depression Win, Analysts Less Sure (Xconomy)

• Legislators Release New Draft Bill Incorporating FDA Ideas for Diagnostics Regulation (GenomeWeb)
• Medtech Company of the Year 2018 Finalists (MDDI)
• FDA grants breakthrough status to joint Merck-Bayer AI program (Medical Design & Outsourcing)
• Fresenius Expands Presence in China With Investments and Acquisitions (MDDI)
• Edwards Lifesciences, Bay Labs ink cardio-focused collab AI-dev deal (MassDevice)
• Hologic wins FDA nod, launches next-gen Omni hysteroscope (MassDevice)
• POPS! Diabetes Care scores 510(k) for connected glucose monitoring system (mobihealthnews)
• Baxter Called Out for Numerous Issues at Colombian Plant (FDANews-$)
• AMRA Receives U.S. FDA Clearance for AMRA® Profiler, a Magnetic Resonance Diagnostic Software Application Enabling Non-Invasive Evaluation of Body Composition (Press)
• BioCardia Submits 510(k) Application to FDA for AVANCE Steerable Introducer for Transseptal Access to Heart (Press)
• Millar wins expanded CE Mark for Mikro-Cath pressure catheter (Medical Design & Outsourcing)

• J&J To Face Bulk Of Buyers' Claims In Remicade Antitrust Suit (Law360-$)
• Merkley Bill Would Fund Addiction Treatment at Opioid Makers’ Expense (FDANews-$)
• Tardy Claim Dooms $100M Biotech IP Suit In Chancery (Law360-$)
• Interesting Appellate Decision on Standing/Irreparable Harm (Drug & Device Law)
• Freedom of Information…Unless Agencies Decide Otherwise? (FDA Law Blog)
• Freshman lawmakers give J&J CEO Alex Gorsky another unwanted turn in the public spotlight (Endpoints)
• I’ve been forced to go through ‘step therapy.’ Don’t make Medicare Part B participants do that (STAT)

• FDA Advisory Committee Calendar

• Clinical trials for medicines: authorisation assessment performance (MHRA)

• China details punishments for IP fraud (BioCentury)

• Aurobindo Pharma arm enters pact to form JV in China with Luoxin (Economic Times)
• Dr Reddy's launches heartburn drug in US market (Economic Times)
• Cadila Healthcare arm gets USFDA nod for ulcer treatment injection (Economic Times)
• Sun Pharma promoters take a hit on personal investments (Economic Times)
• Industry urges union health ministry to give suitable time frame to SMEs to upgrade to GMP standards (PharmaBiz)

• Regulation of Software as a Medical Device (TGA)