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March 12, 2019
by Michael Mezher

Recon: Report Finds Hundreds of Thousands of Deaths Tied to Fake Drugs; Pfizer Pays $1M to Settle Misleading Copay Coupon Claims

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • Exclusive: Lawsuit says Johnson & Johnson was opioid "kingpin" (Axios)
  • Pfizer pays $975,000 to settle charges over misleading copay coupons (STAT) (Law360-$)
  • Regeneron/Sanofi wins US approval for expanded use of skin drug (Reuters) (Endpoints) (Press)
  • FDA Approves 18th Biosimilar, 4th for Herceptin (Focus) (Reuters) (Press)
  • Upcoming market catalysts in Q2 2019 (Nature)
  • Abortions by mail: the FDA is going after online pill providers (Vox)
  • Alex Azar faces off with Congress today (Politico)
  • Hospitals are saving lives with CAR-T. Getting paid is another story (STAT)
  • Lilly's combo therapy succeeds in late-stage lung cancer study (Reuters)
  • Biotech execs predict big M&A deals ahead as mood shifts in wake of a 2018 hangover (Endpoints)
  • UnitedHealth gives drug discounts directly to consumers in move beyond Trump crackdown (CNBC)
  • US Hospitals And Insurers Might Be Forced To Reveal The True Prices They Negotiate (NPR)
  • Trump’s 2020 Budget Seeks FDA Tweaks to Increase Generic Competition (Focus)
  • Trump’s Budget Offers $291M To Fight HIV In U.S. But Trims Overseas Efforts (KHN)
In Focus: International
  • Global 'pandemic' of fake drugs killing children worldwide, report says (CNN) (The Guardian) (AJTMH)
  • Microsoft moves into biological computing with Station B (Financial Times) (Fierce) (Oxford Biomedica)
  • EU Address Complex Clinical Trial Designs In New Guideline (Pink Sheet-$)
  • NICE recommends Janssen's Darzalex myeloma combo (Pharmafile)
  • Fujifilm grabs Biogen biologics plant in Europe to bolster its CDMO business (Fierce)
  • SMC says ‘no’ to Novartis’ Kymriah for adults with lymphoma (PharmaTimes)
  • Backed by OrbiMed, Lilly and now Advantech, China’s InventisBio loads up $70M to propel cancer, metabolic pipeline (Endpoints)
  • UK’s MHRA Offers 6 New No-Deal Brexit Guidances on Importing, Exporting Medicines (Focus)
  • ‘Unacceptable secrecy’ surrounds safety warnings by pharma and regulators in Australia (STAT)
  • Deadly plague breaks out on Uganda-Congo border, WHO says (Reuters)
  • WHO Holds Off on Recalls Following Non-Compliance at Indian Site (Focus)
Pharmaceuticals & Biotechnology
  • Top drugs and companies by sales in 2018 (Nature)
  • Drug pricing under the spotlight (Nature)
  • Roche, Biogen and AbbVie stake new gene therapy claims (Nature)
  • If You Build It, Will They Come? Addressing The Value Equation (LifeSciVC)
  • Let’s Play Name That Biosimilar! (FDA Law Blog)
  • Deregulating buprenophine prescribing for opioid use disorder will save lives (STAT)
  • FDA to Survey Healthcare Professionals on Prescription Drug Marketing (Focus)
  • With Alimta patent cliff looming, Lilly plots stronger foothold in frontline NSCLC with Cyramza (Endpoints)
  • CANCELLED March 27, 2019: Meeting of the Pulmonary-Allergy Drugs Advisory Committee Meeting Announcement (FDA)
  • Another monkey at FDA lab died (Arkansas Democrat)
  • Startup Tiburio nabs Avrobio executive Kreher as chief medical officer (Fierce)
  • AstraZeneca lines up a $20M installment plan to launch a new oncology collaboration with microbiome player Seres (Endpoints)
  • Zafgen’s second try at Prader-Willi syndrome triggers another safety alarm in preclinical tox study (Endpoints)
  • FDA’s Focus Has Sharpened on Water Systems in the Wake of Nonsterile Product Microbial Contamination (IPQ)
  • Biomarkup: creating or promoting medical tests to drive revenue (STAT)
  • Esketamine Faces Challenges In Its Quest To Be A Breakthrough Drug Against Suicidal Ideation (Forbes)
  • FDA Pulls Fast-Track Designation for Tonix’s PTSD Treatment (FDANews-$)
  • Real-Time Oncology Review Quickly Grows Popular; Venclexta Is Latest To Join Pilot (Pink Sheet-$)
Pharmaceuticals & Biotechnology: Study Results, Filings & Designations
  • Allergan files anti-CGRP migraine drug in the US (PharmaTimes)
  • GeNeuro touts a mixed set of extension data in a shot at salvaging their failed mid-stage MS drug (Endpoints)
  • New Phase 3 STELARA® (ustekinumab) Data Show Positive Results As Maintenance Therapy In Adults With Moderate To Severe Ulcerative Colitis (Press)
  • Akebia Therapeutics Announces Positive Top-Line Results from Two Pivotal Phase 3 Studies of Vadadustat in Japanese Patients with Anemia Due to Chronic Kidney Disease (Press)
  • Rocket Pharmaceuticals Announces First Patient Dosed in Phase 1 Clinical Trial of RP-L102 in the U.S. (Press)
Medical Devices
  • CDRH Warns of Device Supply Issues Following Suspension of Illinois Sterilization Facility (Focus)
  • Smith & Nephew puts up $660m for Osiris Therapeutics (MassDevice)
  • Hill-Rom to acquire Voalte for $195m (MassDevice)
  • Alcyone wins breakthrough device status for delivery device (MassDevice)
US: Assorted & Government
  • Supplemental Report - 2017 Essential Diabetes Drugs (Nevada DHHS)
  • Trump proposes e-cigarette user fee to combat youth usage (Reuters)
  • Valeant Conflict Wasn't A Crime, Ex-Execs Tell 2nd Circ. (Law360-$)
  • Guest Post – Some Good News from California for Companies with Self-Insured Retentions. (Drug & Device Law)
Upcoming Meetings & Events Europe
  • EMA Launches Operations in Amsterdam (Focus)
  • Provisional NICE nod for Ilumetri (PharmaLetter-$)
  • Public unaware of how to verify legitimacy of online pharmacies, survey finds (PharmaTimes)
Asia
  • Japan eyes India for tech transfer, business collaboration & maximise manpower expertise in lifesciences-healthcare (PharmaBiz)
India
  • Pharma SMEs seek year-long deadline extension for implementation of new labelling norms (PharmaBiz)
General Health & Other Interesting Articles
  • Evaluation of Journal Registration Policies and Prospective Registration of Randomized Clinical Trials of Nonregulated Health Care Interventions (JAMA)
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.
 
Need to contact the editor of Regulatory Reconnaissance? Email us at [email protected].
 
A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.
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