Regulatory Focus™ > News Articles > 8 > Recon: Allergan Sues Pfizer; US Subpoenas AmerisourceBergen

Recon: Allergan Sues Pfizer; US Subpoenas AmerisourceBergen

Posted 03 August 2018 | By Ana Mulero 

Recon: Allergan Sues Pfizer; US Subpoenas AmerisourceBergen

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

In Focus: US Advertisement: Introducing BSI's Fall Medical Device Roadshow

Join leading global medical device Notified Body/ISO 13485 registrar BSI's full day Roadshow for our current experiences, best practices and latest expectations of the European MDR and quality assurance requirements. Topics include MDR implementation limitations, clinical requirements, labelling and UDI, technical documentation best practices, MDSAP, ISO 14971 application and the Quality Management System (QMS) aspects of the MDR. Click here for full agenda, dates and locations.

In Focus: International
  • To Get the Latest Drugs, Head to China (Bloomberg)
  • China isn’t yet ready to conduct clinical trials for the pharma industry (STAT)
  • Spain's Almirall bets on dermatology with $650 million U.S. deal (Reuters) (Fierce)
  • EMA grants PRIME status for Roche Huntington's drug (PharmaTimes) (Endpoints)
  • Early access to medicines scheme (EAMS) scientific opinion: patisiran-LNP to treat adults with hereditary transthyretin-mediated amyloidosis (MHRA) (Press)
  • Lilly Asian Ventures backs Impact’s PARP research again, chipping in for $30M Series C led by Decheng Capital (Endpoints) (The Pharma Letter)
  • Ebola outbreak in DRC sets up another test for experimental treatments (STAT)
  • WHO to know soon if new Congo Ebola outbreak can use vaccine (AP News) (Reuters)
  • New Ebola outbreak kills 20 in DR Congo just nine days after health workers declared virus contained (The Guardian) (Reuters)
  • WHO warns of new Yemen cholera surge, asks for ceasefire to vaccinate (Reuters)
  • Ireland woos Kerala-based companies, positions itself as base to access European markets (The Hindu Business Line)
Pharmaceuticals & Biotechnology
  • Cellectis snaps up Novartis VP (The Pharma Letter-$) (Endpoints) (Fierce)
  • How drug companies are beating Trump at his own game (Politico)
  • The difficult search for the right recipe in cancer immunotherapy (GEN)
  • Drugs could account for more health spending than we thought (Axios)
  • FTC, FDA Team Up to Fight Drug Monopolies, High Prices (Bloomberg-$)
  • Intercept Shares Rise as Drug Sales Recover After Patient Deaths (Bloomberg-$)
  • Under pressure from investors, Cardinal Health agrees to bolster opioid distribution oversight (STAT-$)
  • To pay for cutting-edge CAR-T therapies, Medicare plays it safe, for now (STAT-$)
  • Poison control calls spike for unapproved drug that produces opioid-like highs (STAT)
  • Antianxiety drugs — often more deadly than opioids — are fueling the next drug crisis in US (CNBC)
  • Cashing in on DNA: race on to unlock value in genetic data (Reuters)
  • Exploring validation and data integrity in pharma (PharmaTimes)
  • Latest PRV sale further evidence of sliding value (BioPharma Dive)
  • F.D.A. Did Not Intervene to Curb Risky Fentanyl Prescriptions (NYT)
  • Teva Braces For A Bigger Hit As Price Competition Intensifies For Copaxone (Scrip-$)
  • Listen: Inexpensive Nerve Drug Often Abused As Opioid Epidemic Grows (KHN)
  • 6 Reasons Celgene Remains The Best Valued Large-Cap Pharma Stock (Seeking Alpha)
  • Regeneron plots DTC advertising and discount push to put Eylea back on track (Fierce)
Pharmaceutical and Biotechnology: Study Results, Filings and Designations
  • Bristol-Myers, Scripps research team touts a new way to control 3D architecture of genetic drugs (Endpoints)
  • Apomorphine results show reduced tremors in Parkinsons patients (The Pharma Letter)
  • Celtaxsys To Hash Out Phase III Cystic Fibrosis Endpoints With US FDA (Scrip-$)
  • Epizyme shuts down failing lymphoma trial as FDA imposes clinical hold (Pharmafile)
  • Zithromax, Zmax (azithromycin): FDA Warning - Increased Risk of Cancer Relapse With Long-Term Use After Donor Stem Cell Transplant (FDA)
  • CMS Grants New Technology Add-on Payment to ZEMDRI (plazomicin) (Press)
Medical Devices
  • Wearable devices: Useful medical insights or just more data? (ScienceDaily)
  • Hologic’s stock dips despite strong quarterly earnings (Fierce)
  • Endomag nets approval for liquid, magnetic, breast-mapping tracer (Fierce)
  • Stryker touts 3D-printed Tritanium cage study results (MassDevice)
  • FDA Issues Final Guidance on Use of EHR Data in Clinical Investigations (AAMI)
  • Recreational Genetics or Research Enterprise? Cloudy Consent Issues Arising from Direct-to-Consumer Genetic Testing (Bill of Health)
  • Boston Scientific Closes Acquisition of Claret Medical, Inc., Announces Positive Reimbursement Decision (Press)
  • Hologic Announces FDA Clearance of the Panther Fusion GBS Assay (Press)
  • Data from the ASSURE Study of Long-Term Use of RELiZORB Published in Journal of Pediatric Gastroenterology and Nutrition (Press)
US: Assorted & Government
  • Watson Health is committed to using AI to tackle major healthcare challenges (IBM Watson Health)
  • Influenza Virus Vaccine for the 2018-2019 Season (FDA)
  • Webinar - FDA Innovation Challenge: Devices to Prevent and Treat Opioid Use Disorder - July 25, 2018 (FDA)
  • FDA Grand Rounds: How Simulation Can Transform Regulatory Pathways (FDA)
  • 2018 Meeting Materials, Antimicrobial Drugs Advisory Committee (formerly known as the Anti-Infective Drugs Advisory Committee) (FDA)
  • What They Said – FDA Press Releases 2d Quarter 2018 (Eye on FDA)
  • FCC Kicks Off Conversation On $100M Telehealth Program (Law360-$) (FCC)
  • Department of Justice Announces Expansion of Program to Enhance Tribal Access to National Crime Information Databases (DOJ)
  • FDA guidance encourages EHR use but doesn’t solve interoperability challenges: Industry responds (Outsourcing-Pharma)
  • CMS drops new EHR incentive requirements (Politico)
  • Stem Cell Clinics Face Long Odds Against FDA in Legal Fight (Bloomberg-$)
  • Welcome to the New Health-Care Debate (Bloomberg)
  • JUUL Labs responds to FDA concerns about flavored e-liquids (TechCrunch)
  • Can eConsults Lower Patient Wait Times And Medicaid Spending Problems? (Forbes)
  • Apple becomes first $1 trillion company in history (Chicago Tribune)
Upcoming Meetings & Events Europe
  • AZ and MSD get orphan designation for neurofibromatosis drug (PharmaTimes)
  • Patents – recent trends in the pharma sector (EPM Magazine)
  • Smoking linked to increased atrial fibrillation risk (Reuters)
  • EMA’s interaction with industry stakeholders: Annual report 2017 (EMA)
  • Vismodegib hard capsule 150 mg product-specific bioequivalence guidance (EMA)
  • Updated: Statutory guidance on MHRA fees (MHRA)
Asia
  • This Biotech Just Had a $903 Million IPO—And It's Disappointed (Fortune)
  • Ascletis Pharma, Asia’s first pre-profit listed biotech, plunges in Hong Kong three days after debut (South China Morning Post)
India
  • In a push to pharma exports, states get NOC booster shot (Times of India)
  • GSK employees demand reopening of factory (The Daily Star)
  • Govt amends MD Rules to remove regulatory hurdle, all NABL-accredited labs can issue performance report on IVDs (Pharmabiz)
  • Two medical device cos soon to start operations at India’s first govt funded medical device park in Andhra Pradesh (Pharmabiz)
Australia
  • Mosquito Wars - A Big Win In Australia Brings Hopeful News For Southern U.S. (Forbes)
  • Chronic care patients forced to have My Health Records to access government's Health Care Homes program (Healthcare IT News)
Canada General Health & Other Interesting Articles
  • What Causes Morning Sickness? (NYT)
  • Most U.S. kids not getting developmental screening (Reuters)
  • Please Do Not Wash Or Reuse Your Condoms, The CDC Warns (BuzzFeed)
  • Does Moderate Alcohol Really Protect Against Dementia? It's Unclear (And There Are Other Risks) (Forbes)
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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