Regulatory Focus™ > News Articles > Regulatory Recon: Purdue Under Investigation Over OxyContin Claims; GSK to Build EU Drug Testing Fac

Regulatory Recon: Purdue Under Investigation Over OxyContin Claims GSK to Build EU Drug Testing Facility as Brexit Contingency (26 October 2017)

Posted 26 October 2017 | By Michael Mezher 

Regulatory Recon: Purdue Under Investigation Over OxyContin Claims GSK to Build EU Drug Testing Facility as Brexit Contingency (26 October 2017)

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

In Focus: US

  • Purdue Is Under Investigation for Opioid Painkiller OxyContin (WSJ) (Bloomberg) (Reuters)
  • US Committee Recommends GSK Shingles Vaccine Over Merck Rival (Reuters)
  • Trump to declare opioids a public health crisis: officials (Reuters) (USA Today) (STAT)
  • Rhode Island doctor pleads guilty to opioid kickback scheme related to Insys (Reuters)
  • Pharmacist guilty of fraud, not murder, over US meningitis outbreak (Reuters)
  • The Wonder Drug for Aging (Made From One of the Deadliest Toxins on Earth) (Bloomberg)
  • CRISPR toolbox gets two new molecular gadgets, boosting gene-editing (STAT) (Forbes) (MIT Technology Review)
  • Celgene shares plummet on deep cut to long-range financial guidance (STAT) (Endpoints) (Press)
  • Bristol-Myers ups guidance, but shares drop on profit miss (Financial Times) (Press)
  • Amgen buries the last big CETP drug, marking the bitter end of a blockbuster quest (Endpoints) (Fierce)
  • FDA rejects PTC's DMD drug Translarna (PharmaTimes) (Reuters) (Endpoints)
  • How Do You Regulate a Self-Improving Algorithm? (The Atlantic)
  • Pfizer to launch consumer health sale in November (Reuters)
  • Teva accuses Lilly in US court of infringing migraine drug patents (Reuters)
  • Gilead faces challenge to US hepatitis C patents from advocacy group (STAT) (Bloomberg)

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In Focus: International

  • GlaxoSmithKline Can't Have it All (Bloomberg) (Reuters)
  • GlaxoSmithKline set to build drug testing plant in Europe (The Guardian) (Reuters)
  • Novo Nordisk warns diabetes costs threaten to overwhelm healthcare (Financial Times)
  • Regeneron plunks down $100M more on Ireland plant, adding another 300 workers (Fierce)
  • The MEB is preparing for Brexit (CBG MEB)
  • The US Opioid Crisis Hits Tasmania's Poppy Farmers (Bloomberg)
  • Sanofi pushes hard into robotics and analytics to get most out of manufacturing (Fierce)
  • Samsung Biologics: EU or US for fourth plant, but not China (BioPharmaReporter)
  • Indian Panel Nudges Eisai Towards Phase IV Compliance For Halaven (Pink Sheet-$)
  • Bayer sales decline as consumer healthcare drags (Financial Times) (Reuters) (Press)
  • Is It Possible to Predict the Next Pandemic? (The Atlantic)
  • Be 'Realistic' When Proposing MAA Submission Dates, EU Guide Urges Industry (Pink Sheet-$)
  • EU scientific opinion: how to assess progress on reduction of antimicrobial resistance and antimicrobial consumption (EMA)

Pharmaceuticals & Biotechnology

  • The Family That Built an Empire of Pain (The New Yorker)
  • The More Lavish the Gifts to Doctors, the Costlier the Drugs They Prescribe (NYTimes)
  • Trial watch: Tracing investment in drug development for Alzheimer disease (Nature)
  • Drug distributor McKesson's quarterly profit beats estimates (Reuters)
  • The Medicine Company's Dangerous Bet On Its LDL Cholesterol Lowering Drug (Forbes)
  • United Therapeutics beats sales, earnings estimates in Q3 (Drug Delivery)
  • Third dose of mumps vaccine recommended for at-risk populations in outbreaks (STAT)
  • Evotec pairs with Tesaro to seek out new immuno-oncology targets (Fierce)
  • PDL gets aggressive with an offer to buy out Neos Therapeutics (Endpoints)
  • Looking for a pharma marketing bump? Check out YouTube bumper ads, agency says (Fierce)
  • John Hood bags $90M for his quest to get fedratinib OK'd by FDA and catapult into the market (Endpoints) (Xconomy)
  • Matthew Schroeder; Denial of Hearing; Final Debarment Order (FDA)

Pharmaceutical and Biotechnology: Study Results, Filings and Designations

  • FDA approves intravenous version of Tesaro drug for chemotherapy nausea (Reuters)
  • AbbVie boasts a PhIII sweep for top psoriasis contender risankizumab, but it has lots of competition (Endpoints)
  • Heron Therapeutics Granted FDA Fast Track Designation for HTX-011 to Reduce Postoperative Pain and the Need for Opioid Analgesics for 72 Hours (Press)
  • MediciNova's repurposed stroke and asthma drug clears MS trial (Fierce)
  • Horizon Pharma enrolls first patient in TED trial (PharmaTimes)
  • Amgen hopes its latest Kyprolis trial hits the mark with regulators (PMLive)
  • Shire's haemophilia A gene therapy wins Orphan status (PharmaTimes) (PMLive)
  • Anika Completes Enrollment in Second Pivotal Phase III Trial of CINGAL for the Treatment of Knee Pain Associated with Osteoarthritis (Press)
  • Bicycle Therapeutics to Present Preclinical Data on Lead Molecule BT1718 at the AACR-NCI-EORTC International Cancer Conference (Press)
  • FDA Accepts Genentech's Supplemental Biologics License Application for Avastin as a Front-Line Treatment for Women with Advanced Ovarian Cancer (Press)
  • Alkermes to Initiate New Clinical Study Evaluating ARISTADA® and INVEGA SUSTENNA® for the Treatment of Schizophrenia (Press)

Medical Devices

  • 'Artificial pancreas' No. 1 in Cleveland Clinic's Top 10 (BioWorld)
  • Stryker to acquire French spinal implant maker Vexim for $216m (MassDevice)
  • Boston Scientific meets The Street with Q3 earnings, tops sales forecast (MassDevice)
  • Abiomed nearly triples fiscal Q2 profits, crushes earnings expectations (MassDevice)
  • Integra Lifesciences slips on missed Q3 expectations (MassDevice)
  • Bard posts Q3 earnings that beat on EPS, miss on sales (MassDevice)
  • DHS warns on vulnerabilities in Boston Scientific cardiac implant programmer (MassDevice)
  • US FDA Rolls out New Market Pathway for Breakthrough Medical Devices (Emergo) (Focus)
  • GE Sends Health IT Asset to the Chopping Block (MDDI)
  • Medical robots to drive commercial robotics market to $4B in 5 years (MassDevice)
  • Iradimed wins FDA nod for MR-compatible patient monitoring system (MassDevice)
  • FDA expands indication for Attune Medical's Enso esophageal temperature management device (MassDevice)
  • FDA approves pivotal trial for Insightec's Exablate Neuro in Parkinson's (MassDevice)
  • Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection of Zika Virus (FDA)
  • Medacta Receives FDA Clearance for Anatomic and Reverse Shoulder Systems (Press)
  • Paraflu Assay Now FDA Cleared on Hologic's New Panther Fusion® System (Press)
  • Nitiloop Announces FDA 510(k) Clearance for its Nova Cross Extreme and Nova Cross BTK Micro catheter for Support of Guidewire Access to Discrete Regions of the Coronary and Peripheral Vasculature (Press)

US: Assorted & Government

  • After Trump talks to Congress, Obamacare fix pushed off (Politico) (Reuters)
  • Frustrated with Trump, Dems introduce drug pricing bill (The Hill)
  • Court To Rule On Whether Relapse By An Addicted Opioid User Should Be A Crime (NPR)
  • Most popular Obamacare plans cost average of 34 percent more for 2018 (CNBC)
  • US insurer Anthem says Obamacare business improving; stock jumps (Reuters)
  • PTAB Won't Review Japanese Co.'s Antibody Tech Patents (Law360-$)
  • Preemption as a Mass Tort Talisman? (Drug & Device Law)
  • Compounder Can't Duck Drug Marketing Suit, Allergan Says (Law360-$)

Upcoming Meetings & Events

Europe

  • Guideline on the requirements for quality documentation concerning biological investigational medicinal products in clinical trials (EMA)
  • SpeeDx Multiplexed VZV, Herpes, Syphilis Assay Gets CE Mark (GenomeWeb)

Asia

  • J&J's Wu On Nurturing Innovation In Asia (SCRIP-$)

India

  • Companies challenge ban on fixed-dose combination drugs (Economic Times)
  • MP expresses concern over US medical device industry's attempt to exert political pressure on India against price control on medical devices (PharmaBiz)

Australia

  • Strengthening the assessment of medical devices and information for consumers (TGA)

General Health & Other Interesting Articles

  • High cholesterol levels among US adults declining: CDC report (Reuters)

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? Find him on Twitter at @Michael_Mezher or send him an email at news@raps.org.

A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.


Categories: Recon, Regulatory News

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