Regulatory Focus™ > News Articles > Regulatory Recon: Valeant Under Criminal Investigation; IQWiG Critical of EMA's Adaptive Pathways Pr

Regulatory Recon: Valeant Under Criminal Investigation IQWiG Critical of EMA's Adaptive Pathways Program (11 August 2016)

Posted 11 August 2016 | By Michael Mezher 

Regulatory Recon: Valeant Under Criminal Investigation IQWiG Critical of EMA's Adaptive Pathways Program (11 August 2016)

Welcome to Regulatory Reconnaissance, your adaily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @Michael_Mezher, @Zachary Brennan and @RAPSorg on Twitter.

In Focus: US

  • Regulatory Explainer: Everything You Need to Know About Biosimilars (Focus)
  • Why Abbvie might think twice before exercising Ablynx option (EP Vantage)
  • The Emergence of the Randomized, Controlled Trial (NEJM)
  • FDA Head Addresses Opioid Epidemic in West Virginia (WSAZ) (Lexington Herald)
  • Woodcock Doesn't Want To Be Commissioner – But Has Some Ideas (Pink Sheet 1, 2-$)
  • DEA denies petition to reclassify marijuana (Reuters) (NYTimes) (DEA 1, 2, 3)
  • The Painkillers That Could End the Opioid Crisis (MIT Technology Review)
  • Assessing the FDA's Safety Drive (FDA Law Blog)
  • Florida CMO Recalls All Lots of Liquid Drugs Due to Bacteria Outbreak (Focus)
  • AstraZeneca bets another $140 million on Moderna's 'messenger' drugs (Reuters)
  • Thinking straight about orphan drugs, Part 1. (The Incidental Economist)
  • Amgen v. Apotex: Amgen Argues They Have Met Their Burden To Prove Infringement (Big Molecule Watch)
  • DMD Drug Review: Heart of Bureaucratic Darkness (WSJ-$)
  • EJM editorial doubles down on resistance to data sharing (STAT)
  • As US Looks to Launch Precision Health Study, Google's Role Emerges (Xconomy)
  • Eli Lilly's Investigational Cancer Drug Hits Snag in Breast Cancer Trial (WSJ-$) (BioCentury)
  • Mylan Sees A Difference In Having Generic Drug User Fees (Pink Sheet-$)
  • Boston Scientific aims to localize chemotherapy drugs to tackle liver cancer (MedCityNews)
  • Valeant Under Criminal Investigation (WSJ-$) (Forbes) (Investors)
  • Perrigo Has a Warning for Valeant (Bloomberg)
  • FDA Supports Greater Access to Naloxone to Help Reduce Opioid Overdose Deaths (FDA Voice)

In Focus: International

  • NHS England launches consultation on HIV PrEP (PharmaTimes)
  • Driven to Suicide by an 'Inhuman and Unnatural' Pressure to Sell (NYTimes)
  • Mylan Confident On Advair Generic First-Round Approval (SCRIP-$)
  • Easing clinical trial rules to compromise safety of subjects, say health activists (Economic Times)
  • EU Drug Safety Actions Speeded Up By New Legislation, Says Commission (Pink Sheet-$) (Focus)
  • IQWiG critical of EMA's adaptive pathway (BioCentury) (PMLive)
  • In China, IBM Watson Partners With Hospitals To Fight Cancer (Forbes)

US: Pharmaceuticals & Biotechnology

  • Why certain drugs don't make the formulary (BioPharmaDive)
  • The Future of Big Data in Healthcare (Geeks Talk Clinical)
  • Are some pharma companies using ClinicalTrials.gov as a marketing tool? (All Trials)
  • Chasing down a missing clinical trial result – a doctor's odyssey (All Trials)
  • Microbiome upstart Vedanta teams up with NYU Langone scientist on checkpoint drugs (Endpoints)
  • Funding An Investigator Sponsored Study? Use Milestone Payments. (Cutting Edge Info)
  • Influenza Virus Vaccine for the 2016-2017 Season (FDA)
  • Vaccines for Children: Information for Parents and Caregivers (FDA)
  • Single-use vendors will continue benefiting from Biopharma demand, expert (BioPharmaReporter)
  • Agilent to up Oligo API capacity with new manufacturing plant (InPharmaTechnologist)
  • Six Retail Chains Now Dominate the Still-Booming 340B Contract Pharmacy Business (DrugChannels)
  • The challenges of pediatric clinical trials (OutsourcingPharma)
  • US FDA warns Concept Products for failing to fix cGMP violations at Tianjin plant (InPharmaTechnologist)
  • Gilead in R&D deals with Polyphor, Genmab (BioCnetury)
  • Genmab ups R&D spending to accelerate early-stage cancer programs (Fierce)
  • FDA Warning Letter Hits US Lab On Data Integrity, Password Sharing (Pink Sheet-$)

US: Pharmaceuticals and Biotechnology: Clinical Study Results, Filings & Designations

  • Medivir: New Interim Phase IIa Data on Simeprevir in Combination with Other DAAs Will Be Presented at the Upcoming EASL AASLD Special Conference (Press)
  • Phase I Clinical Trials Underway for First MERS Treatment (Press)
  • Spark adds fresh evidence that pioneering gene therapy could be a game changer for patients (Endpoints) (Fierce) (Press)

US: Medical Devices

  • FDA Is Really, Really Here to Help You (MDDI)
  • Alere: Abbott can't get out of $6B merger (MassDevice)
  • Covidien spinout Mallinckrodt to acquire Stratatech (MassDevice)
  • Senseonics shows accuracy in US trial as it gears up for FDA submission (MobiHealthNews)
  • FDA to Fix Incorrect Reference in Medical Device Ban Regulations (FDA)
  • Searching for a med device accelerator? Texas Medical Center hosts 11 device startups (MedCityNews)
  • Infectious Disease NGS Draft Guidance: Comment Period Extended (FDA)
  • FDA approves IDE study for bone graft substitute, Cerament G (EPR)
  • FDA draft guidance on 510(k)s omits combination devices (MassDevice)
  • Boston Sci's EMBLEM MRI Subcutaneous Implantable Defibrillator FDA Approved (medGadget)
  • Taris launches another Phase I trial for bladder cancer drug-device combo (MassDevice)

US: Assorted & Government

  • FDA Issues Dietary Ingredient Notifications Draft Guidance(FDA)
  • Some Indirect Claims Stay In Aggrenox Pay-For-Delay Row (Law360-$)
  • VA Extends New Hepatitis C Drugs to All Veterans in Its Health System (JAMA)
  • Lawyer, Adviser Charged With Insider Trading (WSJ-$)
  • New Animal Drug Applications; Contents of Notice of Opportunity for a Hearing; Correction (FDA)
  • California Court Clears The Way For Express Preemption (Drug and Device Law)

Upcoming Meetings & Events

Europe

  • Transparency Update: Germany (Policy and Medicine)
  • FlowAid Medical wins CE Mark for sequential contraction compression device (MassDevice)
  • Spectranetics wins CE Mark for AngioSculptX drug-coated 'scoring' balloon (MassDevice)

Asia

  • Quality Matters: Do It Right the First Time (Pacific Bridge Medical)
  • Diabetes Delivers China Strength For Merck (SCRIP-$)
  • BMS reacquires rights to ASLAN002 from Aslan (BioCentury) (Endpoints)
  • Singapore: Less Than Three Months Left For Companies To Prepare For New Pharma Rules (Pink Sheet-$)
  • Teijin gets Japan rights to Versartis' somavaratan (BioCentury)

Australia

  • MRA GMP clearance application processing timelines (TGA)
  • Medicines Safety Update, Volume 7, Number 4, August 2016 (TGA)

Zika

  • Pregnant Zika Victim Alerted Officials to Florida Outbreak (WSJ-$)
  • Frieden on what we've learned about Zika (Politico)

General Health & Other Interesting Articles

  • The rise of telemedicine (MassDevice)
  • U.S. panel says not enough evidence to support lipid screenings for kids (Reuters) (CardioBrief)
  • NIH releases improved guidelines for diagnosing fetal alcohol spectrum disorder (NIH)

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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