Regulatory Recon: Bayer, J&J's Xarelto Fails Phase III Secondary Stroke Trial; Eli Lilly Beats Alimta Patent Challenge (6 October 2017)

Posted 06 October 2017 By Michael Mezher

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

In Focus: US

  • The FDA Is Approving Drugs at a Staggering Pace (Bloomberg)
  • In a setback, Bayer, J&J say their big PhIII secondary stroke trial for Xarelto failed (Endpoints) (Reuters)
  • New Jersey sues Insys as opioid maker settles with Massachusetts (Reuters) (STAT)
  • Eli Lilly defeats challenge to Alimta cancer drug patent (Reuters) (Press)
  • The Lawyer Who Beat Big Tobacco Takes On the Opioid Industry (Bloomberg)
  • Merck launches frontline PhIII lung cancer study for Keytruda/Yervoy combo (Endpoints)
  • Senator McCaskill drafts bill in response to Allergan patent maneuver (Reuters) (Endpoints)
  • FDA approves first test for screening Zika virus in blood donations (FDA)
  • In a First, Gene Therapy Halts a Fatal Brain Disease (NYTimes)
  • Nearly One-Third Of New Drugs Are No Better Than Older Drugs, And Some Are Worse (Health Affairs Blog)
  • Second US jury finds AbbVie misrepresented risks of AndroGel (Reuters)
  • Price Matters, in Patients' Minds (NYTimes)
  • The opioid epidemic in 6 charts (CBS News)

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In Focus: International

  • Regulatory update - EMA encourages companies to submit type I variations for 2017 by end of November (EMA)
  • ABPI Will Not Appeal Judicial Review Decision on NICE Cost Curbs (ABPI)
  • Teva's Copaxone faces generic competition in Europe after US hit (Reuters)
  • At least six funds interested in Sanofi European generic drugs unit -Le Figaro (Reuters)
  • EFPIA takes issue with BMJ article on efficacy of cancer medicines (PharmaLetter-$) (EFPIA)
  • No EU Fast Track for AZ's Imfinzi In Stage III Lung Cancer (SCRIP-$)
  • Consumer drugs do not always work for big pharma (Financial Times)
  • South Africa's over-charging case against Aspen dissolves, remains against big names (Pharmafile)
  • As CAR-T launch ramps up in US, Novartis' Narasimhan looks to convince Japan on performance-based pricing (Fierce)
  • Dx Companies, Facing New CE-IVD Regulations, Reassess Strategies, Pipelines, Portfolios (GenomeWeb)
  • Regional initiatives for malaria elimination: Building and maintaining partnerships (PLOS)
  • WHO appeals for USD 10.2 million to support critical health interventions in Cox's Bazar, Bangladesh (WHO)
  • Global Database of Age-friendly Practices (WHO)

Pharmaceuticals & Biotechnology

  • A Framework for Regulatory Use of Real World Evidence (Duke Margolis Center)
  • $260M Payout for Misbranded Cancer Drugs: Only Part of Story (Medscape)
  • This tech won the Nobel Prize — and drug developers are avidly putting it to use (STAT)
  • Arming Bodies with CRISPR to Fight Huntington's Disease and ALS (MIT Technology Review)
  • The cancer stories no one wants to hear (STAT)
  • Additional Delivery of Insulin Ready for Distribution in Puerto Rico (Press)
  • Elderly with dementia at risk for inappropriate medications (Reuters)
  • Early data on potential anti-cancer compound now in human trials was falsified, company admits (Retraction Watch)
  • David Meeker starts a new biotech chapter in his career; Sam Kulkarni takes the helm at CRISPR (Endpoints)
  • Launching Science2Startup: Connecting Academics With Venture (LifeSciVC)
  • Different Types Of Meditation Change Different Areas Of The Brain, Study Finds (Forbes)
  • FDA User Fees Promote Manufacturing Readiness (PharmTech)
  • Third Rock, SV bankroll another PhI/II for a new, improved and jab-free wet AMD drug (Endpoints) (Fierce)
  • Cell and Gene Therapy Catapult in new stem-cell deal (PharmaTimes)
  • Monoclonal antibodies against Zika show promise in monkey study (NIH)
  • Baxter Initiates Voluntary Nationwide Recall of One Shipment of Intralipid 20% IV Fat Emulsion Due to Product Being Exposed to Subfreezing Temperatures (FDA)
  • Titan, Opiant partner to develop subcutaneous implant for opioid use disorder (Drug Delivery)
  • FDA approves new trial for Nellix stent graft from Endologix (MassDevice)

Pharmaceutical and Biotechnology: Study Results, Filings and Designations

  • AVEO Oncology Announces Completion of TIVO-3 Study Futility Analysis with No Changes to Study Protocol (Press)
  • FDA Grants Orphan Drug Designation to Kadmon's KD025 for the Treatment of cGVHD (Press)

Medical Devices

  • FDA Corrects Classification Order for Adjunctive Cardiovascular Status Indicators (FDA)
  • Advances in brain pacemaker reduces tremors, helps Parkinson's sufferers live a more normal life (CNBC)
  • CardioBrief: Some Doctors Reluctant To Deactivate LVADs (Medpage)
  • New US FDA FAQ Clarifies De Novo Medical Device User Fee Requirements (Emergo)
  • FDA clears Peerbridge Health's Cor wireless ECG monitor (MassDevice)
  • How to Prevent Battery Disasters (MDDI)
  • Cepheid Xpress Strep A Test Clears FDA (GenomeWeb)
  • Hologic Receives FDA Clearance for Flu A/B/RSV Assay on Panther System (GenomeWeb)
  • Game Ready® Receives FDA 510(k) Clearance For Med4 Elite™ Multi-Modality Recovery Device (Press)

US: Assorted & Government

  • Opioid Hearing: Senators Want Speed, But Agency Heads Stress Time, Effort (Pink Sheet-$)
  • House E&C moves CHIP funding along (Politico)
  • Birth control mandate on tap to be reversed (Politico) (NYTimes)
  • Relevant Social Media Posts are Fair Game for Discovery in the IVC Filter MDL (Drug & Device Law)
  • Could The Delaney Clause Rear Its Head Yet Again? (FDA Law Blog)

Upcoming Meetings & Events          

Europe

  • Cancer Research UK's campaign about the Early Diagnosis Workforce (UK DOH)
  • Janssen to spend €300m on Ringaskiddy facility (BioPharmaReporter)

Asia

  • AbbVie opens biologics plant in Singapore, completing $320m project (BioPharmaReporter)

India

  • Novartis divests anti-infectives brands to Samara Capital (Economic Times)
  • Gland Pharma to leverage Fosun's strengths for growth (Economic Times)
  • Exclusive category of OTC drugs soon, state drug controllers to be consulted (PharmaBiz)
  • Experts see value of pharma patents in India can encourage research for novel drugs (PharmaBiz)
  • Will Intas' Cut-Price Avastin Biosimilar Disrupt The Market? (SCRIP-$)

Canada

  • Updated Notice: Interim Policy on Health Canada's Interpretation of Medicinal Ingredient and Assessment of Identical Medicinal Ingredient (Health Canada)
  • Notice: Release of Draft (Step 2) ICH Guidance: S5(R3): Revision of S5 Guideline on Detection of Toxicity to Reproduction for Human Pharmaceuticals (Health Canada)
  • Notice: Release of Draft (Step 2) ICH Guidance: E9(R1): Addendum: Statistical Principles for Clinical Trials (Health Canada)

Australia

  • Accessing medicines during a medicines shortage (TGA)

General Health & Other Interesting Articles

  • Many women with disabilities don't get cancer screening (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.

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