Regulatory Recon: Galectin Plummets After NASH Candidate Fails in Phase IIb Trial; Montana Sues Purdue Over Opioid Epidemic (5 December 2017)

Posted 05 December 2017 By Michael Mezher

placeholder+image

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

In Focus: US

  • Biopharma's top 10 overseas cash hoards. And what kind of M&A spree would $171B buy? (Endpoints)
  • Galectin Therapeutics stock drops nearly 50% after negative trial results (Market Watch) (Reuters) (Press)
  • Some drug makers are doing a better job of disclosing clinical trial data (STAT)
  • Rare disease companies see US take with one hand as it gives with another (EP Vantage)
  • Congress to Negotiate R&D, Orphan Tax Credits (BioCentury)
  • FDA Extends Comment Period on Regulation Review (Federal Register)
  • Montana sues OxyContin maker Purdue over opioid epidemic (Reuters) (Law360-$)
  • Court-mandated opioid rehab rarely meets medical standards (Reuters)
  • Thanks to CVS, Aetna and Apple, virtual medicine is getting the marketing boost it needs (CNBC)
  • Walgreens unveils rebranding effort as pharmacy wars escalate (CNBC)
  • 3D Printing: FDA Finalizes Guidance for Medical Devices (Focus)
  • Evaluating Analytical Similarity: Stakeholders Raise Questions With FDA Draft Guidance (Focus)
  • Merck and PhRMA to FDA: Wait for ICH Before Finalizing Guidance on Toxicity Testing for Cancer Drugs (Focus)
  • Novartis looks at offloading its generic business in US as market continues to decline (Fierce)
  • Urothelial cancer in 2017: Changes in expectations for metastatic urothelial carcinoma (Nature)
  • AZ' Tudorza hits study goals in COPD patients with CV risk factors (PharmaTimes)
  • AbbVie posts strong psoriasis data but can it stand out from crowd? (Pharmafile)
  • Lilly's Taltz cleared to treat psoriatic arthritis (PharmaTimes)
  • Applications of pharmacogenomics in regulatory science: a product life cycle review (Nature)

RAPS Book Release: Fundamentals of EU Regulatory Affairs, Eighth Edition

  • Get the new, updated ultimate reference guide which includes the latest information on the new Medical Device and In Vitro Device Regulations, developments in implementation of the Clinical Trial Regulation and a number of new topics.
  • Learn more and shop now.

In Focus: International

  • WHO backs Philippines suspension of Sanofi's dengue vaccine (Reuters)
  • Trouble mounts for Sanofi dengue vaccine over safety concerns (Reuters)
  • Trial results of Zika vaccine Sanofi dropped show promise (Reuters)
  • 'Opiophobia' Has Left Africa in Agony (NYTimes)
  • Prescription drug costs should be fair – not cheap (Globe and Mail)
  • Johnson & Johnson's JLABS looks east as it lands in Shanghai (Fierce)
  • Novo Nordisk unveils hard-hitting data for two of its diabetes therapies (Pharmafile)
  • NZ billionaire backs Indiabulls Pharma (Times of India)
  • BeyondSpring CEO: China's New System Will Get Our Drug To Market Faster (SCRIP-$)
  • MSD Executive Shows MEPs How Brexit Will Hit Pharma Supply Chains (Pink Sheet-$)
  • Updated: ICH Updates on MedDRA, New Members and Guidelines (Focus)
  • An analysis of HTA and reimbursement procedures in EUnetHTA partner countries: final report (EUnetHTA)
  • Mazor CEO Under Investigation for Insider Trading (MDDI) (MassDevice)
  • India and Italy sign MoU for enhanced cooperation in health sector (PharmaBiz)

Pharmaceuticals & Biotechnology

  • Chasing Seasonal Influenza — The Need for a Universal Influenza Vaccine (NEJM)
  • ICER Releases Migraine, Psoriasis Draft Scoping Documents (Migraine, Psoriasis)
  • New Antibiotic Action (In the Pipeline)
  • The CVS-Aetna Deal: Five Industry and Drug Channel Implications (Drug Channels)
  • Medytox, Inc. Files Citizen Petition with FDA Requesting Investigation of Application for Botulinum Drug Product (Press)
  • Stealthy Silverback recruits Seattle Genetics' Eric Dobmeier as CEO, filling C-suite with oncology talent (Endpoints)
  • The BioPharma Dive Awards for 2017 (BioPharmaDive)
  • Monthly Round-Up of What to Read on Pharma Law and Policy (Harvard Bill of Health)
  • Dynavax Co-founder Takes Long View on Vaccine Development (Xconomy)
  • Researchers overcome hurdles to test experimental malaria drug (Novartis)
  • Proactive Brand Protection Strategies For Pharma Innovators (Law360-$)
  • USFDA nod for cancer biosimilar is a big triumph: Kiran Mazumdar Shaw (Economic Times)
  • Michael Pellini has just joined Bill Maris at Section 32 — focused on patient care and drug development (Endpoints)
  • FDA Offers Draft Guidance on E-Submissions of REMS Documents (Policy & Medicine)
  • Takeda exec jumps ship to join Biogen (PharmaLetter-$)
  • Ra Pharma puts its best foot forward with PhII Soliris rival, but shares crash after comparison to Alexion's next-gen drug (Endpoints)
  • Mundipharma names Philippe Mazas as new Chief Information Officer (Pharmafile)
  • Pharma-backed Outpost nabs Mitsubishi, Pfizer exec Ian Mills (Fierce)
  • Cellectis lures ex-Servier cancer R&D chief back to industry (Fierce)
  • Jazz Pharma nabs Sunesis CEO as new president and chief operating officer (PharmaLetter-$)
  • Will Continuous Manufacturing Mean Continuous Generic Delay? FDA Hears AAM's Warning (Pink Sheet-$)
  • ALK-Abello unveils multi-year plan to 'succeed in North America' (PharmaLetter-$)

Pharmaceutical and Biotechnology: Study Results, Filings and Designations

  • New Dravet syndrome drug candidate scores in Phase III (PharmaLetter-$)
  • Verastem to Present Results from Pivotal Phase 3 DUO Study in Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma at a Research and Development Event at ASH 2017 (Press)
  • Zymeworks Presents Results of the Completed Dose Escalation Portion of the Ongoing Phase 1 Study of ZW25 at the San Antonio Breast Cancer Symposium (Press)
  • Foresee Pharmaceuticals Announces Results from Phase 1 Clinical Studies (Press)

Medical Devices

  • FDA Finalizes Guidance to Help CMS With Coverage Decisions on Devices (Focus)
  • TPG Sweetens Deal For Medical Device Co. Exactech To $737M (Law360-$)
  • Is medtech behind the curve on value-based care? (Medical Design & Outsourcing)
  • Coordinating Requirements and Objectives Across Silos During Development (MDDI)
  • Silicone patch for laser-assisted tattoo removal wins new FDA clearance (Drug Delivery)
  • Dance Biopharm, Phillips-Medisize ink deal for inhaled insulin device (Drug Delivery)
  • Contrast Clearance Analysis Software Receives FDA 510(k) Clearance (Press)
  • Imagin Medical launches first-in-human trial for i/Blue urological cancer imaging tech (MassDevice)
  • CryoLife closes $225m acquisition of German graft maker Jotec (MassDevice)

US: Assorted & Government

  • Veterans Affairs Contracting: Improvements in Buying Medical and Surgical Supplies Could Yield Cost Savings and Efficiency (GAO)
  • Death rate among people hospitalized for opioids quadrupled since 2000 — with Medicare patients big driver (CNBC)
  • Arizona becomes the latest state to seek to limit Medicaid drug coverage (STAT)
  • Does FDA Rejection Of Label Warning Shield Manufacturers From Tort Suits? (Pink Sheet-$)
  • Pacific Biosciences of California, Inc. v. Oxford Nanopore Technologies, Inc. (D. Del. 2017) (Patent Docs)
  • Appeals court tosses whistleblower suit against Biotronik (MassDevice)
  • Tech, Generics Cos. Spar With Tribes Over Allergan At PTAB (Law360-$)
  • Investors Tell 1st Circ. Sarepta Hid FDA Testing Issues (Law360-$)
  • Janssen Rips Patent Owner's Bid To Appeal Mid-Case (Law360-$)
  • High Court Won't Hear Dow's Appeal Of $455M Bayer Award (Law360-$)
  • Justices Ask SG To Weigh In On Merck's Fosamax MDL (Law360-$)
  • Utah Federal Court Dismisses Birth Defect Failure to Warn Claim (Drug & Device Law)

Upcoming Meetings & Events

Europe

  • Belluscura pulls plans for $13m UK-based IPO (MassDevice)

Asia

  • Asia Executives To Watch: AZ Japan President, Takeda GM, NHFPC Officials (SCRIP-$)

India

  • Indiabulls Pharma receives Rs 155 crore investment from Clermont Group (Economic Times)
  • Track & Trace: Systech Expands to Compete with Local Market in India (InPharma)
  • Karnataka govt unveils State Health Policy, mandates prescription audit & antibiotic policy (PharmaBiz)

Australia

  • Medical devices post-market vigilance - statistics for 2016 (TGA)
  • Medicines and vaccines post-market vigilance - statistics for 2016 (TGA)

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.

Share this article:

Categories: Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence, News

Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News

Regulatory Exchange: Latest Updates From the Community