Regulatory Recon: GW Set to File Cannabis-Based Epilepsy Drug Roche, Biogen Looking Into Report of Rare Brain Infection in MS Patient (25 May 2017)

Posted 25 May 2017 | By Michael Mezher 

Regulatory Recon: GW Set to File Cannabis-Based Epilepsy Drug Roche, Biogen Looking Into Report of Rare Brain Infection in MS Patient (25 May 2017)

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

In Focus: US

  • 26 die after attempting to replace Abbott's blood pump controller themselves (Pharmafile) (MassDevice) (FDA 1, 2, 3)
  • Accelerated Approval and Expensive Drugs — A Challenging Combination (NEJM)
  • GW to file cannabis drug as journal confirms epilepsy success (Reuters) (Fierce) (PharmaTimes) (Forbes) (Washington Post)
  • Drug approvals bounce back as R&D labs churn out new winners (Reuters)
  • McConnell frets about healthcare, hopeful on tax overhaul (Reuters)
  • McConnell expects bipartisan support for bill reauthorizing FDA user fees (Reuters)
  • Millions Of Ill People May Face ‘Extremely High Premiums’ Under House Bill, CBO Says (KHN) (Reuters) (NYTimes) (Health Affairs Blog)
  • Rare Gene Mutations Inspire New Heart Drugs (NYTimes) (NEJM 1, 2)
  • FDA Cracks Down on TV Ad for Prescription Weight Loss Drug (Focus)
  • Amy Reed, Doctor Who Fought a Risky Medical Procedure, Dies at 44 (NYTimes)
  • Senator Seeks More Info From Mallinckrodt on Price Increases of Acetaminophen Injection (Focus)
  • Sanofi exec lays out case for taxpayer funding—and exclusive licensing—on Zika vaccine R&D (Fierce)
  • Inovio’s NIH-backed HIV vaccine shows near 100% immune response rate in early test (Fierce) (Pharmafile)
  • FDA Medical Device Cybersecurity Workshop: Potential Solutions but No Silver Bullets (Emergo)
  • Miami's Zika Outbreak Began Months Before It Was First Detected (NPR) (NIH)
  • Getting Struck Twice: Acquisitions & Spinouts In Biotech (LifeSciVC)

In Focus: International

  • Deadly brain infection in German MS patient prompts Roche investigation (Reuters) (Fierce)
  • Commission Delays EU GMP Guide For Advanced Therapies To Address Inspectorates’ Concerns (Pink Sheet-$)
  • French drugmaker Servier to face trial over weight-loss Mediator (Reuters)
  • Sharing Clinical and Genomic Data on Cancer — The Need for Global Solutions (NEJM)
  • WHA Approves WHO Biennial Budget (WHO)
  • European Regulatory Roundup: Merck Accused of Blocking Remicade Biosimilars (Focus)
  • Challenges Providing Pharmaceutical Products to Syrian Refugees (Focus)
  • Strength in clinical trials set to grow with funding boost from Australian govt (PharmaLetter-$)
  • Pierre Fabre sets sights on bigger I-O business (PharmaLetter-$)
  • Celltrion Gets Go-Ahead For Remsima Trials In China, Mulls JV (SCRIP-$)
  • Getting On – And Staying In – the EMA’s PRIME Scheme (Pink Sheet-$)
  • EU regulators widen approval for Zebinix (PharmaTimes)
  • UK biotech takes pole position in Europe (PharmaTimes) (Fierce)

Pharmaceuticals & Biotechnology

  • Korean Pharma Spawns US Cancer Biotech Startup (SCRIP-$)
  • Amid Budget Concerns, NIH Preps Beta Test for Precision Medicine Plan (Xconomy)
  • Months after trial setbacks, Merck licenses Teijin Alzheimer’s candidate (Fierce)
  • Sickle Cell Disease Treatment Gets Panel Nod Despite Efficacy Concerns (Pink Sheet-$)
  • Opioid Prescriber Training: US FDA Still Debating Mandate; CMS Policies Having Impact Now (Pink Sheet-$)
  • Opioid REMS: New CME 'Blueprint' To Include Immediate-Release Drugs (Pink Sheet-$)
  • Claims Data Can't Substitute for Adjudication in CV Trials (Medpage)
  • Estimation of the cost-effectiveness of HIV prevention portfolios for people who inject drugs in the United States: A model-based analysis (PLOS)
  • ​​​​​​​Cel-Sci, in trying to escape clinical hold, creates new problems for Multikine R&D program at the FDA (Fierce)
  • Which pharma execs win the popularity contest? Roche grabs two top-3 slots, for one (Fierce)
  • GSK Researchers Identify Dual-Stage Antimalarials (BioCentury)
  • Pharmaceutical companies and patient advocacy groups: Natural allies in the support of patients (Pharmafile)
  • A Bioactive Chemical Markers Based Strategy for Quality Assessment of Botanical Drugs: Xuesaitong Injection as a Case Study (Nature)
  • Granules India confirms $35m US plant expansion will create jobs (InPharmaTechnologist)
  • BioCorRx to meet with the FDA for injectable, sustained-release opioid addiction therapy (Drug Delivery)
  • Merck rolls out cost cutting high density perfusion media (BioPharmaReporter)

Pharmaceuticals and Biotechnology: Study Results, Filings and Designations

  • Roclatan successfully achieves primary efficacy endpoint in Mercury 2 Study (PharmaLetter-$)
  • CalciMedica Receives Fast-Track Designation for CM4620, a Novel CRAC Channel Inhibitor to Treat Acute Pancreatitis (Press)
  • GlycoMimetics’ GMI-1271 Receives EU Orphan Drug Designation for Acute Myeloid Leukemia (Press)
  • X4 Pharmaceuticals Announces Initiation of the Phase 2 Expansion of Its Phase 1/2 Study of X4P-001 in Patients with Advanced Clear Cell Renal Cell Carcinoma (Press)
  • BMS, leading I-O in liver cancer, nabs Opdivo 'priority' tag and nears Bayer showdown (Fierce) (Press)

Medical Devices

  • LivaNova snags former J&J exec Huston as CFO (MassDevice)
  • FDA Issues 483 to Repro-Med Over Reporting, Quality Systems Issues (Focus)
  • Interview with Rupa Basu, BIOTRONIK’s Senior VP of Marketing, Corporate Accounts and Strategy (MedGadget)
  • Boston Scientific’s post-approval Alair study shows long-term asthma improvement (MassDevice)
  • Medtronic Enrolls First Patient in Study of IN.PACT(TM) AV Access Drug-Coated Balloon in Patients with End-Stage Renal Disease (Press)

US: Assorted & Government

  • Former Heritage Pharma executives settle with states (Reuters)
  • DEA Administrative Decisions Update: Has DEA Established New Grounds for Summary Disposition? (FDA Law Blog)
  • Picking Up the Post-Preemption Pieces (Drug & Device Law)
  • Citizen Petitions to Come Front and Center (Policy & Medicine)
  • A Year Later, FDA Is Better and Stronger in Protecting Consumers from Unsafe Foods (FDA Voice)
  • UC, Medivation Settle Drug Royalty Row On Eve Of Trial (Law360-$)
  • Theranos Dodges Investors’ ‘Boundless’ Docs Bid, For Now (Law360-$)
  • Bristol-Myers, Pfizer Made Faulty Blood Thinner, Suit Says (Law360-$)
  • Johnson & Johnson sold us the talc product, Valeant CEO says. Now it should cover our legal defense (Fierce)

Upcoming Meetings & Events


  • Gore wins Japanese regulatory nod for Gore Excluder IBE (MassDevice)


  • Coming soon: Clinical trials transparency (Economic Times)
  • US Price Pressure Clouds Lupin Outlook – Can Its Pipeline Deliver? (SCRIP-$)
  • Karnataka pharma industry and pharmacy trade do not see any long-term impact under GST regime (PharmaBiz)
  • CDSCO recommendation awaited to issue fresh certifications after state FDA cancels WHO-GMP licenses of 2 firms (PharmaBiz)

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

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

Categories: Recon, Regulatory News

Regulatory Focus newsletters

All the biggest regulatory news and happenings.


Most Viewed Articles