Regulatory Recon: Adamis Wins FDA Approval for EpiPen Rival; BMS to Sell Ireland API Plant to SK Biotek (16 June 2017)

Posted 16 June 2017 By Michael Mezher

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

In Focus: US

  • Pharma unfazed by specter of executive action on drug prices (Politico) (Endpoints)
  • Nevada forces drugmakers to reveal insulin pricing, profits (Washington Post)
  • The myth of "leaner and meaner" pharma (Endpoints)
  • Adamis wins U.S. approval to sell EpiPen rival, shares soar (Reuters) (WSJ) (Pharmafile)
  • Eli Lilly CEO David Ricks weighs in on drug costs and health reform (CNBC)
  • Pharma companies fight behind-the-scenes wars over generic drugs (STAT)
  • Sanofi chief says U.S. Supreme Court ruling on biologics has "immediate impact" (Reuters)
  • Trump Vowed to 'Take Care' of Opioid Crisis. Some See Few Signs of Action. (NYTimes)
  • Cancer's Big Infrastructure Problem (Forbes)
  • Overcoming Opioids: Easing an epidemic 1 doctor at a time (Washington Post)
  • In the hunt for new antibiotics, scientists hit pay dirt (Washington Post)
  • Secrecy Surrounding Senate Health Bill Raises Alarms in Both Parties (NYTimes)
  • Dangerous unproven treatments for 'chronic Lyme disease' are on the rise (Washington Post) (CDC)
  • Epizyme's Positive Cancer Drug Results Likely to Catch the Eye of Celgene, J&J (The Street)
  • Johnson & Johnson closes $30B Actelion buyout (Drug Delivery) (Press)
  • J&J sets out to build a new R&D group after a $1B biotech christening (Endpoints)
  • These medical device companies are holding the most cash offshore (MassDevice)
  • Parexel, Sanofi explore use of wearables for remote clinical trial data collection (Fierce) (Drug Delivery)

Sponsored Content: Going Digital with RIM

In Focus: International

  • Bristol-Myers selling Ireland plant to South Korean company with large aspirations (Fierce) (GEN) (Press)
  • First Benelux Joint Pricing and Reimbursement Pilot Fails Over Vertex' Orkambi (Pink Sheet-$)
  • Elephantiasis: The race to zero (Financial Times)
  • Paradigm Biopharmaceuticals plunges 67% on clinical trial letdown (Financial Times)
  • Basilea's Business Strategy Emboldened By $500m Pfizer Deal (SCRIP-$)
  • Dompé On A Roll After Securing A "Yes" Under The UK's Early Access Scheme (Pink Sheet-$)
  • Bavarian Nordic delays phase 3 cancer vaccine data again, pushing back Bristol-Myers opt-in decision date (Fierce)
  • US genomic cancer profiling firm FMI heading for China, where access to new therapies lags (CNBC)
  • Population-level impact of an accelerated HIV response plan to reach the UNAIDS 90-90-90 target in Côte d'Ivoire: Insights from mathematical modeling (PLOS)

Pharmaceuticals & Biotechnology

  • Bristol-Myers bets biomarkers will show who needs "bigger hammer" (PharmaLetter-$)
  • Hiring:  Using Your Team To Build A Team (LifeSciVC)
  • Are drug makers overlooking the next big category of sleep drugs? (STAT)
  • Genentech's Ocrevus Manufacturing Process Still A Work In Progress (Pink Sheet-$)
  • Interview – Bicycle takes a spin into the clinic (EP Vantage)
  • Will Epoetin Biosimilar Serve As Non-Medical Switching Case Study? (SCRIP-$)
  • Shooting for the moon: The National Cancer Institute's Formulary (Pharmafile)
  • Increasing transparency on generic drug cost data could save $4 billion (Modern Healthcare)
  • What We Talk About When We Talk About Confirmatory Evidence (Pink Sheet-$)
  • Therapy focus – Lupus hopes build but data remain on the distant horizon (EP Vantage)
  • Sanofi report shows fake drugs awareness growing (Securing Industry)
  • Checkmate Pharma Clinches $27M for More Studies in Skin Cancer (Xconomy)
  • FDA Announces Minor Use/Minor Species (MUMS) Grant Application Period Due August 11, 2017 (FDA)
  • NIH study: Glutamine suppresses herpes in mice and guinea pigs (NIH)
  • Loxo Raises $226.8m In Follow-On (BioCentury)
  • Sonar Products ordered to cease operations, Stratus Pharmaceuticals ordered to cease distributing unapproved drugs (FDA)
  • Hospira Issues a Voluntary Nationwide Recall For 8.4% Sodium Bicarbonate Injection, USP, Neut tm (Sodium Bicarbonate 4% Additive Solution), QUELICIN tm (Succinylcholine Chloride Injection, USP) and Potassium Phosphates Injection, USP Due To a Potential For Lack Of Sterility Assurance (FDA)
  • Advanced Pharma, Inc. D/B/A Avella of Houston Issues Voluntary Nationwide Recall of All Unexpired Nitroglycerin Injection In 5% Dextrose USP Products Produced At Its Houston Location From March 3, 2017 Through May 31, 2017 Due To Sub-Potency (FDA)
  • Teva Pharmaceuticals, USA Extends Voluntary Nationwide Recall to Consumer/User Level for One Lot of Paliperidone Extended-Release Tablets, 3mg, 90 Count Bottles Distributed Under the Actavis Pharma Inc. Label Due to Dissolution Test Failure (FDA)

Pharmaceuticals and Biotechnology: Study Results, Filings and Designations

  • Extended Follow-Up Data Evaluating Opdivo (nivolumab) Shows Durable Response in Adult Patients with Relapsed or Progressed Classical Hodgkin Lymphoma (Press)
  • EULAR 2017: Lilly's Taltz® (ixekizumab) Demonstrated No Progression or Minimal Progression of Radiographic Disease in Patients with Psoriatic Arthritis Through 52 Weeks (Press)
  • EULAR 2017: Lilly's Taltz® (ixekizumab) Demonstrated Significant Improvements in Disease Signs and Symptoms at 24 Weeks Among Patients with Active Psoriatic Arthritis Who Had Prior Inadequate Response or Intolerance to TNF Inhibitors (Press)
  • New Safety and Long-Term Efficacy Data from Baricitinib Clinical Trials in Patients with Moderate-to-Severe Rheumatoid Arthritis Presented at EULAR 2017 (Press)
  • Pfizer Announces Results from XELJANZ® (tofacitinib citrate) ORAL Strategy Study Published in The Lancet and Presented at the EULAR Annual Congress (Press)
  • Voclosporin Remission Data from the Phase IIb AURA-LV Study Highlighted at EULAR 2017 (Press)
  • Portola Reports Response Rates For Cerdulatinib (BioCentury)
  • RASRx Receives Orphan Drug Designation from FDA (Press)
  • ResQ Pharma Receives FDA Orphan Drug Designation for LipidRescue™ Therapy for the Treatment of Local Anesthetic Systemic Toxicity (Press)
  • Cerveau Technologies, Inc. Announces FDA Acceptance of Investigational New Drug (IND) for Tau Imaging Agent MK-6240 (Press)
  • Aldeyra eyes Phase 3 after flunking Phase 2b (BioPharmaDive)

Medical Devices

  • FDA Clears MAGNETOM Vida 3T MRI System From Siemens Healthineers (Press)
  • Drug delivery devices: Here is West's plan for success (MassDevice)
  • FDA warns on frameless stereotactic navigation systems (MassDevice) (FDA)
  • BD recalls select Plastipak catheter tip syringes over leakage issues (Drug Delivery)
  • Hologic's Cynosure wins FDA expanded indications for SculpSure (MassDevice)
  • FDA clears Siemens Healthineers Magnetom Vida 3T MRI scanner (MassDevice)

US: Assorted & Government

  • Fed. Circ. Ruling Clears Judge To OK Mylan's Lialda Generic (Law360-$)
  • Pharmacy exec seeks new trial over role in deadly U.S. meningitis outbreak (Reuters)
  • Memory Supplements: Clarifying FDA and FTC Roles Could Strengthen Oversight and Enhance Consumer Awareness (GAO)
  • BIO Statement on SCOTUS Biosimilar Products Ruling (BIO)
  • Third Circuit Gets Right Result In Affirming Daubert Exclusion (Drug & Device Law)
  • Top 100 Universities Worldwide Granted U.S. Patents in 2016 (Patent Docs)
  • Supreme Court Ruling on SEC Statute of Limitations May Affect Other Agencies' Pursuit of Disgorgement (FDA Law Blog)
  • Statement from FDA Commissioner Scott Gottlieb, M.D., on the 2016 National Youth Tobacco Survey results (FDA)

Upcoming Meetings & Events

Europe

  • Post-implementation Review of the Human Medicines Regulations 2012 (MLX 391) (MHRA)
  • New SCOPE ADR e-learning module receives European-wide CME/CPD accreditation (MHRA)
  • NHS unveils plans to better integrate care (PharmaTimes)
  • Further rollout for diabetes prevention programme (PharmaTimes)
  • Novo Nordisk files to add Lantus-matching CV data to Tresiba's European label (Fierce)

Asia

  • Asian patient groups give pharma above average marks for reputation (PMLIve)

India

  • Seventy pharma cos set up PV cells for monitoring ADRs (PharmaBiz)

General Health & Other Interesting Articles

  • Alzheimer's Affects Twice As Many People As Estimated, And The Numbers Are Climbing (Forbes)
  • Three mutations could make bird flu a potential pandemic: study (Reuters)
  • More pregnant women getting whooping cough vaccine (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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