Regulatory Recon: Takeda Buys Ariad for $5.2 Billion; Merrimack to Sell Oncology Assets to Ipsen (9 January 2017)

Posted 09 January 2017 By Michael Mezher

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

In Focus: US

  • Califf to Leave FDA on Inauguration Day; Ostroff Next in Line for Acting Commissioner (FDANews-$)
  • Gene-edited cows, rogue clinics, speedier approvals: the challenges facing Trump's FDA chief (Nature)
  • US biosimilars will continue to blossom under Trump, say experts (BioPharmaReporter)
  • Sanofi beats Novo to launch with diabetes combo Soliqua (Fierce)
  • Medicare to Cover Infliximab Biosimilar (Medpage)
  • The Biosimilars Litigation Landscape For 2017 (Law360-$)
  • FTC, NY State Charge Supplement Marketer Over Deceptive Memory, Cognitive Improvement Claims (FTC)
  • Senator Chuck Grassley Wants CMS to Investigate Dilaudid, Prilosec (FDANews-$)
  • Liquid Biopsies Are About to Get a Billion Dollar Boost (MIT Technology Review)
  • Could Amgen's Patent Victory Be Bad For Medicine? (Forbes)
  • Generic Drug Price-Fixing Suits Just Tip Of The Iceberg (Law360-$)
  • Biotech Starts Year With a Look Ahead (WSJ)
  • Regeneron Is Down, Not Out (WSJ)
  • Parkinson's Therapy Gets Fresh Look From Device Makers (WSJ)
  • Takeda Pays $5.2B for Leukemia Drug Maker Ariad (The Street) (Forbes) (Press)
  • Merrimack Pharmaceutical to Sell Onivyde, Generic Doxil to Ipsen (WSJ) (BioWorld) (Press)

In Focus: International

  • Studies find worrying over- and underuse of medicine worldwide (Reuters)
  • Training For 'Huge' EU Clinical Trials Portal And Database On Track For 2017 (Pink Sheet-$)
  • Poor global revenue outlook will drive biopharmaceutical M&A in 2017; report (PharmaLetter-$)
  • Updates on South Korean Medical Device Regulatory Changes (Emergo)
  • Ebola Can Linger, Perhaps Replicate in Lungs (Medpage) (PLOS)
  • Targovax promotes new CFO (Pharmafile)
  • Aurobindo Pharma to buy Portugal's Generis for 135 mn euro (Economic Times)
  • India and Sweden soon to begin collaborative research in diagnostics, devices & AMR (PharmaBiz)
  • Standards for biological medicines - understanding them and how they make a difference (MHRA 1, 2)
  • Shire selling Baxalta site in Austria once earmarked to make hemophilia drug (BioPharmaReporter)

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US: Pharmaceuticals & Biotechnology

  • The Speedy Appointment of a New Commissioner? (Alliance for a Stronger FDA)
  • Celgene strikes possible takeover deal for in-demand Anokion (Fierce) (Press)
  • Few black diabetes patients in US drug trials (Reuters)
  • Immatics bags $1B tie-up with Amgen for cancer immunotherapies (Fierce) (Press)
  • Dynamic versus static biomarkers in cancer immune checkpoint blockade: unravelling complexity (Nature)
  • CBER Director Touts Center's FY2016 Performance (Focus)
  • Valbenazine FDA Panel Cancellation Is A Good Sign, Neurocrine Says (Pink Sheet-$) (BioCentury)
  • Incyte and Merck to advance clinical development program investigating the combination of Epacadostat with Keytruda (Reuters) (Press)
  • Sanofi and Immunext enter into agreement to develop treatments for autoimmune diseases (Reuters) (Press)
  • Critics Blast Star-Studded Advisory Board of Anti-Aging Company (MIT Technology Review)
  • Biomarker in blood may help predict recovery time for sports concussions (NIH)
  • Cell-in-a-Box: PharmaCyte seeks FDA advice for inoperable cancer trial (BioPharmaReporter)
  • IBM and Illumina Partner to Standardize Genomic Data Interpretation (IBM)
  • Taking multiple medications? You may also be taking excess risks. (Washington Post)
  • A Year After CEO's Departure, Quintessence Remains 'Dormant' (Xconomy)
  • Biopharma Industry, Heal Thyself (Without Government Help) (Xconomy)

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

  • FDA speeds up review of Roche's Tecentriq to treat another bladder cancer (Reuters) (Press)
  • The Medicines Company Announces Positive Top-Line Results from Day 180 Interim Analysis in Ongoing ORION-1 Phase 2 Study of Inclisiran (formerly, PCSK9si) (Press)
  • Tricida Announces Positive Topline Phase 1/2 Clinical Trial Results for TRC101 in 135 Subjects with Chronic Kidney Disease and Metabolic Acidosis (Press)
  • Enanta Announces High SVR12 Rates Achieved in Genotype 1 Chronic HCV Infected Japanese Patients with Eight Weeks of Treatment with AbbVie's Investigational, Pan-Genotypic, Ribavirin-free Regimen of Glecaprevir/Pibrentasvir (G/P) (Press)
  • NeuroGenetic Pharmaceuticals Completes Phase 1 Clinical Trials for NGP 555 to Treat and Prevent Alzheimer's Disease; Shown as Safe and Well-Tolerated in Healthy Volunteers (Press)
  • Alexion Submits U.S. and EU Applications Seeking Approval of Soliris® (Eculizumab) as a Treatment for Patients with Refractory Generalized Myasthenia Gravis (gMG) (Press)
  • Stargardt Disease Drug Candidate Receives Orphan Drug Status (MPR)
  • RG7916 Granted Orphan Drug Designation in the U.S. for the Treatment of Spinal Muscular Atrophy (Press)

US: Medical Devices

  • Theranos cuts 41% of workforce as it concentrates on miniLab (MedCityNews)
  • Orthopedic Devices; Reclassification of Pedicle Screw Systems, Henceforth To Be Known as Thoracolumbosacral Pedicle Screw Systems, Including Semi-Rigid Systems (FDA)
  • FDA Clears World's Smallest CPAP, ResMed AirMini™ (Press)
  • Orthofix Receives FDA and CE Mark Approvals for New Bone Growth Stimulators (Press)
  • Medicrea Announces 510(k) Submission for FDA Clearance of Proprietary 3D-Printed Titanium Spinal Interbody Devices (Press)

US: Assorted & Government

  • Fresenius Medical, DaVita subpoenaed over premium assistance (Reuters) (NYTimes)
  • Senate to act this week on Obamacare repeal, McConnell says (Reuters)
  • Replacing, repealing Obamacare at same time 'ideal': top Trump aide (Reuters)
  • Obamacare Taxes Complicate GOP's Repeal Strategy (WSJ)
  • Lipitor MDL Court Grants Pfizer's Omnibus Summary Judgment Motion: No Evidence of Causation (Drug & Device Law)
  • Top Five Stories of 2016 (Patent Docs)
  • J&J Settles Latest Risperdal Case Before Trial (Law360-$)
  • DEA Finalizes Amendments on Imports and Exports, But Misses Opportunity to Improve Re-Export Requirements (FDA Law Blog)

Upcoming Meetings & Events

Europe

  • Danish Regulator Suspends Parallel Importer's GMP Certificate (Focus)
  • Britain's health service in a 'humanitarian crisis': Red Cross (Reuters)
  • The future of biotech (PMLive)
  • The Government and FARMAINDUSTRIA renew the Agreement for Sustainability, Access and Innovation (Farmaindustria)
  • Hemorrhagic and thromboembolic risks associated with double anticoagulation by AVK and heparin therapy (LMWH) during the initiation of AVK in uncomplicated atrial fibrillation: the results of a study by the ANSM - Information Point (ANSM)
  • HPRA Compliance Information Days 2017 (HPRA)
  • IncellDx Gets IVD, CE-IVD Status for Single-Cell Prep Kit (GenomeWeb)
  • Brexit Update: The EU Endorses Procedures for Negotiations With the UK (National Law Review)
  • Genmab achieves first sales-based milestone from Darzalex (PharmaLetter-$)
  • Globus Medical wins CE Mark for Excelsius GPS robotic guidance device (MassDevice)

Asia

  • Former Novartis exec new president of R&D, chief scientific officer at 3SBio (PharmaLetter-$)

India

  • How top Indian drug makers like Sun Pharma, Glenmark are building a brands business in the US (Economic Times)
  • Spanish pharma trade group and Indian gov't renew agreement for sustainability, access and innovation (PharmaLetter-$)
  • Pharma companies want you to pay more for 'risky' bioresorbable stents (Economic Times)
  • Singh brothers, Malvinder and Shivinder, set to cede control in key businesses (Economic Times)
  • Cipla appoints Peter Lankau as independent director (Economic Times)
  • Divis Laboratories files response to USFDA observations (Economic Times)
  • Karnataka DC dept finds 44 drugs as not-of-standard quality during surprise inspection drives (PharmaBiz)
  • India holds growth opportunities for non-invasive patient monitoring devices: Masimo chief (PharmaBiz)

Canada

  • Summary Safety Review - KEPPRA (levetiracetam) - Assessing the Potential Risk of Acute Kidney Injury (Acute renal failure/Interstitial nephritis) (Health Canada)
  • Summary Safety Review - Amiodarone (intravenous) - Assessing the potential risk of side effects in fetuses and newborns (Health Canada)
  • Summary Safety Review - Selective Serotonin Reuptake Inhibitors (SSRIs) - Assessing the Potential Risk of Autism (Health Canada)

Zika

  • Authorization of Emergency Use of an In Vitro Diagnostic Device for Detection of Zika Virus; Availability (FDA)

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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