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Regulatory Recon: FDA Turns Lens to Stem-Cell Therapies Celltrion's Biosimilar Remsima Picks up More Than 100,000 Prescriptions in Europe (30 August 2016)

Posted 30 August 2016 | By Michael Mezher 

Regulatory Recon: FDA Turns Lens to Stem-Cell Therapies Celltrion's Biosimilar Remsima Picks up More Than 100,000 Prescriptions in Europe (30 August 2016)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @Michael_Mezher, @Zachary Brennan and @RAPSorg on Twitter.

In Focus: US

  • Stem-Cell Treatments Become More Available, and Face More Scrutiny (WSJ)
  • Drug Development Is Lagging For The World's Leading Killer (Forbes) (Endpoints)
  • Drug-Eluting or Bare-Metal Stents for Coronary Artery Disease (NEJM)
  • Purdue Pharma rejects request from New Hampshire attorney general for information on suspected diversion of OxyContin (LA Times)
  • Superbug resistant to two last-resort antibiotics found in US for first time (STAT) (Reuters)
  • How 12 EpiPens Saved My Life (NYTimes)
  • Abbott's deal headaches go beyond bad luck (Crain's)
  • FDA Pushes Back Enforcement of UDI Rule Provisions (Focus)
  • CROs, convergence, and commercial opportunities (KPMG)
  • CAR-T cells take aim at autoimmunity (Nature)
  • Eli Lilly to FDA: Follow the science in defining a protein (BioWorld)
  • Senators Raise Concerns About Mylan's EpiPen Price Hike (Sanders)
  • House Oversight Committee Reqeusts Info From Mylan Over EpiPen Pricing (Letter)
  • Illinois Sues Controversial Drug Maker Over Deceptive Marketing Practices (ProPublica)
  • Merck plays long game in precision medicine battle (Financial Times)
  • KaloBios, Post-Shkreli, Vows 'Maniacal' Focus On R&D And Transparency (Forbes) (WSJ)
  • FDA grants Santhera $246,000 for muscular dystrophy trial (EPR)
  • Authorized Generics: Why Mylan Would Compete With Itself in the EpiPen Market (Focus)
  • Think EpiPen is Mylan's first scandal? Here's a timeline of jet use, an unearned MBA and more (Fierce)
  • Editorial EpiPen price gouging demonstrates need for more competition in generic drugs (LA Times) (Forbes)

In Focus: International

  • Celltrion's biosimilar prescribed over 100,000 times in Europe (The Investor)
  • Global regenerative medicine market to grow by 13% (BioSpectrum)
  • Novartis Subsidiary Pays $16m to Settle Charges of Illegally Shipping Drugs and Devices to Iran, Syria and Sudan (Focus)
  • New Heart Failure Drug Struggles To Find Its Footing (CardioBrief)
  • Mixed results cardiovascular stem cell therapy at ESC (PMLive)
  • China Drug Sales to the U.S. Grow Despite Safety Concerns at Home (Bloomberg)
  • Pharma pricing body moves to recover money overcharged by firms (The Hindu)
  • Praluent slashes need for apheresis treatment (PharmaTimes)
  • UK's annual asthma bill tops £1 billion (PharmaTimes)
  • Amgen, Sanofi and Regeneron trot out new PCSK9 data at European heart meeting (Fierce)
  • Cipla receives FDA approval for generic version of Valeant antidepressant (Pharmafile) (Economic Times)
  • Carmat jumps after first implantation of its bioprosthetic artificial heart (Reuters) (Press)
  • New Opportunities for U.S. Medtech Exporters in Saudi Arabia (MDDI)
  • Court battle over Zydus Cadila's breast cancer drug continues (Economic Times)
  • Vectura's therapy misses primary goal in late stage lung disease trial (Reuters) (Fierce) (GEN)

US: Pharmaceuticals & Biotechnology

  • Docs facing more parents who refuse to vaccinate kids (Reuters)
  • Doctors Will Play a Critical Role in the Opioid Epidemic (NYTimes)
  • Deal watch: Galderma pursues 'itchy cytokine' by licensing antibody from Roche's Chugai (Nature)
  • FDA Requests Characterization Data in ANDAs for Risperdal Generics (FDANews-$)
  • Synthetic Genomics Creates Host Organism Optimized for Bio Industry (Xconomy)
  • CDC releases genetic data on antibiotic resistant Salmonella infections (CDC)
  • Efforts Accelerate to Streamline Postapproval Change Process (PharmTech)
  • Study finds links between physicians setting cancer care guidelines and drug industry (MNT)
  • Notice: Health Canada and United States Food and Drug Administration (US FDA) Joint Public Consultation on International Council on Harmonisation (ICH) Guidelines for Registration of Pharmaceuticals for Human Use (Health Canada)
  • Impax Laboratories, Inc. Issues Voluntary, Nationwide Recall for One Lot of Lamotrigine Orally Disintegrating Tablet 200 mg Due to the Potential for 100 mg Blister Cards being Packaged in 200 mg Containers (FDA)
  • Cempra's solithromycin gets Nov. 4 FDA panel (BioCentury)

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

  • Amgen's Prolia achieves positive top-line Phase III results after 12 months (Pharmafile)
  • Neurocrine submits valbenazine NDA (BioCentury)
  • mRNA-based drug approaches Phase I milestone (Nature)
  • FDA Grants Fast Track Designation to Sublingual Apomorphine (FDANews-$)
  • Rigel's fostamatinib hits PhIII goal, but shares yo-yo on data (Fierce)
  • FDA Grants Orphan-Drug Designation for Regenicin's NovaDerm® Cultured Skin Substitute (Press)
  • Rigel's bleeding disorder drug clears first of two key trials (Reuters)
  • Abeona Therapeutics completes cohort in Sanfilippo syndrome trial (EPR)
  • SIGA Announces Completion of Enrollment and Dosing in the Final Cohort of Phase III Study of TPOXX™ (tecovirimat) (Press)

US: Medical Devices

  • St. Jude Medical: Alleged Merlin@home 'crash' is actually a security feature (MassDevice)
  • Muddy Waters refutes St. Jude response, presses on security flaws (MassDevice)
  • When Medical Device Software Changes Warrant a new FDA 510(k) (Emergo) (Focus)
  • Medtronic Hints at LVAD Plans (MDDI)
  • Study: TAVR safer than surgery in low-risk heart failure patients (MassDevice)
  • Fortimedix wins FDA nod for FMX314 single-port surgery platform (MassDevice)

US: Assorted & Government

  • A Banner Week For Buckman Preemption (Drug and Device Law)
  • MEDICARE PART B: Data on Coupon Discounts Needed to Evaluate Methodology for Setting Drug Payment Rates (GAO)
  • Breaking News – California High Court Expands "Specific" Personal Jurisdiction To Recreate Exorbitant" Personal Jurisdiction Rejected by Daimler v. Bauman (Drug and Device Law)
  • Obamacare Marketplaces Are in Trouble. What Can Be Done? (NYTimes)
  • FSIS Now Allows Use of the Term GMO in "Negative Claims" (FDA Law Blog)

Upcoming Meetings & Events


  • Hikma continues beefing up US and European manufacturing capabilities (In-PharmTechnologist)
  • European Commission Grants Orphan Drug Designation to ALXN1007 for the Treatment of Patients with Graft-Versus-Host Disease (GVHD) (Press)
  • Medtronic touts 12-month data on Micra leadless pacemaker | ESC 2016 (MassDevice)
  • Bluegrass Vascular wins CE Mark for Surfacer vascular access device (MassDevice)
  • UK's NICE set to recommend Heartflow's FFRct (MassDevice)


  • Seikagaku, Ferring in pain deal (BioCentury)
  • AMED joining the Global Alliance for Chronic Diseases (GACD) as a newest member. (29 June, 2016.) (AMED)
  • IPEC Association (China) becomes a member of EXCiPACT (Manufacturing Chemist)
  • Taiwan's iStat Biomedical Gets CE Mark for HPV-Associated Cancer Products (GenomeWeb)


  • Pharma cos offer freebies to doctors, violate code: MP (Economic Times)


  • Dalton Pharma Services completes $5 million expansion of sterile filling and API manufacturing operation (Manufacturing Chemist)


  • Zika around the world: Where do we stand? (CNN)
  • Adult mosquitoes can pass Zika to their offspring: U.S. study (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

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

    Categories: Recon, Regulatory News

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