Regulatory Recon: BMS' Empliciti Approved to Treat Multiple Myeloma (30 November 2015)

Posted 30 November 2015 | By Michael Mezher 

Regulatory Recon: BMS' Empliciti Approved to Treat Multiple Myeloma (30 November 2015)

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

  • FDA declines expanded approval for Bristol-Myers' Opdivo drug (Reuters) (SCRIP-$) (PharmaLetter-$)
  • FDA deems Boston Scientific's atherectomy component recall Class I (MassDevice) (FDA)
  • How a system meant to develop drugs for rare diseases broke down (STAT)
  • FDA approves Empliciti, a new immune-stimulating therapy to treat multiple myeloma (FDA)
  • FDA Talent Hunt: Is Recruiting From Academia Better Than Industry? (Pink Sheet-$)
  • Working to Lower Drug Costs by Challenging Questionable Patents (NYTimes)
  • Human-genome editing summit to sample global attitudes (Nature) (STAT)
  • Supreme Court rejects Covidien bid to restore patent verdict against Ethicon (Reuters)

In Focus: International

US: Pharmaceuticals and Biotechnology

  • Califf Supports Changing Combo Product Pathway; FDA Developing Proposal (Tan Sheet-$)
  • Biosimilars Uptake Will Fail Without Trust, Accountability (SCRIP-$)
  • Animal Venom Database Could Be Boon To Drug Development (Forbes) (DD&D)
  • Roche pulls out of 'superbug' antibiotic project (Reuters)
  • Liquid Biopsies – Circulating Tumor Cells and DNA as Important Players in the Future of Precision Medicine (Thomson Reuters)
  • The Common Rule NPRM: Single IRB Review (Harvard Bill of Health)
  • Misleading HPV vaccine websites are easy to find (Reuters)
  • New PD-1 Immunotherapy Combinations Push The Envelope In Melanoma (Pink Sheet-$)
  • How Fast Do PD-1s Get To Market? (Pink Sheet-$)
  • Over-the-Counter Medicines' Benefits and Dangers (NYTimes)
  • Genentech's Siegel: Why Not More Accelerated Approvals In Immunology? (Pink Sheet-$)
  • AbbVie ready to defend Humira's IP after Amgen files biosimilar (BioPharma-Reporter)
  • Keytruda's Path From 32-Patient Study To Approval (Pink Sheet-$)
  • Beyond Phase I: Expansion Cohort Trials Bring Efficiencies, Regulatory Challenges (Pink Sheet-$)
  • How pharma is trying to get patients to stay on their meds—and out of the hospital (BioPharmaDive)

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

  • Ironwood Reports Positive Top-Line Data from Phase II Trial of Linaclotide in Adult Patients With Opioid-Induced Constipation (Press)
  • Eisai and Arena Pharmaceuticals Announce FDA Acceptance of New Drug Application for Extended Release Formulation of Lorcaserin (Press)
  • CapGenesis Files Five Orphan Drug Designation Requests With the FDA and EMA for CGS-200 as a Topical Analgesic (Press)
  • Eiger BioPharmaceuticals Granted Orphan Drug Status for Ubenimex in Pulmonary Arterial Hypertension (Press)
  • FDA Grants Orphan Drug Designation to Triphase (PharmPro)

US: Medical Devices

  • St. Jude's Proclaim Elite Spinal Cord Stimulator for Chronic Pain FDA Approved (medGadget)
  • Siemens Receives FDA Clearance for Multitom Rax Robotic X-ray System (Press)
  • Dell announces monitor purpose-built for healthcare (BioSpectrum)
  • FDA Clears Siemens CT Scanners for Low-Dose Lung Cancer Screening (Press)
  • Covalon Announces FDA Clearance for Its New SilverCoat™ Silicone Foley Catheter (Press)

US: Assorted and Government

  • Califf's Ethics Letter Lists Conflicts He Averted (Tan Sheet-$)
  • FDA Reorganization Advocates Seek Senate Boost For Disease-Oriented Structure (Pink Sheet-$)
  • DEA, FDA continue to block state's effort to get lethal injection drugs (KETV Omaha)
  • Outlook 2016: A Pharma Pile-On (MMM)
  • A Step Forward for Contraceptive Access (NYTimes)

Upcoming Meetings and Events              


  • MHRA to phase out regulatory submissions for medicines on physical media (MHRA)
  • No Additional Staff But EMA 'Mobilizing Correct Expertise' To Deliver On PRIME (SCRIP-$)
  • Caution Needed When Updating Europe's Orphan Drugs Procedures, Industry Says (SCRIP-$)
  • EU Approves Amgen's Blincyto to Treat Rare Form of ALL (DD&D)
  • EMA Clinical Trials Portal Training Reflects 'Big Change Management' For All (Pink Sheet-$)
  • NICE Declines Amgen & Roche Drugs (PharmPro)
  • Novartis launch drug for rare lung cancer subtype but patients in England may be denied access (MNT)
  • EU review for novel cancer-related weight-loss and muscle wasting drug (PharmaTimes)
  • Praxbind (idarucizumab) approved in European Union for the specific reversal of Pradaxa (Press)
  • Sobi and Biogen's Elocta (rFVIIIFc) approved in Europe for the treatment of haemophilia A (MNT)
  • Roche receives EU approval of Cotellic for use in combination with Zelboraf in advanced melanoma (Press)
  • Helsinn says EMA accepts marketing authorization application for anamorelin (PharmaLetter-$)
  • Horizon Pharma plc Receives European Commission Approval for RAVICTI(R) (glycerol phenylbutyrate) Oral Liquid for the Treatment of Urea Cycle Disorders in Patients Two Months of Age and Older (Press)


    • China FDA Generic Rejections Show Tightening Quality Noose (PharmAsiaNews-$)
    • Beijing aims to refill medicine chest with 'Made in China' drugs (Reuters)


    • India moves to offer drugs at lower prices through Jan Aushadhi campaign (PharmaLetter-$)
    • FDA grants Dr Reddy's Labs additional time to respond to warning letter (PharmaLetter-$)
    • Centre to issue guidelines for regn & import licence; to raise import regn fee from Rs. 1 lakh to Rs. 5 lakh (PharmaBiz)
    • DoP to confer awards for best performing Indian pharma cos under various categories (PharmaBiz)
    • Update On Clinical Trials In India (24 Insight)
    • Aurobindo gets FDA approval for generic Revatio (DSN)
    • Pharma cos need to adopt bar coding to rein in counterfeit medicines (PharmaBiz)
    • Government in talks with various markets to accept Indian drug norms (Economic Times)
    • Exporters demand to enhance validity of WHO GMP certificate from 2 to 3 years (PharmaBiz)
    • Hepatitis C cure may cost as low as Rs 67,000 (Economic Times)


    • Australian regulatory guidelines for OTC medicines (ARGOM) (TGA)

    Other International

    • Accelerate expansion of antiretroviral therapy to all people living with HIV (WHO)
    • Turkey's "Additional Customs Duties" – Will Medical Devices Be Next? (FDA Life)
    • Guinea's last Ebola case, a baby girl, leaves hospital (Reuters)

    General Health & Interesting Articles

    • Indestructible 'Water Bears' Have Really Weird Genomes (Forbes)

    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.

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