Regulatory Recon: FDA Approves Multiple Myeloma Drug Against Expert Advice (24 February 2015)

Posted 24 February 2015 | By Alexander Gaffney, RAC 

Regulatory Recon: FDA Approves Multiple Myeloma Drug Against Expert Advice (24 February 2015)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.  Today marks an exciting day for Regulatory Recon—it's our 500th edition! Thanks for reading, and here's to the next 500.

In Focus: US

In Focus: International

  • MHRA Issues Report on Advertising Compliance (MHRA)
  • Doctors: NHS 'must step in' over Avastin row (BBC)
  • Indian regulator places 5-year ban on Kivi Labs for forgery (Fierce)
  • China, Switzerland looks at mutual recognition potential for conformity assessment (Clinica-$)
  • Gilead hauled up over ADR reporting in Japan (Fierce)
  • New Rules on Biosimilars Take Effect in Mexico (FDAnews-$)

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US: Pharmaceuticals and Biotechnology

  • FDA approves Farydak for treatment of multiple myeloma (FDA) (Reuters) (PharmaTimes) (Pink Sheet-$) (Press) (BioCentury) (PMLive) (SCRIP-$)
  • Evaluating the Effectiveness of New Animal Drugs for the Reduction of Pathogenic Shiga Toxin-Producing Escherichia coli in Cattle; Draft Guidance for Industry (FDA) (Guidance)
  • FDA panel: Don't compound Vioxx, Bextra, oxy-ER (SCRIP-$)
  • Ezekiel Emanuel Proposes Creation of $2 Billion Prize Pool for New Antibiotics (NYTimes)
  • FDA Grants Seven Years’ Market Exclusivity to Eagle Pharmaceuticals’ Ryanodex for the Treatment of Malignant Hyperthermia (Press)
  • IOM Meeting: Policy Issues in the Clinical Development and Use of Biomarkers for Molecularly Targeted Therapies (IOM)
  • First Circuit Extends Mensing Preemption To Innovator Drugs (D&D Law)
  • Sagent brings production in house after FDA finds fault with Indian CMO (Fierce)
  • Biosimilar Notification Bill Advances in Utah (SLT)
  • Connecticut legislature considers letting terminally ill patients try experimental drugs (RegisterCitizen) (CTPost)
  • Another Right to Try Bill Filed in Texas (KXAN)
  • Sagent Pharmaceuticals Initiates Voluntary Recall of Atracurium Besylate Injection (Press) (FDA)

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

  • Lilly Delays Filing of Long-Acting Insulin Peglispro, Citing Safety Problems (Press) (Fierce) (Reuters) (MM&M) (PinkSheet-$) (PMLive) (PharmaPhorum) (SCRIP-$)
  • CymaBay's gout drug meets main goal in mid-stage study (Reuters)
  • Enanta Announces JAMA Publication of Results from AbbVie’s Study of VIEKIRA PAK (ombitasvir, paritaprevir, ritonavir tablets; dasabuvir tablets) in Chronic Hepatitis C Patients with HIV-1 Co-Infection (TURQUOISE-I) (Press)
  • Alkermes To Discontinue Development of Pain Treatment (WSJ-$)
  • Phase 3 Data Shows BI's Allergy Drug Improves Lung Function (Press)
  • The Lancet Respiratory Medicine and AAAAI Publish Positive Data from Phase III Trials of Teva’s Reslizumab for the Treatment of Moderate to Severe Asthma in Patients with Elevated Blood Eosinophils (Press)
  • New Data on Eli Lilly/Incyte's Once-Daily Baricitinib for RA From Phase 3 Trial (Press)
  • Teva Announces Positive Results for TEV-48125 in Phase IIb Chronic Migraine Study Meeting Primary and Secondary Endpoints (Press)

US: Pharmaceuticals and Biotechnology: General

  • Big U.S. majority favors mandatory vaccinations (Reuters)
  • Celltrion, Hospira avoid biosimilar traffic jam in U.S. (BioCentury)
  • Rare Disease R&D Increasing (BIO)
  • Insurance companies receive outrageous billing for unwanted prescription creams (CBS)
  • ‘We Need a Petition’ to Lower Cancer Drug Prices (Pharmalot)

US: Medical Devices

  • What happens when an FDA-cleared app gets “recalled”? (MobiHealthNews)
  • FDA panel green lights VertiFlex spinal stenosis device (Mass Device) (Fierce) (Press)
  • FTC fines marketers of two apps that claim to detect melanoma (WaPo) (MobiHealthNews) (The Hill) (MedCityNews) (FTC)
  • FDA official casts doubt on new method to clean scopes linked to infections (LA Times)
  • HeartWare issues urgent recall for heart-pump controllers (Mass Device) (Fierce)
  • U.S. lawmaker seeks congressional hearing on ‘superbug’ outbreak (Reuters)
  • Report: C.R. Bard to settle W. Va. pelvic-mesh case (Mass Device)
  • J&J Adds Up To $350M To $2.5B Hip Implant Settlement (Law 360-$)
  • Recall for Hospira Infusion System (FDA)
  • Neurological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting (FDA)
  • FDA clears Neuronetrix portable EEG device (Mass Device)
  • Biotronik says its investigational nitinol stent performed well in clinical trials (Fierce)
  • bioLytical's INSTI HIV Assay Receives FDA Approval for HIV-2 (Press)
  • GE explains the recall of its MRI systems (Fierce)
  • FDA Lawyer Epiphany: Lawyers Helping FDA on LDTs (FDA Life)
  • CRE superbug hits in N.C.; endoscopes not pinpointed as culprit this time (ModernHealthcare)
  • Bioness Announces FDA 510K Clearance of StimRouter System; a Novel Implantable Neuromodulation Device Designed to Treat Chronic Peripheral Pain (Press)

US: Dietary Supplements

  • NY AG Expands Herbal Supplements Investigation (AP)
  • Fabricant: NYAG's manufacturer probe is perplexing (Press)
  • Plaintiffs Look Beyond Labels And Toward Product Testing (Law 360-$)

US: Assorted And Government

  • What industry, FDA must do to realize the potential of patient engagement (BioCentury-$)
  • Recommendations concerning the new U.S. National Institutes of Health initiative to balance the sex of cells and animals in preclinical research (FASEB)
  • With 21st Century Cures Act Getting Under Way, FDA Hiring a Congressional Affairs Specialist (FDA)

Upcoming Meetings

Ebola Outbreak


  • MHRA Issues Report on Advertising Compliance (MHRA)
  • Doctors: NHS 'must step in' over Avastin row (BBC)
  • Accessibility to suitable and age-appropriate unlicensed medicines for children: the “PaedForm” project (EDQM)
  • Cytori Receives Positive European Opinion on Orphan Drug Status (Press)


  • Indian regulator places 5-year ban on Kivi Labs for forgery (Fierce)
  • Centre may lift restrictions on sale of swine-flu drug (India Times)
  • Mylan Signs Exclusive Agreement with Gilead Sciences to Distribute Hepatitis C Medication in India (DD&D)


  • China, Switzerland looks at mutual recognition potential for conformity assessment (Clinica-$)
  • Drug tender in China's Hunan province has industry up in arms (Fierce)


  • Gilead hauled up over ADR reporting in Japan (Fierce)


  • Canada must ensure all orphan drugs are priced fairly to allow patient access (Press)

Other International

  • New Rules on Biosimilars Take Effect in Mexico (FDAnews-$)
  • Accelerated access to innovative medicines for patients in need (PubMed)
  • WTO TRIPS Council (February 2015): LDC request for extension of transition period for pharmaceutical products (KEI)

General Regulatory And Interesting Articles

  • High Value But Little Glory: Innovating The Unmentionable (Forbes)
  • Merck puts HIV drug in shared patent pool (Pharmafile) (PharmaTimes) (AP) (Press)
  • Why it took so long for the world to start using ‘smart,’ self-destructing syringes (WaPo)
  • Marijuana may be even safer than previously thought, researchers say (WaPo)

Regulatory Reconnaissance #500 – 24 February 2015

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 @AlecGaffney 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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