Regulatory Focus™ > News Articles > Regulatory Recon: ICER Says Multiple Myeloma Drugs Are Too Costly, France Looks to Boost Biosimilar

Regulatory Recon: ICER Says Multiple Myeloma Drugs Are Too Costly, France Looks to Boost Biosimilar Uptake (9 May 2016)

Posted 09 May 2016 | By Michael Mezher 

Regulatory Recon: ICER Says Multiple Myeloma Drugs Are Too Costly, France Looks to Boost Biosimilar Uptake (9 May 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

  • Cheap, Paper-Based Zika Diagnostic Tests Are Here (MIT Technology Review)
  • Shortages of emergency-care drugs are increasing (Washington Post)
  • My Mother's Last Chance Isn't FDA Approved, Are There Any Options? (Forbes)
  • Researchers Urge Caution on Expanding Priority Review Voucher Programs (Focus)
  • House Panel to Consider Lab Test Bill in Late May: Attorney (Bloomberg)
  • GOP Senators Raise Concerns With FDA's Draft Guidance Policies (Focus)
  • How A Cancer Drug Has Saved People From Going Blind (NPR)
  • A Tale of Two Startup Worlds: Biotech And Tech VC Ecosystems (LifeSciVC)
  • Independent group finds multiple myeloma drugs too costly in US (Reuters)
  • Tech-Savvy Families Use Home-Built Diabetes Device (WSJ)
  • 'Salvaging some good': The unexpected side effect of the tragic opioid epidemic (Washington Post)

In Focus: International

  • Allergan chief persists with his prescription for growth (Financial Times)
  • Chiesi nears cardiovascular assets deal with Medicine Co: sources (Reuters)
  • Gates Foundation backs Takeda polio vaccine with $38 million grant (Reuters)
  • ICH Looks to Global Expansion (Focus)
  • UK would lose two pharma bodies in event of Brexit, lawyers warn (Financial Times) (The Guardian)
  • France Relaxes Stance On Biosimilar Switching (SCRIP-$) (ANSM)
  • Focus: Governments evaluate policies, reforms as drug pricing debate rages on (Pharmafile)
  • Single-Use Device Reprocessors Get Another Year To Comply With Canadian Regulations (SCRIP-$)
  • China regulator to launch probe into foreign, local drug firms (Reuters) (Fierce) (Pharmafile) (SCRIP-$)
  • UPS-backed Rwandan blood deliveries show drones' promise, hurdles (Reuters)

US: Pharmaceuticals & Biotechnology

  • J&J's Compassionate Use Advisory Cmte. May Become Industry Model (Pink Sheet-$)
  • Little Milo wrestles for gene therapy spotlight (Fierce)
  • Rockstar researcher licenses out new CAR-T platform to upstart (Fierce)
  • Opko Health unit and Vifor Fresenius Medical Care enter into development and license deal (Reuters)
  • No stranger to gambling, this biotech CEO is going all-in on a first drug approval (STAT)
  • Pioneering Lipoprotein Researcher Richard Havel Dead (CardioBrief)
  • Priority Review Vouchers: Does Novartis Have User's Regret? (Pink Sheet-$)
  • Two Andrews and an Algorithm Aim to Accelerate Drug Discovery (IEEE)
  • PharMEDium Issues Voluntary Nationwide Recall Sterile Preparations Compounded With a Single Recalled Lot of Fresenius Kabi Sensorcaine-MPF (bupivacaine HCl) Due to the Presence of Glass Particulate Matter (FDA)
  • The Opioid Epidemic We Failed to Foresee (NYTimes)
  • Research Misconduct Finding: Kenneth Walker, Ph.D. (ORI)
  • Generic Tricor Market Gets Second Indian Generic Company With Approval (24 Insight)
  • MGB Biopharma and FDA discuss MGB-BP-3 regulatory strategy (EPR)
  • US FDA issues draft rules on Comparability Protocols for Human Drugs & Biologics, seeks response before July (PharmaBiz)
  • Merck has high Keytruda hopes outside U.S., but Q1 details sparse (Fierce)
  • Restrictive REMS Is Least Favored Path For Opioid Prescriber Education (PinkSheet-$)
  • FDA Revises Guidance on Special Protocol Assessments, Attempts to Reduce Uncertainty (FDA Law Blog)
  • Research Suggests Diabetes Drug Acts Differently from Previous Theories (DD&D)
  • Supplier Audits -- Do's and Don'ts: Managing Supplier Quality & Reliability (Pharmaceutical Manufacturing)

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

  • Bayer's Stivarga improves liver cancer survival rates, trial shows (PharmaLetter-$)
  • FDA accepts IND app for Epizyme's mesothelioma drug (Fierce)
  • Phase 1 study demonstrating ability of intravaginal ring to deliver large molecular weight peptide published (MNT)
  • Phase III trial meets primary endpoint for Allergan's fibroid treatment (Pharmafile) (Fierce)
  • FDA Expands IMBRUVICA (ibrutinib) Label to Include Overall Survival Data in Previously Untreated Chronic Lymphocytic Leukemia (CLL) and New Indication for Small Lymphocytic Lymphoma (SLL) Patients (Press)
  • Acucela Initiates Phase 2 Clinical Trial Addressing Proliferative Diabetic Retinopathy (Press)
  • X4 Pharmaceuticals Announces Initiation of Phase 1/2 Study of X4P-001 in Patients with Advanced Clear Cell Renal Cell Carcinoma (Press)

US: Medical Devices

  • FDA Extends Comment Period for Hearing Aid GMPs (FDA)
  • Medtronic Unveils Data Showing Feasibility of New Approach to ICD Therapy (Press)
  • Akili Interactive Labs to launch ADHD clinical trial with eye on FDA clearance (MobiHealthNews)
  • Medicaid Program Integrity: Improved Guidance Needed to Better Support Efforts to Screen Managed Care Providers (GAO)
  • Siemens Healthcare's 'Healthineers' re-branding is widely panned (MassDevice)
  • Signostics Receives FDA Clearance for Uscan – The World's First Smart Mobile-Connected Visualization Device Specialized for Urologic Care (Press)
  • Intarcia clears final trial hurdle before applying for FDA approval of diabetes pump (Boston Business Journal)
  • Mass. General-developed device may provide rapid diagnosis of bacterial infections (MNT)
  • Irvine Scientific is the First Company to Receive FDA 510(k) Clearance on Vitrification Media for Use With Oocytes (Press)

US: Assorted & Government

  • Medtronic Says Guidant Could Be Liable For Patent Row Fees (Law360-$)
  • Get Ready for Higher Obamacare Rates Next Year (NYTimes)
  • SRSLY: What the DEA Doesn't Know Exists Can Definitely Kill You (ProPublica)
  • FDA Looks To Hone Supplement GMP Compliance With Sharper Focus For Inspections (Pink Sheet-$)
  • Debt, integration and buyer's remorse: can Abbott pull off its deals? (EP Vantage)
  • USPTO Patent Guidelines Give Hope To Life Sciences Cos (Law360-$)

Upcoming Meetings & Events


  • AZP-531 and its potential in Prader-Willi Syndrome (EPR)
  • The EUnetHTA JA2 Final Technical Report approved to be submitted to the European Commission (EUnetHTA)
  • Growing Like Weeds- MedTech Europe Adopts New Code of Ethical Business Practice (Policy and Medicine)
  • Wide variation across England in the use of therapies to protect against stroke (ABPI)
  • Clinical data back Oxford BioMedica's gene therapy platform (PharmaTimes)
  • UK pharmaceutical industry letter to The Observer, 8 May 2016 (ABPI)


  • China's New Medical Device Good Clinical Practices to Go Into Effect June 1, 2016 (Inside Medical Devices)
  • Bayer notes pharma price pressure in Japan, China (Fierce)
  • China researchers claim 90% complete remission rates in CAR-T trial (PharmaPhorum) (PMLive)
  • China hospitals may need official nod for major medical equipment (Fierce)
  • China FDA issues device guidelines, highlights training for inspectors (Fierce)


  • CDSCO, Pharmexcil to meet PDMA, Japan to strengthen pharma trade between India & Japan (PharmaBiz)
  • 18 Indian Generic ANDAs Receive Approval In April 2016 (24 Insight)
  • Ghana may adopt Indian Pharmacopoeia soon, CDSCO to provide technical training (PharmaBiz)
  • DoP working on war footing to establish mega parks for APIs (PharmaBiz)
  • Around 3,700 blood transfusion related ATRs reported under HvPI (PharmaBiz)


  • Canada Consults On Changes To List Of Recognized Medical Device Standards (SCRIP-$)
  • Summary Safety Review - Proton Pump Inhibitors - Assessing the Potential Risk of Clostridium difficile Infection (Health Canada)


  • Brazil scientists seek to unravel mystery of Zika twins (Reuters)

General Health & Other Interesting Articles

  • John Oliver exposes how the media turns scientific studies into "morning show gossip" (Vox)

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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