Regulatory Focus™ > News Articles > Regulatory Recon: FDA Approves Darzalex, NICE Says Kadcyla Too Expensive for NHS (17 November 2015)

Regulatory Recon: FDA Approves Darzalex, NICE Says Kadcyla Too Expensive for NHS (17 November 2015)

Posted 17 November 2015 | By Michael Mezher 

Regulatory Recon: FDA Approves Darzalex, NICE Says Kadcyla Too Expensive for NHS (17 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

In Focus: International

  • Roche breast cancer drug at center of UK pricing row (Reuters) (The Guardian)
  • India and the UK establish a strategic partnership in healthcare (GOV.UK)
  • Korea Aims To Nurture Medical Device Sector With Four-Point Plan (SCRIP-$)

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US: Pharmaceuticals and Biotechnology

  • Valeant's Newest Problem: The Female Libido Pill Isn't Selling (Bloomberg)
  • PhRMA Says BJM Clinical Trial Report Misleading (The Catalyst)
  • Uphill Adcomm Battle For Telesta Bladder Cancer Agent? (SCRIP-$) (FDANews-$) (Pink Sheet-$)
  • GSK Has The Nerve To Innovate Medicine (Forbes)
  • New HIV Therapeutics Benefit from Two Decades of Research (Thomson Reuters)
  • Amyloidosis group to submit guidance to FDA (BioCentury)
  • Antibiotic-Preserving Strategies Must Be Implemented to Battle Resistance (ICT)
  • Could involving patients decrease antibiotic prescriptions? (Reuters)

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

  • Turing Initiates Dosing in Phase I Clinical Trial of TUR-004 for Epileptic Encephalopathies (Press)
  • Quark Pharmaceutical announces initiation of patient recruitment for global pivotal study of QPI-1007 in NAION (MNT)
  • U.S. Food and Drug Administration Accepts for Priority Review the Supplemental Biologics License Application for Opdivo (nivolumab) in Patients with Advanced Renal Cell Carcinom (Press)
  • Sofosbuvir and Velpatasvir for HCV Genotype 1, 2, 4, 5, and 6 Infection (NEJM)
  • Alcoholism drug can "wake up" dormant HIV to be killed, study finds (Reuters)
  • Nexvet canine osteoarthritis drug meets main goal in study (Reuters)
  • Merck's third-place hep C combo posts quick cures in new study data (FierceBiotech) (Press) (Pink Sheet-$)

US: Medical Devices

  • New Diagnostic Tools Emerge in War Against Superbugs (WSJ)
  • How exchange rates are affecting the medical device industry (Emergo)
  • FDA cancels TransMedics advisory panel meeting (MassDevice)
  • FDA grants expedited access for UW’s wearable artificial kidney (MassDevice)
  • Staff Training Visits On Combination Products, Biocompatibility Sought By US FDA (SCRIP-$)
  • How Easy Is It to Allege Proximate Causation in a Medical Device Case (Drug and Device Law)
  • Medtronic's Endurant AAA Stent Graft Delivers Durable, Consistent and Proven Outcomes at Four Years in Real-World Setting (Medtronic)
  • Workshop Attendees Help Advance FDA Thinking on Analytical, Clinical Validity Standards for NGS (GenomeWeb) (Focus 1, 2)
  • AUM Cardiovascular finishes pivotal trial enrollment (MassDevice)
  • Adoption of Drug-Coated Balloons Set to Increase (MDDI)

US: Assorted and Government

  • FDA Urged To Block Sales Of OTC Congestion Drug (Law360-$)
  • Loestrin Pay-For-Delay Suit Lacks Hard Data, 1st Circ. Told (Law360-$)
  • NEJM joins the fray in drug pricing debate as 2 thought leaders share divergent perspectives (BioPharmaDive)
  • Top 20 generics companies by 2014 revenue (FiercePharma)
  • The Ghost of Bendectin – Exorcized by the FDA? (Drug and Device Law)
  • Burden of hepatitis C now that it can be cured and the cost of curing (PharmaLetter-$)
  • Access to HIV/AIDS Drugs Restricted in Calif., Other Exchanges (California Healthline)
  • PTAB rejects Bass' challenge to Revlimid, Pomalyst (BioCentury)
  • 'Unsustainable' Drug Pricing Requires 'Global Solution'  (SCRIP-$)
  • Successful Ruling In Patent Infringement Litigation For Antiemetic Agent Aloxi In The United States (Eisai)
  • Avedro eyes FDA approval for vision correction tech with $32M in financing (FierceMedicalDevices)

Upcoming Meetings and Events              


  • New strategy to fight antimicrobial resistance (EMA)
  • Responsible Antibiotics Use is Key to Addressing the Rise of AMR (EFPIA)
  • Rasi Back To Work As EMA Executive Director (SCRIP-$) (Focus)
  • EMA Drafts Agenda For Clinical Trials Portal, Database; Industry Wants A System That 'Makes Sense' (SCRIP-$)
  • Medical Device Quality Standard EN ISO 13485 To Be Available Earlier Than Expected In EU (SCRIP-$)
  • SOBI says wins European Medicines Agency approval for Xiapex (Reuters)
  • NeuroSigma wins CE Mark for eTNS ADHD system (MassDevice)


  • Taken remedial actions at two plants in Maharashtra: Drug firm Novartis (Economic Times)
  • Ajanta Pharma launches generic asthma drug in US market (Economic Times)
  • Indian drugmakers eye Japanese market for acquisitions (FiercePharmaAsia)
  • DoP asks NPPA to take action against Softesule for overcharging Ferisis capsules (PharmaBiz)
  • India plans to cap prices on 18 new branded essential drugs (PharmaLetter-$)


  • China FDA seeks comments on device, drug approval backlog plans (FiercePharmaAsia)


  • Updated: Novartis Japan issued business improvement order by MHLW (FiercePharmaAsia)


  • 26BB Legislative Instrument: Frequently asked questions (TGA)
  • Essential principles - consent for noncompliance (TGA)

Other International

  • World Antibiotic Awareness Week (WHO) (CDC) (ICT)
  • The medical devices market in Latin America (Emergo)
  • Why The World Is Falling Behind In The Campaign To Kill Measles (NPR)

General Health and Other Interesting Articles

  • Rocky Mountain spotted fever isn’t limited to the Rockies, and it’s deadly (Washington Post)
  • Study Sheds Light on Why Parasite Makes TB Infections Worse (ICT)
  • Thrombosis During Sepsis is a Consequence of Protective Host Immune Responses (ICT)

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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