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Regulatory Recon: Oversized Cancer Drug Vials Lead to $3bn in Waste Annually Should NICE Charge a User Fee? (1 March 2016)

Posted 01 March 2016 | By Michael Mezher 

Regulatory Recon: Oversized Cancer Drug Vials Lead to $3bn in Waste Annually Should NICE Charge a User Fee? (1 March 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

  • Waste in Cancer Drugs Costs $3 Billion a Year, a Study Says (NYTimes) (Study)
  • Valeant Pharmaceuticals Is Under S.E.C. Investigation (NYTimes)
  • Entrepreneuring Post-Pharma (LifeSciVC)
  • I support Obama's cancer 'moonshot.' Unfortunately, it won't save me. (Washington Post)
  • Patients get mixed reactions from docs over mail-ordered genetic tests (Reuters)
  • 'Female Viagra' Only Modestly Increases Sexual Satisfaction, Study Finds (NYTimes) (Reuters) (Study)

In Focus: International

  • Should industry pay for NICE Technology Appraisals? (PharmaPhorum)
  • China FDA chief Bi updates press on quality crackdown (Fierce)
  • How big pharma and the Indian government are letting millions of patients down (The Caravan)
  • NICE to take control of England's Cancer Drugs Fund (Pharmaceutical Journal)
  • UK shows progress on rare disease strategy (PharmaTimes)

US: Pharmaceuticals & Biotechnology

  • AstraZeneca Ditches A Second I/O Monotherapy (SCRIP-$)
  • How Your Supplements Interact With Prescription Drugs (WSJ)
  • 'Wilhemina's War' Explores Barriers To AIDS Treatment In U.S. South (NPR)
  • Genome editing attracts big bucks from Bayer and Baxalta (EP Vantage)
  • Endo International to Close Astora Women's Health Due to Lawsuit Concerns (WSJ-$)
  • New FDA Guidance for First Responders as Track-and-Trace Requirements Take Effect (Focus)
  • Fecal Transplants to Treat C. difficile: FDA Seeks Comment on What IND Requirements to Waive (Focus)
  • $2 Million in Funding From FDA for Rare Disease Natural History Studies (Focus)
  • BioMarin Faces a Key Test of Rare Disease Pipeline (The Street)
  • Hantavirus Protein Structure is Promising Drug Design Model (DD&D)
  • Five Reasons To Be Optimistic About The Precision Medicine Initiative (Fobres)

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

  • Eylea outperforms Avastin for diabetic macular edema with moderate or worse vision loss (NIH)
  • Heron Therapeutics Provides Update on SUSTOL NDA (Press)
  • FDA approves Roche's Gazyva (obinutuzumab) for certain people with previously treated follicular lymphoma (Press)
  • Concert Pharmaceuticals Announces CTP-656 Solid Dose Phase 1 Results Confirmed Superior Pharmacokinetic Profile to Kalydeco (Press)
  • Protalex Receives Positive Interim Review from Independent Safety Monitoring Committee in Its U.S. Phase 1/2 Study of PRTX-100 for Immune Thrombocytopenia (Press)
  • Clementia Announces Last Patient Enrolled In Phase 2 Trial Of Palovarotene (Press)

US: Medical Devices

  • [Update] FDA: New Postmarketing Study, Black Box Warning for Essure (Focus)
  • New Device Lights Up Cancer Surgery (MIT Technology Review)
  • At Workshop, FDA Gathers Input on How to Regulate NGS Panels to Guide Cancer Treatment (GenomeWeb) (Focus)
  • Abbott's MitraClip Class I Recall Results From Delivery Snafus (Gray Sheet-$)
  • FDA Reclassifies Blood Establishment Computer Software and Accessories to Class II (FDA)
  • First Medical Isotope Facility in the U.S. in 50 Years Granted Construction Permit (medGadget)
  • FDA Panel Endorses Class II Status for Surgical Mesh Instrumentation (Gray Sheet-$)
  • 5 Tips to Help Your FDA 510(k) Submission (checklist included) (MedCityNews)
  • Bacteria or Virus? New Tests May Identify What's Causing Your Infection (WSJ)
  • Reapplix Receives US FDA 510(K) Clearance (Press)
  • Intuitive Surgical touts less complications in robot-assisted hysterectomy study (MassDevice)
  • FDA approves InVivo neuro-spinal scaffold trial amendment (MassDevice) (Press)
  • CoorsTek Medical Announces FDA 510(k) Clearance for Total Hip System Incorporating CeraSurf-p Implantable Ceramic Components (Press)
  • First Patients in Presbia Microlens FDA Study Complete 12-Month Postoperative Visits (Press)

US: Assorted & Government

  • Agencies Engaged in Federal Biotech Overhaul to Host Final Two Public Sessions in March (National Law Review)
  • Here's Why Healthcare Is So Expensive, According To Your Favorite Presidential Candidate (Forbes)
  • FTC Issues Report on ANDA Settlement Agreements (Patent Docs)
  • Trying to Revive H.M.O.s, but Without Those Scarlet Letters (NYTimes)
  • Amgen Patent Suit Targets Sandoz's Enbrel Biosimilar (Law360-$) (Pink Sheet-$)
  • Vascular Solutions vindicated in off-label marketing suit over varicose vein device (Fierce)
  • Biogen Wants Supreme Court To Tackle MS Drug Patent Rights Dispute (Pink Sheet-$)
  • International Pharmaceutical Supply Chain Imperiled Like Never Before (FDA Law Blog)
  • New York Court of Appeals Rejects Specific Causation Expert Opinion under Frye Standard (Drug and Device Law)
  • Sunscreen Data Guidance Out Of Balance On Risk/Benefit – Comments (Tan Sheet-$)
  • Forest Fights Class Claims In Antidepressant Marketing MDL (Law360-$)
  • Drug Patent Battler Asks: 'What's Michelle Lee Hiding?' (Law360-$)
  • Senator Requests Information on ANDA Backlog in Letter to Califf (FDANews-$)
  • FTC: Hikma Must Sell Off Drugs to Purchase Roxane (FDANews-$)

Upcoming Meetings & Events


  • EFPIA Challenges Conclusions Of New EC Report On Drug Pricing (SCRIP-$)
  • EU Pilot On Incident Reporting: Lessons Learned So Far And Next Steps (Clinica-$)
  • Guideline on epidemiological data on blood transmissible Infections (Revised) (EMA)
  • Aveo's kidney cancer drug submitted for approval in Europe (Boston Business Journal)
  • Zambon launches Xadago in Italy (PharmaLetter-$)
  • GenSight begins Phase III retinal disease trials (Pharmafile)
  • EUSA Pharma files kidney cancer drug in the EU (PharmaTimes)
  • EOS Imaging wins CE Mark for spineEOS (MassDevice)
  • E-cigarettes: regulations for consumer products (MHRA)


  • Medical devices should come under Drug Price Control Order: Department of Pharmaceuticals (Economic Times)
  • Zydus Cadila gets USFDA nod for anti-diabetics tablets (Economic Times)
  • Aurobindo Pharma gets USFDA nod for antidote to analgesic overdose (Economic Times)
  • Indian pharma needs to accelerate research on Phyto drug development: Dr DBA Narayana (PharmaBiz)
  • Budget 2016: Duty waiver for dialysis equipment to cut costs for renal patients (Economic Times)
  • Govt to come out with study on safety of PET bottles use for packaging liquid orals soon (PharmaBiz)
  • IPC to enroll 20 plus AMCs under PvPI by March 2016 bringing total over 200 (PharmaBiz)
  • NPPA gives final chance to cos to register under IPDMS till March 31, 2016 (PharmaBiz)
  • Irbm, An Italian Drug Development Company, Obtains An Indian Patent For Hepatitis C Treatment (24 Insight)
  • Rhodes Pharma's Aptensio Challenged In Latest USFDA Para IV Certification List (24 Insight)


  • TGA business plan 2015-2016 (TGA)
  • Mandatory requirements for an effective over-the-counter medicines application (TGA)
  • Common Technical Document Module 1: OTC medicines (TGA)


  • Guidance Document: Preparation of Drug Regulatory Activities in the "Non-eCTD Electronic-Only" Format (Health Canada)

Zika Virus

  • New Study Links Zika Virus to Temporary Paralysis (NYTimes) (Reuters)
  • CDC adds 2 destinations to interim travel guidance related to Zika virus (CDC)
  • Reporting On The Zika Virus Means Getting Up Close And Personal (NPR)
  • Zika is expected to infect 1 in 5 Puerto Ricans, raising threat to rest of U.S. (Washington Post)

Other International

  • Statement by Mr Michel Sidibe, Executive Director UNAIDS on opening of the 3rd Africa Pharmaceutical Summit (PharmaAfrica)

General Health & Other Interesting Articles

  • One-third of U.S. women seeking abortions get misleading information: study (Reuters)
  • Shedding Light On The Hearts Of Pro Basketball Players (CardioBrief)
  • Teen Advocates Lobby And Inspire On Rare Diseases Day (Forbes)
  • Mom and dad often catch hospital errors doctors missed (Reuters)
  • Metabolic syndrome tied to cognitive impairment risk (Reuters)
  • Should healthcare systems implement routine recontacting services in clinical practice? Some legal and logistical considerations (Harvard Bill of Health)
  • Lizard chilling on remote island for a million years just discovered by humans (Washington Post)

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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