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Regulatory Recon: NICE Approves Two New Cancer Drugs for NHS Use Study Finds Patent System Drives Drug Prices Higher (24 August 2016)

Posted 24 August 2016 | By Michael Mezher 

Regulatory Recon: NICE Approves Two New Cancer Drugs for NHS Use Study Finds Patent System Drives Drug Prices Higher (24 August 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

  • Results from Anticipated Heart Failure Trial Delayed Again (Medpage)
  • Government-Protected 'Monopolies' Drive Drug Prices Higher, Study Says (KHN) (Reuters) (NPR) (Patent Docs) (JAMA)
  • Busting the billion-dollar myth: how to slash the cost of drug development (Nature)
  • Medical Device Industry, FDA Forge Nearly $1B Reauthorization of User Fee Program (Focus) (Politico)
  • Turing Pharmaceuticals Accused of Retaliating for Sex Assault Complaint (NYTimes)
  • The EpiPen, a Case Study in Health Care System Dysfunction (NYTimes) (CBS)
  • Drug delivery: Leukocyte-like carriers (Nature)
  • What's In A Name? A Quick Guide To Biologic Drug Names (Big Molecule Watch)
  • Power morcellation rates plunged after FDA warnings (MassDevice)
  • FDA Proposes New Rule to Overhaul Regulations for Nonclinical Studies (Focus)
  • Rawlsian Questions about CRISPR Gene Editing (Harvard Bill of Health)
  • FDA Finalizes Two Medical Device Guidelines (Focus)
  • Florida announces Zika case hundreds of miles from Miami (Reuters) (NYTimes)
  • FDA's Eighth Annual Report to Congress on 505(q) Citizen Petitions: New Numbers, But the Same Punchline (FDA Law Blog) (Focus)
  • Brain Scans of Brazilian Babies Show Array of Zika Effects (NYTimes)
  • Pfizer to buy antibiotics business from AstraZeneca (Reuters) (Fierce) (The Guardian)
  • In Florida Keys, Some Worry About 'Science and Government' More Than Zika (NYTimes)

In Focus: International                  

  • Chile issues health alert after faults found in condoms (Reuters)
  • AZ, Roche and Pfizer push emerging markets growth in Q2, while GSK drags (Fierce)
  • Australia's PBAC says Enbrel biosimilar can be substituted (BioCentury)
  • CDSCO Releases GMP and GLP Checklists (CDSCO)
  • 49 PIC/S Inspectorates Test-Drive Data Integrity Guidance (Pink Sheet-$)
  • NICE approves new cancer drugs for routine NHS use (NICE)
  • NICE recommends Eylea as first-line treatment for sight threatening condition (Pharmafile)
  • CFDA Vice Minister Teng Jiacai meets UNOPS Country Director in China (CFDA)
  • Action between Boehringer Ingelheim and Gennova over stroke medicine moves to court (Economic Times)
  • First approval for Hemispherx' Ampligen, in Argentina (PharmaLetter-$)
  • Asia Regulatory Roundup: CFDA Revises Preclinical Guidance  (Focus)

US: Pharmaceuticals & Biotechnology

  • AMRI licenses CRISPR gene editing tech from Broad Institute (Fierce) (Press)
  • Life After Martin Shkreli -- A Conversation With Turing Pharmaceutical's R&D Head (Forbes)
  • Antibodies elicited by the first non-viral prophylactic cancer vaccine show tumor-specificity and immunotherapeutic potential (Nature)
  • Interview – Cytokinetics muscles up in Lou Gehrig's disease (EP Vantage)
  • Stryker's Sage Products expands med wipes recall over B. cepacia contamination concerns (MassDevice)
  • Cell Medica, UCL team up on modified T cell receptor cancer meds (Fierce)
  • Sagent recalls second lot of antibiotic made by Astral SteriTech after rust found in vial (In-PharmaTechnologist)
  • GSK urges teens to 'Take 5' for MenB with new awareness push (Fierce)
  • NIH announces winners of public-private undergraduate biomedical engineering design competition (NIH)

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

  • FDA Accepts Clovis Oncology's New Drug Application for Rucaparib for Priority Review for the Treatment of Advanced Mutant BRCA Ovarian Cancer (Press) (BioCentury)
  • Inotek Pharmaceuticals Announces the Completion of the Recruitment Phase of MATrX-1, the First Phase 3 Clinical Trial of Trabodenoson for Glaucoma (Press)
  • Perrigo Announces Tentative FDA Approval For Generic Version Of Suprep® Oral Solution And Confirms Patent Challenge For Generic Version Of Mirvaso® Gel (Press)

US: Medical Devices

  • Abbott, BD, Bio-Rad likely to continue dominance in Microbiology testing market (BioSpectrum)
  • Medtronic closes $1B HeartWare buyout (MassDevice)
  • Mallinckrodt (MNK) Enters Agreement to Sell Its Nuclear Imaging Business to IBA Molecular For Approximately $690 Million (BioSpace)
  • Brad Thompson: FDA software guidance provides much-needed clarity (Fierce)
  • What will make for tomorrow's medical device winners – 3 key questions to ask (MassDevice)
  • NY State Rescinds Conditional Approval of Four Rosetta Genomics PCR Assays (GenomeWeb)
  • SRS Medical Announces First Patients Enrolled in FDA IDE Study to Expand Indications for Spanner Prostate Stent (Press)
  • Admedus touts Phase II follow-on data for CardioCel (MassDevice)

US: Assorted & Government

  • Genentech Seeks Quick Win In Cancer Drug Dosage Case (Law360-$)
  • Television, Personal Jurisdiction, and Whether Corporate Knowledge Can be Imputed from Internet Drivel (Drug and Device Law)
  • Gault must cough up Super Bowl ring in Heart Tronic case (MassDevice)

Upcoming Meetings & Events


  • Novartis licenses its anti-PCSK9 to sepsis startup Cyon (Fierce)
  • Dodgy Datchet ED drugs dealer jailed (MHRA)
  • Nestle and Galderma Files Patent Suit Against Perrigo (FDA News-$)
  • Call for tender N° Chafea/2015/Health/51 concerning 2 studies: a study on the added value of the strategic and life-course approach to vaccination and a study on shortcomings related to low vaccination coverage in health care workers (EC)
  • Janssen Submits Application to the European Medicines Agency (EMA) to Expand Use of DARZALEX® (daratumumab) to Include Combination with Standard of Care Regimens (Press)


  • Pharmaceutical R&D In Turkey: Important Steps Forward But A Long Way To Go (SCRP-$)
  • Ono Pharma to start marketing Opdivo for blood cancer in Japan (PharmaLetter-$)
  • Korea opportunities: A look at drug and biologic manufacturing in the land of morning calm (In-PharmaTechnologist)


  • Strides Shasun gets USFDA tentative nod for Ranitidine tablets (Economic Times)
  • Amgen's plan for a speedy launch of Repatha in India hits the skids (Fierce)


  • TGA presentations: Medical devices: how to stay included (TGA)


  • Summary Safety Review - Lanoxin, Toloxin, Apo-digoxin, PMS-digoxin, (Digoxin) - Assessing the Potential Higher Risk of Death Compared to Patients not Using Digoxin (Health Canada)
  • Summary of Cancellation for panobinostat (*FARYDAK) (Control number 187504) (Health Canada)

General Health & Other Interesting Articles

  • Gum disease linked to heart disease (Reuters)
  • Concussions and Repercussions (PLOS) (Study)

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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