Regulatory Focus™ > News Articles > Regulatory Recon: NICE Backs Incyte's Iclusig, Rejects AZ's Daxas; More Fallout From Marthon's Emfla

Regulatory Recon: NICE Backs Incyte's Iclusig, Rejects AZ's Daxas More Fallout From Marthon's Emflaza Pricing (13 February 2017)

Posted 13 February 2017 | By Michael Mezher 

Regulatory Recon: NICE Backs Incyte's Iclusig, Rejects AZ's Daxas More Fallout From Marthon's Emflaza Pricing (13 February 2017)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

In Focus: US

  • Sen. Grassley Opens Inquiry Into Orphan Drug Act (Focus) (KHN) (NPR) (Incidental Economist)
  • Games Drugmakers Play (Bloomberg)
  • Amgen's Parsabiv Approved With Unusual Postmarketing Requirements (Pink Sheet-$)
  • Sandoz Kicks Off Supreme Court Biosimilar Battle (Law360-$)
  • Questions Linger Over Scope, Utility of Drug, Device Company Payment Data (Bloomberg)
  • Where is the Future of Drug Discovery for Cancer? (Cell)
  • FluMist mystery on experts' agenda: Why was it so weak, and only in US studies? (STAT)
  • Democratic senators float bill to protect 'scientific integrity' (MassDevice) (Law360-$)
  • Allergan set to bolster 'medical aesthetics' unit with $2.5 billion Zeltiq deal (Pharmafile)
  • Intercept Pharma: We Can't Enroll Our NASH Study so We're Changing the Study. Trust Us, All Good (The Street)
  • FDA-Approved Labeling ≠ Medical Standard Of Care (Drug & Device Law)
  • PhRMA Urges USTR to Protect American Innovators Abroad (PhRMA) (Special 301 Submission)
  • PhRMA, BIO, MIWG File Petition To Block FDA's Intended Use Rule (IHP-$) Pink Sheet-$)
  • Marathon's R&D program for Duchenne MD drug likely came in at a bargain basement price (Endpoints)
  • PhRMA, Marathon Is Why You Can't Have Nice Things (Harvard Bill of Health)
  • Marathon Pharmaceuticals to Charge $89,000 for Muscular Dystrophy Drug After 70-Fold Increase (WSJ) (Forbes) (WSJ)
  • Republicans, Aiming to Kill Health Law, Also Work to Shore It Up (NYTimes)
  • With eye on Obamacare, Price takes helm as U.S. health secretary (Reuters) (WSJ)
  • How to Fix (or Wreck) Obamacare: Advice for Tom Price (NYTimes)
  • If Obamacare is Out, Where's Trumpcare? (NYTimes)
  • Human Genome Editing: Science, Ethics, and Governance (NAS)
  • PSCK9 Battle: Sanofi Not Negotiating Praluent Fate With Amgen; Ruling Possible By June (Pink Sheet-$)

In Focus: International

  • BMS Label Issue Adds To China Drug Shortage Woes (Pink Sheet-$)
  • Roche Fights Roche for $9 Billion Drug Business (Bloomberg)
  • Teva Pharmaceuticals beats on the top and bottom lines (Business Insider)
  • Revisions to Mexico's Medical Device Regulations under Consideration for 2018 (Emergo)
  • Yemen cancer patients struggle to survive war shortages (Reuters)
  • Pfizer to shut Australian Neulasta biosimilar plant and move production to Croatia (BioPharmaReporter)
  • Cinven in €3.5bn offer for German drugmaker Stada (Financial Times)
  • NICE turns down AZ's chronic obstructive pulmonary disease drug Daxas (Pharmafile) (PharmaTimes)
  • NICE backs routine use of Incyte's leukaemia drug  Iclusig (PharmaTimes)
  • PMDA Head Talks Priorities for 'Rational Medicine' (Focus)
  • Turkish Govt Using Purchasing To Foster Local Generic Production (SCRIP-$)
  • Lilly €200m expansion of Cork site under review (Pharmafile)
  • Drugmaker Ipsen to buy some products from Sanofi for 83 million euros (Reuters) (PharmaTimes) (Pharmafile)
  • Pfizer and Flynn: How are 'excessive' prices for generic drugs possible and should competition authorities do more about exploitative pricing? (Pharmafile)
  • Biosimilar Firms Say Irish Price Deal Hinders Uptake, As Govt Plans New Policy Measures (Pink Sheet-$)
  • Looking for life sciences opportunities in a post-Brexit world (EPR)
  • South Korea to import 4.8 million vaccines against foot-and-mouth disease  (Reuters)
  • Sales of pharmaceutical companies increase by EGP 10bn, growing by 31% (Daily News Egypt)

US: Pharmaceuticals & Biotechnology

  • Akari Hopes Tick-Based Drug Will Be Safer, Cheaper Than Alexion's Soliris (SCRIP-$)
  • From Poisons To Pills: Peptides (LifeSciVC)
  • Neurocrine gets rights to Bial-Portela's PD drug (BioCnetury)
  • Spinal muscular atrophy approval boosts antisense drugs  (Nature)
  • Intercept rises after adjusting Phase III NASH study (BioCentury)
  • Can We Engage Private Pharmacies To Help Control Drug-Resistant Tuberculosis? (Forbes)
  • Novartis expands Vivinda TV, offering docs digital access to medical conferences (Fierce)

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

  • Aeterna Zentaris Announces Plans to Pursue FDA Registration of Macrilen™ (Press)
  • XTL Biopharmaceuticals Expands Clinical Advisory Board to Support Phase II Study of HCDR1 in Sjogren's Syndrome (Press)
  • BRIEF-Delmar Pharmaceuticals announces dosing of first patient in Phase two clinical trial of VAL-083 (Reuters)

US: Medical Devices

  • Report: Med device recalls up 44% in 2nd half of 2016 (MassDevice)
  • Medical Wearables: Do's and Don'ts (MDDI)
  • 5 Ways to Jumpstart Your Career in Medtech (MDDI)
  • Corindus touts 1st commercial use of 2nd-gen CorPath robotic platform (MassDevice)
  • Medtronic Expands Coronary Portfolio to Include New DxTerity(TM) Diagnostic Catheters and Suite of Tools for the Transradial Approach (MassDevice)
  • Class 1 Device Recall Biomet Comprehensive Reverse Shoulder Humeral (FDA)
  • Class 1 Device Recall LIFEPAK 15 Monitor/Defibrillator (FDA)

US: Assorted & Government

  • DOD, HHS, and DHS Should Use Existing Coordination Mechanisms to Improve Their Pandemic Preparedness (GAO)
  • Rare Basis for False Claims Act Settlement (FDA Law Blog)
  • Retractable Technologies seeks Supreme Court review of BD decision (MassDevice)
  • Regeneron Subpoenaed Over Patient Assistance Nonprofits (Law360-$)
  • Fresenius Doctor Grilled Over Label On Dialysis Drug (Law360-$)
  • Sanofi Says Amphastar, Ex-K&L Atty Doctored Evidence (Law360-$)
  • Ethicon Asks 4th Circ. To Rethink $3M Pelvic Mesh Verdict (Law360-$)
  • BIO, PhRMA Back Call For Fed. Circ. To Broaden AIA Estoppel (Law360-$)
  • 10 Years Of MedImmune: The Fed. Circ. Decisions (Law360-$)

Upcoming Meetings & Events

Europe

  • How Italy and France take on rare sarcoma cancers (EurActiv)
  • Health matters should supersede European bureaucracy (EurActiv)
  • Cannabis for Medical Use - A Scientific Review (HPRA)
  • First-ever approved fertility app more effective than the pill, experts say (Pharmafile)
  • Biosimilar anticancers get support from British oncology pharmacists (Pharmaceutical Journal)
  • CR UK awards £71m to first Grand Challenge winners (PharmaTimes)
  • Reckitt Benckiser Is Building A 21st Century Procter & Gamble (Forbes) (WSJ)

India

  • Aurobindo building Indian manufacturing plant to support 12 biosimilar pipeline (BioPharmaReporter)
  • India asks drug firms to help discourage off-prescription antibiotic sales (InPharmaTechnologist)
  • Pharma and Med Tech Zone to be set up soon at Bengaluru: Ananth Kumar (Economic Times)
  • Government removes duty anomalies to boost medical devices mfg: Ananth Kumar (Economic Times)
  • Govt to amend norms to empower NPPA to fix prices of 350 drugs (Economic Times)
  • Life-saving Wilson's disease treatment available in India once again: Government (Economic Times)
  • How the biopharma twins ended up heading two biopharma companies in Mumbai (Economic Times)
  • Ahmedabad-based WHO-GMP firm under Gujarat FDCA scanner for supplying spurious drugs to govt hospitals (Pharmabiz)
  • Gujarat FDCA in collaboration with US-based UL rolls out 50 new courses on GMP to train another group of drug inspectors (Pharmabiz)
  • Health ministry notifies D&C Rules to specify norms for drug imports by charitable hospitals & fixes time frame for drug tests (Pharmabiz)

Australia

  • Submissions and TGA response: Non-steroidal anti-inflammatory drugs: proposed additional advisory statement (TGA)
  • Submissions and TGA response: paracetamol and ibuprofen: proposed additional advisory statement (TGA)

Canada

  • Notice: Submission Filing Requirements - Good Manufacturing Practices (GMP)/Drug Establishment Licences (DEL) (Health Canada)

Other International

  • Medtronic debuts outcomes training program for EMEA (MassDevice)

General Health & Other Interesting Articles

  • Artificial Intelligence and Medical Liability (Part II) (Harvard Bill of Health)
  • Molecule from malaria parasite attracts hungry mosquitoes (C&EN)

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 news@raps.org.

A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.

Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

In Focus: US

  • Sen. Grassley Opens Inquiry Into Orphan Drug Act (Focus) (KHN) (NPR) (Incidental Economist)
  • Games Drugmakers Play (Bloomberg)
  • Amgen's Parsabiv Approved With Unusual Postmarketing Requirements (Pink Sheet-$)
  • Sandoz Kicks Off Supreme Court Biosimilar Battle (Law360-$)
  • Questions Linger Over Scope, Utility of Drug, Device Company Payment Data (Bloomberg)
  • Where is the Future of Drug Discovery for Cancer? (Cell)
  • FluMist mystery on experts' agenda: Why was it so weak, and only in US studies? (STAT)
  • Democratic senators float bill to protect 'scientific integrity' (MassDevice) (Law360-$)
  • Allergan set to bolster 'medical aesthetics' unit with $2.5 billion Zeltiq deal (Pharmafile)
  • Intercept Pharma: We Can't Enroll Our NASH Study so We're Changing the Study. Trust Us, All Good (The Street)
  • FDA-Approved Labeling ≠ Medical Standard Of Care (Drug & Device Law)
  • PhRMA Urges USTR to Protect American Innovators Abroad (PhRMA) (Special 301 Submission)
  • PhRMA, BIO, MIWG File Petition To Block FDA's Intended Use Rule (IHP-$) Pink Sheet-$)
  • Marathon's R&D program for Duchenne MD drug likely came in at a bargain basement price (Endpoints)
  • PhRMA, Marathon Is Why You Can't Have Nice Things (Harvard Bill of Health)
  • Marathon Pharmaceuticals to Charge $89,000 for Muscular Dystrophy Drug After 70-Fold Increase (WSJ) (Forbes) (WSJ)
  • Republicans, Aiming to Kill Health Law, Also Work to Shore It Up (NYTimes)
  • With eye on Obamacare, Price takes helm as U.S. health secretary (Reuters) (WSJ)
  • How to Fix (or Wreck) Obamacare: Advice for Tom Price (NYTimes)
  • If Obamacare is Out, Where's Trumpcare? (NYTimes)
  • Human Genome Editing: Science, Ethics, and Governance (NAS)
  • PSCK9 Battle: Sanofi Not Negotiating Praluent Fate With Amgen; Ruling Possible By June (Pink Sheet-$)

In Focus: International

  • BMS Label Issue Adds To China Drug Shortage Woes (Pink Sheet-$)
  • Roche Fights Roche for $9 Billion Drug Business (Bloomberg)
  • Teva Pharmaceuticals beats on the top and bottom lines (Business Insider)
  • Revisions to Mexico's Medical Device Regulations under Consideration for 2018 (Emergo)
  • Yemen cancer patients struggle to survive war shortages (Reuters)
  • Pfizer to shut Australian Neulasta biosimilar plant and move production to Croatia (BioPharmaReporter)
  • Cinven in €3.5bn offer for German drugmaker Stada (Financial Times)
  • NICE turns down AZ's chronic obstructive pulmonary disease drug Daxas (Pharmafile) (PharmaTimes)
  • NICE backs routine use of Incyte's leukaemia drug  Iclusig (PharmaTimes)
  • PMDA Head Talks Priorities for 'Rational Medicine' (Focus)
  • Turkish Govt Using Purchasing To Foster Local Generic Production (SCRIP-$)
  • Lilly €200m expansion of Cork site under review (Pharmafile)
  • Drugmaker Ipsen to buy some products from Sanofi for 83 million euros (Reuters) (PharmaTimes) (Pharmafile)
  • Pfizer and Flynn: How are 'excessive' prices for generic drugs possible and should competition authorities do more about exploitative pricing? (Pharmafile)
  • Biosimilar Firms Say Irish Price Deal Hinders Uptake, As Govt Plans New Policy Measures (Pink Sheet-$)
  • Looking for life sciences opportunities in a post-Brexit world (EPR)
  • South Korea to import 4.8 million vaccines against foot-and-mouth disease  (Reuters)
  • Sales of pharmaceutical companies increase by EGP 10bn, growing by 31% (Daily News Egypt)

US: Pharmaceuticals & Biotechnology

  • Akari Hopes Tick-Based Drug Will Be Safer, Cheaper Than Alexion's Soliris (SCRIP-$)
  • From Poisons To Pills: Peptides (LifeSciVC)
  • Neurocrine gets rights to Bial-Portela's PD drug (BioCnetury)
  • Spinal muscular atrophy approval boosts antisense drugs  (Nature)
  • Intercept rises after adjusting Phase III NASH study (BioCentury)
  • Can We Engage Private Pharmacies To Help Control Drug-Resistant Tuberculosis? (Forbes)
  • Novartis expands Vivinda TV, offering docs digital access to medical conferences (Fierce)

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

  • Aeterna Zentaris Announces Plans to Pursue FDA Registration of Macrilen™ (Press)
  • XTL Biopharmaceuticals Expands Clinical Advisory Board to Support Phase II Study of HCDR1 in Sjogren's Syndrome (Press)
  • BRIEF-Delmar Pharmaceuticals announces dosing of first patient in Phase two clinical trial of VAL-083 (Reuters)

US: Medical Devices

  • Report: Med device recalls up 44% in 2nd half of 2016 (MassDevice)
  • Medical Wearables: Do's and Don'ts (MDDI)
  • 5 Ways to Jumpstart Your Career in Medtech (MDDI)
  • Corindus touts 1st commercial use of 2nd-gen CorPath robotic platform (MassDevice)
  • Medtronic Expands Coronary Portfolio to Include New DxTerity(TM) Diagnostic Catheters and Suite of Tools for the Transradial Approach (MassDevice)
  • Class 1 Device Recall Biomet Comprehensive Reverse Shoulder Humeral (FDA)
  • Class 1 Device Recall LIFEPAK 15 Monitor/Defibrillator (FDA)

US: Assorted & Government

  • DOD, HHS, and DHS Should Use Existing Coordination Mechanisms to Improve Their Pandemic Preparedness (GAO)
  • Rare Basis for False Claims Act Settlement (FDA Law Blog)
  • Retractable Technologies seeks Supreme Court review of BD decision (MassDevice)
  • Regeneron Subpoenaed Over Patient Assistance Nonprofits (Law360-$)
  • Fresenius Doctor Grilled Over Label On Dialysis Drug (Law360-$)
  • Sanofi Says Amphastar, Ex-K&L Atty Doctored Evidence (Law360-$)
  • Ethicon Asks 4th Circ. To Rethink $3M Pelvic Mesh Verdict (Law360-$)
  • BIO, PhRMA Back Call For Fed. Circ. To Broaden AIA Estoppel (Law360-$)
  • 10 Years Of MedImmune: The Fed. Circ. Decisions (Law360-$)

Upcoming Meetings & Events

Europe

  • How Italy and France take on rare sarcoma cancers (EurActiv)
  • Health matters should supersede European bureaucracy (EurActiv)
  • Cannabis for Medical Use - A Scientific Review (HPRA)
  • First-ever approved fertility app more effective than the pill, experts say (Pharmafile)
  • Biosimilar anticancers get support from British oncology pharmacists (Pharmaceutical Journal)
  • CR UK awards £71m to first Grand Challenge winners (PharmaTimes)
  • Reckitt Benckiser Is Building A 21st Century Procter & Gamble (Forbes) (WSJ)

India

  • Aurobindo building Indian manufacturing plant to support 12 biosimilar pipeline (BioPharmaReporter)
  • India asks drug firms to help discourage off-prescription antibiotic sales (InPharmaTechnologist)
  • Pharma and Med Tech Zone to be set up soon at Bengaluru: Ananth Kumar (Economic Times)
  • Government removes duty anomalies to boost medical devices mfg: Ananth Kumar (Economic Times)
  • Govt to amend norms to empower NPPA to fix prices of 350 drugs (Economic Times)
  • Life-saving Wilson's disease treatment available in India once again: Government (Economic Times)
  • How the biopharma twins ended up heading two biopharma companies in Mumbai (Economic Times)
  • Ahmedabad-based WHO-GMP firm under Gujarat FDCA scanner for supplying spurious drugs to govt hospitals (Pharmabiz)
  • Gujarat FDCA in collaboration with US-based UL rolls out 50 new courses on GMP to train another group of drug inspectors (Pharmabiz)
  • Health ministry notifies D&C Rules to specify norms for drug imports by charitable hospitals & fixes time frame for drug tests (Pharmabiz)

Australia

  • Submissions and TGA response: Non-steroidal anti-inflammatory drugs: proposed additional advisory statement (TGA)
  • Submissions and TGA response: paracetamol and ibuprofen: proposed additional advisory statement (TGA)

Canada

  • Notice: Submission Filing Requirements - Good Manufacturing Practices (GMP)/Drug Establishment Licences (DEL) (Health Canada)

Other International

  • Medtronic debuts outcomes training program for EMEA (MassDevice)

General Health & Other Interesting Articles

  • Artificial Intelligence and Medical Liability (Part II) (Harvard Bill of Health)
  • Molecule from malaria parasite attracts hungry mosquitoes (C&EN)

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 news@raps.org.

A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.


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