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Contributors: Tim Blackstock
Topics: Obesity, Orexigen, Mysimba, Contrave, Saxenda, "Novo Nordisk", "Takeda Pharmaceutical", approvals

…there are none for ages and then several come along at once. In the United States, physicians managing obese patients were essentially only able to prescribe Roche’s Xenical (orlistat) and phentermine (and other noradrenergic anorectic agents) for years, and then Arena Pharmaceutical/Eisai’s Belviq (lorcaserin) and Vivus’s Qsymia (phentermine/topiramate fixed-dose combination [FDC]) were approved in June and July, respectively, during 2012.

Read more.
Posted on: 3/27/2015 2:53:49 PM | with 0 comments


Tim BlackstockContributor: Tim Blackstock
Topics: Obesity, Contrave, Mysimba, Orexigen, FDA, Regulatory Approval, Cardiovascular Outcomes

Orexigen has made interim data from the LIGHT study publically available in a financial report; details can be viewed here.
 

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Posted on: 3/11/2015 11:26:21 AM | with 0 comments


Stefanie MatlokContributor: Stefanie Hoffart
Therapeutic area: Cardiovascular and Metabolic Disorders

Novo Nordisk recently announced the first positive Phase 2 results for an oral GLP-1 analogue. Oral therapies are typically utilized in the early lines of therapy for type 2 diabetes, but as the disease progresses more aggressive treatment is required so patients can end up on multiple oral medications.

Read more.
Posted on: 3/6/2015 11:13:08 AM | with 0 comments


Stefanie Matlok Graeme GreeneWriiten by: Stefanie Hoffart and Graeme Green

Topic: Cardiovascular

On January 19, 2015, the European Medicines Agency (EMA) approved the thrombin receptor antagonist vorapaxar (Merck’s Zontivity) for secondary prevention of atherothrombotic events in adult patients with a history of myocardial infarction (MI), co-administered with acetylsalicylic acid (ASA) and, if necessary, clopidogrel.

Read more.
Posted on: 2/17/2015 10:49:37 AM | with 0 comments


Tim BlackstockContributor: Tim Blackstock
Topics: Cardiovascular

The link between high low-density lipoprotein cholesterol (LDL-C) and cardiovascular (CV) risk is well established, as is, the evidence showing that agents that reduce LDL-C can prevent CV events. Read more.
Posted on: 2/12/2015 3:58:28 PM | with 0 comments


Contributors: Anees Malik and Hristina Ivanova

The unanimous recommendation by the Oncologic Drugs Advisory Committee (ODAC) for FDA approval of Sandoz’s biosimilar filgrastim (EP2006; Zarxio)–the first biosimilar filing to be accepted in the United States– moves the biosimilar product tantalizingly close to FDA approval. Oncology, Biosimilars, “Anees Malik”, “Hristina Ivanova” Read more.
Posted on: 1/22/2015 3:44:26 PM | with 0 comments


Conor WalshContributor: Conor Walsh

AstraZeneca yesterday (January 14, 2015) announced that the Phase III PEGASUS-TIMI 54 study—a large-scale outcomes trial involving over 21,000 post-myocardial infarction (MI) patients—successfully met its primary efficacy end point. The company also reported that preliminary analysis did not reveal any unexpected safety issues. This study represents the first of several large studies that are set to complete over the next two years seeking to expand Brilinta’s (ticagrelor) label and drive sales growth.
Read more.
Posted on: 1/15/2015 4:53:03 PM | with 0 comments


Contributor: Dan Roberts PhD

In 2011, the UK government introduced the Cancer Drugs Fund (CDF) in England, which funds cancer drugs which have not been deemed cost-effective or have not yet been assessed by the National Institute of Health and Care Excellence (NICE). Read more.
Posted on: 1/14/2015 4:47:28 PM | with 0 comments


 Contributors: Tim Blackstock

It’s a wonderful time of the year: spending quality time with friends and family, and eating good food. And then it’s January, and you hop on the scales – and then you hop off quickly in disbelief – how can it take such a short time to add so many pounds when it takes so long to lose just a few?! Read more.
Posted on: 12/17/2014 10:53:24 AM | with 0 comments


Gideon HeapGideon HeapContributors: Tim Blackstock and Conor Walsh

The latest news from the battle of the PCSK9 inhibitors is that Pfizer has increased enrollment by approximately 40% in its SPIRE-1 and SPIRE-2 cardiovascular outcomes trials (CVOTs).
Read more.
Posted on: 11/11/2014 9:36:25 AM | with 0 comments


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DRugwatch Blog

Quick insight on intriguing drug market developments from Decision Resources’ analysts.

Recent posts

Post title:
Obesity drug approvals are like buses…
Post date:
3/27/2015 2:53:49 PM
Post Summary:

Contributors: Tim Blackstock
Topics: Obesity, Orexigen, Mysimba, Contrave, Saxenda, "Novo Nordisk", "Takeda Pharmaceutical", approvals

…there are none for ages and then several come along at once. In the United States, physicians managing obese patients were essentially only able to prescribe Roche’s Xenical (orlistat) and phentermine (and other noradrenergic anorectic agents) for years, and then Arena Pharmaceutical/Eisai’s Belviq (lorcaserin) and Vivus’s Qsymia (phentermine/topiramate fixed-dose combination [FDC]) were approved in June and July, respectively, during 2012.


Post title:
Sweet results for Contrave leave a bad taste in the mouth
Post date:
3/11/2015 11:26:21 AM
Post Summary:

Tim BlackstockContributor: Tim Blackstock
Topics: Obesity, Contrave, Mysimba, Orexigen, FDA, Regulatory Approval, Cardiovascular Outcomes

Orexigen has made interim data from the LIGHT study publically available in a financial report; details can be viewed here.
 


Post title:
Creating oral versions of injectable therapies for chronic diseases – a “win-win-win” concept
Post date:
3/6/2015 11:13:08 AM
Post Summary:

Stefanie MatlokContributor: Stefanie Hoffart
Therapeutic area: Cardiovascular and Metabolic Disorders

Novo Nordisk recently announced the first positive Phase 2 results for an oral GLP-1 analogue. Oral therapies are typically utilized in the early lines of therapy for type 2 diabetes, but as the disease progresses more aggressive treatment is required so patients can end up on multiple oral medications.


Post title:
Next Steps for Vorapaxar: EU PAD Label and Antidote Development?
Post date:
2/17/2015 10:49:37 AM
Post Summary:

Stefanie Matlok Graeme GreeneWriiten by: Stefanie Hoffart and Graeme Green

Topic: Cardiovascular

On January 19, 2015, the European Medicines Agency (EMA) approved the thrombin receptor antagonist vorapaxar (Merck’s Zontivity) for secondary prevention of atherothrombotic events in adult patients with a history of myocardial infarction (MI), co-administered with acetylsalicylic acid (ASA) and, if necessary, clopidogrel.


Post title:
Bococizumab: Late to Great? Dyslipidemia Déjà vu?
Post date:
2/12/2015 3:58:28 PM
Post Summary:
Tim BlackstockContributor: Tim Blackstock
Topics: Cardiovascular

The link between high low-density lipoprotein cholesterol (LDL-C) and cardiovascular (CV) risk is well established, as is, the evidence showing that agents that reduce LDL-C can prevent CV events.

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