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DRugwatch Blog

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


Gideon HeapContributor: Gideon Heap

Eisai has released results of a trial in which good old phentermine was added to the company’s obesity treatment, Belviq (lorcaserin). The primary endpoint for the trial was to discover if the combination increased the risk of patients having serotonergic adverse events (bad) after 12 weeks. It didn’t (good). However, twice as many patients (10.1%) on the combo dropped out due adverse events compared with Belviq alone.

Read more.
Posted on: 11/7/2014 10:07:43 AM | with 0 comments


  Contributor: Conor Walsh

 This year’s line-up of Late-Breaking Clinical Trial sessions looks very interesting; with many trials having the   potential to significantly impact clinical practice. The trial results will be presented over four days in separate sessions focusing on:

  • Risk and benefit of dual antiplatelet therapy (DAPT),
  • Anti-lipid therapy and prevention of coronary artery disease,
  • Treatment of structural heart disease
  • Drugs, devices and systems of care for ischemic heart disease.
Read more.
Posted on: 10/22/2014 5:22:24 PM | with 0 comments


Contributor: Orestis Mavroudis-Chocholis

NSCLC is considered by many to be the poster child for personalized medicine in oncology. The approval of TKIs for the treatment of EGFR-mutation-positive and ALK-translocation-positive NSCLC patients has redefined the NSCLC treatment algorithm and developers are now in fierce competition to be the first to market novel, more efficacious and better tolerated TKIs which can be used as follow-on treatment options or replacements for currently approved front-line TKIs. Read more.
Posted on: 10/9/2014 1:33:46 PM | with 0 comments


Contributors: Kirsha Naicker and Dan Roberts

HPV vaccinations were voted by ASCO this year to be one of the top five advances in modern oncology in the past 50 years. Read more.
Posted on: 10/8/2014 10:15:17 AM | with 0 comments


Contributor: Sehrish Rafique

Companies are now striving towards developing targeted therapies for advanced gastric cancer. Exploiting biomarkers is a dominant strategy and clinical data presented at the recent ESMO conference highlighted significant advances in the treatment of gastric cancer.
Read more.
Posted on: 10/7/2014 9:06:40 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:
Sandoz’s Biosimilar Filgrastim Scores Positive Recommendation from FDA Advisory Committee
Post date:
1/22/2015 3:44:26 PM
Post Summary:
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”

Post title:
AstraZeneca’s Brilinta Meets Primary End Point in PEGASUS-TIM 54 Study
Post date:
1/15/2015 4:53:03 PM
Post Summary:
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.

Post title:
Cancer Drugs Funding in England is Flawed and Needs Reform
Post date:
1/14/2015 4:47:28 PM
Post Summary:

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).

Post title:
New Year, new resolutions, new drugs
Post date:
12/17/2014 10:53:24 AM
Post Summary:
 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?!

Post title:
Pfizer Increases Enrollment by 40% in the SPIRE Cardiovascular Outcomes Trials for PCSK9 Inhibitor Bococizumab
Post date:
11/11/2014 9:36:25 AM
Post Summary:
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).

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