DRugwatch Blog

Contributor: Adelina Adjei

The three-arm clinical trial design aims to compare U.S.- and EU-sourced reference products to the biosimilar in one trial, while generating the requisite pharmacokinetic(PK)/pharmacodynamic (PD) data to support approval in the United States and Europe. Pfizer started its fifth three-arm Phase I trial for its biosimilar bevacizumab molecule (PF-06439535) in February 2014, firmly embedding this as a strategy for its biosimilar development program. Pfizer is not alone, however; between December 2011 and April 16th 2014, fourteen biosimilar molecules have entered three-arm Phase I trials.
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Posted on: 4/17/2014 3:05:38 PM | with 0 comments

Tim BlackstockContributor: Tim Blackstock

The 63rd Annual Scientific Sessions of the American College of Cardiology (ACC.14) was in Washington D.C. – the ‘heart of the nation’ as the ACC president described the U.S. capital. As I expressed in my previous blog, I was eagerly anticipating live debate amongst leading physicians and scientists on the recently released ACC/American Heart Association cholesterol guidelines, as well as presentation of Phase III data on Amgen’s PCSK9 inhibitor evolocumab (AMG 145). Cholesterol is close to my heart – although hopefully not too close…
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Posted on: 4/15/2014 1:54:46 PM | with 0 comments

Conor WalshContributor: Conor Walsh

On April 8th2014, Teva announced the approval of the generic equivalent to GlaxoSmithKline’s Lovaza in the United States. Teva believes it is first-to-file and thus far is the only company to receive an approval from the FDA and plans are in place to commence shipping immediately. In the United States, Lovaza is used to lower triglyceride levels in patients with very high triglycerides (> 500 mg/dL) and, according to IMS data, Lovaza’s annual sales totaled $1.1 billion in the United States in 2013.
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Posted on: 4/10/2014 1:19:12 PM | with 0 comments

Contributor:  Anees Malik

France’s recent legislation that allows for biosimilar substitution is one of the latest and strongest signals that healthcare payers worldwide are prepared to take substantial steps to ensure the uptake of the next wave of biosimilars. Driving this behavior is the alluring healthcare savings on offer, particularly from biosimilars of some of the most costly therapies in the next one to three years, at a time when nations around the world need to reduce drug budgets due to economic austerity. Read more.
Posted on: 4/8/2014 9:01:35 AM | with 0 comments

Joseph DwyerGraeme GreenContributors: Joseph Dwyer and Graeme Green

In the realm of cardiovascular agents, the heart failure segment currently represents a hotspot for product development. Ivabradine (Servier’s Procoralan) represents one of the most recent entries into the heart failure market, having found use in both the treatment of chronic heart failure (CHF) and stable angina in Europe.
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Posted on: 3/27/2014 11:24:21 AM | with 0 comments

Graeme GreenConor WalshContributors: Graeme Green and Conor Walsh

On March 24, Daiichi Sankyo announced that it received approval from the Ministry of Health, Labour and Welfare (MHLW) in Japan for the oral antiplatelet agent prasugrel for the treatment of patients with ischemic heart disease undergoing percutaneous coronary intervention.
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Posted on: 3/26/2014 1:07:41 PM | with 0 comments

Tim BlackstockContributor: Tim Blackstock

Sorry about the title ― couldn’t resist. I have also been unable to resist the 63rd Annual Scientific Sessions of the American College of Cardiology, to which I am winging my way shortly. Two of the things I am looking forward to most are assessing the impact of the most recently released U.S. cholesterol guidelines, and the seeing the latest data on the PCSK9 inhibitors.
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Posted on: 3/25/2014 12:50:20 PM | with 0 comments

Contributor: Adi Reske

On March 20, 2014, the EMA CHMP has recommended granting a marketing authorization for the cell adhesion molecule  inhibitor vedolizumab (Takeda’s Entyvio) for the treatment of adult patients with moderate to severe active UC and CD. In March 2013, Takeda filed an MAA with EMA based on the GEMINI Phase III pivotal trials. We expect the European Commission to adopt the CHMP recommendation and grant vedolizumab full approval.
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Posted on: 3/24/2014 1:43:10 PM | with 0 comments

Contributor: Dan Roberts

Colorectal Cancer (CRC) is the third most common cancer in the United States. The majority of CRCs arise from adenomatous polyps, and therefore the removal of these polyps before they become cancerous can prevent the manifestation of CRC. The goal of CRC screening is to detect these precancerous and cancerous lesions at an early stage because early diagnosis results in improved overall prognosis. 
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Posted on: 3/13/2014 3:16:24 PM | with 0 comments

Contributor: Eamonn O'Connor

Lysosomal Storage Disorders (LSDs) are rare metabolic diseases caused by the malfunction, or deficiency, of specific enzymes that cause disruption in the function of the lysosome, the intracellular organelle with a role in the metabolism of lipids and glycoproteins. Since the identification of the first LSD, Tay-Sachs disease, in 1881 approximately 60 LSDs have subsequently been identified.
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Posted on: 2/19/2014 2:44:58 PM | with 0 comments

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