Contributor: 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.
Contributor: 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.
Wriiten by: Stefanie Hoffart and Graeme Green
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.
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.
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.
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.
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.
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.
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).
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.