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Conor WalshContributors: Conor Walsh, M.Sc., Ph.D.
Topics: Cardiovascular

On June 22nd, 2015 the U.S. FDA approved Kengreal (cangrelor), the Medicines Company’s intravenous antiplatelet drug for use “as an adjunct to percutaneous coronary intervention (PCI) for reducing the risk of periprocedural myocardial infarction, repeat coronary revascularization, and stent thrombosis in patients in who have not been treated with a P2Y12 platelet inhibitor and are not being given a glycoprotein IIb/IIIa inhibitor.” Read more.
Posted on: 6/23/2015 1:22:54 PM | with 0 comments


Contributor: Dana Gheorghe, Ph.D
Topics
: Conference Commentary, Oncology


Recent years have seen an added emphasis on the relationship between cancer and the activity of the immune system. Novel agents that aim to harness the immune system have already been approved in the U.S. for solid tumors (Bristol-Myers Squibb/Ono Pharmaceutical’s Opdivo [nivolumab] for NSCLC and malignant melanoma, and Merck & Co.’s Keytruda [pembrolizumab] for malignant melanoma), and are in development for a plethora of other oncology indications. Most of the development has been targeted towards solid tumors, but the potential of immune checkpoint inhibitors in hematological malignancies is becoming increasingly evident. Read more.
Posted on: 6/17/2015 9:32:42 AM | with 0 comments


Contributor: Eamonn O'Connor, Ph.D.

The recent American Diabetes Association’s 75th Scientific Sessions in Boston saw the release of data from the ELIXA cardiovascular outcomes trial (CVOT) for lixisenatide (Sanofi/Zealand Pharma’s Lyxumia), the first such trial completed for the GLP-1 receptor agonist drug class. However, it was the publication of the data from the CVOT for sitagliptin (Merck’s Januvia/Ono’s Glactiv), known as TECOS1, that was most eagerly anticipated; this is because the previous CVOTs for saxagliptin (AstraZeneca’s Onglyza) and alogliptin (Takeda/Furiex’s Nesina/Vipidia) had raised significant concerns about a potential risk for increased rates of hospitalization due to heart failure. The results from TECOS therefore, were viewed as pivotal as to whether this risk was a feature specific to the DPP-IV inhibitor drug class. Read more.
Posted on: 6/12/2015 10:26:05 AM | with 0 comments


Contributor: Natalia Reoutova, M.Sc.
Topics: Conference Commentary, Oncology

The past five years have seen unprecedented progress in the treatment of malignant melanoma, which translated into approval of highly efficacious immunotherapies, targeted small-molecule therapies, and several combination regimens. Read more.
Posted on: 6/5/2015 2:52:20 PM | with 0 comments


Contributor: Khurram Nawaz, M.Sc.
Topics: Conference Commentary, Oncology

The 2015 ASCO annual meeting promised to be packed with new and exciting data on cancer immunotherapies, including immune checkpoint inhibitors, therapeutic vaccines, and T-cell therapies (to name a few examples). The meeting has certainly lived up to our expectations—with a few surprises along the way. Read more.
Posted on: 6/3/2015 4:22:51 PM | with 0 comments


Contributors: Orestis Mavroudis-Chocholis, Ph.D.
Topics: Conference Commentary, Oncology

The immune checkpoint inhibitor buzz began almost 3 years ago to the day, with the first presentation of Opdivo data from a Phase I trial, at the annual ASCO meeting in 2012. Since then, two PD-1 inhibitors have been approved for the treatment of melanoma (Keytruda and Opdivo in the second half of 2014) and NSCLC (Opdivo in early 2015). Read more.
Posted on: 6/3/2015 9:49:13 AM | with 0 comments


Contributor: Tim Blackstock
Topics: "PCSK9 inhibitors", evolocumab, alirocumab, bococizumab, Amgen, Sanofi, Regeneron, Pfizer, EMA, FDA, "drug approvals", lipids, dyslipidemia, "cardiovascular disease"

Everyone who knows anything about lipids and cardiovascular (CV) disease loves the proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors: dyslipidemia experts, giant pharma companies, and even humble analysts all recognize the excellent low-density lipoprotein cholesterol (LDL-C)-lowering efficacy, the high likelihood of real CV benefits, and the clean safety profile of the PCSK9 inhibitors – they are one of the “it” drug classes for 2015. Read more.
Posted on: 5/28/2015 4:02:39 PM | with 0 comments


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.
 

Read more.
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


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DRugwatch Blog

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

Recent posts

Post title:
FDA Approval for The Medicines Company’s Intravenous Antiplatelet Kengreal
Post date:
6/23/2015 1:22:54 PM
Post Summary:
Conor WalshContributors: Conor Walsh, M.Sc., Ph.D.
Topics: Cardiovascular

On June 22nd, 2015 the U.S. FDA approved Kengreal (cangrelor), the Medicines Company’s intravenous antiplatelet drug for use “as an adjunct to percutaneous coronary intervention (PCI) for reducing the risk of periprocedural myocardial infarction, repeat coronary revascularization, and stent thrombosis in patients in who have not been treated with a P2Y12 platelet inhibitor and are not being given a glycoprotein IIb/IIIa inhibitor.”

Post title:
Hematological Malignancies: Are Immune Checkpoint Inhibitors Checking-in?
Post date:
6/17/2015 9:32:42 AM
Post Summary:
Contributor: Dana Gheorghe, Ph.D
Topics
: Conference Commentary, Oncology


Recent years have seen an added emphasis on the relationship between cancer and the activity of the immune system. Novel agents that aim to harness the immune system have already been approved in the U.S. for solid tumors (Bristol-Myers Squibb/Ono Pharmaceutical’s Opdivo [nivolumab] for NSCLC and malignant melanoma, and Merck & Co.’s Keytruda [pembrolizumab] for malignant melanoma), and are in development for a plethora of other oncology indications. Most of the development has been targeted towards solid tumors, but the potential of immune checkpoint inhibitors in hematological malignancies is becoming increasingly evident.

Post title:
Cardiovascular Outcomes Trials Answer Long-Asked Questions – But New Questions Arise
Post date:
6/12/2015 10:26:05 AM
Post Summary:
Contributor: Eamonn O'Connor, Ph.D.

The recent American Diabetes Association’s 75th Scientific Sessions in Boston saw the release of data from the ELIXA cardiovascular outcomes trial (CVOT) for lixisenatide (Sanofi/Zealand Pharma’s Lyxumia), the first such trial completed for the GLP-1 receptor agonist drug class. However, it was the publication of the data from the CVOT for sitagliptin (Merck’s Januvia/Ono’s Glactiv), known as TECOS1, that was most eagerly anticipated; this is because the previous CVOTs for saxagliptin (AstraZeneca’s Onglyza) and alogliptin (Takeda/Furiex’s Nesina/Vipidia) had raised significant concerns about a potential risk for increased rates of hospitalization due to heart failure. The results from TECOS therefore, were viewed as pivotal as to whether this risk was a feature specific to the DPP-IV inhibitor drug class.

Post title:
Malignant Melanoma: Evolving Standards of Care
Post date:
6/5/2015 2:52:20 PM
Post Summary:
Contributor: Natalia Reoutova, M.Sc.
Topics: Conference Commentary, Oncology

The past five years have seen unprecedented progress in the treatment of malignant melanoma, which translated into approval of highly efficacious immunotherapies, targeted small-molecule therapies, and several combination regimens.

Post title:
Dual Immune Checkpoint Blockade in Oncology: Ready for Prime Time?
Post date:
6/3/2015 4:22:51 PM
Post Summary:
Contributor: Khurram Nawaz, M.Sc.
Topics: Conference Commentary, Oncology

The 2015 ASCO annual meeting promised to be packed with new and exciting data on cancer immunotherapies, including immune checkpoint inhibitors, therapeutic vaccines, and T-cell therapies (to name a few examples). The meeting has certainly lived up to our expectations—with a few surprises along the way.

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