Drug makers accuse V Mohan of possible conflict of interest in getting diabetes drug Pioglitazone banned

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Bhushan Pundlik Shirude

In January this year, Mohan had written a letter to the Prime Minister’s Office, detailing the risks of bladder cancer caused by the prolonged use of
In January this year, Mohan had written a letter to the Prime Minister’s Office, detailing the risks of bladder cancer caused by the prolonged use of

MSD Pharma, on its defence, has said that the company follows the highest standards of ethics, compliance and regulations, which take precedence over business without any compromise. “Our support to CCEBDM(Certificate Course in Evidence BasedDiabetes Management) is in line with our philosophy of putting patients above all else. This multi-stakeholder programme is being managed by Public Health Foundation of India (PHFI) in association with Mohan’sDiabetes Education Academy, and is successfully addressing the much required capacity development needs among general physicians in the country for a rapidly growing disease like type 2 diabetes.

MSD strongly denies any allegations regarding this programme which have recently appeared in some sections of the media,” said an MSD…

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Silos in Drug Development

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The Next Element

I was in Chicago last month for the American Society of Clinical Oncology (ASCO) annual meeting where as you would expect the topic of conversation was cancer at every turn. While it is generally easy to get wrapped up in these conversations, this year was different. Just a couple of weeks before the meeting, I lost someone very special to me who had been undergoing treatment for cancer. 

While some people come to drug development searching for a solution for someone they care about, my journey had been more about intellectual curiosity than passion. In my training as a chemist, my emotions generally involved frustration with reactions that wouldn’t work or elation when a multi-step synthesis resulted in the molecule I was trying to make. When I moved away from the bench, I took on the alternate responsibilities and tasks associated with clinical development, which eventually included reviewing case report…

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Pfizer’s Xeljanz approved in Switzerland, first European country to approve the drug

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July 15 2013 | By Márcio Barra

Pfizer just issued a press release where it reports that Switzerland’s SwissMedic has approved its rheumatoid arthritis treatment Xeljanz (tofacitinib citrate) for sale. This makes Switzerland the first European country to approve Xeljanz for adult patients with moderate-to-severe active RA who had an inadequate response or intolerance to the antirheumatic agent methotrexate.

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Hypertension- Maybe Your Blood’s too Thick

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Medical Revolt

BLOOD PRESSURE CHECK

While watching the documentary Forks Over Knives I heard a physician explain that it was possible that a vegan diet may lower blood pressure by lowering the blood viscosity (thickness). He stated this in passing but to me it was earth-shaking. I have had thousands of patients with high blood pressure and am treating it on a daily basis. I have sat through countless lectures on hypertension and still to this day we do not really know what causes it. The leading explanations include increased sympathetic activity (think high adrenaline, anxiety), decrease kidney function with age, increased hormone called angiotensin II, or complex interaction of genetic factors. However all of these fail to really explain why obesity, inactivity and diet raise blood pressure.

When I heard that it could be the viscosity (thickness) of the blood I was overwhelmed by the simplicity of it. If the blood is thicker it…

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Alkermes unveils three new drug candidates

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New Drug Approvals

Alkermes has unveiled three new drug candidates, including: a monomethyl fumarate (MMF) prodrug programme for the treatment of multiple sclerosis; ALKS 7106 for the treatment of pain; and RDB 1419, a cancer immunotherapy candidate based on interleukin-2 (IL-2) and its receptors, Alkermes’ first proprietary biologic.

According to Alkermes, these drug candidates demonstrate the company’s focus on unmet medical needs in specific patient populations and show the productivity of its expanded R&D capabilities.

read all at

http://www.manufacturingchemist.com/news/article_

page/Alkermes_unveils_three_new_drug_candidates/90167

 

 

 

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Antibody Effective Against Norovirus

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New Drug Approvals

 

Antibody Effective Against Norovirus
Researchers have released data showing that a monoclonal antibody can neutralize human norovirus. Norovirus causes roughly 20 million cases of acute diarrhea and vomiting annually in the United States, alone. It is also responsible for roughly 800 deaths annually.

FULL STORY

http://www.dddmag.com/news/2013/07/antibody-effective-against-norovirus?et_cid=3387991&et_rid=523035093&type=headline

 

What is Norovirus?

Norovirus is a stomach bug that sets in within 10 hours of transmission and usually lasts up to three days. It is completely different from the flu in that only your stomach is affected. While most people recover completely after three days, norovirus is more serious for young children, the elderly and people with other serious health conditions. Every year 70,000 people are hospitalized and 800 deaths are caused by the virus.

What are the symptoms?

The most common symptoms of norovirus include stomach pain, vomiting, diarrhea and nausea. Some people also experience a low-grade fever, headache and body…

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Cabergoline therapy for cushing disease throughout pregnancy

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Great!

New Drug Approvals

CABERGOLINE

Obstet Gynecol. 2013 Aug;122(2 Pt 2):485-7. doi: 10.1097/AOG.0b013e31829e398a.

http://www.ncbi.nlm.nih.gov/pubmed/23884269
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Woo I, Ehsanipoor RM.
Source
Department of Gynecology and Obstetrics and Division of Maternal-Fetal Medicine, Department of Gynecology and Obstetrics, Johns Hopkins University School of Medicine, Baltimore, Maryland.
Abstract
BACKGROUND:
Cushing disease during pregnancy is rare and is associated with significant maternal and fetal morbidity and mortality. Transsphenoidal pituitary surgery is the first-line therapy; however, in cases of failed surgery or in patients who are not surgical candidates, medical therapy has been used to control symptoms.
CASE:
A 29-year-old woman with Cushing disease and a noncurative transsphenoidal pituitary surgery was successfully treated with cabergoline, a dopamine agonist. After approximately 1 year of therapy, she became pregnant. She was maintained on high-dose cabergoline throughout her pregnancy and had an uncomplicated antenatal course. She went into spontaneous labor at 38 weeks of gestation and delivered a healthy female neonate.
CONCLUSION:
Cabergoline…

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Breast Cancer Drugs in Late-Stage Development/Recently Approved

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New Drug Approvals

The article is 2012-2013 based and reader discretion is sought to ascertian the stage of approval

Afinitor® (everolimus)

http://newdrugapprovals.wordpress.com/2013/04/27/drug-spotlight-afinitor-everolimus-novartis/

Sponsor: Novartis

Method of Action: Mammalian target of rapamycin (mTOR) inhibitor

Indications/Phase of Trial: Hepatocellular carcinoma; human epidermal growth factor receptor 2-positive (HER2+) breast cancer first-line and second-line; lymphoma; nonfunctional carcinoid tumor (Phase III; all new indications)

Approved in July in U.S., EU for advanced hormone-receptor-positive (HR+) and human epidermal growth factor Receptor 2-negative (HER2-) metastatic breast cancer with exemestane in postmenopausal women who have already received certain other medicines for their cancer

Approved earlier for adults with pancreatic neuroendocrine tumors (PNET) that cannot be treated with surgery; adults with advanced renal cell carcinoma (RCC) when certain other medicines have not worked; adults with angiomyolipoma, seen with tuberous sclerosis complex (TSC), when surgery is not required immediately; and adults and children with TSC who have a brain tumor called subependymal giant…

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