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FDA discusses revised draft guidance for drug development for RA

This morning, the FDA held a webinar to discuss and summarize the revised draft guidance for industry for development of drugs for rheumatoid arthritis. Since the last guidance document published back in 1999, a lot has happened in the way of medical advancements, the agency felt the time was right to update their recommendations for industry to ac...

Another runner drops out of the biosimilars race

Teva and Lonza have just announced the termination of their joint venture to co-develop biosimilars, upon the realization that the development costs and time to market were beyond initial estimations. The agreement was formed in 2009. When biosimilars were first a hot topic, it was a common perception that the scenario would be similar to producing...

Health Insurance Exchange (HIX) Funding Finding Few Friends in Congress

Last year's Congress did not pass any legislation with funding for implementation of HIXs. This year, The White House has been very aggressive in cobbling together funding from other sources to attempt to get the job done. Even with this last ditch effort, funding will not be available until October 1, 2014, one year after the ACA mandate to implem...

Capturing The Smartphone Opportunity For Consumer M2M Applications

Blackberry and Google recently announced that the wireless communication protocol, Bluetooth low energy (BLE), will be included in their latest releases in Blackberry 10 and Android platforms respectively. The idea that BLE could become the dominant protocol for wireless communication particularly for establishing machine-to-machine applications w...

Healthcare.gov - Promoting Health Insurance Exchange Enrollment

The Website created by CMS dedicated solely to educating and and encouraging Americans to use health insurance exchanges (HIXs) beginning in October to shop for health insurance is suggesting there are 3 things you need to know: The Marketplace is an easier way to shop for health insurance. By marketplace, they are of course referring to HIXs. C...

Leica Biosystems Acquires Kreatech Diagnostics and a Brazilian Distributor Aotec Within a 3-month Period

Source: Leica Biosystems News Release; July 9, 2013 and News Release; April 24, 2013 Anatomic pathology player, Leica Biosystems, a division of Leica Microsystems, makes 2 strategic acquisitions within 3 months: fluorescent in situ hybridization (FISH) probe supplier Kreatech Diagnostics based in the UK and Aotec, Leica’s histopathology and micros...

Roche Terminates Diabetes Drug Aleglitazar in Phase 3

Roche announced yesterday that they have terminated all trials of aleglitazar, a dual PPAR alpha/gamma agonist in Phase 3 for diabetes management as well as cardiovascular risk reduction in diabetes patients.  All ongoing trials were discontinued due to safety concerns that arose in AleCardio, the trial assessing the potential benefit of the drug i...

Roche and AstraZeneca to Share Drug Data

MedChemica, a UK consulting company specializing in medicinal chemistry, recently announced an agreement between Roche/Genentech and AstraZeneca to share details of their respective drug molecular designs and some relevant experimental results, with MedChemica acting as the third party to analyze the data using Matched Molecular Pair analysis.   Th...

FDA advisory panel re-reviews Avandia's cardiovascular safety

Earlier this month, a joint meeting of the FDA Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) and Drug Safety and Risk Management Advisory Committee (DSaRM) was held to re-visit the cardiovascular risk profile of Avandia (rosiglitazone). This high profile meeting was held to discuss the readjudication of the Rosiglitazone Evaluated f...

FDA Promotes Transparency and Patient Engagement with New Website

The FDA Patient Network On April 23, FDA Commissioner Margaret Hamburg, M.D. announced the launch of The FDA Patient Network website in a blog post on the FDA site. Hamburg states that the “FDA Patient Network website is an interactive tool for educating patients, patient advocates, and consumers on how their medications—both prescription and over...

Merck and Pfizer - Strange bedfellows?

In a surprising announcement made yesterday, Merck and Pfizer are teaming up to commercialize Pfizer’s SGLT2 inhibitor ertugliflozin for diabetes.  This announcement took the pharma world by surprise, especially since Merck in particular is not known for forming partnerships with other big pharmas.  Typically these partnerships leverage the individ...

Umbilical Cord blood - A savior !

http://www1.umn.edu/news/features/2013/UR_CONTENT_440332.html ...

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