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Who is the customer?

July 19, 2009

Mass. Panel Backs Radical Shift in Health Payment | www.nytimes.com

 In any business, it is paramount to keep your customers content.If we change our system, who will the customer be?  

Difficult, but not imposible, trial to complete

May 1, 2008

NeuroSearch initiates pivotal Phase III programme with ACR16 for the treatment of Huntington’s disease | www.pipelinereview.com

ACR16 is part of a class of drugs called dopaminergic stabilizers. These drugs modulate the effect of dopamine (a neurotransmitter secreted naturally by the brain). While more effects and interactions related to dopamine are constantly being discovered, it is known that dopamine plays a role in movement disorders such as Huntington’s disease and Parkinson’s disease, amongst others. Huntington’s disease is a universally fatal, relatively rarer hereditary disorder that results in dementia, involuntary movement and psychiatric symptoms. It affects younger and middle age patients.

Mipomersen will make it to market but with limited market share

May 1, 2008

FDA Provides Clarity to Isis Regarding the Development Path for Mipomersen | www.pipelinereview.com

Mipomersen (formerly known as ISIS 301012) is a in class of novel therapeutic agents that reduce the production of a protein in the liver that is responsible for cholesterol production. It is though that inhibiting that production on a molecular level would decrease the levels of cholesterol. Mipomersen distribute preferentially to the liver and therefore mya have liver related side effects (though so far those have been mild in current studies). In current studies, the focus is as an adjunct therapy for a patient group that has a particular hereditary mutation resulting in high cholesterol.

BiTE shows more promise than most but no fianlity yet

April 28, 2008

Micromet Enrolls First Patient in Phase 1 Clinical Trial with MT110, the First BiTE Antibody for Treatment of Solid Tumors | www.pipelinereview.com

Antibodies are formed by the bodies own immune system to any foreign substances it encounters. Tumors are considered by the body to be foreign at it often requires a genetic mutation for cells to become cancerous. Cancers are able to circumvent these natural antibodies by various means but there is interest in ‘helping’ the bodies own immune system fight cancers by manufactured antibodies. BiTE is one of many such antibody variants that is in a relatively more advanced stage than some of its competition.

Hefty price but promising potential

April 28, 2008

GlaxoSmithKline to acquire Sirtris Pharmaceuticals, a world leader in 'Sirtuin' research and development | www.pipelinereview.com

Situins are enzymes that regulate predetermined cell death, activity in muscle and fat cells as well as energy expenditure. There are several classes of these enzymes (SIRT 1 through 7). The technology is promising in that it promises to regulate some of the causes of diabetes and obesity rather than treat its effects.

GSK joining the RNA wave

April 28, 2008

GlaxoSmithKline and Regulus Therapeutics form strategic alliance to develop microRNA targeted therapeutics to treat inflammatory diseases | www.pipelinereview.com

MicroRNA and their related cousins small interfering RNA, are small molecules that operate in cell regulation. As such they have function in cancer, inflammatory disease, heart and kidney disease.

Paying to play catch-up

April 22, 2008

Roche fully acquires privately-owned biotech company Piramed | www.pipelinereview.com

PI 3-kinases are enzymes that play a role in the functioning of cells and their response to stimuli. In essence, these enzymes form portions of the ‘production line’ in cells. Turning up the tempo in this 'production line' is though to play a role in cancer growth and uncontrolled inflammation (as in rheumatoid arthritis). Patients in whom these enzymes become permanently ‘switched on’ show greater resistance to the usual anti cancer-therapies. Piramed has staked their entire development process on developing drugs to modulate these Kinases, particularly the Alpha and Delta variety.

Many Interleukins in the pipeline, when will they all come together?

April 21, 2008

MedImmune Advances Asthma Program with Start of a Phase 2 Trial in Europe and Australia and First U.S.-Based Clinical Trial for Antibody Targeting IL-13 | www.pipelinereview.com

Interleukins (IL's) are a family of mediators that play a part in the inflammatory response. As such they play a role in asthma and other allergic disorders. There are at least 29 interleukins known of which three types are currently being targeted by Medimmune (a division of Astra).

License Agreement is a feather in the cap for Airmid but is a long shot to deliver an approvable drug

April 21, 2008

Debiopharm and Airmid Sign Option and License Agreement | www.pipelinereview.com

Potassium channels are ‘pores’ in the membrane surrounding cells that modulate the flow of potassium (also called ‘K+’). This modulation is one of the basic interactions of life in all living cells. The scientific community is still learning the ramification of the modulation of these channels.

Broader implications to Novartises Announcement

April 21, 2008

ASA404 begins pivotal trial to explore new approach in treating lung cancer, the leading cause of cancer death | www.pipelinereview.com

Novartis has a leading pipeline in cancer drugs and has staked their profits on the cancer market more than any of the major drug makers. The drug in question (ASA404) is a Non-small cell lung cancer treatment candidate, This cancer accounts for up to 90% of all lung cancers. Worldwide, lung cancer is the leading cancer cause of death.

Results are good for a press release - the real implication are questionable

April 21, 2008

Pluristem's PLX Cells Show a Statistically Significant Advantage in a Pre-Clinical Study in the Multiple Sclerosis Model | www.pipelinereview.com

Multiple sclerosis is a disease of ultimately as yet undefined etiology. There are several postulated mechanisms as to why the brains fibers loose there covering (the equivalent of electric wiring loosing its insulation). Autoimmune mechanisms are thought to be involved but that does not explain the geographic preponderance of this disease in colder climate and some genetic issues. Therefore, the genesis is likely multifactorial including toxins, genetics and autoimmune.

Aclasta has implications for a large cohort of healthcare patients

April 21, 2008

Study Shows Once-yearly Aclasta Better Than Risedronate at Increasing Bone Mass in Patients with Osteoporosis Caused by Glucocorticoids | pharmalive.com

Osteoporosis is a major issue in the aging population. Fractures of the hip and spine can be catastrophic occurrences for the elderly as even with surgical and image guided treatment, the ensuing morbidity can alter a patients life style. Reducing osteoporosis can reduce medical costs but preventing fractures.

Phase III data for Advexin - the devil is in the details

April 21, 2008

New Phase III Data Confirm Phase II Findings of Advexin Efficacy | pharmalive.com

The p53 tumor suppressor gene is though to be a in-built protective agent for cells against their transforming into cancer cells. Loss of this gene during the cell’s life predisposes it to become cancerous. Potential therapies that may stop or reverse this loss of protection, may be beneficial in cancer treatment.

Cervical Artificial Discs - What will it add to the bottom line?

July 27, 2007

Medtronic Neck Disc as Good as Fusion: FDA Staff | www.medscape.com

While there are intuitive advantages to disc replacement therapy, the reality is that Medtronics trial design only showed equivalency rather than superiority to traditional fusion and considering the fact that most insurance companies do not pay for disc replacements and the huge body of experience with fusion may make adoption of this technology slower than anticipated. Once more data is collected to convince insurers and patients of the superiority of this technology, disc replacement may become the treatment of choice for degenerative disc disease.

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