AstraZeneca plc’s planned buyout of Omthera Pharmaceuticals Inc. to gain Phase III-validated Epanova, the anti-triglyceride therapy based on ultra-pure fish oil, puts the firm at a “distinct commercial advantage” over Amarin Corp. plc, with its recently launched Vascepa (icosapent ethyl), said Decision Resources (DR) analyst Paramjit Narang.
http://www.bioworld.com/content/omthera-fish-oil-drug-hooks-astrazeneca-323m-buyout-0
Bristol Myers Squibb Co. (BMY), Gilead Sciences, Inc. (GILD), Halozyme …
Insider Monkey (blog)
present data on its Phase 3 drug nivolumab, which is closest to reaching the market. (Its FDA approval is expected in late 2014 or early 2015.) Nivolumab has the potential to treat a vast array of cancers. At ASCO, Bristol Myers Squibb Co.
Bristol Myers Squibb Co. (NYSE:BMY) present data on its Phase 3 drug nivolumab, which is closest to reaching the market. (Its FDA approval is expected in late 2014 or early 2015.)
Nivolumab has the potential to treat a vast array of cancers. At ASCO, Bristol Myers Squibb Co. (NYSE:BMY) will be presenting data for a Phase 1 study of nivolumad combined with Yervoy to treat melanoma. In a 52-patient study, patients with advanced melanoma saw an overall tumor shrinkage rate of 40%.
However, the company’s most advanced study with nivolumab is in treating advanced non-small cell lung cancer. There, it produced an overall survival of 9.6 months, which is 30% better than standard-of-care. It’s also produced a 22-month overall survival rate in patients with advanced kidney cancer; compared to 20 months for the current standard of care
EPFL scientists have revealed the mechanism, hidden deep within cell mitochondria, that is responsible for making organisms age. Nematodes treated with antibiotics designed to disrupt this mechanism lived longer and healthier lives.
(Photo Credit: EPFLnews)
Slowing the aging process using only antibiotics
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| Why is it that within a homogeneous population of the same species, some individuals live three times as long as others? EPFL researchers investigated this question and found the mechanism responsible for aging hidden deep within mitochondria. The were able to dramatically slow aging down in worms by administering antibiotics to the young, achieving a … more… |
liraglutide
Danish pharmaceutical company Novo Nordisk announced plans to re-brand and sell its diabetes drug liraglutide (Victoza) as a weight loss drug for obese people by 2015. Currently, the drug is approved and sold to help regulate insulin production in people living with type 2 diabetes.
Sirolimus (INN/USAN), also known as rapamycin, is an immunosuppressant drug used to prevent rejection in organ transplantation; it is especially useful in kidney transplants. It prevents activation of T cells and B cells by inhibiting their response to interleukin-2 (IL-2). Sirolimus is also used as a coronary stent coating.
A macrolide, sirolimus was discovered by Brazilian researchers as a product of the bacterium Streptomyces hygroscopicus in a soil sample from Easter Island — an island also known as Rapa Nui. It was approved by the FDA in September 1999 and is marketed under the trade name Rapamune by Pfizer (formerly by Wyeth).
Sirolimus was originally developed as an antifungal agent. However, this use was abandoned when it was discovered to have potent immunosuppressive and antiproliferative properties. It has since been shown to prolong the life of mice and might also be useful in the treatment of certain cancers.
Rapamycin Holdings Hopes To Exploit Commercial Potential Of UT Health …
BioNews Texas
Rapamycin Holdings will be looking to raise an additional $6 million as it approaches the point of taking its first drug product to Phase 1 clinical trials. On December 7, 2012, Rapamycin Holdings Chief Executive Officer George Fillis announced that …
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Rituximab (trade names Rituxan and MabThera) is a chimeric monoclonal antibody against the protein CD20, which is primarily found on the surface of B cells. Rituximab destroys B cells, and is therefore used to treat diseases which are characterized by excessive numbers of B cells, overactive B cells, or dysfunctional B cells. This includes many lymphomas, leukemias, transplant rejection, and autoimmune disorders.
Rituxan
Tiny Biotech Developing Drugs Akin To Biogen’s Rituxan Seen As Potential …
Forbes
One small biopharmaceutical that believes it has a proven technology for another blockbuster is TG Therapeutics (TGTX), which is focused on developing drugs for the treatment of cancer and other underserved therapeutic needs, including hematologic …read all
isavuconazonium as sulfate
Isavuconazole (BAL4815) is a triazole antifungal. Its prodrug, Isavuconazonium sulfate (BAL8557) is currently in Phase III clinical trials.
Basilea reports isavuconazole orphan drug designation by US FDA
ITNews
Pharmaceutica AG / Basilea reports isavuconazole orphan drug designation by U.S. FDA .
Basel, Switzerland, May 28, 2013 – Basilea Pharmaceutica Ltd. (SIX: BSLN) reported today that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to isavuconazole for the treatment of invasive aspergillosis. An FDA orphan drug designation provides several benefits to the sponsor including a seven-year market exclusivity from product approval in the U.S. Isavuconazole was previously granted FDA fast track status that is designed to facilitate development and expedite the review of drugs to treat serious diseases
Isavuconazole (drug substance: isavuconazonium sulfate) is an investigational intravenous and oral broad-spectrum antifungal.
In collaboration with Astellas Pharma Inc., isavuconazole is being investigated in phase 3 clinical … read all at
http://newdrugapprovals.wordpress.com/2013/05/28/drug-manufacturing-presentation-processes/
DRUG MANUFACTURING PRESENTATION-PROCESSES
