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Basic Science May Not Be Translating Into Drug Approvals.

5/24/2010

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Dr.Shruti Bhat, Leader Pharmaceutical R&D and Expert in hiTech formulation development for over 35 different therapeutic class of drugs moeities, brings to you some highlights from current pharma and clinical research news, views and data.

She has initiated a new blog Http://www.PharmaceuticalCareerDevelopment.blogspot.com that would contain articles on motivation, career counselling and coaching, job search strategies, personal branding etc. 

Presented below are updates in Pharmaceutical and clinical research-

Spanish Translations Of Prescription Information May Often Be Inaccurate Or Confusing.
 

The Chicago Tribune reported that, "Pharmacies that print prescription labels translated in Spanish often issue inaccurate or confusing instructions that could be potentially hazardous to a patient's health, according to a report in the May issue of Pediatrics journal." The researchers evaluated "76 medicine labels generated by 13 different computer programs that many pharmacies use to make translations and found an overall error rate of 50 percent." The study also found that prescription information given in a mix of English and Spanish "is a frequent problem."  

Merck To Seek FDA Approval For Five New Drugs In 2010.  

Bloomberg News reported that, "Merck & Co. said it will seek US regulatory approval for five new medicines this year, including new treatments for hepatitis C and diabetes." The company also said US and European regulators are currently reviewing four other Merck drugs and 20 drugs are in late-stage testing. Some of the drugs that Merck will file for approval in 2010 include "a new form of contraception called Nomac/E2; an extended release form of the diabetes treatment Janumet [metformin/sitagliptin]; a pill that combines the cholesterol drug Zocor [simvastatin] with the diabetes treatment Januvia [sitagliptin metformin HCl]; the hepatitis C treatment boceprevir; and ridaforolimus for sarcoma, also reported that Merck has halted the development of an experimental anemia drug. 

Majority Of US' Best-Selling Drugs Are Generics.  

Forbes reported,, "The most popular medicine in the US," Vicodin (acetaminophen/hydrocodone), "was prescribed 128 million times last year, even as a panel of experts called together by the Food and Drug Administration recommended that regulators ban it." Forbes notes, "Only one drug in the top 15, Pfizer's Lipitor [atorvastatin], is a big-selling brand-name medication. The rest are cheap generic versions of one-time big sellers that have lost their patent protection and become commodities."  

Abbott To License Products From Zydus Cadila To Sell In Emerging Markets.  

The AP reported that, Abbott Laboratories will license at least 24 products in emerging markets through a new unit created to boost sales outside of the US. Specifically, "Abbott said it will license products from Zydus Cadila, based in India, and will sell them in 15 emerging markets." The device and drugmaker "did not specify which products, but said they complement its own generic drugs, including medicines for pain, cancer, and cardiovascular, neurological and respiratory diseases."  

Bloomberg Newsreported that Abbott "gained rights to market the drugs in 15 countries, among them Russia, Turkey, and Brazil. Financial terms weren't disclosed." Company spokesman Scott Stoffel explained that "Zydus Cadila will make the drugs for sale under the Abbott brand." Under terms of the agreement, Abbott maintains "options on licenses to market more than 40 additional Zydus Cadila products, the company said in its statement."  

The Wall Street Journal quoted Olivier Bohuon, executive vice president of Abbott's pharmaceutical products group, as saying, "The Zydus agreement complements our established products strategy, augmenting this business with a broad portfolio of branded generics."  

Basic Science May Not Be Translating Into Drug Approvals.  

Newsweek reported that "frustration is growing with how few seemingly promising discoveries in basic biomedical science lead to something that helps patients, especially in what is supposed to be a golden age of genetics, neuroscience, and biomedical research in general." Newsweek added that many of the "potential cures, or at least treatments, are stuck in the chasm between a scientific discovery and the doctor's office: what's been called the valley of death." In addition, for "academia and the NIH, the system of honors, grants, and tenure rewards basic discoveries...not the grunt work that turns such breakthroughs into drugs."  

Extended-Release Carvedilol May Not Increase Triglyceride Levels In Hypertensive Patients Without Dyslipidemia.  

MedWire reported, "Extended-release carvedilol differs to extended-release metoprolol in its effect on triglyceride levels, but has a similar impact on high-density lipoprotein (HDL) cholesterol in hypertensive patients without dyslipidemia, trial findings suggest." The study "randomly assigned 568 hypertensive patients who did not have diabetes or require lipid-lowering therapy to receive extended-release carvedilol 20-80 mg or extended-release metoprolol 50-200 mg once daily titrated" and found triglyceride "levels did not significantly change with extended-release carvedilol," whereas "triglyceride levels significantly increased with extended-release metoprolol. Geometric mean HDL levels significantly decreased with both treatments, but the difference in mean percent change was not statistically significant."  

Newly Developed Vaccine May Reverse, Cure Malignant Melanoma.  

Researchers have developed a vaccine, "which will be tested on British patients over the next few months" that "can reverse and even cure malignant melanoma." The "vaccine...can target a tumour and kill it without damage to surrounding healthy tissues or cells." The treatment "contains DNA and fragments of tumour" that "activate only the specific immune cells which target melanoma." Trials of the vaccine are expected to "begin at hospitals in Manchester, Nottingham and Newcastle." 

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