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The article reports on weight loss drugs and approval by the U.S. Food and Drug Administration (FDA). Acomplia, a weight loss pill by Sanofi-Aventis, is being sold in 20 countries but the U.S. Food and Drug Administration turned it down due to memory loss, depression, and dizziness reported as side effects during clinical trials. Daniel M. Bradbury, chief executive officer of Amylin Pharmaceuticals, says the FDA is becoming more strict forcing companies to focus on safety. INSET: LINKS.

An interview with Patrick Sexton, head of the Drug Discovery Biology theme at the Monash Institute of Pharmaceutical Science, is presented. Topics discussed include his interest in studying science, doing Doctor of Philosophy (PhD) in a medical environment, investigation G protein-coupled receptors (GPCRs) during his PhD project, a collaborative program with pharmaceutical company Amylin Pharmaceuticals related to the peptide amylin and collaborating with biotechnology company Alchemia.

OBJECTIVE--To determine variables associated with glycemic and body weight responses when adding exenatide to basal insulin-treated type 2 diabetes. RESEARCH DESIGN AND METHODS--Exploratory subgroup analyses based on baseline AIC, disease [...]

OBJECTIVE--We previously showed that exenatide (EXE) enhanced insulin secretion after 1 year of treatment, relative to insulin glargine (GLAR), with a similar glucose-lowering action. These effects were not sustained after a 4-week off-drug period. This article reports the results after additional 2 years of exposure. RESEARCH DESIGN AND METHODS--Sixty -nine metformin-treated patients with type 2 diabetes were randomized to EXE or GLAR. Forty-six patients entered the 2-year extension study in which they continued their allocated therapy. Thirty-six completed (EXE: n = 16; GLAR: n = 20) the 3-year exposure period. Insulin sensitivity (M value) and β-cell function were measured by euglycemic hyperinsulinemic clamp followed by hyperglycemic clamp with arginine stimulation at pretreatment (week 52) and 4 weeks after discontinuation of study medication (week 56 and week 172). First-phase glucose stimulated C-peptide secretion was adjusted for M value and calculated as the disposition index (DI). RESULTS--At 3 years, EXE and GLAR resulted in similar levels of glycemic control: 6.6 ± 0.2% and 6.9 ± 0.2%, respectively (P = 0.186). EXE compared with GLAR significantly reduced body weight (-7.9 [+ or -] 1.8 kg; P < 0.001). After the 4-week off-drug period, EXE increased the M value by 39% (P = 0.006) while GLAR had no effect (P = 0.647). Following the 4-week off-drug period, the DI, compared with pretreatment, increased with EXE, but decreased with GLAR (1.43 ± 0.78 and -0.99 ± 0.65, respectively; P = 0.028). CONCLUSIONS--EXE and GLAR sustained [HbA.sub.1c] over the 3-year treatment period, while EXE reduced body weight and GLAR increased body weight. Following the 3-year treatment with EXE, the DI was sustained after a 4-week off-drug period. These findings suggest a beneficial effect on β-cell health., Type 2 diabetes is characterized by progressive β-cell dysfunction against a background of obesity-related peripheral and hepatic insulin resistance (1). Current treatment guidelines promote a stepwise approach starting with lifestyle [...]

The article reports on the status of mergers and acquisitions (M & A) of in the bioscience industry worldwide. It mentions that the global bioscience sector had 450 M & A deals in 2012, approximately 10% lower compared to 2011. The merger between Bristol-Myers Squibb Co. and Amylin Pharmaceuticals Inc. and followed by Watson Pharmaceuticals Inc. and Actavis Group hf.

The article informs that AstraZeneca PLC has made an initial payment of 3.2 billion U.S. dollars to Amylin Pharmaceuticals Inc. following its acquisition by Bristol-Myers Squibb Co. The payment is part of the expansion of the diabetes alliance between AstraZeneca and Bristol-Myers Squibb to incorporate the development and marketing of Amylin's portfolio of diabetes products. The profits and losses arising from the collaboration will be shared equally by both the companies.

The article informs that Bristol-Myers Squibb Co. has reported results for the 2nd quarter of 2012. It also highlights the acquisition of Amylin Pharmaceuticals Inc. and the presentation of clinical data from the company's immuno-oncology pipeline. It also informs that the company has adjusted its generally accepted accounting principles earnings per share guidance range for 2012.

The article reports on an announcement made by Bristol-Myers Squibb Co. and Amylin Pharmaceuticals Inc. related to the acquisition of later by the former at 31 dollars per share in cash. As per Lamberto Andreotti, chief executive officer (CEO) of Bristol-Myers Squibb, the Amylin Pharmaceuticals has innovative diabetes portfolio with talented people and good state-of-the art facility which will enable the company to stand firmly in the market.

The article offers information on clinical study findings of an investigational medication, metreleptin from Amylin Pharmaceuticals Inc. to determine the efficacy of the drug in treatment of diabetes in patients with reduced blood glucose and triglyceride levels. The findings were discussed with the help of posters which were presented at the Endocrine Society's 94th Annual Meeting and Exposition (ENDO) held in Houston, Texas.

The article informs that Amylin Pharmaceuticals Inc. and Alkermes PLC has released the results from its clinical trial of BYDUREON for the treatment of type 2 diabetes. It mentions that the efficacy of once-weekly treatment BYDUREON and twice-daily BYETTA was compared which revealed that BYDUREON controls glycemic level more efficiently. It further informs that the results were presented at the Scientific Sessions of the American Diabetes Association in Philadelphia, Pennsylvania.

The article informs that Amylin Pharmaceuticals Inc. has released the results from its comparative clinical trial of BYETTA and Amaryl for the treatment of type 2 diabetes. It mentions that BYETTA resulted in glycemic durability, weight loss and reduced risk of hypoglycemia. It further informs that the results were presented at the Scientific Sessions of the American Diabetes Association in Philadelphia, Pennsylvania.

The article informs that Amylin Pharmaceuticals Inc. and Alkermes PLC has released the results from its clinical trials of BYDUREON and Levemir for the treatment of type 2 diabetes. A comparative study revealed that BYDUREON is a once weekly treatment which is more efficient in controlling glucose level and reducing weight. It further informs that the results were presented at the Scientific Sessions of the American Diabetes Association which was held in Philadelphia, Pennsylvania.

The article informs that Amylin Pharmaceuticals Inc. has released the results from its clinical studies of SYMLIN for the treatment of diabetes. It mentions that SYMLIN is a synthetic analogue of human amylin which is administered in combination with insulin. It further informs that the company has presented the results at the Scientific Sessions of the American Diabetes Association which was held in Philadelphia, Pennsylvania.

The article informs that Amylin Pharmaceuticals Inc. and Alkermes PLC have released the results from its clinical trial of BYDUREON for the treatment of type 2 diabetes. It mentions that BYDUREON is a once-weekly formulation of exenatide which has been approved by the U.S. Food and Drug Administration. It further informs that the companies have presented the results at the Scientific Sessions of the American Diabetes Association which was held in Philadelphia, Pennsylvania.

The article offers information on the 72nd Scientific Sessions of the American Diabetes Association (ADA) 2012 Meeting to be held in Philadelphia from June 8-12, 2012 in which Amylin Pharmaceuticals Inc. will present clinical trial results for diabetes treatment drugs.

The article provides information on the financial results of Amylin Pharmaceuticals Inc. for the first quarter ended March 31, 2012. It indicates that total revenue for the first quarter of 2012 was 153.7 million U.S. dollars. The company also reported research & development expenses of 51.2 million dollars and non-GAAP operating loss of 30.1 million dollars in the first quarter of 2012. The company will webcast its quarterly update conference call on April 26, 2012.

The article offers brief information on several medications for diseases in the endocrine system such as diabetes, including Amaryl from Sanofi-Aventis SA, Avandia from GlaxoSmithKline, and Byetta from Amylin Pharmaceuticals Inc. and Lilly Industries Inc. Amaryl, containing sulfonylurea, is indicated for type 2 diabetes and to be combined with metformin. Avandia, containing thiazolidinedione, is also indicated for type 2 diabetes with combination of metformin and sulfonylurea.

The article reports that Eli Lilly & Co., Alkermes Inc., and Amylin Pharmaceuticals Inc., announced that the U.S. Food & Drug Administration (FDA) recognized the companies' BYDUREON (&x2122;) resubmission and the action date is on January 28, 2012. Christian Weyer, senior vice president of Amylin Pharmaceuticals Inc., says that if BYDUREON is approved then it will be an important choice for type 2 diabetes patients. BYDUREON obtained marketing authorization from the European Union on June 2011.

The article focuses on Byetta, an innovative treatment for diabetes mellitus. It is also known as exenatide, the first incretin mimetic that simulates one of the key hormones which is insufficient in people with type 2 diabetes. In addition, Byetta is approved for marketing in 2005 from Eli Lilly and Amylin Pharmaceuticals. Moreover, Byetta is injected two times a day with breakfast and dinner in 5 or 10-μg doses. INSET: Did the FDA go far enough?.

The article features several products and drugs for diabetics. The Accu-Chek Aviva blood glucose meter provides results in 5 seconds and allows to perform checks on six different sites on the body. The Home Diagnostics Sidekick, on the other hand, is a vial of 50 test strips with a blood glucose meter on top. Meanwhile on drugs, Byetta is a prescription-only injectable type 2 drug which enhances insulin secretion in the presence of high blood glucose from Amylin Pharmaceuticals.

This article reports on Ginger Graham, chief executive of Amylin Pharmaceuticals Inc. Graham, although she does not have diabetes, insists on living her life as if she were a diabetic. She watches her diet and her glucose intake and even tests her tests her blood sugar daily by pricking her finger. In the spring of 2005, Amylin scored approval from the U.S. Food & Drug Administration for both its first and second products.

Reports on the development of new medications to help people suffering from diabetes and obesity. Example of a new drug called Symlin, developed by Amylin Pharmaceuticals Inc., which helps type 1 diabetics control their blood sugar levels; Announcement by FDA Commissioner Mark McClellan that the fast-track approval process normally reserved for cancer treatments would also be applied to some obesity and diabetes drugs; Details of how the new drugs work by simulating hormones naturally produced by the body; Predictions of sales of Symlin; Research on a molecule called peroxisome proliferator-activated receptor, which could help obese people lose weight; Challenges of gaining FDA approval of drugs designed to correct metabolic disorders.

Discusses biotechnology company Amylin Pharmaceuticals. Outlook when Johnson & Johnson dissolved their partnership concerning marketing of Amylin's diabetes drug; How Amylin has rebounded with a diabetes drug that it hopes to market by 2002; Role of Joseph C. Cook Jr. in Amylin's resurgence and his views on why Johnson & Johnson abandoned rights to the drug Symlin.