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Byetta Manufacturer Reportedly at a Crossroads

Byetta Manufacturer Reportedly at a Crossroads May 2, 2012. By Gordon Gibb.
San Diego, CA: Those with a thirst for corporate entanglement have lots of fodder thanks to various issues surrounding Amylin Pharmaceuticals Inc., now the sole manufacturer and distributor of Byetta. Various legal tidings have taken, for now, the focus away from concerns over Byetta acute pancreatitis, and whether once-weekly injectable Bydureon has the potential to suffer the same fate.
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Byetta Side Effects Do Not Stop Additional Use Approval

Byetta Side Effects Do Not Stop Additional Use Approval April 7, 2012. By Heidi Turner.
Dallas, TX: When patients deal with serious conditions such as diabetes, drugs like Byetta can be lifesavers. The problem, however, is when patients have to deal with reported Byetta side effects and other health problems allegedly brought about by their use of the drug. Despite some reported concerns about Byetta side effects, the diabetes drug has been approved for additional uses beyond the original approvals.
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Byetta Patients Must Be Aware of the Risks

Byetta Patients Must Be Aware of the Risks March 4, 2012. By Heidi Turner.
Fort Worth, TX: For patients dealing with Type II diabetes, there may be a growing concern about what medications are safe to take. After all, drugs such as Byetta and Actos come with stern warning labels, while drugs like Avandia have been all but pulled from the market. And while debate swirled about the safety of Avandia two years ago, Byetta news took a back seat in the minds of many. But according to warning labels, the risk of Byetta side effects can be serious, and patients should still be careful.
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Will Byetta Side Effects Haunt the Approval of Bydureon?

Will Byetta Side Effects Haunt the Approval of Bydureon? February 14, 2012. By Gordon Gibb.
Washington, DC: The long-anticipated approval of a once-weekly injectable version of Byetta was sealed late last month when the US Food and Drug Administration (FDA) gave the Type 2 diabetes drug its blessing. However, the news is not without controversy, given the various delays and setbacks inherent with the approval of Bydureon. The FDA snubbed its nose at Bydureon twice in 2010.
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Amylin Pharmaceuticals Takes Over Byetta

Amylin Pharmaceuticals Takes Over Byetta December 20, 2011. By Heidi Turner.
Dallas, TX: Amylin Pharmaceuticals has taken full control of Byetta marketing in the US and will take full control globally in 2013, according to reports. Eli Lilly formerly partnered with Amylin to market Byetta (known generically as exenatide). Byetta side effects reportedly include an increased risk of acute pancreatitis.
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Drug Companies' Complaints Get Study Withdrawn

Drug Companies' Complaints Get Study Withdrawn November 24, 2011. By Heidi Turner.
Washington, DC: A study published in the journal Gastroenterology that suggested serious Byetta side effects, including a potential risk of pancreatitis, has been withdrawn, following letters of complaint from the drug's makers. The study suggested a link between Byetta use and an increased risk of pancreatic cancers and pancreatitis. The Byetta study's withdrawal was covered in BMJ.
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Doctors, Researchers to Debate Safety of Diabetes Drugs

Doctors, Researchers to Debate Safety of Diabetes Drugs September 13, 2011. By Lucy Campbell.
London, UK: A higher rate of cancers occurring in diabetics who use Amylin Pharmaceutical's Byetta or Novo Nordisk's Victoza (Liraglutide) will be the subject of a debate among researchers and clinicians at the European Association for the Study of Diabetes conference being held in Lisbon, Portugal this week.
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Amylin Posts Third-Quarter Loss As Byetta Sales Decline

Amylin Posts Third-Quarter Loss As Byetta Sales Decline November 20, 2010. By Charles Benson.
San Diego, CA: As sales of the diabetes drug Byetta continued to slip, Amylin Pharmaceuticals Inc. recently reported a larger third-quarter loss than last year, Bloomberg Businessweek reports.
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Much-Anticipated Byetta Cousin Rejected Again by the FDA

Much-Anticipated Byetta Cousin Rejected Again by the FDA November 6, 2010. By Gordon Gibb.
Washington, D.C.: The makers of Byetta have been dealt a serious blow by the US Food and Drug Administration (FDA) after the regulatory agency rejected the much-anticipated, once-weekly Bydureon injection. This is the second time Bydureon, to be manufactured by Amylin, Eli Lilly and Alkermes, has been given the thumbs-down. The response letter from the FDA, according to a recent report in The New York Times, cited the need for a study to test for cardiac effects—something the manufacturers say could take two years.
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Will We Start Hearing of Bydureon Acute Pancreatitis One Day?

Will We Start Hearing of Bydureon Acute Pancreatitis One Day? October 23, 2010. By Gordon Gibb.
Washington, DC: The manufacturers of Byetta continue to pursue their quest to bring a new, once-weekly injectable suspension to market. Known as Bydureon exenatide extended-release, the product provides much promise for diabetes patients who tire of daily injections, and is expected to do well. The prospect of having to undertake an injection once per week—rather than twice per day—should translate into healthy sales for the manufacturers if, and when, Bydureon comes to market.
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