PhaseBio Pharmaceuticals‘ phase I/IIa clinical study for its drug, Glymera, for the treatment of hyperglycemia in patients with type 2 diabetes, met with positive results, according to a release from the company.The single and multiple ascending dose study of 80 subjects in three U.S. study centers assessed the safety, tolerability and pharmacokinetic or PK profile [...]
[Read more of this report]NuPathe (NASDAQ: PATH) said it will resubmit a new drug application for its transdermal migraine patch for approval by the U.S. Food and Drug Administration after receiving a complete response letter from the regulator, according to the company’s third quarter earnings report.NuPathe said the issues raised in the August 29 letter from the FDA and [...]
[Read more of this report]Endo Pharmaceuticals (NASDAQ:ENDP) has ended its developments of an octreotide implant to treat a disorder in which the body produces too much growth hormone following a review of its research and development priorities, according to a filing with the U.S. Securities and Exchange Commission.The move was prompted in part by a request by the U.S. [...]
[Read more of this report]Auxilium Pharmaceuticals (NASDAQ:AUXL) has reshuffled its marketing and public relations team to help boost sales of its drug Xiaflex as it reported earnings for the third quarter.The Malvern, Pennsylvania drug company said it will eliminate the position of executive vice president of sales and marketing, a position held byRogerD. Graham Jr.,effective Nov.28, according to a [...]
[Read more of this report]Merck (NYSE:MRK) posted net income of $1.6 billion in the third quarter, eclipsing its performance for the same time last year, aided by its cervical cancer vaccine and strong growth in China.Revenue for the Whitehouse Station, New Jersey pharmaceutical company for the quarter rose 8 percent to $12 billion. Sales of combination diabetes drug Janumet [...]
[Read more of this report]So, you not only come up with a great medical device or drug that will improve or save lives, you spend years getting your product through clinical trials. And, finally, it’s approved by the U.S. Food and Drug Administration. Now, your product is ready to launch.But one major issue highlighted at a panel discussion at [...]
[Read more of this report]Current medical news and unique business news for anyone who cares about the healthcare industry.Generics will make prescription drugs cheaper. Seven of the world’s 20 best-selling drugs will have their patents expire in the next 14 months, allowing for more affordable generics to be developed and sold. Included in the bunch are cholesterol drug Lipitor [...]
[Read more of this report]Current medical news and unique business news for anyone who cares about healthcare.Advances in male birth control. Scientists are testing types of a male birth control pill that use testosterone and progestin hormones to trigger the body to stop producing sperm. The goal, obviously, is to find a method of birth control for men [...]
[Read more of this report]A company executive at Eden Prairie, Minnesota-based UAS Laboratories Inc. expressed surprise Wednesday that U.S. Marshals at the behest of the U.S. Food and Drug Administration had seized some of its products.On Tuesday, federal marshals seized several probiotic products in powder and capsule form made by the company and charged that while UAS Laboratories was [...]
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