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US FDA accepts NDA for exenatide once weekly for review
Published July 9, 2009, 5:48 am, PharmaBiz
Amylin Pharmaceuticals, Inc, Eli Lilly and Company and Alkermes, Inc announced that the New Drug Application (NDA) for exenatide once weekly has been accepted for review by the US Food and Drug Administration (FDA).
My Pharmiweb.com
Published July 9, 2009, 2:34 am, PharmiWeb
Tokyo and Osaka, Japan - July 8, 2009 – Wyeth K.K. (Wyeth) and Takeda Pharmaceutical Company Limited (Takeda) announced that on July 7, 2009 Wyeth had received approval from the Japanese Ministry of Health, Labour and Welfare to add the indication of treating polyarticular Juvenile Idiopathic Arthritis (JIA) to “ENBREL 25mg for S.C. Injection,” (etanercept) which Wyeth and Takeda co-promote.
Study shows Amgen drug helps prevent cancer-linked bone injury
Published July 7, 2009, 5:45 pm, Ventura County Star
(AP) — Shares of Amgen Inc. surged more than 13 percent in Tuesday after-hours trading, after the Thousand Oaks drugmaker said a late-stage clinical trial showed its experimental osteoporosis drug denosumab outperformed a rival product at preventing bone injuries in breast cancer patients. Amgen said patients treated with denosumab were free of skeletal injury — including fracture, bone ...
New Drug Application for Exenatide Once Weekly Accepted for Review by FDA
Published July 7, 2009, 4:13 pm, redOrbit
SAN DIEGO, INDIANAPOLIS and CAMBRIDGE, Mass., July 7 /PRNewswire-FirstCall/ -- Amylin Pharmaceuticals, Inc., (Nasdaq: AMLN), Eli Lilly and Company (NYSE: LLY) and Alkermes, Inc.
Amgen: Denosumab delays cancer-linked bone injury
Published July 7, 2009, 3:44 pm, INO News
(AP:THOUSAND OAKS, Calif.) Shares of Amgen Inc. surged more than 13 percent in Tuesday after-hours trading, after the drugmaker said a late-stage clinical trial showed its experimental osteoporosis drug denosumab outperformed a rival product at preventing bone injuries in breast cancer patients.
(AFX UK Focus) 2009-07-07 22:08 U.S. FDA advisory meetings through Aug 13
Published July 7, 2009, 2:39 pm, Interactive Investor
THIS DIARY IS FILED AS THE FOOD AND DRUG ADMINISTRATION UPDATES ITS SCHEDULE. ALL TIMES EDT/GMT. For more information on the FDA's Advisory Committee meetings, see: http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm
New Drug Application for Exenatide Once Weekly Accepted for Review by FDA
Published July 7, 2009, 1:06 pm, Business Wire via Yahoo! Finance
SAN DIEGO, INDIANAPOLIS & CAMBRIDGE, Mass.----Amylin Pharmaceuticals, Inc., , Eli Lilly and Company and Alkermes, Inc. today announced that the New Drug Application for exenatide once weekly has been accepted for review by the U.S.
Zosano Pharma, Inc. Secures $30 Million in New Round of Financing
Published July 7, 2009, 1:00 pm, Business Wire via Yahoo! Finance
FREMONT, Calif.----Zosano Pharma, Inc., a privately held pharmaceutical company developing products based on its novel transdermal delivery technology, today announced that the company has closed a new round of financing in the amount of $30 million.
Schering-Plough announces phase II and III data for corifollitropin alfa
Published July 2, 2009, 9:48 pm, PharmaBiz
Schering-Plough Corp., announced results from the phase III Engage clinical trial demonstrating that a single injection of corifollitropin alfa, first in the class of sustained follicle stimulants, achieved similar efficacy to recombinant follicle stimulating hormone (rFSH) given once daily for seven days.
The Online Information Source for the Medical Device Industry
Published July 2, 2009, 7:07 am, Medical Device Link
Convergent technologies are making new frontiers in medicine possible. Convergent technologies just may be the key to the future of medicine. Advances in nanotechnology, coatings, and molecular diagnostics have blurred the lines of devices and pharmaceuticals.
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