Amylin, Eli Lilly And Alkermes Reply To Complete Response Letter Issued By U.S. Food and Drug Administration (FDA) Print E-mail
By Staff and Wire Reports   
Thursday, 28 July 2011 19:30
Below is a look at some of the headlines for companies that made news in the healthcare sector on July 28, 2011.

Amylin Pharmaceuticals, Inc. (NASDAQ:AMLN), Eli Lilly and Company  (NYSE:LLY) and Alkermes, Inc. (NASDAQ:ALKS)  announced that the companies have submitted their reply to a complete response letter issued in October 2010 by the U.S. Food and Drug Administration (FDA) regarding BYDUREON (exenatide extended-release for injectable suspension), an investigational medication for type II diabetes.

The companies expect to receive an updated Prescription Drug User Fee Act (PDUFA) action date from the FDA within the next two weeks. Since the reply included additional data, it will likely be categorized as a Class II resubmission requiring up to six months for review.

The reply submission includes results from the recently completed thorough QT (tQT) study, which showed that exenatide, at and above therapeutic levels, did not prolong the corrected QT interval in healthy individuals as defined by the FDA’s published guidance. The reply also contains results from the DURATION-5 study, which compared the commercial formulation of BYDUREON to BYETTA (exenatide) injection.

Additionally, it includes an update of safety information from studies ongoing or completed since the last submission, as is standard practice in a complete response scenario. BYDUREON is the proposed brand name for exenatide extended-release for injectable suspension. It is an investigational medication for type II diabetes designed to deliver continuous therapeutic levels of exenatide in a single weekly dose.


Also Thursday:


BioMarin Pharmaceutical Inc. (Nasdaq:BMRN) today announced an update on the GALNS Phase 1/2 extension study (MOR-100) in which patients have continued treatment on an ongoing basis.

BioMed Realty Trust, Inc. (NYSE:BMR) announced today the signing of a new lease with BIND Biosciences, Inc. at its Vassar Street property located in Cambridge, Massachusetts.

Cardium Therapeutics (NYSE Amex: CXM) today provided an update regarding its plan to acquire substantially all of Transdel Pharmaceuticals' business assets in connection with a proposed asset purchase under Chapter 11 of the U.S. Bankruptcy Code.

Codexis, Inc. (Nasdaq:CDXS) today announced introduction of the CodeXol™ detergent alcohol product line, and announced financial results for the second quarter ended June 30, 2011.

Gen-Probe Incorporated (NASDAQ:GPRO) today reported financial results for the second quarter of 2011, with total revenues of $135.9 million and non-GAAP earnings per share (EPS) of $0.51.

InterMune (NASDAQ:ITMN) today announced that it will release its second quarter 2011 financial results on Thursday, August 4, 2011.

Lexicon Pharmaceuticals, Inc. (Nasdaq:LXRX)
, a biopharmaceutical company focused on discovering breakthrough treatments for human disease, announced today that it has successfully completed a Phase 1 clinical trial of LX1033, an orally-delivered small molecule drug candidate for diarrhea-predominant irritable bowel syndrome (IBS-d).

Life Technologies Corporation (NASDAQ:LIFE) today announced results for its second quarter ending June 30, 2011. Non-GAAP revenue for the second quarter was $945 million, an increase of 4 percent over the $906 million reported for the second quarter of 2010.

Codexis, Inc. (Nasdaq:CDXS) and Chemtex, a global technology and engineering Company wholly-owned by Italy's Gruppo Mossi & Ghisolfi ("M&G Group"), today announced a broad collaboration to develop and produce sustainable detergent alcohols for use in the household products market.

Neurocrine Biosciences, Inc. (NASDAQ:NBIX) today announced its financial results for the quarter ended June 30, 2011. For the second quarter of 2011, the Company reported net income of $2.0 million, or $0.04 per share, compared to a net loss of $5.2 million, or $0.09 loss per share, for the same period in 2010.

OncoGenex Pharmaceuticals, Inc. (NASDAQ:OGXI) announced that the Company's second quarter 2011 financial results will be released on Thursday, August 4, 2011 after the NASDAQ Global Market closes at 4:00 p.m. ET, and that the Company will host a conference call and live webcast at 4:30 p.m. ET that afternoon.

Oncolytics Biotech Inc. (TSX:ONC) (NASDAQ: ONCY) ("Oncolytics" or the "Company") today announced its financial results and operational highlights for the quarter ended June 30, 2011.

Questcor Pharmaceuticals, Inc. (NASDAQ:  QCOR) announced today that executive management will present at the Canaccord Genuity Growth Conference to be held August 9-11, 2011 at the InterContinental Boston in Boston, MA.

Shire plc (LSE: SHP, NASDAQ:SHPGY), the global specialty biopharmaceutical company, announces results for the three months to June 30, 2011.

Codexis, Inc. (Nasdaq:CDXS) today announced that Pedro I. Mizutani, Executive Vice President, Upstream Business, Raizen Energia Participacoes S.A, has been elected to the Codexis Board of Directors.

United Therapeutics Corporation (NASDAQ:UTHR) today announced its financial results for the quarter ended June 30, 2011.

Verenium Corporation (NASDAQ:VRNM), a pioneer in the development and commercialization of high-performance industrial enzyme solutions, today announced that it repurchased approximately $5.2 million in principal amount of its 5.5% Notes and approximately $3 million in principal amount of 9% Notes.

ViroPharma Incorporated (Nasdaq:VPHM) reported today its financial results for the second quarter ended June 30, 2011.



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