FDA OKs Eli Lilly's Cialis for enlarged prostate. FDA Approves Merck Combination Diabetes, Cholesterol Drug. Print E-mail
By Staff and Wire Reports   
Friday, 07 October 2011 19:23
Below is a look at some of the headlines for companies that made news in the healthcare sector on October 7, 2011.

The Food and Drug Administration approved Eli Lilly's (NYSE:LLY) Cialis drug to treat enlargement of the prostate, expanding use of the blockbuster impotence medicine.

The FDA said Cialis could be labeled for treatment of the signs and symptoms of a non-cancerous enlarged prostate, called benign prostatic hyperplasia (BPH), and also be used for people who have both BPH and erectile dysfunction.  U.S. researchers reported in the journal Urology in 2008 that impotence drugs could help reduce the symptoms caused by an enlarged prostate.

The FDA said it has approved eight other drugs to treat BPH, including Merck & Co's (NYSE:MRK) Proscar, GlaxoSmithKline's (NYSE:GSK) Avodart and Pfizer's (NYSE:PFE) Cardura.

In an interview in July, Eli Lilly CEO John Lechleiter said he expects the longer-lasting Cialis to overtake Pfizer's Viagra to become the market leader for impotence drugs.

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The FDA Friday approved the first combination product to treat type 2 diabetes and high cholesterol in one tablet.  The drug combines the active ingredient in Merck & Co.'s (NYSE: MRK) diabetes drug Januvia with the medication simvastatin, which is designed to lower high cholesterol. The combination product will be sold as Juvisync by Merck.

The FDA said Juvisync is a convenience combination and should only be prescribed when it is appropriate for a patient to be placed on both of these drugs.


Also Friday:


Acura Pharmaceuticals, Inc. (NASDAQ: ACUR), a specialty pharmaceutical company innovating abuse deterrent drugs, announced that J. Bradley Rivet has been named the Company's Vice President of Marketing effective today.

Adherex Technologies Inc. (TSX: AHX) (PINKSHEETS: ADHXF), a biopharmaceutical company focused on cancer therapeutics, today announced that the FDA's Pediatric Subcommittee of the Oncologic Drugs Advisory Committee will discuss the development of Sodium Thiosulfate Injection, USP, 25% (STS) on November 1, 2011.

Affymetrix, Inc. (NASDAQ:AFFX) today announced its third quarter 2011 operating results will be reported on Wednesday, November 2, 2011, after market close.

Akorn, Inc. (NASDAQ: AKRX) will host a conference call on Tuesday, November 1, 2011, to discuss third quarter 2011 results followed by a Q&A session.  

American Oriental Bioengineering, Inc. (NYSE: AOB), or (the "Company") today announced that the Company submitted its plan to cure stock price deficiency with respect to the listing standard of the New York Stock Exchange ("NYSE") on October 5, 2011.

Bio-Rad Laboratories, Inc. (NYSE: BIO) and (NYSE: BIO.B), a multinational manufacturer and distributor of life science research and clinical diagnostic products, will report financial results for the third quarter 2011 on Tuesday, November 1, 2011, after the close of the market.

Cepheid (Nasdaq: CPHD) today announced that it will report financial results for its 2011 third quarter ended September 30, 2011, on Thursday, October 20, 2011, after the close of the market.

China Biologic Products, Inc. (NASDAQ: CBPO), one of the leading plasma-based biopharmaceutical companies in the People's Republic of China, today announced two changes in its board of directors.

CorMedix Inc. (“CorMedix”) (NYSE Amex: CRMD), a pharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of Cardiorenal disease, today announced that a conference call will be held on Tuesday, October 11, 2011 at 4:15 p.m. ET to discuss the Company’s recent developments. Richard M. Cohen, Executive Chairman of CorMedix, will host the call.

Fluidigm Corporation (NASDAQ:FLDM) today announced it is affirming its previously disclosed 2011 financial outlook.

Health Discovery Corporation (OTCBB: HDVY) is pleased to announce that it has recently received notices of allowance in two of its patent applications covering the Company’s SVM-RFE technology.

Illumina, Inc. (NASDAQ:ILMN) today announced estimated third quarter revenue of approximately $235 million.

Intellect Neurosciences, Inc. (OTCBB: ILNS) a biopharmaceutical company with an internal preclinical and clinical-stage pipeline, and multiple licenses with major pharmaceutical companies covering products in late-stage clinical trials, announces that an interview with Dr. Daniel Chain, Ph.D., Chairman and CEO will be posted on Wall Street Reporter.

Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) announced today that John Higgins, President and Chief Executive Officer of Ligand will present at the BioCentury NewsMakers Conference on Friday, October 21, 2011 at 10:30 a.m. Eastern time (7:30 a.m. Pacific).

MMRGlobal, Inc. (OTCBB: MMRF)
today announced that Hector V. Barreto will serve the Company as Chairman of its Board of Advisors.

PerkinElmer, Inc., (NYSE:PKI) a global leader focused on improving the health and safety of people and the environment, today announced that on Thursday, November 3, 2011, after market close, the Company will release third quarter 2011 results.

QIAGEN N.V. (NASDAQ: QGEN) today announced the date for the webcast of its conference call related to the publication of results for the third quarter and first nine months of 2011.

Savanna East Africa, Inc. (PINKSHEETS: NVAE) released a Webcast to the Company's corporate website yesterday to provide a business plan update.

Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) will announce its third quarter 2011 financial results on Thursday, October 27, 2011 after the financial markets close.

Watson Pharmaceuticals, Inc. (NYSE: WPI) today confirmed that its subsidiary, Watson Laboratories, Inc. - Florida, filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market Morphine Sulfate and Naltrexone Hydrochloride Extended-release Capsules 30 mg/1.2 mg, 50 mg/2 mg, 60 mg/2.4 mg, 80 mg/3.2 mg, and 100 mg/4 mg. 



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