Pharmaceuticals News and Research

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Phase III study demonstrates superiority of imiquimod cream 2.5% and 3.75% in treatment of AK

The Journal of the American Academy of Dermatology (JAAD) has published Phase III data evaluating the safety and efficacy of imiquimod cream at two doses - 2.5% and 3.75% - administered daily on a 2-week treatment cycle. The study demonstrates that both formulations were superior to placebo, and that imiquimod 3.75% on a daily 2-week treatment cycle is superior to imiquimod 2.5% in treating actinic keratosis (AK) on a large surface area - the face or balding scalp.

9 Mar 2010

Harvard University, Dana-Farber Cancer Institute complete major licensing agreement with Acetylon

Harvard University and Dana-Farber Cancer Institute announced today that they have concluded a major licensing agreement with Acetylon under which Harvard and Dana-Farber granted an exclusive therapeutic license to a robust platform technology and chemical methodology that enables high-throughput screening and lead optimization for HDAC inhibitor compounds.

9 Mar 2010

JAAD publishes Phase III data evaluating safety and efficacy of imiquimod in patients with AK

The Journal of the American Academy of Dermatology has published Phase III data evaluating the safety and efficacy of imiquimod cream at two doses – 2.5% and 3.75% – administered daily on either 2-week or 3-week treatment cycles.

9 Mar 2010

Herceptin as add-on to standard chemotherapy for gastric cancer earns Decision Resources' gold standard status

Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that, for the treatment of gastric cancer, Roche/Genentech/ Chugai's Herceptin as an add-on to standard chemotherapy earns Decision Resources' proprietary clinical gold standard status in 2013, following its approval for the first-line treatment of human epidermal growth factor receptor 2 (HER2)-positive gastric cancer in 2010.

9 Mar 2010

Usage of gonadotropins in assisted reproductive technologies significantly improves outcomes

The U.S. infertility specialty has empirically incorporated greater amounts of human menopausal gonadotropin (hMG) into stimulation protocols, according to a new review article, "Gonadotropins in the Treatment of Infertility" by George T. Koulianos, MD, published in a recent issue of US Obstetrics & Gynecology, supported by an educational grant from Ferring Pharmaceuticals. The article reviews the wealth of clinical evidence supporting this trend, and demonstrates how the use of gonadotropins in the treatment of infertility, especially in assisted reproductive technologies, has significantly improved outcomes.

9 Mar 2010

Obesity - Body's effort to protect organs from lipids' toxic effects

The collection of symptoms that is the metabolic syndrome-insulin resistance, high cholesterol, fatty liver, and a greater risk for diabetes, heart disease, and stroke-are all related to obesity, but, according to a review in the March 9th issue of the Cell Press publication Trends in Endocrinology and Metabolism, not in the way you probably think they are.

9 Mar 2010

Watson Laboratories sued over ANDA filing for generic Opana ER

Watson Pharmaceuticals, Inc., a leading specialty pharmaceutical company, today confirmed that its subsidiary, Watson Laboratories, Inc., has been sued by Endo Pharmaceuticals Inc. and Penwest Pharmaceuticals Co. in connection with the filing of Watson's Abbreviated New Drug Application (ANDA) for Oxymorphone Hydrochloride Extended-Release Tablets, 40mg.

9 Mar 2010

ISTA Pharmaceuticals' sNDA for once-daily XiDay: FDA assigns PDUFA action date

ISTA Pharmaceuticals, Inc., today announced the Company's supplemental New Drug Application (sNDA) for once-daily XiDay™ (bromfenac ophthalmic solution) has been accepted for review by the U.S. Food and Drug Administration (FDA).

8 Mar 2010

GTA's stockholders voted to approve merger between GTA and Pernix Therapeutics

Golf Trust of America, Inc. announced that GTA's stockholders voted to approve the four proposals that were conditions to closing the previously-announced merger between GTA and Pernix Therapeutics, Inc. at a Special Meeting of Stockholders held earlier today.

8 Mar 2010

FDA approves Taro Pharmaceutical Industries' Fluorouracil Topical Cream ANDA

Taro Pharmaceutical Industries Ltd. today reported that it received approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for Fluorouracil Topical Cream USP, 5%.

8 Mar 2010

BioSpecifics Technologies' XIAFLEX now available to Dupuytren's contracture patients in the U.S.

BioSpecifics Technologies Corp., a biopharmaceutical company developing first in class collagenase-based products, today announced that XIAFLEX™ is now available in the U.S. by prescription, for the treatment of adult Dupuytren's contracture patients with a palpable cord. Dupuytren's contracture is a debilitating disease resulting from excessive collagen deposition that causes contractures of the fingers.

8 Mar 2010

White House emphasizes rising health insurance costs as reason for reform

The Los Angeles Times analyzes how insurance costs became a focal point: "The Democrats' bill was in serious trouble when news broke of planned rate hikes by the California insurer. ... Anthem Blue Cross was seeking double-digit rate increases for many of its 800,000 individual policyholders. Company executives had little reason to worry. Insurers can raise premiums in the individual market as often -- and as much -- as they like, within certain guidelines. For years, such requests were routinely approved."

8 Mar 2010

Poniard Pharmaceuticals reports net loss of $13.2M for fourth-quarter 2009

Poniard Pharmaceuticals, Inc., a biopharmaceutical company focused on innovative oncology therapies, today reported financial results for the fourth quarter and year ended December 31, 2009.

8 Mar 2010

Rexahn Pharmaceuticals granted Japanese patent for Archexin

Rexahn Pharmaceuticals, Inc, a clinical stage pharmaceutical company commercializing potential best in class oncology and CNS therapeutics, today announced that the Japanese Patent Office has issued a patent for its novel anti-cancer compound, Archexin®.

8 Mar 2010

Enzon Pharmaceuticals’ outstanding principal balance of 4% convertible notes is now $134.5M

Enzon Pharmaceuticals, Inc. today announced the results from the recent tender and increased conversion periods of the 4 percent convertible notes due in 2013. As a result of the sale of the specialty pharmaceutical business on January 29, 2010, the Company was required to offer to repurchase for cash any and all of its convertible notes at face value. This offer expired on March 5, 2010 and no notes were tendered.

8 Mar 2010

Ricerca Biosciences to acquire Discovery and Preclinical business of MDS Pharma Services

Ricerca Biosciences, LLC, announced today the finalization of the acquisition of the Discovery and Preclinical business of MDS Pharma Services with facilities and almost 600 associates in Bothell, Washington; Lyon, France; and Taipei, Taiwan.

8 Mar 2010

GeneGo's industry-FDA MetaTox partnership program: Tools and contents released

GeneGo announces the release of the first set of tools and content to come out of its industry-FDA MetaTox™ partnership program. The MetaTox partnership is developing a unique comprehensive systems toxicology suite designed for compound safety assessment in chemical and pharmaceutical R&D.

8 Mar 2010

Acceptance of initial regulatory filings for BMS-PCSK9Rx triggers $6M milestone payment to Isis Pharmaceuticals

Isis Pharmaceuticals, Inc. announced today that it has earned a $6 million milestone payment from Bristol-Myers Squibb Company related to the acceptance of initial regulatory filings to begin Phase 1 clinical studies for BMS-PCSK9Rx. BMS-PCSK9Rx is an antisense drug that arose out of the ongoing collaboration between Bristol-Myers Squibb and Isis to identify antisense drugs targeting PCSK9 to lower low-density lipoprotein (LDL) cholesterol.

8 Mar 2010

Global Genes Project: World Rare Disease Day 2010, a tremendous success

The Global Genes Project, a worldwide rare disease awareness initiative, today announced the success from its World Rare Disease Day 2010 efforts and laid out plans for future rare disease awareness campaigns.

8 Mar 2010

Lexicon Pharmaceuticals proposes $95 million underwritten public offering of common stock

Lexicon Pharmaceuticals, Inc. today announced that it is offering to sell, subject to market and other conditions, $95,000,000 of its common stock pursuant to an effective shelf registration statement in an underwritten public offering. Lexicon also intends to grant the underwriters a 30-day option to purchase up to an additional $14,250,000 of common stock to cover over-allotments, if any.

8 Mar 2010

Pharmaceuticals News and Research

Phase III study demonstrates superiority of imiquimod cream 2.5% and 3.75% in treatment of AK

Harvard University, Dana-Farber Cancer Institute complete major licensing agreement with Acetylon

JAAD publishes Phase III data evaluating safety and efficacy of imiquimod in patients with AK

Herceptin as add-on to standard chemotherapy for gastric cancer earns Decision Resources' gold standard status

Usage of gonadotropins in assisted reproductive technologies significantly improves outcomes

Obesity - Body's effort to protect organs from lipids' toxic effects

Watson Laboratories sued over ANDA filing for generic Opana ER

ISTA Pharmaceuticals' sNDA for once-daily XiDay: FDA assigns PDUFA action date

GTA's stockholders voted to approve merger between GTA and Pernix Therapeutics

FDA approves Taro Pharmaceutical Industries' Fluorouracil Topical Cream ANDA

BioSpecifics Technologies' XIAFLEX now available to Dupuytren's contracture patients in the U.S.

White House emphasizes rising health insurance costs as reason for reform

Poniard Pharmaceuticals reports net loss of $13.2M for fourth-quarter 2009

Rexahn Pharmaceuticals granted Japanese patent for Archexin

Enzon Pharmaceuticals’ outstanding principal balance of 4% convertible notes is now $134.5M

Ricerca Biosciences to acquire Discovery and Preclinical business of MDS Pharma Services

GeneGo's industry-FDA MetaTox partnership program: Tools and contents released

Acceptance of initial regulatory filings for BMS-PCSK9Rx triggers $6M milestone payment to Isis Pharmaceuticals

Global Genes Project: World Rare Disease Day 2010, a tremendous success

Lexicon Pharmaceuticals proposes $95 million underwritten public offering of common stock

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