|Endo Says FDA Issues CRL on Aveed NDA, Added Trials Not Included; FDA Lifts Clinical Hold on PharmAthene's SparVax|
|By Staff and Wire Reports|
|Thursday, 30 May 2013 18:47|
Endo Pharmaceuticals Inc., a subsidiary of Endo Health Solutions Inc. (Nasdaq: ENDP) announced the U.S. FDA has issued a complete response letter regarding the New Drug Application (NDA) for Endo's long-acting testosterone undecanoate injection, AVEED™, for men diagnosed with hypogonadism.
The complete response letter did not include requests for the company to perform additional clinical studies. The FDA outlined the steps necessary to support approval of the NDA and updated the requirement for a Risk Evaluation and Mitigation Strategy (REMS). Specifically, the FDA has requested that the REMS include a Medication Guide as well as Elements to Assure Safe Use (ETASU) to mitigate the risks and severe complications related to post-injection reactions.
PharmAthene, Inc. (NYSE: PIP), a biodefense company developing medical countermeasures against biological and chemical threats, announced the U.S. FDA has lifted the clinical hold previously placed on a proposed Phase II study of SparVax®, a next generation recombinant anthrax vaccine.
In a letter to the Company, the FDA acknowledged that PharmAthene had satisfactorily addressed all of the Agency's clinical hold issues and that consequently, the clinical hold had been lifted, effective immediately.
The clinical hold was enacted in August 2012, prior to the commencement of a proposed Phase II clinical trial of SparVax®. In its original notification to the Company, the FDA requested that PharmAthene provide additional stability data for both its engineering and GMP lots of U.S. manufactured Final Drug Product, as well as additional information about the intended stability indicating assays.
3SBio Inc. (NASDAQ: SSRX), a leading China-based biotechnology company focused on researching, developing, manufacturing and marketing biopharmaceutical products, announced today the completion of the merger (the "Merger") contemplated by the previously announced agreement and plan of merger dated February 8, 2013, among Decade Sunshine Limited, an exempted company with limited liability incorporated under the laws of the Cayman Islands ("Parent"), Decade Sunshine Merger Sub, an exempted company with limited liability incorporated under the laws of the Cayman Islands and a direct wholly owned subsidiary of Parent ("Merger Sub"), and the Company, as amended by Amendment No. 1 to the Agreement and Plan of Merger, dated as of April 24, 2013 (the "Merger Agreement").
ARCA biopharma, Inc. (Nasdaq: ABIO), a biopharmaceutical company developing genetically-targeted therapies for cardiovascular diseases, today announced the pricing of the previously announced public offering of the Company’s preferred stock.
ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) today announced that it will present at the Jefferies 2013 Global Healthcare Conference being held in New York City. Timothy P. Clackson, Ph.D., president of research and development and chief scientific officer, will provide an overview of the Company’s business on Wednesday, June 5, 2013 at 10:00 a.m. (ET).
ArQule, Inc. (Nasdaq: ARQL) today announced that the Company will present at the Jefferies 2013 Global Healthcare Conference on Thursday, June 6, 2013 at 11:00 a.m.
AtheroNova Inc. (OTCBB: AHRO), a biotech company focused on the research and development of compounds to safely regress atherosclerotic plaque and to improve lipid profiles in humans, today announced that it has shipped the necessary clinical supplies of AHRO-001 to its Russian licensing partner, CardioNova.
DaVita®, a division of DaVita HealthCare Partners Inc. (NYSE: DVA) and a leading provider of kidney care services, will be conducting a hurricane preparedness exercise in Jacksonville, Fla., on June 1.
DHS Holding, Co. (PINKSHEETS: DHSM) announces today that, in its ongoing efforts to market LuckyFoxCasino.com, the company will be seeking to partner up with an off-shore casino for a joint venture in the first LuckyFoxCasino.com Poker Tournament.
GTx, Inc. (Nasdaq: GTXI) announced today that the company will showcase the development of enobosarm at an Industry Expert Theater Presentation on Sunday, June 2nd from 9:45am-10:45am during the upcoming 2013 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, Illinois.
Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced today that Kenneth C. Frazier, chairman and chief executive officer, Merck, is scheduled to present at the Sanford C. Bernstein Strategic Decisions Conference in New York on May 31 at 9:00 a.m. EDT.
Oncothyreon Inc. (NASDAQ: ONTY) and Array BioPharma Inc. (NASDAQ: ARRY) today announced that they will collaborate to develop and commercialize ARRY-380, an orally active, reversible and selective small-molecule HER2 inhibitor. HER2, also known as ErbB2, is a receptor tyrosine kinase that is over-expressed in breast cancer and other cancers such as gastric and ovarian cancer.
Oncothyreon Inc. (NASDAQ: ONTY) today announced that it has agreed to sell 5,000,000 shares of its common stock and warrants to purchase 5,000,000 shares of common stock for gross proceeds of approximately $10 million.
Orexigen® Therapeutics, Inc. (Nasdaq: OREX) today announced that management will present a company overview at the Jefferies 2013 Global Healthcare Conference in New York.
OxySure Systems, Inc. (OTCQB: OXYS), a medical device innovator of life-saving, easy-to-use emergency oxygen solutions with its "oxygen from powder" technology is pleased to announce that the Company has received approval from the Ministry of Health in Israel for its OxySure Model 615 medical device and all related OxySure products and accessories.
PharmAthene, Inc. (NYSE MKT: PIP), a biodefense company developing medical countermeasures against biological and chemical threats, announced today that the U.S. Food and Drug Administration (FDA) has lifted the clinical hold previously placed on a proposed Phase II study of SparVax®, a next generation recombinant anthrax vaccine.
As part of its mission to capture a share of the fast-growing, $232 billion personalized medicine market, Rainbow Coral Corp. (OTCBB: RBCC) is making plans to empower patients to demand better care through a potent combination of innovation and education.
Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) today announced that as of May 30, 2013, it had purchased from Olon S.p.A. (formerly Solmag) a pending patent application claiming amorphous rifaximin and an issued patent that Olon recently acquired from Apotex Pharmachem, Inc. claiming amorphous rifaximin, together with related intellectual property rights.
Simulations Plus, Inc. (NASDAQ: SLP), a leading provider of consulting services and software for pharmaceutical discovery and development, will be presenting at the SeeThruEquity Second Annual Investor Conference on Tuesday, June 4, 2013, at the Penn Club of New York.
Sequenom, Inc. (NASDAQ: SQNM), a life sciences company providing innovative genetic analysis solutions, today announced that it, along with its wholly owned subsidiary, Sequenom Center for Molecular Medicine (Sequenom CMM), has entered into technology licensing and marketing agreements with Laboratoire Cerba in France for noninvasive prenatal aneuploidy testing.
Sucampo Pharmaceuticals, Inc. (NASDAQ: SCMP), a global biopharmaceutical company, today announced that it will webcast its corporate presentation at the Jefferies 2013 Global Healthcare Conference on Thursday, June 06, 2013, at 10:00 am Eastern.
Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the company’s supplemental new drug application (sNDA) for COPAXONE® (glatiramer acetate injection) 40mg/ 1mL, a higher concentration dose of COPAXONE® that offers a less frequent three times a week dosing regimen administered subcutaneously for patients with relapsing-remitting multiple sclerosis (RRMS).
Ventripoint Diagnostics Ltd. (TSX VENTURE:VPT) (OTCQX:VPTDF) announces that it has hired Mr. Jerry Gatewood as its Vice-President of Sales and Marketing.
Viratech Corp. (PINKSHEETS: VIRA), the first open source biotech research social network platform, announced today the signing of an agreement for a license issued from Chris Ryan and Kevin Buckman for a patent-pending, provisional application titled "Method of Lowering a Cancer Patient's Morbidity Rate by Increasing Quality of Life of Patient by Leveraging Cause-Based Electronic Social Support Networks."