|Watson and Actavis Receive FTC 2nd Request; Zogenix Begins Schizophrenia Clinical Trial|
|By Staff and Wire Reports|
|Thursday, 12 July 2012 19:00|
Watson Pharmaceuticals, Inc. (NYSE: WPI) announced it has received a request for additional information from the Federal Trade Commission ("FTC") in connection with Watson's pending acquisition of Actavis Group. The information request was issued under notification requirements of the Hart.Scott Rodino Antitrust Improvements Act of 1976, as amended.
The effect of the second request is to extend the waiting period imposed by the HSR Act until 30 days after Watson and Actavis have substantially complied with the request, unless that period is extended voluntarily by the parties or terminated sooner by the FTC. Watson intends to cooperate fully with the FTC's review and continues to expect the transaction to close in the fourth quarter of 2012.
Zogenix Inc. (Nasdaq: ZGNX) announced it has initiated its first IND clinical trial for Relday™, a product candidate based on a combination of its DosePro® needle-free, subcutaneous drug delivery system with a proprietary, subcutaneous once-monthly formulation of risperidone for treating schizophrenia. The Phase 1 clinical trial for Relday is a single-center, open-label, safety and pharmacokinetic (PK) trial that will enroll 30 patients with chronic, stable schizophrenia or schizoaffective disorder. Zogenix expects that study results will be available by the end of 2012. Further study information can be found at http://www.clinicaltrials.gov and reference NCT01592110.
Roger L. Hawley, chief executive officer of Zogenix, said, "Relday represents a significant opportunity to leverage our proprietary DosePro needle-free drug delivery system in combination with a novel long-acting formulation of an established antipsychotic to provide psychiatrists and their patients with an improved treatment option. We look forward to completing this trial by the end of the year which we believe will enable us to begin discussions with potential partners for rest-of-world development and commercialization."
Risperidone is one of the most widely prescribed medications used to treat the symptoms of schizophrenia in adults and teenagers 13 years of age and older. The global long-acting injectable antipsychotic market was approximately $2 billion in 2011, with currently approved products using a 21-gauge or larger needle for intramuscular injections. The leading product in the category requires twice-a-month dosing and drug reconstitution prior to use. The combined market for oral and injectable antipsychotic products was estimated at more than $16 billion in 2010.
Advanced Cell Technology, Inc. (OTCBB: ACTC), a leader in the field of regenerative medicine, today announced treatment of the fourth patient, the first in the second patient cohort, in its U.S. clinical trial for Stargardt’s Macular Dystrophy (SMD).
Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), a leading RNAi therapeutics company, and Ascletis Pharmaceuticals (Hangzhou) Co., Ltd.., a privately held US-China joint venture pharmaceutical company, announced today that they have formed a strategic collaboration for the development of ALN-VSP, a first-in-class, systemically delivered RNAi therapeutic for the treatment of liver cancers including hepatocellular carcinoma (HCC), a significant area of unmet need in China.
Amarantus BioSciences, Inc. (OTCBB: AMBS), a biotechnology company developing new treatments for human disorders including Parkinson's disease and Traumatic Brain Injuries (TBI) centered on its proprietary anti-apoptotic therapeutic protein known as MANF, today announced that its President & CEO Gerald E. Commissiong will be presenting a corporate overview today, July 12th, 2012, to be broadcast live from OneMedForum 2012 Conference at 11:20am ET from the Metropolitan Club in New York City.
BioClinica®, Inc. (NASDAQ: BIOC), a global provider of clinical trial management solutions, today announced that members of its team will attend, participate in and lead discussions at several upcoming industry conferences in July, August, and September.
Cubist Pharmaceuticals, Inc. (NASDAQ: CBST) today announced the initiation of its pivotal Phase 3 studies evaluating the efficacy and safety of CB-315 in patients with Clostridium difficile-associated diarrhea, or CDAD, with enrollment of a patient in the first of two planned identical global trials.
Cubist Pharmaceuticals, Inc. (NASDAQ: CBST) will issue its second quarter 2012 financial results at 4:00 p.m. ET on Thursday, July 19th, 2012.
eHealth, Inc. (NASDAQ: EHTH), the leading online source of health insurance for individuals, families, and small businesses, announced today that the company plans to release second quarter 2012 financial results on July 26, 2012.
EnteroMedics Inc. (NASDAQ: ETRM), the developer of medical devices using neuroblocking technology to treat obesity, metabolic diseases and other gastrointestinal disorders today announced that it has received $3.6 million from the exercise of 1,653,635 warrants through 2012 to date.
Fero Industries (OTCBB: FROI) (the "Company"), today announced that a majority of the Company's shareholders had approved the removal of two (2) board members, changing of the corporate name to PharmaRoth Labs, Inc., a roll back of a previous stock dividend, and the election of Luis Lopez as Chairman of the Board of Directors.
GeoVax Labs, Inc. (OTCQB: GOVX) (OTCBB: GOVX), an Atlanta-based biotechnology firm developing vaccines to prevent and treat Human Immunodeficiency Virus (HIV) infections, is presenting at the SeeThruEquity MicroCap Investor Forum taking place July 18 in New York City at The Cornell Club, located at 6 East 44th Street.
Hadasit Bio-Holdings Ltd. (OTC: HADSY, TASE: HDST) a publicly traded portfolio of biotech companies, all based on intellectual property developed and owned by Hadassah University Hospital, Israel's foremost medical research center, today announced its CEO, Ophir Shahaf, was interviewed by the Wall Street Reporter.
Medistem Inc. (PINKSHEETS: MEDS) announced today it has been chosen by the Romanian Cultural Association to give a keynote talk at its annual gathering in Hamilton, Canada.
Osiris Therapeutics, Inc. (NASDAQ: OSIR), the leading stem cell company, announced today that C. Randal Mills, Ph.D., President and Chief Executive Officer, is scheduled to present at the Seventh Annual JMP Securities Healthcare Conference on Friday, July 13, 2012 at 10:00 a.m. ET in New York City.
Pressure BioSciences, Inc. (OTCQB: PBIO) ("PBI" or the "Company") today announced a continuation in the growth of its global sales reach by entering into distribution agreements with three companies having combined sales coverage in six new countries.
PURE Bioscience, Inc. (NASDAQ: PURE), creator of the patented silver dihydrogen citrate (SDC) antimicrobial, today announced it has partnered with PRIDE Industries for distribution of the PURE Complete System throughout PRIDE’s extensive facilities services business segment.
Simulations Plus, Inc. (NASDAQ: SLP), a leading provider of simulation and modeling software for pharmaceutical discovery and development, today reported financial results for its third quarter of fiscal year 2012 ended May 31, 2012 (3QFY12).
Takeda Pharmaceuticals U.S.A. (TPUSA) and Affymax, Inc. (Nasdaq:AFFY) today announced that Takeda Pharmaceuticals America, Inc. (TPA) has entered into a supply agreement for sourcing and supply of OMONTYS® (peginesatide) Injection to Fresenius Medical Care North America and certain of its affiliates.
ThromboGenics NV (NYSE Euronext Brussels: THR), a biopharmaceutical company focused on developing innovative ophthalmic medicines, announces that it has received a transparency declaration from Fidelity Management & Research Company LLC in accordance with the Belgian Law of 2 May 2007 concerning disclosure of major holdings in issuers whose shares are admitted to trading on a Belgian regulated market.
Verastem, Inc., (NASDAQ: VSTM) a biopharmaceutical company focused on discovering and developing drugs to treat breast and other cancers by targeting cancer stem cells, announced a research collaboration with Eisai for the next-generation of small molecule Wnt inhibitors.
Verastem, Inc., (NASDAQ: VSTM) a biopharmaceutical company focused on discovering and developing drugs to treat breast and other cancers by targeting cancer stem cells, hosted its annual Research and Development Day where Robert Weinberg, Ph.D., Verastem co-founder and chair of the Scientific Advisory Board, gave a seminar on cancer stem cells.
Walgreens (NYSE: WAG) (NASDAQ: WAG) announced today, consistent with its board of directors succession and rotational planning process, the appointment of James A. Skinner, Walgreens board member since 2005 and recently retired McDonalds chief executive officer, as the new non-executive chairman of the board of Walgreens.
Take Care Health Systems, a division of Walgreens (NYSE: WAG) (NASDAQ: WAG), and the University of Notre Dame, today announced the opening of an on-site wellness center located on the Notre Dame campus.
World Health Energy Holdings, Inc. (OTCQB: WHEN), a public holding company developing joint venture partnerships for algae production for biodiesel and commercial fish food, announced today that it has begun testing its system for water purification.