|Warner Chilcott Says FDA Has Approved MINASTRIN 24 FE; ViroPharma Says Phase 2 Study of VP20621 Resulted In High Rates Of Colonization|
|By Staff and Wire Reports|
|Monday, 22 April 2013 18:55|
Warner Chilcott plc (Nasdaq: WCRX) announced that the United States FDA has approved MINASTRINTM 24 FE (norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules) for the prevention of pregnancy. MINASTRIN 24 FE is manufactured for Warner Chilcott by a third party.
The Company does not expect to be in a position to commercially launch MINASTRIN 24 FE during 2013.
ViroPharma Incorporated (Nasdaq: VPHM), an international biopharmaceutical company committed to developing and commercializing innovative products that address unmet medical needs and rare diseases, announced the results of a Phase 2 study of VP20621 (non-toxigenic Clostridium difficile; NTCD) a novel treatment approach for preventing recurrent C. difficile infections (CDI). CDI is a common and dangerous gastrointestinal infection typically occurring in older adults after use of antibiotic medications. VP20621 contains the spores of a naturally occurring non-toxin producing strain of C. difficile.
In this study of 168 patients who were randomized and dosed following antibiotic treatment for CDI, VP20621 was well tolerated, with mild-moderate headache the only notable associated adverse event reported by 10 percent of subjects compared to 2 percent on placebo. Viable non-toxigenic C. difficile was detected in stool culture (the primary endpoint of the study) in 54 percent of subjects treated with the low dose of VP20621 and up to 79 percent of those receiving the high dose. In addition, across all dose groups, VP20621 reduced the incidence of CDI recurrence (a secondary endpoint of the study) by greater than or equal to 50 percent vs. placebo, with a similar reduction in antibacterial treatment for CDI vs. placebo in this study. The CDI recurrence rate was two percent (2/86) in the subgroup of patients successfully colonized with VP20621.
3SBio Inc. (NASDAQ: SSRX), a leading China-based biotechnology company focused on researching, developing, manufacturing and marketing biopharmaceutical products, today announced that the independent committee of its board of directors (the "Independent Committee") has received a proposal letter (the "Proposal Letter") dated April 22, 2013 from Dr. Jing Lou, the Company's Chairman and Chief Executive Officer ("Dr. Lou"), and CPEChina Fund, L.P., an exempted limited partnership registered under the laws of the Cayman Islands and a China-focused private equity fund associated with CITIC Private Equity Funds Management Co. Ltd. ("CITIC PE"), in connection with the proposed merger under the agreement and plan of merger dated as of February 8, 2013, by and among the Company, Decade Sunshine Limited ("Parent") and Decade Sunshine Merger Sub (the "Merger Agreement").
Advaxis, Inc., (OTCBB: ADXS), a leader in developing the next generation of immunotherapies for cancer and infectious diseases, announced that the first patient has been dosed in a Phase 1/2 study of ADXS-HPV in 25 patients with HPV-associated anal cancer coordinated by the Brown University Oncology Research Group (BrUOG).
Advaxis, Inc., (OTCBB: ADXS), a leader in developing the next generation of immunotherapies for cancer and infectious diseases, announced that it has entered into a Memorandum of Understanding (MoU) with FusionVax, Inc. (“FusionVax”) setting forth the main terms under which Advaxis will, subject to the entry of a definitive agreement, exclusively license its lead clinical stage product candidate, ADXS-HPV, to FusionVax for Asia.
ARCA biopharma, Inc. (Nasdaq: ABIO), a biopharmaceutical company developing genetically-targeted therapies for cardiovascular diseases, today announced that it has entered into an agreement with Medtronic, Inc. (NYSE:MDT), a leader in medical technologies to improve the treatment of chronic diseases, including cardiac rhythm disorders, to collaborate on ARCA’s proposed clinical trial, known as GENETIC-AF, of its lead developmental drug Gencaro (bucindolol hydrochloride).
Cabot Corporation (NYSE: CBT) announces Wendy Pryce Lewis will be honored by Mass High Tech as one of the 2013 Women to Watch at an awards ceremony to be held at the Westin Boston Waterfront Hotel in Boston on May 9.
CorMedix Inc. (NYSE MKT: CRMD), a pharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of cardiorenal disease, received a notice from the NYSE MKT that the NYSE-MKT has accepted CorMedix’s plan to regain compliance with Section 1003(a)(iv) of the continued listing standards of the NYSE-MKT and granted CorMedix an extension until June 30, 2013 to regain compliance.
PDL BioPharma, Inc. (PDL) (NASDAQ: PDLI) and Avinger, Inc. announced today that they closed a structured financing and royalty transaction on April 18, 2013, in which PDL will provide Avinger with up to $40 million of financing.
Elan Corporation, plc (NYSE: ELN) (Elan) today announced that its Board of Directors, after careful review and consideration and with the assistance of its executive management team as well as outside financial and legal advisors, has determined that privately held investment firm Royalty Pharma's offer, through its shell subsidiary Echo Pharma Acquisition Limited, to acquire all of the shares of Elan for $11.25 or less per share, substantially undervalues the company.
iBio, Inc. (NYSE MKT: IBIO) today announced the achievement of a critical technology transfer milestone verified by an independent third party laboratory. The validation milestone comprised proof that an independent party, without guidance or assistance from iBio, could use the iBioLaunch™ system to reliably replicate production of commercial yields of targeted biopharmaceuticals including vaccines and therapeutics.
Metabolix, Inc. (NASDAQ: MBLX), an innovation-driven bioscience company focused on delivering sustainable solutions for plastics, chemicals and energy, today announced that its researchers will make technical presentations at the ANTEC Conference being held April 22-25 in Cincinnati, Ohio.
Merck (NYSE:MRK) today announced it has entered into a non-exclusive agreement with Bristol-Myers Squibb to conduct a Phase II clinical trial to evaluate the safety and efficacy of a once-daily oral combination regimen consisting of Bristol-Myers Squibb’s investigational NS5A replication complex inhibitor daclatasvir and Merck's investigational NS3/4A protease inhibitor MK-5172 for the treatment of chronic hepatitis C virus (HCV) infection, genotype 1.
MiMedx Group, Inc. (OTCBB: MDXG), an integrated developer, manufacturer and marketer of patent protected regenerative biomaterials and bioimplants processed from human amniotic membrane, announced today that its common stock has been approved for listing on The NASDAQ Capital Market under the ticker symbol "MDXG."
MMRGlobal, Inc. (OTCQB: MMRF) today announced that the Australian Patent Office has issued a Notice of Allowance (NOA) for the Company's anti-CD20 monoclonal antibody assets, #2007338607, under the title, "Antibodies and Methods for Making and Using Them." The patent application was originally filed on September 14, 2007.
Goldman Small Cap Research, a stock market research firm focused on the small cap and micro cap sectors, has released a research report which highlights the valuation for the medical marijuana segment of Nuvilex, Inc. (OTCQB: NVLX).
Ohr Pharmaceutical Inc. (OTCQB: OHRP), a pharmaceutical company focused on the development of novel therapeutics for unmet medical needs, today announced that Ohr raised approximately $5.05 million dollars from institutional and accredited shareholders through the exercise of Series B Warrants.
Oramed Pharmaceuticals Inc. (NASDAQCM: ORMP) (http://www.oramed.com), a developer of oral delivery systems, announced today that the Company's CEO Nadav Kidron has been invited to be a panelist for a breakouts session at the BIO International Convention in Chicago, Illinois, USA.
Orexigen® Therapeutics, Inc. (Nasdaq: OREX), a biopharmaceutical company focused on the treatment of obesity, announced today that Michael Narachi, president and chief executive officer, has been named to the Board of Directors of the Pharmaceutical Research and Manufacturers of America (PhRMA). Narachi will serve as a director for a term of two years.
Senesco Technologies, Inc. (OTC QB: SNTI) reported today that it has completed cohort 2 in its Phase 1b/2a clinical study of SNS01-T.
Synta Pharmaceuticals Corp. (NASDAQ: SNTA) announced today that the first patients have been treated in the randomized GALAXY-2 Phase 3 trial designed to evaluate docetaxel plus ganetespib, its investigational Hsp90 inhibitor, versus docetaxel alone for the second-line treatment of non-small cell lung adenocarcinoma.
With allergy season underway and experts predicting a longer and more intense season, a new survey from Target Corp. (NYSE: TGT) finds that nearly seven out of 10 adult Americans suffer from spring allergies and more than half (56 percent) of sufferers are seeking advice from a pharmacist or doctor.
Titan Medical Inc. (TSX VENTURE:TMD) (OTCQX:TITXF) today announces that it has successfully completed the design and fabrication of beta versions of its highly dexterous instruments for use with the Company's Single Incision robotic surgical system.
TNI BioTech, Inc. (OTC Pink: TNIB) (www.tnibiotech.com), announced it has filed its Form 10 to become a fully reporting public company with the Securities and Exchange Commission.