|Gilead Submits NDA for Cobicistat; Mylan Confirms First-to-File Patent Challenge on Pristiq|
|By Staff and Wire Reports|
|Thursday, 28 June 2012 18:49|
Gilead Sciences, Inc. (Nasdaq: GILD) announced it has submitted a New Drug Application (NDA) to the U.S. FDA for marketing approval of cobicistat, a pharmacoenhancing or “boosting” agent that increases blood levels of certain commercially available protease inhibitors, including atazanavir and darunavir, in order to enable once-daily dosing.
Cobicistat is also a component of the Quad once-daily single tablet regimen for HIV, which is currently under U.S. and European regulatory review for treatment-naïve adult patients.
Mylan Inc. (Nasdaq: MYL) confirmed the company has been sued by Pfizer Inc., Wyeth LLC, Wyeth Pharmaceuticals Inc., and PF Prism C.V. in connection with the filing of an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) for Desvenlafaxine Succinate Extended-release Tablets, 50 mg and 100 mg. This product is the generic version of Pfizer's Pristiq® Tablets, which are indicated for the treatment of major depressive disorder (MDD) in adults.(1)
Mylan believes it is one of the first companies to have filed a substantially complete ANDA containing a Paragraph IV certification for both strengths and expects to share 180 days of marketing exclusivity upon final FDA approval. The plaintiffs filed the lawsuit in the U.S. District Court for District of Delaware.
For the 12 months ending March 31, 2012, Pristiq Tablets had total sales of approximately $559.4 million, according to IMS Health.
3SBio Inc. (NASDAQ: SSRX) ("3SBio" or "the Company"), a leading China-based biotechnology company focused on researching, developing, manufacturing and marketing biopharmaceutical products, today announced that the State Food and Drug Administration ("SFDA") has approved 3SBio's application to conduct the China arm of the multi-center phase III trial of voclosporin, a new generation calcineurin inhibitor licensed from Isotechnika Pharma Inc. ("Isotechnika") (TSX: ISA).
Abaxis, Inc. (NasdaqGS: ABAX), a company manufacturing point of care instrumentation and consumables for the medical, veterinary, and research markets, announced today that a leading international medical supplies sourcing and support company has entered into a definitive agreement with Abaxis to purchase up to 300 CLIA waived Piccolo Xpress Chemistry Analyzers.
ACCESS PHARMACEUTICALS, INC. (OTCBB: ACCP), a biopharmaceutical company developing treatments in areas of oncology and oncology supportive care, announced that Dr. Ron R. Allison of Carolina Radiation Medicine, Greenville, NC, presented results from its ongoing MuGard Phase 4 clinical trial in oral mucositis (OM) at the Multinational Association of Supportive Care in Cancer (MASCC) Conference in New York City.
Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZ) (the "Company") today announced that its Japanese partner Yakult Honsha ("Yakult") (Tokyo: 2267) has initiated a Phase 1 trial in multiple myeloma, a form of blood cancer, with perifosine, the Company's oral Akt/PI3K inhibitor drug.
Bayer HealthCare and Onyx Pharmaceuticals (NASDAQ: ONXX) announced today that the U.S. Food and Drug Administration (FDA) has granted priority review designation to Bayer HealthCare's New Drug Application (NDA) filed end of April 2012 for the oral multi-kinase inhibitor regorafenib, for the treatment of patients with metastatic colorectal cancer (mCRC) whose disease has progressed after approved standard therapies.
BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) today announced that Dr. William P. Sheridan, Senior Vice President and Chief Medical Officer plans to provide a corporate summary and update regarding the Company’s clinical programs at the 7th Annual JMP Securities Healthcare Conference in New York on Thursday, July 12, 2012 at 9 a.m. Eastern Time.
BioLineRx Ltd. (NASDAQ:BLRX) (TASE:BLRX.TA), a biopharmaceutical development company, today announced that its Chief Financial and Operating Officer, Philip Serlin, will be presenting at the 2012 Annual JMP Securities Healthcare Conference at the Peninsula Hotel in New York.
Dyax Corp. (NASDAQ:DYAX) will host a webcast and conference call, including an open question and answer session, Thursday, July 19, 2012. During the call, management will discuss the Company’s financial results for the second quarter ending June 30, 2012 and progress regarding its key value drivers - the KALBITOR® (ecallantide) business and angioedema franchise, as well as the Licensing and Funded Research Program (LFRP).
GenSpera, Inc. (OTCBB:GNSZ) announced that a study titled, “Engineering the Plant Product Thapsigargin into a PSMA-Activated Tumor Endothelial Cell Prodrug for Cancer Therapy,” was published in the journal, SCIENCE OF TRANSLATIONAL MEDICINE, on June 27, 2012 (http://stm.sciencemag.org/content/4/140/140ra86).
Hydromer, Inc. (OTCQB: HYDI) (PINKSHEETS: HYDI) and N8 Medical, Inc. have entered into a Supply and Support Agreement.
Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) will be presenting at the Seventh Annual JMP Securities Healthcare Conference on July 12, 2012, at 9:00 a.m. ET in New York City.
Lifeline Biotechnologies, Inc. (PINKSHEETS: LLBO) announces the USPTO has awarded US Patent #8,185,485 B2 for a Device for Analyzing Thermal Data Based on Breast Surface Temperature for the Detection for use in Determining Cancerous Conditions.
mPhase Technologies, Inc. (OTCBB: XDSL) said today that it is developing its launch strategy for its new automotive and marine product with an experienced marketing agency and launch firm.
Medical Marijuana Inc (OTC: MJNA) a leading hemp industry innovator, is pleased to update its shareholders on the status of its portfolio company, PhytoSPHERE Systems, LLC and related products.
The board of directors of Pfizer Inc. (NYSE: PFE) today declared a 22-cent third-quarter 2012 dividend on the company’s common stock, payable September 5, 2012, to shareholders of record at the close of business on August 3, 2012.
pSivida Corp. (NASDAQ: PSDV) (ASX: PVA), a leader in developing sustained release, drug delivery products for treatment of back-of-the-eye diseases, today announced the enrollment of the first patient in an investigator-sponsored clinical trial of its injectable sustained release device in posterior uveitis.
Response Genetics, Inc. (NASDAQ:RGDX), a company focused on the development and sale of molecular diagnostic tests for cancer, today announced a new anaplastic lymphoma kinase (ALK) testing program aimed to provide clinicians a more complete picture of the ALK rearrangement status of their non-small-cell lung cancer (NSCLC) patients.
Sucampo Pharmaceuticals, Inc. (NASDAQ: SCMP) today announced that Silvia Taylor has joined the company as Senior Vice President of Investor Relations, Public Relations, and Corporate Communications, reporting to Cary J. Claiborne, Chief Financial Officer.
Unigene Laboratories, Inc. (OTCBB: UGNE),a leader in the design, delivery, manufacture and development of peptide-based therapeutics, today announced that data from the Company's oral parathyroid hormone (PTH) analog Phase 2 proof-of-concept trial results will be part of two presentations by Dr. Lorraine Fitzpatrick, Medicine Development Leader for GlaxoSmithKline (GSK), at prestigious scientific conferences.
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 that the Company will host its annual Research and Development Day on Thursday, July 12, 2012, from 9:00am – 12:00pm (ET) at 215 First Street, Cambridge, MA, 02142.
Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) announced today final data from a Phase 2 study of VX-809 and KALYDECO™ (ivacaftor) that showed statistically significant improvements in lung function among adults with cystic fibrosis (CF) who have two copies (homozygous) of the most common mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene, F508del.
WuXi PharmaTech (NYSE: WX), a leading pharmaceutical, biotechnology and medical device R&D services company with operations in China and the United States, announced that it has been selected as one of the Top Ten Outsourcing Enterprise in China for 2012 by China's Ministry of Commerce (MOC).