|Perrigo Announces FDA Final Approval and Launch of OTC Lansoprazole; Watson Confirms Patent Challenge|
|By Staff and Wire Reports|
|Friday, 18 May 2012 23:28|
Perrigo Company (Nasdaq: PRGO) announced it has received final approval from the U.S. Food and Drug Administration for its abbreviated new drug application (ANDA) for Lansoprazole capsules (15 mg). Shipments of product to customers have already begun.
This new product for the U.S. store brand market is bioequivalent to Novartis' Prevacid® 24HR capsules (15 mg) and is indicated for the treatment of frequent heartburn, which occurs two or more days in a week. Sales for Prevacid OTC were approximately $220 million.
Watson Pharmaceuticals, Inc. (NYSE: WPI) confirmed its subsidiary, Watson Laboratories, Inc., filed an Abbreviated New Drug Application (ANDA) with the U.S. FDA seeking approval to market Norethindrone Acetate/Ethinyl Estradiol and Ethinyl Estradiol and Ferrous Fumarate Tablets,1 mg/0.01 mg and 0.01 mg and 75 mg.
Watson's ANDA product is a generic version of Warner Chilcott Company LLC's Lo Loestrin^® Fe which is indicated for use by women to prevent pregnancy.
Advanced Cell Technology, Inc. (OTCBB: ACTC), a leader in the field of regenerative medicine, announced today that chairman and CEO Gary Rabin will be presenting at the World Stem Cells and Regenerative Medicine Conference, May 21-23, in London.
ArQule, Inc. (Nasdaq: ARQL) and Daiichi Sankyo, Co., Ltd. (TSE 4568) today announced that recruitment of patients has been completed in the randomized, double-blind, controlled Phase 3 MARQUEE pivotal trial of their investigational selective c-MET inhibitor, tivantinib, in combination with erlotinib in previously treated patients with locally advanced or metastatic, non-squamous, non-small cell lung cancer (NSCLC).
Biovest International, Inc. (OTCQB: BVTI), a majority-owned subsidiary of Accentia Biopharmaceuticals, Inc. (OTCQB: ABPI), today announced that an abstract reporting new data from the BiovaxID® Phase II mantle cell lymphoma clinical trial conducted by the U.S. National Cancer Institute (NCI) is now available on-line with the significance of these results to be presented by the NCI at the 2012 American Society of Clinical Oncology Annual Meeting (ASCO 2012).
Boston Scientific Corporation (NYSE: BSX) announces two-year results from the PLATINUM Small Vessel study, demonstrating excellent safety and effectiveness outcomes for the 2.25 mm PROMUS Element™ Everolimus-Eluting Platinum Chromium (PtCr) Stent System in treating de novo coronary lesions in small coronary vessels.
Boston Scientific Corporation (NYSE: BSX) announces that seven abstracts and additional clinical data analyses will be presented at Digestive Disease Week® (DDW), May 19 – 22 in San Diego.
Bruker Corporation (NASDAQ: BRKR) announced today that it will host its Inaugural Analyst Day on Friday, June 1st, from 8:30 a.m. to 11:30 a.m. Eastern Daylight Time, at the InterContinental New York Barclay Hotel, 111 East 48th Street, in New York City.
Cannabis Science, Inc. (OTCBB:CBIS) a pioneering U.S. biotech company developing pharmaceutical cannabis (marijuana) products, is pleased to voice our support for Gustin L. Reichbach, a justice of the State Supreme Court in Brooklyn NY.
Celldex Therapeutics, Inc. (Nasdaq: CLDX) will host a conference call at 4:30 P.M. Eastern Time on Wednesday, May 23, 2012 to announce interim, topline results of the Phase 2b EMERGE study of CDX-011 in patients with advanced breast cancer.
Champions Oncology Inc. (OTC: CSBR) announced today that it has received U.S. Clinical Laboratory Improvement Amendment (CLIA) certification from the Maryland Department of Health and Mental Hygiene Office of Health Care Quality required for the company to conduct medical laboratory tests.
Chembio Diagnostics, Inc. (OTCQB: CEMI) (PINKSHEETS: CEMI), which develops, manufactures, markets and licenses point-of-care diagnostic tests, today announced that the Company is a proud sponsor and Co-Chair Advocate for the 27th Annual AIDS Walk New York, which takes place this Sunday, May 20th and begins and ends in Central Park.
First China Pharmaceutical Group, Inc. (OTCBB: FCPG) ("First China" or the "Company"), a rapidly growing and technologically advanced pharmaceutical distribution company based in Yunnan, China, today announced its unaudited financial results for the three-month period ended March 31, 2012.
Forest Laboratories, Inc. (NYSE: FRX) and Almirall, S.A. (ALM.MC) today announced that they will present aclidinium-related data in 1 poster discussion session and 3 poster presentations at the American Thoracic Society (ATS) International Conference scheduled May 18 - 23 in San Francisco, CA.
Generex Biotechnology Corporation (OTCBB: GNBT) announced today that additional members have joined the Scientific Advisory Board (SAB) of its wholly-owned subsidiary, Antigen Express, Inc., for the company's AE37 breast cancer vaccine.
Intellect Neurosciences, Inc. (OTCPK: ILNS) announces that Dr. Daniel G. Chain, the company's chairman and CEO, will be presenting at the Seventh Annual Neurotech Investing and Partnering Conference.
Medgenics, Inc. (NYSE MKT: MDGN and AIM: MEDU, MEDG) (the “Company”), the developer of the novel Biopump™ technology for the sustained production and delivery of therapeutic proteins in patients using their own tissue, today announced that Andrew L. Pearlman, Ph.D., the Company’s President and CEO, will present a corporate overview at the 11th Annual Israeli Life Sciences Industry Biomed 2011 Conference taking place at the David Intercontinental Hotel in Tel Aviv, Israel from May 21-23, 2012.
Pfizer Inc. (NYSE: PFE) announced today the results of studies on Lyrica® (pregabalin) capsules CV presented at the American Pain Society Annual Meeting in Honolulu.
Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) today announced that numerous presentations and educational activities related to the investigation of several of the Company’s products or relevant disease states are scheduled to take place during Digestive Disease Week DDW® 2012. DDW 2012 is being held in San Diego, CA, Saturday, May 19 – Tuesday, May, 22.
Sequenom, Inc. (NASDAQ: SQNM), a life sciences company providing innovative genetic analysis solutions, today announced that a new publication from the large Women & Infants multi-center clinical study on the Sequenom Center for Molecular Medicine's (Sequenom CMM) MaterniT21 PLUS laboratory-developed test (LDT) has been published online in the peer-reviewed journal, Prenatal Diagnosis.
SpectraScience, Inc. (OTCQB: SCIE) (PINKSHEETS: SCIE), a San Diego based medical device company, is exhibiting its WavSTAT4 Optical Biopsy System at the Digestive Disease Week Conference (DDW) May 19-22, 2012 at the San Diego Convention Center.