|pSivida Announces NDA Resubmission for ILUVIEN; Rockwell Issues Calcitriol Data for Approval|
|By Staff and Wire Reports|
|Monday, 01 April 2013 19:23|
pSivida Corp. (NASDAQ: PSDV), a specialty pharmaceutical company which is a leader in the development of sustained release ophthalmic drug treatments, announced that its licensee Alimera Sciences, Inc. reported the submission of its response to the second Complete Response Letter from the U.S. Food and Drug Administration (FDA) with respect to ILUVIEN® for chronic diabetic macular edema (DME).
Alimera reported in its 10-K filing that it submitted the response, which includes additional analyses of the risks and benefits of ILUVIEN based on the clinical data available from the previously completed Phase III studies (FAME), following a meeting with the FDA in the second quarter 2012. Alimera said that the resubmission focuses on the safety aspects of ILUVIEN and the population of patients with chronic DME. This is the same group for which marketing approval of ILUVIEN has been granted in six EU countries thus far. Alimera reported that it will communicate the Prescription Drug User Fee Act (PDUFA) date once it is known from the FDA and that Alimera does not plan to conduct additional trials for ILUVIEN for DME at this time.
pSivida is entitled to the same net profit share on sales of ILUVIEN for DME by Alimera in the EU. Alimera has announced its intent to commercially launch ILUVIEN in Germany and for private patients in the UK in the second quarter of 2013, upon approval of the commercial batch size.
Rockwell Medical, Inc. (NASDAQ: RMTI), a fully-integrated biopharmaceutical company targeting end-stage renal disease (ESRD) and chronic kidney disease (CKD) with innovative products and services for the treatment of iron deficiency, secondary hyperparathyroidism and hemodialysis, announced today they have submitted data to the FDA for approval to manufacture Calcitriol, the Company's injectable active vitamin D drug.
Actavis, Inc. (NYSE: ACT) today confirmed that it has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market Testosterone Gel, 1.62%.
Adherex Technologies Inc. (TSX:AHX) (OTCQB:ADHXF), provided an update on recent progress with its clinical programs and reported financial results for the fiscal year ended December 31, 2012. All amounts are in U.S. dollars unless otherwise specified.
Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) announced today that Eisai Laboratorios S. de R.L. de C.V., a subsidiary of Eisai Inc., has submitted a marketing authorization application (MAA) for BELVIQ®(lorcaserin HCl) in Mexico with the Federal Commission for the Protection Against Sanitary Risk (COFEPRIS).
ArQule, Inc. (NASDAQ: ARQL) today announced it has regained worldwide rights for the development and commercialization of compounds covered under its AKT collaboration with Daiichi Sankyo Co., Ltd., including the lead compound emerging from this collaboration, ARQ 092.
BioLife Solutions, Inc. (OTCQB: BLFS), a leading developer, manufacturer and marketer of proprietary clinical grade hypothermic storage and cryopreservation freeze media for cells and tissues, and contract aseptic media manufacturer, today announced financial results for the fourth quarter and year ended December 31, 2012.
Cryoport, Inc. (OTCBB: CYRX) today announced it has appointed Richard G. Rathmann to its Board of Directors.
DelMar Pharmaceuticals, Inc. (OTCQB: DMPI) ("DelMar") today announced that the company would present an abstract entitled "A Phase I/II study of VAL-083 in patients with recurrent malignant glioma or secondary brain tumor" at the American Association of Cancer Research (AACR) Annual Meeting, which is being held April 6 – 10, 2013 in Washington D.C., USA.
Derma Sciences, Inc. (Nasdaq: DSCI), a medical device and pharmaceutical company focused on advanced wound care, today reported financial and operating results for the fourth quarter and year ended December 31, 2012.
Derma Sciences, Inc. (Nasdaq: DSCI), a medical device and pharmaceutical company focused on advanced wound care, announced today that it has signed a long-term exclusive global rights agreement with New Cast Industries Co. Ltd. of Korea for the casting element within the TCC-EZ® total contact casting system.
Ferro Corporation (NYSE: FOE) announced today that it has completed the sale of its pharmaceuticals business, Pfanstiehl Laboratories, to PLI Holdings, Inc., an affiliate of Med Opportunity Partners, LLC.
Hansen Medical, Inc. (NASDAQ: HNSN), a global leader in intravascular robotics, today announced it will showcase its Magellan™ Robotic System at the 35th Annual Charing Cross International Symposium from April 6-9 in London.
Ingen Technologies, Inc. (PINKSHEETS: IGNT) is pleased to announce that is currently negotiating terms to merge with ATMC, Inc., a seasoned and licensed telecommunications company in the multi-billion dollar telecommunications market.
Laboratory Corporation of America® Holdings (LabCorp®) (NYSE:LH) today announced that LabCorp Clinical Trials has been selected as a preferred provider for full-service global central laboratory services and biomarker testing by Bristol-Myers Squibb Company (NYSE: BMY).
Laboratory Corporation of America® Holdings (LabCorp®) (NYSE: LH) announced today the availability of an expanded testing menu to help clinicians diagnose, treat and monitor the course of Inflammatory Bowel Disease (IBD).
La Jolla Pharmaceutical Company (OTCQB: LJPC) (the "Company" or "La Jolla"), a leader in the development of therapeutics targeting galectin-3, announced fourth-quarter and full-year 2012 financial results and highlighted recent corporate progress.
As the global market leader in human identification, Life Technologies Corporation (NASDAQ: LIFE) announced today it signed a global exclusive agreement with LGC Forensics for the right to distribute ParaDNA®, a portable rapid DNA system that determines the quality of human DNA faster and more economically than any existing method.
Merck (NYSE: MRK), known as MSD outside the United States and Canada, will hold its first-quarter 2013 sales and earnings conference call with institutional investors and analysts at 8:00 a.m. EDT on Wednesday, May 1.
MMRGlobal, Inc. (OTCQB: MMRF) ("MMR"), a leading provider of Personal Health Records ("PHRs"), MyEsafeDepositBox storage solutions and electronic document management and imaging systems for healthcare professionals, today announced that based on interest in licensing its growing patent portfolio in advance of patient engagement requirements under Stage 2 Meaningful Use to be implemented by January 1, 2014.
Nuvilex, Inc. (OTCQB: NVLX) CEO, Dr. Robert Ryan knew exactly what he was doing two years ago when he announced Dr. Gerald Crabtree would be joining his team as the company's Chief Operating Officer (COO).
Onyx Pharmaceuticals, Inc. (NASDAQ: ONXX) today highlighted the presentation of three studies, among several, from its proteasome inhibitor franchise at the 14th International Myeloma Workshop (IMW), April 3-7, 2013, in Kyoto, Japan.
Opexa Therapeutics, Inc. (NASDAQ: OPXA), a leader in developing a patient specific T-cell immunotherapy for multiple sclerosis (MS) is pleased to announce the strengthening of its management team through the appointment of several key individuals.
Proteonomix, Inc. (OTC: PROT), a biotechnology company focused on developing therapeutics based upon the use of human cells and their derivatives, today announced that it has settled investor litigation upon the following terms and conditions.
Regulus Therapeutics Inc. (NASDAQ: RGLS), a biopharmaceutical company leading the discovery and development of innovative medicines targeting microRNAs, announced today that it has appointed William H. Rastetter, Ph.D. to its Board of Directors effective immediately.
Rosetta Genomics Ltd. (NASDAQ: ROSG), a leading developer and provider of microRNA-based molecular diagnostics, announces that a manuscript regarding the development and validation of the Company's microRNA-based diagnostic assay for the classification of renal cell tumors has been accepted for publication by Molecular Oncology.
Tengion, Inc. (OTCQB: TNGN), a leader in regenerative medicine, today announced the acceptance of the Company's Clinical Trial Application (CTA) filed with the Medical Products Agency (MPA) in Sweden to initiate a Phase 1 clinical trial to evaluate the safety and delivery of its Neo-Kidney Augment™ product in up to five patients with advanced chronic kidney disease (CKD).
ULURU Inc. (OTCQB: ULUR) today announced its financial results for the fourth quarter and year ended December 31, 2012 and provided a review of its operating activities.