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Boston Scientific Announces FDA Approval of Stem Cell Drug; Osiris Receives ...
BioMedReports (subscription) - May 18, 2012 By Staff and Wire Reports Below is a look at some of the headlines for companies that made news in the healthcare sector on May 17, 2012.
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pSivida Corp. Announces Expiration of 2.7 Million Warrants
SunHerald.com - May 17, 2012 WATERTOWN, Mass. -- 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 expiration on May 15, 2012 of warrants to purchase 2735337 ...
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pSivida Corp. Announces Expiration of 2.7 Million Warrants
MarketWatch (press release) - May 17, 2012 WATERTOWN, Mass., May 17, 2012 (BUSINESS WIRE) -- 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 expiration on May 15, ...
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pSivida Corp. Reports Results for the Third Quarter Ended March 31, 2012
MarketWatch (press release) - May 9, 2012 WATERTOWN, Mass., May 09, 2012 (BUSINESS WIRE) -- 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 financial results for its third quarter ...
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Vertex Soars on Promising Drug Data; Arena Awaits FDA Advisory Meeting
BioMedReports (subscription) - May 8, 2012 By Staff and Wire Reports Below is a look at some of the headlines for companies that made news in the healthcare sector on May 7, 2012.
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pSivida Corporation nears sales of ILUVIEN® in the U.K. with granting of ...
Proactive Investors Australia - May 7, 2012 pSivida Corporation (ASX: PVA, NASDAQ: PSDV) has been granted marketing authorisation in the UK for its ILUVIEN® product for the treatment of vision impairment associated with chronic diabetic macular edema (DME).
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pSivida Corp. Announces United Kingdom Grants ILUVIEN® Marketing Authorization ...
SunHerald.com - May 7, 2012 WATERTOWN, Mass. -- 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 Medicines and Healthcare products Regulatory Agency of the United ...
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Alexza Receives Response Letter for Adasuve; Oxygen Secures Clinical Supply of ...
BioMedReports (subscription) - May 3, 2012 By Staff and Wire Reports Below is a look at some of the headlines for companies that made news in the healthcare sector on May 2, 2012.
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Company Profile
pSivida Corp., develops drug delivery products that are administered by implantation, injection or insertion. Once administered, the drug is released on a controlled and level basis for months or years.
lead development product ILUVIEN® is under FDA review for the treatment of Diabetic Macular Edema (DME). This delivery device is designed to provide sustained release of fluocinolone acetonide (FA) directly into the back of the eye for up to three years after a single injection. Three year safety and efficacy results from two independent Phase III clinical trials were submitted as part of the NDA in May 2011 and we anticipate a decision from the FDA in late 2011. ILUVIEN utilizes Medidur™, a third generation miniature sustained release drug delivery technology".
In June 2011 they commenced a phase I/II clinical trial study for a new bio-erodible drug delivery implant for the treatment of glaucoma and ocular hypertension via the delivery of Pfizer's latanoprost. pSivida has a worldwide collaborative research and license agreement with Pfizer Inc. to develop additional ophthalmic products. In the submission, Alimera requested priority review, which, if granted, could result in an action letter from the FDA in the fourth quarter of 2010. Alimera has also submitted a Marketing Authorization Application (MAA) to the Medicines and Healthcare Products Regulatory Agency (MHRA) in the United Kingdom (UK) for Iluvien. Applications have also been submitted in Austria, France, Germany, Italy, Portugal and Spain.
pSivida’s two FDA approved sustained release products to treat chronic back of the eye diseases are Retisert® for the treatment of posterior uveitis and Vitrasert® for the treatment of AIDS-related cytomegalovirus (CMV) retinitis. pSivida has licensed both of these products and the technologies underlying them to Bausch & Lomb Incorporated. Vitrasert and Retisert provide sustained release for six to nine months and two and a half years, respectively.
pSivida is developing a series of additional miniaturized, bioerodible technologies designed to provide long term (months and years) release to virtually any site in the body. One of these technologies is BioSilicon™, a bioerodible form of silicon. The most advanced BioSilicon product candidate, BrachySil™, is in a dose ranging clinical trial to treat pancreatic cancer. BrachySil is designed to deliver a therapeutic P32, a radioactive form of phosphorus used to treat cancer, directly to solid tumors to minimize side effects and maximize efficacy.have successfully conducted a dose ranging clinical trial in pancreatic cancer. The study was designed to determine the safety of escalating radiation doses of the BrachySil device, with tumor response as a secondary endpoint.
Finances:
Revenues for Jan-Mar 2011 quarter were $360,000 compared to $515,000 a year earlier. Revenues for the 2011 quarter consisted primarily of Retisert(R) royalty income, which resumed following completion of an earlier agreement with Bausch & Lomb.
The Company reported a net loss of $2.7 million, or $0.13 per share, for the third quarter ended March 31, 2011, compared to a net loss of $2.7 million, or $0.15 per share, for the third quarter of the prior year.
2010 June 30 Cash and cash equivalents and marketable securities totaled $23.1 million at March 31, 2011 compared to $14.6 million at December 31, 2010
The comapny is also NASDAQ listed as PSDV.
