SurModics Inc. (NSDQ:SRDX) named two board members put forth by its largest shareholder, New York-based investment firm Ramius LLC.
The Eden Prairie, Minn.-based company said it named Ramius managing director Jeffrey Smith and Wheatley Partners partner Dr. David Dantzker to the board effective immediately.
pSivida Corp. (NSDQ:PSDV) partner Alimera Sciences Inc. (NSDQ:ALIM) received a rejection letter from the Food & Drug Administration for their drug-device combination Iluvien.
The two companies are developing the system to treat diabetic macular degeneration. The investigational drug delivery system is designed for sustained release of Iluvien with an intra-vitreal insert.
Pulmatrix Inc. landed a $5.7 million contract from the Defense Advanced Research Projects Agency to develop a drug/device combination aimed at protecting military personnel and civilians against biological weapons.
DARPA selected the Lexington, Mass.-based company as part of its “7-day Biodefense Initiative,” a project to develop inhaled therapeutics for respiratory infections caused by airborne agents.
For companies like Medtronic Inc. (NYSE:MDT), developing breakthrough technologies to treat untreatable diseases can be expensive and have little promise of financial returns.
The risk is high enough for — even companies as well-resourced as Fridley, Minn.-based Medtronic — that alternative funding sources are welcomed and highly sought after.
pSivida Corp. (NSDQ:PSDV) sailed into the black with a 388 percent increase in revenues during the fourth quarter of fiscal 2010.
The Watertown, Mass.-based ophthalmic drug-delivery device maker posted net earnings of $13.1 million, or 68 cents per diluted share, on sales of $15.7 million during the three months ended June 30. That compares with a net loss of $534,000, or 3 cents per diluted share, on sales of $3.2 million during the same period last year.
Zogenix Inc. is attempting to raise $90 million through an initial public offering.
The San Diego-based company said it plans utilize the new funds to help commercialize its Sumavel DosePro drug-device combination and the clinical advancement of its ZX002 drug in a Securities & Exchange Commission filing.
The Food & Drug Administration put pSivida Corp. (NSDQ:PSDV) and Alimera Sciences Inc. (NSDQ:ALIM) on the fast track, granting an expedited review for their drug/device combination designed to treat diabetic macular edema.
Watertown, Mass.-based pSivida and Alpharetta, Ga.-based Alimera filed a new drug application with the FDA in June for Iluvien, a sustained release drug delivery system that delivers flucocinolone acetonide, a steroid, for the treatment of DME.
After raking in $33.8 million, Delcath Systems Inc. (NSDQ:DCTH) closed its public offering of 5.2 million shares.
According to a Securities & Exchange Commission filing, the New York-based company plans to use the proceeds from the sale to fund "clinical trials, research & development, obtaining regulatory approvals, manufacturing, operations, sales, commercialization of its products and other general corporate purposes including capital expenditures and working capital."
Echo Therapeutics Inc. (OTC:ECTE) announced the completion of a clinical trial of its Prelude SkinPrep transdermal drug delivery system, saying an application for 510(k) clearance from the Food & Drug Administration is imminent.
The Franklin, Mass.-based company launched the trial in April, in partnership with Ferndale Pharma Group Inc., to test the drug-device combination with Ferndale’s 4 percent topical lidocaine. The needle-free system ablates a thin layer of skin before a drug is applied.
pSivida Corp. (NSDQ:PSDV) is touting its inclusion on Russell Investment Group’s Microcap Index.
According to the Watertown, Mass.-based maker of eye therapy implants, their selection means automatic inclusion in the "appropriate growth and value style indexes."
