pSivida Set to File 3-year Durasert NDA
pSivida Corp. this month expects to file a New Drug Application with the Food and Drug Administration for its Durasert implant for three-year treatment of noninfectious uveitis. pSivida said that the FDA had granted its request for a small business waiver of the Prescription Drug User Fee Act (PDUFA) fee of approximately $2.4 million for the NDA. Durasert releases the corticosteroid fluocinolone acetonide over a prolonged period.
Ophthalmology at Biotech Showcase
pSivida Corp. will be one of the 327 companies making presentations at the 10th Annual Biotech Showcase starting Sunday, January 7, and concluding Wednesday, January 10, at the Hilton Union Square in San Francisco. Other ophthalmology players scheduled to present are Acucela, which is developing a variety of therapies for retinal disease, cataract, and presbyopia; and Eleven Biotherapeutics Inc., which has partnered with Roche to develop EBI-031 for treatment of diabetic macular edema.
Ophthalmology at J.P. Morgan Conference
Ophthalmology companies will be appearing just up the street on San Francisco’s Main Stage at J.P. Morgan’s 36th Annual Healthcare Conference at the Westin St. Francis on Union Square. Ophthalmology players are stacked on the agenda on opening day, Monday, January 8, starting with Mallinckrodt Pharmaceuticals. Mark Trudeau, president and CEO, and Matthew Harbaugh, executive vice president and CFO, will represent the company with a presentation at 7:30 a.m. Pacific Standard Time (PST), followed by a question-and-answer session from 8 to 8:25 a.m.
A few hours later, at 11:30 a.m. PST, Regeneron Pharmaceuticals is scheduled to present. The presentation and a breakout session to immediately follow can be accessed through Regeneron’s website. Biogen Inc., which is developing XLRS gene therapy for x-linked retinoschisis with AGTC, will present at 2:30 p.m. PST, with the live webcast available at www.biogen.com/investors. Then at 3 p.m., Allergan chairman and CEO Brent Saunders will deliver his company’s presentation to the group. The presentation will be webcast live and can be accessed on Allergan’s Investor Relations website at www.allergan.com/investors. Glaukos Corp. will present at 9 a.m. PST on Wednesday, January 10, at the conference. A live audio webcast will be available in the Investors section of the Glaukos website at http://investors.glaukos.com.
More than 400 public and private companies are scheduled to deliver presentations to more than 8,000 attendees at the J.P. Morgan conference, which runs through Thursday, January 11.