News 
Market Data 
Discover
Replies to post #185466 on Biotech Values
01/12/15 2:56 PM
02/17/15 2:00 PM
Teva Pharmaceutical Industries Ltd. and Eagle Pharmaceuticals, Inc. today announce that the companies have entered into an exclusive license agreement for EP-3102, Eagle’s bendamustine hydrochloride (HCl) rapid infusion product for the treatment of chronic lymphocytic leukemia (CLL) and indolent B-cell non-Hodgkin lymphoma (NHL).
Teva will be responsible for all U.S. commercial activities for the product including promotion and distribution. Eagle has responsibility for obtaining all regulatory approvals, conducting post-approval clinical studies, if required, and initially supplying drug product to Teva.
Eagle has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the rapid infusion bendamustine product for the treatment of patients with CLL and patients with indolent B-cell NHL that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen. Eagle has requested Priority Review of the NDA; this product candidate has received Orphan Drug Designations for both CLL and indolent B-cell NHL, and therefore may be eligible for seven years of exclusivity upon approval. The NDA is supported by data from Eagle’s recently-completed clinical trials demonstrating that the rapid infusion bendamustine HCl product can be administered in ten minutes in a low-volume, 50 mL admixture.
…As part of the agreement, Teva will waive its orphan drug exclusivities for NHL and CLL with respect to EP-3102, which should allow the product to come to market more quickly. Under the terms of the exclusive license agreement, Eagle will receive an upfront cash payment of $30 million and is eligible to receive up to $90 million in additional milestone payments. In addition, Eagle will receive double-digit royalties on net sales of the product, assuming FDA approval.
02/19/15 10:30 AM
Adage Capital Management, L.P. ("Adage"), Broadfin Capital LLC, Sectoral Asset Management, Cormorant Asset Management and certain funds and accounts managed by T. Rowe Price Associates, Inc. participated in this financing along with another institutional investor. Following the close of the transaction, Adage will own approximately 19% of the outstanding shares of Advaxis. Proceeds from this financing will be used primarily to fund the continued clinical development of Advaxis's cancer immunotherapy pipeline.
03/10/15 11:08 AM
Pending the FDA's acceptance of the IND application, the Company plans to initiate a clinical study evaluating the safety and efficacy of AGTC's proprietary gene therapy for treating XLRS during the second quarter of 2015 and expects to have initial data during the second half of 2015.
XLRS is an inherited retinal disease caused by mutations in the RS1 gene, which encodes the retinoschisin protein. XLRS is characterized by abnormal splitting of the layers of the retina, resulting in poor visual acuity in young boys, which can worsen as the patients age. There are currently no approved treatments for XLRS.
03/13/15 9:17 AM
03/16/15 4:08 PM
03/17/15 4:18 PM
03/21/15 5:16 PM
03/30/15 10:05 AM
04/08/15 10:40 AM
05/04/15 11:37 AM
05/05/15 4:24 PM
05/18/15 10:05 AM
