Pacira posts Phase 3 nerve block study; completes EXPAREL pilot hernia study. Pacira has posted the design and is about to begin a Phase III nerve block study with EXPAREL in patients undergoing thoracic surgery. The trial will enroll 180 patients and data collection is due by August. Nerve block is the next major market for[…]
Coronado announced the initiation of an investigator-sponsored pilot study to evaluate CNDO-201 (TSO) for the treatment of moderate-to-severe psoriasis. This is first new TSO study since Harlan Weisman joined the Company as CEO in early January. As a reminder, Weisman led the development of Remicade, JNJ’s best-selling product and approved for several of the same indications[…]
The Orphan Drugs Leader. With 2012 exceeding $500 million, BioMarin has vaulted itself into an elite group of the top-tier biotech companies. Naglazyme ($257 million, +14% Y/Y) and Kuvan ($143 million, +23%) each had solid years and royalties from Aldurazyme ($80 million, +6%) continue to deliver strong cash flow. With a truly impressive pipeline filled[…]
GSK Begins Pivotal Trial For ISIS-TTR. The company earned a $7.5 million milestone payment from their partner, GlaxoSmithKline (GSK), on the initiation of a Phase II/III trial for ISIS-TTR. ISIS-TTR is an antisense drug development candidate for the treatment of transthyretin (TTR) amyloidosis, a severe and rare genetic disease characterized by progressive dysfunction of peripheral[…]
March 1, 2013 Below is a pdf for Issue 749 of the Medical Technology Stock Letter. [gview file=”http://www.bioinvest.com/wp-content/uploads/2013/03/MTSL-749-March-1-2013C.pdf” save=”1″]
Roche received FDA approval for IMGN’s T-DM1 (Kadcyla) for the treatment of late-stage metastatic breast cancer patients who fail to respond to Herceptin and taxol. While this was a widely expected approval, it represents a significant milestone for IMGN as this is their first drug approval. The company will receive a $10.5 million milestone payment[…]
Abbott To Develop Diagnostic for p17 del Gene in High-Risk CLL for PCYC/JNJ â Abbott Labs announced that it would collaborate with PCYC and JNJ to develop a companion diagnostic test using their FISH technology to identify patients with high-risk CLL patients that present with a deletion of the p17 chromosome. As a reminder, ibrutinib[…]
PCYC held its quarterly call this week, two days after announcing the receipt of a “Breakthrough Therapy Designation” from the FDA for ibrutinib in refractory MCL/WM. The plethora of positive data continues to build for ibrutinib, and management confirmed the NDA filing for relapsed/refractory MCL by year-end. No one knows exactly what the new designation[…]
ISIS Starts Phase II Study for ISIS-CRP. ISIS also initiated Phase II trials with ISIS-CRP, which targets C-reactive protein (CRP), which is elevated in many inflammatory diseases, in patients with atrial fibrillation (AF). The goal is to reduce the frequency of AF episodes and provide proof-of-principle for CRP as a drug development target. In addition, ISIS[…]
CNDO signed an R&D, joint ownership and exclusive license agreement with Freie Universität Berlin for the identification and evaluation of secretory proteins from Trichuris suis. By collaborating with Dr. Susanne Hartman, one of the world leaders in parasitology, the deal extends Coronadoâs research into TSO (Trichuris suis ova or CNDO-201). Preclinical models will further explore the[…]
“Celgene Announces Accelerated $600 Million Share Repurchase Program” In a clear sign of optimism about its corporate outlook, CELG today announced it would accelerated share repurchases of $600 million of the companyâs common stock, representing approximately 1.4% of shares outstanding. The long-awaited PFS data for the Revlimid MM-020 trial is due end-Q2/early Q3. With renewed growth[…]
Incyte’s Q4:12 results exceeded Wall Street’s expectations, driving the stock up 10%. Sales of Jakafi were strong, but more importantly, the Company’s guidance for 2013 was impressive and could prove conservative. It appears new COO Jim Daly, who joined INCY in October from Amgen, is having a very positive impact, effectively educating physicians of the[…]
