07:00 , Oct 21, 2013 |  BC Week In Review  |  Company News

Novartis musculoskeletal news

The U.S. Supreme Court refused to rehear an appeals court ruling that upheld that Novartis is responsible for punitive damages after failing to adequately warn about the risks of Zometa zoledronic and Aredia...
07:00 , Jul 21, 2011 |  BC Innovations  |  Distillery Therapeutics

Indication: Infectious disease

Indication Target/marker/pathway Summary Licensing status Publication and contact information Infectious disease Influenza virus Not applicable Mouse studies suggest bisphosphonates could help treat influenza A infection. In mouse...
08:00 , Nov 17, 2008 |  BC Week In Review  |  Clinical News

Aclasta regulatory update

FDA said that a review of data from nearly 40,000 patients in placebo-controlled trials of four marketed bisphosphonates showed no clear association between bisphosphonate exposure and the rate of atrial fibrillation (AF). The review followed...
08:00 , Jan 14, 2008 |  BC Week In Review  |  Clinical News

Aredia pamidronate regulatory update

Based on an ongoing review of post-marketing reports, FDA issued a warning to inform healthcare professionals and patients that treatment with bisphosphonates may result in severe and possibly incapacitating musculoskeletal pain. FDA said the association...
08:00 , Mar 6, 2006 |  BC Week In Review  |  Clinical News

Ganite gallium nitrate: Phase II data

In a double-blind Phase II trial in 64 patients, 69% of patients who received Ganite achieved normal calcium levels (normo-calcemia) vs. 56% of those who received Aredia. The difference was not significant. In patients...
08:00 , Dec 19, 2005 |  BC Week In Review  |  Clinical News

Thalomid thalidomide cancer data

Celgene Corp. (CELG), Summit, N.J.   Pharmion Corp. (PHRM), Boulder, Colo.   Product: Thalomid thalidomide   Business: Cancer   Molecular target: Unknown   Description: Small molecule alpha-(N-phthalimido) glutarimide immunomodulatory agent   Indication: Treat multiple myeloma (MM) following autologous transplant   Endpoint:...
07:00 , May 23, 2005 |  BC Week In Review  |  Clinical News

Aredia pamidronate regulatory update

NVS issued a "Dear Dental Healthcare Professional" letter and added a precaution to the label for Aredia pamidronate. The precaution describes osteonecrosis of the jaw (ONJ), which has been reported in cancer patients using the...
03:33 , Mar 3, 2005 |  BC Extra  |  Company News

ODAC to review Iressa status

FDA's Oncologic Drugs Advisory Committee will receive a briefing Friday from AstraZeneca (LSE:AZN; AZN) about preliminary data from a confirmatory trial in which Iressa gefitinib did not provide a survival benefit in non-small cell lung...
07:00 , Aug 2, 2004 |  BioCentury  |  Finance

CMS squeezes

CMS squeezes CMS squeezes Comparison of 2004 and 2005 reimbursement rates of frequently used drugs covered under Medicare's Part B program, using new average sales price (ASP) methodology. Part B drugs are furnished incident to...
07:00 , Aug 25, 2003 |  BioCentury  |  Regulation

CMS shopping list

CMS shopping list Drug Company Rank 2002 CMS charges ($M) (A) 2002 U.S. sales ($M) 2001 avg AWP Spread (B) Epogen epoetin alfa (C) Amgen ...