Cromos Pharma, where the patients are

FDA

FDA approves Cyramza for stomach cancer

Wednesday, April 23, 2014 02:23 PM

The FDA has approved Cyramza (ramucirumab) to treat patients with advanced stomach cancer or gastroesophageal junction adenocarcinoma, a form of cancer located in the region where the esophagus joins the stomach.

More... »

CRF Health eCOA webinar series

FDA proposes expedited access program for devices that address unmet needs

Wednesday, April 23, 2014 02:17 PM

The FDA has proposed a new program to provide earlier access to high-risk medical devices that are intended to treat or diagnose patients with serious conditions whose medical needs are unmet by current technology.

More... »


Report: Inventor incentives could spur medical innovation, cut spending

Wednesday, April 23, 2014 01:55 PM

To help rein in massive healthcare spending, a new RAND study concludes U.S. policymakers should urgently find ways to incentivize pharmaceutical companies and device makers to develop products that produce more value. RAND is a research organization that develops solutions to public policy challenges.

More... »

U.S. cancer researchers launching five-drug personalized medicines trial

Monday, April 21, 2014 01:12 PM

U.S. cancer researchers plan to launch a five-drug clinical trial for patients with advanced lung cancer in mid-May, in a public-private collaboration between several major cancer organizations and five pharmaceutical companies that marks the second American multi-drug research program into personalized medicines to treat different cancers.

More... »

GSK, Genmab receive FDA approval for Arzerra (ofatumumab) for CLL

Monday, April 21, 2014 09:27 AM

GlaxoSmithKline and Genmab have announced that the FDA has approved a Supplemental Biologic License Application (sBLA) for the use of Arzerra (ofatumumab), a CD20-directed cytolytic monoclonal antibody, in combination with chlorambucil for the treatment of previously untreated patients with chronic lymphocytic leukemia (CLL) for whom fludarabine-based therapy is considered inappropriate.

More... »

BioAlliance Pharma, Topotarget to merge

Wednesday, April 16, 2014 01:18 PM

BioAlliance Pharma, an innovative company specialized in developing drugs within orphan oncology diseases, and Topotarget, a Scandinavian-based biopharmaceutical company, intend to merge to create an orphan oncology company with highly complementary pipelines of late-stage products addressing significant unmet medical needs.

More... »

Trial results for AbbVie’s Hepatitis C candidate heat up race for effective treatment

Monday, April 14, 2014 12:51 PM

The race to replace interferon with a far more effective treatment for hepatitis C has become one of the most promising and lucrative battles in drug development, as AbbVie, Gilead Sciences, Merck and Bristol-Myers Squibb vie for the finish line.

More... »

HHS Secretary Sebelius, proponent of clinical research, resigns

Friday, April 11, 2014 03:33 PM

Health and Human Services Secretary Kathleen Sebelius—whose agenda included keeping clinical research a priority—has resigned on the heels of the Affordable Care Act (ACA) web site turmoil last October, even though more recently she had achieved the goal of 7.5 million registrations for coverage.

More... »

FDA approves expanded indication for certain pacemakers and defibrillators

Friday, April 11, 2014 01:38 PM

The FDA has approved an application from Medtronic for revised labeling for two cardiac resynchronization pacemakers (CRT-P) and eight cardiac resynchronization defibrillators (CRT-D), expanding the indication for use to patients with atrioventricular (AV) block and less severe heart failure.

More... »

Pharmacyclics files sNDa for IMBRUVICA

Friday, April 11, 2014 01:16 PM

Pharmacyclics has submitted a supplemental New Drug Application (sNDA) to the FDA, based on data from the randomized, multi-center, open-label phase III RESONATE study, PCYC-1112, a head-to-head comparison of single agent IMBRUVICA (ibrutinib) versus ofatumumab in 391 patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), who had received at least one prior therapy. IMBRUVICA is being jointly developed and commercialized by Pharmacyclics and Janssen Biotech.

More... »

CenterWatch Data Library
CLINICAL TRIAL RESOURCES

Search:

NEWS ONLINE ARCHIVE

Browse by:

CWWeekly

April 14

Proposal calls for back-to-back trials to measure efficacy and effectiveness prior to FDA approval

Study: Minority populations under-represented in cancer trials, but have higher rates of incidence

Already a subscriber?
Log in to your digital subscription.

Subscribe to CWWeekly.

The CenterWatch Monthly

April

Make way for mobile health in clinical trials
Despite patient retention, data quality benefits, regulatory hurdles persist

Global clinical trial laboratories decentralize
Regional labs reducing complexity, delivering cost and time savings

Already a subscriber?
Log in to your digital subscription.

Purchase the April issue.

Subscribe to
The CenterWatch Monthly.

The CenterWatch Monthly

March

Strategic alliances hit bumps in the road
Mixed relationship performance driving new approaches

Tapping community hospitals for clinical trial volunteers
New study finds high potential but infrastructure, resources are lacking

Already a subscriber?
Log in to your digital subscription.

Purchase the March issue.

Subscribe to
The CenterWatch Monthly.

JobWatch centerwatch.com/jobwatch

Featured Jobs