Theorem Clinical Research

Clinical Intelligence

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... »


Minomic to commence two trials of prostate cancer screening technology MiStat

Friday, April 11, 2014 12:28 PM

Private Australian biotechnology company Minomic International will launch two overseas trials of its MiStat prostate cancer screening test, following an agreement with CUSP Group, a uro-oncology trials management organization in the U.S.

More... »


FDA grants IND approval for CardioCell’s phase IIa itMSC Therapy trial

Wednesday, April 2, 2014 03:41 PM

CardioCell, a global biotechnology company, has just received the FDA’s Investigational New Drug (IND) approval for a U.S.-based, phase IIa clinical study using its allogeneic stem-cell therapy to treat subjects with chronic heart failure (CHF), which generates more than one million hospitalizations annually. Preparation is underway to initiate the study at Emory University, Northwestern University and the University of Pennsylvania in May 2014.

More... »

The CenterWatch Monthly, April 2014

Tuesday, April 1, 2014 09:06 AM

Make way for mobile health in clinical trials

More... »

FDA approves long-acting recombinant coagulation Factor IX concentrate for hemophilia B

Monday, March 31, 2014 01:10 PM

The FDA has approved Alprolix, Coagulation Factor IX (Recombinant), Fc Fusion Protein, for use in adults and children who have Hemophilia B. Alprolix is the first Hemophilia B treatment designed to require less frequent injections when used to prevent or reduce the frequency of bleeding.

More... »

Kite Pharma granted FDA Orphan Drug Designation for Anti-CD19

Monday, March 31, 2014 01:06 PM

Kite Pharma, a clinical-stage biotechnology company focused on developing engineered autologous T cell therapy (eACT) products for cancer, has announced that the FDA Office of Orphan Products Development (OOPD) granted Orphan Drug Designation for the company's lead investigational therapy, an autologous engineered T cell product that targets CD19 expression on B cell malignancies, for the treatment of diffuse large B cell lymphoma (DLBCL).

More... »

Janssen expands global cardiovascular research program with three new studies

Monday, March 31, 2014 12:56 PM

Janssen R&D is adding three new clinical trials to its EXPLORER global cardiovascular research program for XARELTO (rivaroxaban), a broadly indicated oral Factor Xa inhibitor. The additional trials will evaluate rivaroxaban for the treatment or prevention of deep vein thrombosis (DVT) and pulmonary embolism (PE) in pediatric and other patient populations, including those at risk for DVT or PE due to a concurrent medical illness. The new studies will include more than 11,000 patients in over 30 countries.

More... »

FDA approves Topamax for migraine prevention in adolescents

Monday, March 31, 2014 12:55 PM

The FDA has approved Topamax (topiramate) for prevention (prophylaxis) of migraine headaches in adolescents ages 12 to 17. This is the first FDA approval of a drug for migraine prevention in this age group. The medication is taken on a dailybasis to reduce the frequency of migraine headaches.

More... »

FDA approves Otezla to treat psoriatic arthritis

Friday, March 28, 2014 12:50 PM

The FDA has approved Otezla (apremilast) to treat adults with active psoriatic arthritis (PsA).

More... »

Mast Therapeutics initiates phase II study of MST-188 for acute limb ischemia

Friday, March 28, 2014 12:48 PM

Mast Therapeutics has initiated a phase II, clinical proof-of-concept study of MST-188 in combination with recombinant tissue plasminogen activator (rt-PA) in patients with acute lower limb ischemia.

More... »

Subscribe to The CenterWatch Monthly
CLINICAL TRIAL RESOURCES

Search:

NEWS ONLINE ARCHIVE

Browse by:

CWWeekly

October 20

Toronto Star, with FDA data, exposes weaknesses in Health Canada's clinical trial, inspection oversight

Crowdsourcing effort aims to fund updated online social media guide for sponsor interaction with patients

Already a subscriber?
Log in to your digital subscription.

Subscribe to CWWeekly.

The CenterWatch Monthly

September

Today's fastest, most economical sponsors
Standout sponsors reveal how they shorten regulatory, clinical cycle times

From the trenches: Sites' eye view of state of the industry
CW’s first site focus groups uncover frustration with 'progress,' but a passion for their mission

Already a subscriber?
Log in to your digital subscription.

Purchase the September issue.

Subscribe to
The CenterWatch Monthly.

The CenterWatch Monthly

August

Reality of costs and impact rain on Sunshine Act
Concerns mount over compliance burden on CROs, sponsors, unanticipated consequences for research

Cloud computing expanding into all areas of clinical trial conduct
Benefits outweigh the complexities, challenges of finding right vendors

Already a subscriber?
Log in to your digital subscription.

Purchase the August issue.

Subscribe to
The CenterWatch Monthly.

JobWatch centerwatch.com/jobwatch

Featured Jobs