Clinical Intelligence

Shire's SHP609 receives FDA Fast Track designation

Thursday, January 29, 2015 01:27 PM

The FDA has granted Fast Track designation for Shire’s SHP609 (idursulfase-IT; also known as HGT-2310) for the treatment of neurocognitive decline associated with Hunter syndrome (mucopolysaccharidosis II or MPSII).

More... »


FDA approves Natpara for blood calcium levels related to hypoparathyroidism

Thursday, January 29, 2015 01:15 PM

The FDA has approved Natpara (parathyroid horomone) to control hypocalcemia (low blood calcium levels) in patients with hypoparathyroidism, a rare disease that affects approximately 60,000 people in the U.S.

More... »


Genticel to continue per protocol its phase II study with ProCervix after review by DSMB

Thursday, January 29, 2015 10:54 AM

Genticel, a French biotechnology company and developer of therapeutic vaccines, has announced that the Data and Safety Monitoring Board (DSMB), an independent committee of experts which monitors safety data every six months during a study, met as scheduled on Jan. 22. It recommended the RHEIA-VAC study proceed without any modifications. The DSMB already had made the same recommendation during the first review on July 1, 2014.

More... »

CytRx announces FDA's removal of partial clinical hold for aldoxorubicin trials

Thursday, January 22, 2015 02:41 PM

CytRx, a biopharmaceutical R&D company specializing in oncology, has announced that the FDA has removed the partial clinical hold on the company's aldoxorubicin clinical trials. Enrollment and dosing of new patients now is permitted after study sites' Institutional Review Boards (IRBs) approve the revised trial protocols.

More... »

VolitionRx begins first ovarian cancer detection study

Thursday, January 22, 2015 02:39 PM

VolitionRx, a Belgium-based life sciences company focused on developing blood-based diagnostic tests for a broad range of cancer types and other conditions, has signed an agreement to commence a pilot ovarian cancer study in collaboration with Singapore General Hospital (SGH). Blood and tissue samples collected from 40 patients will be assessed to establish the feasibility of VolitionRx's proprietary NuQ assays in detecting ovarian cancer. If this test proves to be accurate, it could offer hope as an early-stage screening tool.

More... »

Celator Pharmaceuticals receives FDA Fast Track for CPX-351 for AML

Thursday, January 22, 2015 01:54 PM

The FDA granted Fast Track designation for Celator Pharmaceuticals’ CPX-351 (cytarabine:daunorubicin) for the treatment of elderly patients with secondary acute myeloid leukemia (AML).

More... »

TapImmune reports positive immune responses in phase I cancer trial

Friday, January 16, 2015 01:08 PM

TapImmune, an immunotherapy company, has reported the completion of data analysis from all 21 evaluable patients treated in a phase I clinical trial. In addition, the recent financing provides immediate, short term and long term access to the capital required to execute its exclusive option to license these very promising peptides and to progress its on-going clinical program into phase II trials.

More... »

Biotronik announces first enrollments in new thromboembolic events study

Friday, January 16, 2015 01:03 PM

Biotronik, a manufacturer of cardiovascular medical technology, has announced the first enrollments in its prospective, multi-center, international Reduce-TE Pilot study (Reduction of AF Ablation Induced Thrombo-Embolic Incidence). The study will assess the ability of the advanced irrigated ablation catheter AlCath Flux eXtra Gold to reduce the incidence of silent microemboli (SME). SME are a complication associated with catheter ablation of the pulmonary veins, a common treatment for atrial fibrillation (AF). The Biotronik ablation catheter features a GoldTip and a 3-D irrigation system which study investigators believe can diminish the number of SME via optimized cooling, thereby improving patient safety.

More... »

FDA approves VBLOC vagal blocking therapy for obesity

Friday, January 16, 2015 12:52 PM

The FDA has approved medical device company EnteroMedics’ VBLOC vagal blocking therapy, delivered via the Maestro System, for the treatment of adult patients with obesity who have a Body Mass Index (BMI) of at least 40 to 45 kg/m2, or a BMI of at least 35 to 39.9 kg/m2 with a related health condition such as high blood pressure or high cholesterol levels, and who have tried to lose weight in a supervised weight management program within the past five years.

More... »

Inovio Pharmaceuticals HIV immunotherapy shows vital characteristics

Thursday, January 8, 2015 02:28 PM

Inovio Pharmaceuticals has reported results from a 12-patient, phase I study of Inovio's HIV immunotherapy, PENNVAX-B, in HIV-infected patients revealed that immune response characteristics generated by the immunotherapy were similar to those observed in HIV-infected individuals who without treatment do not progress to further stages of the disease.

More... »

Subscribe to The CenterWatch Monthly
CWWeekly

January 26

2015 CRO outlook: M&As, IPOs, strategic partnerships and increased eClinical outsourcing expected to continue

IOM, industry stakeholders propose standards, guidelines for open sharing of clinical trial data

Already a subscriber?
Log in to your digital subscription.

Subscribe to CWWeekly.

The CenterWatch Monthly

January

All eyes on EMA’s adaptive licensing pilot
Sponsors could offer innovative drugs to patients 8 years sooner

Ice Bucket Challenge a boon for ALS research
Donations soar, but phenomenon difficult to replicate

Already a subscriber?
Log in to your digital subscription.

Purchase the October issue.

Subscribe to
The CenterWatch Monthly.

The CenterWatch Monthly

December

Growing adoption of feasibility review committees
Early reports cite fewer amendments, improved cycle time

AMCs vying to better compete for industry trials
Working to conquer study start-up delays, IRB review process

Already a subscriber?
Log in to your digital subscription.

Purchase the October issue.

Subscribe to
The CenterWatch Monthly.

JobWatch centerwatch.com/jobwatch

Featured Jobs