Clinical Intelligence

AbbVie’s Venetoclax receives FDA Breakthrough Therapy designation for CLL

Thursday, May 7, 2015 12:54 PM

AbbVie has announced its investigational medicine venetoclax, an inhibitor of the B-cell lymphoma-2 (BCL-2) protein that is being developed in partnership with Genentech and Roche, has been granted Breakthrough Therapy designation by the FDA for the treatment of chronic lymphocytic leukemia (CLL) in previously treated (relapsed/refractory) patients with the 17p deletion genetic mutation.

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CytRx’s Aldoxorubicin shows improved QoL in chemotherapy resistant cancers

Monday, May 4, 2015 02:33 PM

CytRx, a biopharmaceutical R&D company specializing in oncology, has announced an interim analysis from its two ongoing phase Ib aldoxorubicin combination studies pairing aldoxorubicin with either gemcitabine or ifosfamide. Both studies combine standard doses of gemcitabine or ifosfamide with escalating doses of aldoxorubicin. The combinations appear to be well-tolerated, and even at the lowest dose level of aldoxorubicin (170mg/m2), impressive tumor responses have been observed so far in patients with bone cancer (osteosarcoma) and a variety of soft tissue sarcomas. As such, aldoxorubicin has the potential when used in combination with other cancer agents to become an important new weapon against chemotherapy resistant cancers.

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Phase I ALS trial shows positive results for stem cell therapy

Monday, May 4, 2015 12:58 PM

Hanyang University and Corestem, both in Seoul, South Korea, and Inje University College of Medicine in Busan released positive results in a phase I clinical trial for amyotrophic lateral sclerosis (ALS).

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The CenterWatch Monthly, May 2015

Friday, May 1, 2015 08:00 AM

Job satisfaction mixed as workload increases

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PTC Therapeutics' cancer stem cell program targeting BMI1 enters phase I

Thursday, April 30, 2015 11:45 AM

PTC Therapeutics has announced that its oncology program targeting BMI1, a protein linked to drug-resistant cancers, has entered a phase I study in patients with advanced solid tumors. The open-label, first-in-human study will investigate the safety and pharmacokinetics of PTC596, an orally available small molecule. PTC's BMI1 program is supported by a collaboration with the Wellcome Trust.

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Benitec Biopharma doses fifth patient, initiates additional trial site for hepatitis C trial

Thursday, April 30, 2015 11:41 AM

Benitec Biopharma, a Sydney, Australia-based biopharmaceutical company focused on providing potentially curative therapies with its proprietary gene-silencing technology called ddRNAi or "expressed RNAi,” has doesed the fifth patient in the company's first-in-man, phase I/IIa dose escalation clinical trial of TT-034 for hepatitis C virus (HCV) infection at the Duke Clinical Research Unit. The fifth patient is the third and final patient to be dosed in cohort two.

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FDA approves first generic Abilify to treat mental illnesses

Thursday, April 30, 2015 11:07 AM

Alembic Pharmaceuticals, Hetero LabsTeva Pharmaceuticals and Torrent Pharmaceuticals have received FDA approval to market generic Abilify (aripiprazole) in multiple strengths and dosage forms. Generic aripiprazole is an atypical antipsychotic drug approved to treat schizophrenia and bipolar disorder. 

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DanDrit Biotech USA, GISCAD Foundation form final collaboration agreement

Wednesday, April 29, 2015 12:08 PM

DanDrit Biotech USA, a biotechnology company developing a vaccine for the treatment of colorectal cancer, has signed a final collaboration agreement with GISCAD Foundation, an Italian group focused on digestive tract cancer studies.

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Mitotech releases positive phase II data of SkQ1 for dry eye

Friday, April 24, 2015 02:11 PM

Mitotech, a Luxembourg-based clinical-stage biotechnology company developing novel antioxidant molecules targeting mitochondria, has achieved significant positive results in its U.S. phase II clinical trial of SkQ1 compound in patients with moderate to severe dry eye syndrome. SkQ1 is a small molecule engineered specifically for reducing oxidative stress inside mitochondria, which proved to be effective in a topical ophthalmic formulation for treatment of dry eye syndrome.

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Biohaven to begin phase I study in 3Q2015, readying for phase III study start by 1Q2016

Friday, April 24, 2015 01:58 PM

Biohaven Pharmaceutical Holding is on schedule to initiate a phase I pharmacokinetic and biomarker study with its lead drug development candidate BHV-0223. Biohaven plans to initiate the trial no later than 3Q2015. After confirming projected drug exposure levels in the phase I study, Biohaven will move directly into a phase III registrational trial in affective disorders.

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CWWeekly

June 29

FDA and PatientsLikeMe collaborate to test social media adverse event reporting

Boston-area teaching hospitals launch web portal to attract life science companies

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The CenterWatch Monthly

July

Integrated research partnerships build momentum
Research function provides infrastructure, leverages large pool of health systems' patients and data

'Right to Try' laws challenge clinical trial process
20 states pass, 20 more pending allowing access to study drugs without FDA and IRB approval

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The CenterWatch Monthly

June

TransCelerate Biopharma turns three
High-profile consortium has made inroads fixing wasteful practices, but it still has more work ahead

Pharma industry improves its tarnished reputation
Delivering innovation, social responsibility will help rebuild trust

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