Clinical Intelligence

Abeona Therapeutics receives FDA Orphan Drug Designations for Sanfilippo

Wednesday, May 14, 2014 02:54 PM

Abeona Therapeutics, a start-up company created around intellectual property licensed from Nationwide Children's Hospital to develop treatments for Sanfilippo Syndrome Types A and B, has been granted Orphan Drug Designations for its lead investigational therapies by the FDA Office of Orphan Products Development. Following the successful close of seed financing in late 2013, Abeona is raising funds to advance its gene therapy-based clinical programs for both Sanfilippo Syndrome type A and B. Phase I/II clinical trials for both diseases are anticipated to begin in 2014.

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FDA approves Bayer's Kogenate FS Antihemophilic Factor VIII (recombinant)

Monday, May 12, 2014 12:35 PM

The FDA has approved a new indication for Bayer's Kogenate FS antihemophilic factor VIII (recombinant) for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults with hemophilia A. The approval is based on data from the SPINART study, in which 84 patients ages 15 to 50 were randomized to either prophylaxis (25IU/kg three times per week) or on-demand treatment.

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FDA approves Zontivity to reduce risk of heart attacks and stroke

Friday, May 9, 2014 12:50 PM

The FDA has approved Zontivity (vorapaxar) tablets to reduce the risk of heart attack, stroke, cardiovascular death and need for procedures to restore the blood flow to the heart in patients with a previous heart attack or blockages in the arteries to the legs.

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BioDelivery hits mid-enrollment in phase III diabetic neuropathy trial

Thursday, May 8, 2014 01:55 PM

BioDelivery Sciences International, a specialty pharmaceutical company, has randomized more than half of the planned number of patients required for its ongoing initial phase III study of Clonidine Topical Gel, BDSI's proposed treatment for painful diabetic neuropathy (PDN).

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FDA approves EPANOVA for severe hypertriglyceridemia

Wednesday, May 7, 2014 02:43 PM

AstraZeneca has announced the FDA approved EPANOVA (omega-3-carboxylic acids) as an adjunct to diet to reduce triglyceride levels in adults with severe hypertriglyceridemia (triglyceride levels greater than or equal to 500mg/dL).

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Upsher-Smith announces positive data for epilepsy drug USL261

Friday, May 2, 2014 12:23 PM

Upsher-Smith Laboratories has announced positive phase I data for USL261 (investigational intranasal midazolam) in patients with epilepsy. Results demonstrated that USL261 at a single dose of up to 7.5mg was rapidly absorbed and exhibited a short half-life. Additionally, USL261 generally was well-tolerated in patients with epilepsy and demonstrated a rapid onset of pharmacodynamic effects with return to baseline function by four hours post dose.

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The CenterWatch Monthly, May 2014

Thursday, May 1, 2014 08:55 AM

Patient-centric strategies taking flight

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Edmond Pharma’s Erdosteine receives Orphan Drug Status from FDA

Wednesday, April 30, 2014 03:29 PM

The FDA has granted Orphan Drug Status to Erdosteine, a molecule discovered and developed by Italian pharmaceutical company Edmond Pharma. The Orphan Drug Status refers to the new indication for the treatment of bronchiectasis, a rare disease for which no drug therapies currently are approved in the U.S.

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FDA approves Zykadia for late-stage lung cancer

Wednesday, April 30, 2014 03:01 PM

The FDA has granted accelerated approval to Zykadia (ceritinib) for patients with a certain type of late-stage (metastatic) non-small cell lung cancer (NSCLC).

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FDA approves Sylvant for rare Castleman’s disease

Thursday, April 24, 2014 11:39 AM

The FDA has approved Sylvant (siltuximab) to treat patients with multicentric Castleman’s disease (MCD), a rare disorder similar to lymphoma (cancer of the lymph nodes).

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December 15

Cancer Treatment Centers of America chooses WCG as its exclusive IRB, sheds five local hospital IRBs

Five southern research groups form public-private network to help save time, money for clients with early-stage biologics

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December

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

AMCs vying to better compete for industry trials
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Private equity driving dynamic CRO growth
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