Clinical Intelligence

Inhibikase Therapeutics receives Orphan Drug Designation for PML

Thursday, May 22, 2014 11:08 AM

Inhibikase Therapeutics, a developer of products to treat infectious diseases with little or no resistance, has received Orphan Drug Designation for imatinib to treat progressive multifocal leukoencephalopathy (PML) from the FDA.

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Pfizer receives kosher certification for Elelyso for injection

Monday, May 19, 2014 09:52 AM

Pfizer has announced that the Orthodox Union (OU) has granted kosher certification to ELELYSO (taliglucerase alfa) for injection, an enzyme replacement therapy (ERT) for the long-term treatment of adults with a confirmed diagnosis of Type 1 Gaucher disease. ELELYSO is the first prescription medication to be certified kosher by the OU, a milestone for the brand which was approved by the FDA in May 2012. 

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Pernix to acquire Treximet migraine tablets from GlaxoSmithKline

Thursday, May 15, 2014 11:23 AM

Pernix Therapeutics, a specialty pharmaceutical company, has signed an agreement with GlaxoSmithKline to acquire the U.S. rights to Treximet (sumatriptan / naproxen sodium) for the acute treatment of migraine attacks with or without aura in adults.

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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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CWWeekly

July 27

AB Science warned about putting study volunteers in danger

FDA, Google unite to detect search-data adverse events

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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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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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