Clinical Intelligence

Lilly, AstraZeneca receive FDA Fast Track for Alzheimer’s treatment AZD3293

Tuesday, August 23, 2016

Eli Lilly and AstraZeneca  have received FDA Fast Track designation for the development program in Alzheimer’s disease for AZD3293, an oral beta secretase cleaving enzyme (BACE) inhibitor currently in phase III clinical trials. The FDA’s Fast Track program is designed to expedite the development and review of new therapies to treat serious conditions and tackle key unmet medical needs.

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The CenterWatch Weekly, August 22, 2016

Monday, August 22, 2016

As necessity for real-world evidence rises, PPD acquires of Evidera

Pharmaceutical Product Development (PPD) has agreed to buy Evidera, a Maryland-based company that provides evidence-based solutions for the healthcare industry, as demand rises for research that shows the effectiveness and value of new medicines in real world settings.

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FDA grants Soligenix’s Dusquetide Orphan designation for Macrophage Activation Syndrome

Friday, August 19, 2016

Soligenix, a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, has announced that the Office of Orphan Products Development of the FDA has granted Orphan drug designation to the active ingredient dusquetide for treatment of macrophage activation syndrome (MAS). Dusquetide has previously received Orphan drug designation for the treatment of acute radiation syndrome (ARS). 

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Endo drops abuse deterrent labeling for OPANA ER

Monday, August 15, 2016

Endo International has announced that, based on an August 11, 2016 discussion with the FDA, the company has decided to withdraw its supplemental New Drug Application (sNDA) relating to specific abuse deterrent labeling for OPANA ER without prejudice to re-filing. The company plans to continue collecting and analyzing epidemiological data relating to OPANA ER. Endo’s financial projections for 2016 did not assume approval of the sNDA.

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FDA accepts grants Marathon’s Duchenne drug Deflazacort priority review

Thursday, August 11, 2016

Marathon Pharmaceuticals, a biopharmaceutical company developing treatments for rare diseases, has announced the New Drug Applications (NDA) for the investigational drug deflazacort have been accepted for filing and granted Priority Review by the FDA. The NDAs (one for immediate-release tablet formulations and one for an oral suspension formulation) request approval for deflazacort for the treatment of patients with Duchenne muscular dystrophy (DMD), the most common and most severe form of muscular dystrophy.

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Heron announces FDA approval of Sustol for chemotherapy-induced nausea

Thursday, August 11, 2016

Heron Therapeutics has announced that the FDA has approved SUSTOL (granisetron) extended-release injection. SUSTOL is a serotonin-3 (5-HT3) receptor antagonist indicated in combination with other antiemetics in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic chemotherapy (MEC) or anthracycline and cyclophosphamide (AC) combination chemotherapy regimens.

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AstraZeneca announces positive phase III SYMBICORT data

Thursday, August 11, 2016

AstraZeneca has announced positive top-line results from two international, multicenter studies in adult and pediatric patients with chronic obstructive pulmonary disease (COPD) and asthma, respectively, that showed SYMBICORT (budesonide/formoterol fumarate dihydrate) Inhalation Aerosol was well tolerated and achieved the primary endpoints in both studies.

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