Addex Gives Vague Update on Q1 Data Readout
Insights - This morning, Addex (ADXN) announced that Janssen has completed the enrolment of Part 1 of their Phase 2 clinical study of ADX71149 in epilepsy. Data … Continue Reading
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DON’T CONFUSE A MEDICAL DEVICE “CLEARANCE” WITH “APPROVAL”
Education - New investors often confused medical device 510k clearance with FDA approval. The hurdles are quite different. Here's what you need to know.
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HOW GENERIC DRUGS ARE APPROVED AND WHAT THEY MEAN FOR DRUG DEVELOPERS
Education - Generic pharmaceuticals are drug products designed to be functionally identical (bioequivalent) to brand name drugs in terms of the active ingredient, dosage strengths, forms, indications, … Continue Reading
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DRUG PATENTS AND EXCLUSIVITY: AN INVESTOR’S GUIDE
Education - New drugs are expensive and time-consuming to develop and market. Some studies estimate that the cost of bringing a drug to market—from R&D to FDA … Continue Reading
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UNDERSTANDING THE FDA’S EXPEDITED APPROVAL PROCESSES
Education - How the FDA's approval processes differ, a investor's guide. Including Breakthrough Therapy, Accelerated Approval, Priority Review, and Fast Track.
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Paratek Attractive Following It’s Latest Catalyst
Research - Paratek Pharmaceuticals (PRTK) released their top-line, OASIS-2 results after the bell yesterday, comparing oral omadacycline to linezolid in ABSSSI infections. Omadacycline achieved all primary and … Continue Reading
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ASCO: Loxo Steals the Show, and Consistent Data from Bluebird
Research - ASCO is in full swing, which we covered in our last two webinars (April / May). Some of these are playing out today, most notably … Continue Reading
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