Food and Drug Administration
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Malvern-Based Annovis Bio Reports Positive Clinical Trial Results for Parkinson’s Disease Drug
Malvern-based Annovis Bio recently reported positive clinical trial results for buntanetap, the biopharmaceutical company’s lead new drug candidate in Parkinson’s disease patients, writes John George…
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Breaking News: Supreme Court Overrules Chevron Doctrine — What Does This Mean?
Friday, Jun. 28, marked a massive change in legislative history. The United States Supreme Court overturned a longstanding legal precedent that required courts to defer…
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Malvern-Based Annovis Bio to Focus Future Development of Its Experimental Drug on Early Alzheimer’s Patients
Malvern-based Annovis Bio plans to focus on patients who have the early form of Alzheimer’s disease in the future development of its experimental treatment for…
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After ‘Challenging but Rewarding Journey’, CEO of Malvern’s Venatorx Pharmaceuticals Steps Down
Christopher Burns, a co-founder of Malvern-based Venatorx Pharmaceuticals, is stepping down from his position as the company’s CEO, writes John George for the Philadelphia Business…
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As Malvern’s Endo Emerges from Bankruptcy, It Focuses on Growing Branded Pharmaceuticals Segment
Endo Inc., formed as a result of Malvern-based Endo International’s bankruptcy reorganization plan, has finalized the acquisition of most of the assets of its predecessor,…
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A Mother’s Crusade: Raising Nearly $1M and Launching Bala Cynwood Nonprofit After Daughter’s Diagnosis
When the Food and Drug Administration recently approved the first gene therapy to treat metachromatic leukodystrophy, a fatal childhood inherited brain disease, Maria Kefalas was…
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Malvern-Based Tela Bio Launches New Product ‘Kind of Like Krazy Glue’ for Healthcare Repair Use
Malvern-based Tela Bio recently launched a new product it is expecting to see significant revenue from, writes John George for the Philadelphia Business Journal. The…
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Malvern-Based Venatorx Pharmaceuticals Expects Big News About Its Lead Antibiotic Candidate
Venatorx Pharmaceuticals, a Malvern life sciences company, expects to hear from the Food and Drug Administration regarding its new drug application for its lead antibiotic…
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Malvern-based Galera Therapeutics Looks for Ways to Stay Afloat with Help from Third Party
After failing to convince the Food and Drug Administration that there is no need for additional testing for its lead new drug candidate, Malvern-based Galera…
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Newtown Pharma Co. Has One Township Supervisor Wishing Its Principals Were ‘Better Corporate Citizens’
Newcomer drug manufacturer KVK Tech Inc. and its occupancy of the dormant Lockheed site were considered a Newtown boon in 2015, but it didn’t take…
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Malvern’s Galera Therapeutics in Line for $37.5 Million Payday
Malvern-based Galera Therapeutics recently triggered a $37.5 million payment by completing enrollment for a late-stage study of Avasopasem. John George reported on the new drug…
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Malvern Company Readies for FDA Submission of COVID-19 Vaccine
Later this month, Malvern-based Ocugen will seek an emergency-use authorization from the FDA to cooperate with Bharat Biotech for the India-based company’s COVID-19 vaccine, Covaxin,…
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If at First You Don’t Succeed … Chesterbrook-Based Trevena Tries Again with Experimental Opioid
Chesterbrook-based Trevena has refiled its drug application to the Food and Drug Administration for IV oliceridine, an opioid pain relief medicine with fewer side effects…
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Malvern-Based Recro Pharma Sees Its Stock Plummet 34 Percent
Malvern-based Recro Pharma saw its stock plunge by more than 34 percent after the Food and Drug Administration rejected its new drug application for a…
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Malvern-Based Endo’s FDA Lawsuit Up in the Air After Government Shutdown
Endo International’s lawsuit against the Food and Drug Administration has been indefinitely delayed after the government shutdown, writes John George for the Philadelphia Business Journal.…
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Exton’s Fibrocell Granted Rare Designation by FDA
Exton’s Fibrocell has been granted the Rare Pediatric Disease Designation by the Food and Drug Administration for its gene therapy candidate to treat children with…
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FDA Decides Risks Outweigh Benefits of Endo’s Opioid Painkiller
A Food and Drug Administration panel has found that the benefits no longer outweigh the risks of Endo International’s opioid painkiller, Opana ER, writes John…
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Chester County Daily News Business Briefs
VISTA Today Daily News Business Briefs are concise stories that bring you up to date with what’s going on around Chester County. This morning: Wolf…
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