GENTEC Pharmaceutical Group

Pharma Tech

JelikaLite Corp | January 07, 2022

JelikaLite Corp, a medical technology company, announced that the U.S. Food and Drug Administration has granted the Breakthrough Device Designation to its Cognilum System for the reduction of symptoms of moderate to severe autism spectrum disorder in pediatric patients who are 2 to 6 years of age. The FDA’s Breakthrough Device Program recognizes medical devices that meet the criteria and hold the potential for more effective treatment or diagnosis of life-threatening or irre...

Business Insights, PHARMACY MARKET

Accord Healthcare | March 14, 2023

On March 13, 2023, Accord Healthcare informed that it has expanded its portfolio with Teriflunomide, a film-coated tablet equivalent to Sanofi Genzyme's Aubagio. The drug treats relapsing forms of MS in adults, including clinically-isolated syndrome and active secondary progressive disease. The company offers Teriflunomide in 14 mg and 7 mg tablets, now available for shipping. Teriflunomide has been granted FDA approval as an immunomodulatory agent for patients aged 18 and a...

Sdcexec | April 28, 2020

Last week, the U.S. energy sector faced a severe blow as the value of oil to be delivered in May dropped to a staggering -$37.60 per barrel—the first negative close in history. Pharma and manufacturing industries are facing similar wake-up calls for a future riddled with uncertainty. But the key to maintaining operations during and after the coronavirus crisis revolves around digital transformation and document management for processes, analytics, and an agile workforce, according to Brian...

Business Insights

Direct Biologics | April 13, 2022

Direct Biologics, an innovative biotechnology company with a groundbreaking extracellular vesicle platform drug technology, announced that the U.S. Food and Drug Administration has awarded their EV drug product ExoFlo with a Regenerative Medicine Advanced Therapy (RMAT) designation for the treatment of Acute Respiratory Distress Syndrome associated with COVID-19. The RMAT program is designed to expedite the approval of promising regenerative medical products in the US that demonstrate clin...