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Business Insights

Akorn Pharmaceuticals | August 17, 2022

Akorn Operating Company LLC, a specialty pharmaceutical company, announces that it received FDA approval for a generic version of Cetrorelix Acetate for Injection, 0.25 mg. This is the first approved AP-Rated bioequivalent version of Merck Serono's Cetrotide®.1 "We are pleased to announce the first approved AP-rated generic option for women receiving fertility treatments. As an increasing number of infants are being conceived via the use of ART, ...

Ultragenyx | July 03, 2020

Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE), a biopharmaceutical company focused on the development and commercialization of novel products for rare and ultra-rare diseases, today announced that the U.S. Food and Drug Administration (FDA) has approved Dojolvi™ (triheptanoin) as a source of calories and fatty acids for the treatment of pediatric and adult patients with molecularly confirmed long-chain fatty acid oxidation disorders (LC-FAOD). LC-FAOD are a group of rare, lifelong and life...

Pharmacy Market

Alcami Corporation | March 02, 2022

Alcami, a U.S.-based pharmaceutical contract development and manufacturing organization announced the addition of a 3,800 ft² Non-GMP Formulation Development Laboratory (FDL). The dedicated Non-GMP formulation development space, which is co-located within the same facility as Alcami's parenteral manufacturing operation that offers four isolator filling lines for liquid and lyophilized products, is ready to support customers with Preclinical and Clinical development programs. Read More

PharmaNewsIntelligence | March 11, 2020

Oregon Health & Science University (OHSU) held the first-ever gene therapy clinical trial, BRILLIANCE, to address blindness-causing gene mutation, LCA10, according to a recent press release The clinical trial, sponsored by Allergan plc and Editas Medicine, is one of 14 different clinical trials investigating new genetic treatments for ophthalmic conditions and nearly 50 vision-related clinical trials. The procedure uses gene-editing tool CRISPR to edit human genes, also known as in vivo gene...