Phase III
The U.S. Food and Drug Administration (FDA) rejected Englewood, Colorado-based Ampio Pharmaceuticals’ Biologics License Application (BLA) for its drug for osteoarthritis of the knee, Ampion.
Shares of Paratek Pharmaceuticals are climbing in pre-market trading after the company announced a U.S. Food and Drug Administration advisory committee voted overwhelmingly in favor of the company’s intravenous and oral treatments for acute bacterial skin and skin structure infections (ABSSSI).
After a slight delay, things remain on schedule for Alnylam’s new $200 million manufacturing facility. The company expects the site to open in late 2019, which could follow regulatory approval of patisiran, its RNAi treatment for Hereditary ATTR Amyloidosis.
Shares of Novo Nordisk are down about five percent this morning after the company reported an overall decline in sales during the second quarter of this year. Sales were particularly disappointing in North America.
Shares of Bellerophon Therapeutics have plunged nearly 75 percent this morning after the company announced its Phase III pulmonary arterial hypertension failed to meet endpoints following a pre-specified interim analysis from a Data Monitoring Committee.
An investigational gene therapy treatment for hemophilia A has seen a 97 percent response rate after one treatment for the 12 trial participants, Spark Therapeutics announced this morning.
Ironwood Pharmaceuticals, located in Cambridge, Massachusetts, released its second-quarter financial report and updated its business activities. Key among the announcements was the termination of a license deal with AstraZeneca for its lesinurad franchise.
Scientists with Framingham, Massachusetts-based Alzheon identified a substance in the human brain that inhibits the formation of beta-amyloid, the primary driver of Alzheimer’s disease. The substance is 3-sulfopropanoic acid (3-SPA).
Now that July is over, the U.S. Food and Drug Administration (FDA) appears to be back in full swing with a full docket of drug decisions to make. There are four therapeutics with PDUFA dates this week involving six biopharma companies. Here’s a look.
Shionogi, based in Osaka, Japan and Florham Park, New Jersey, announced that the U.S. Food and Drug Administration (FDA) approved Mulpleta (lusutrombopag) for thrombocytopenia in adults with chronic liver disease who were about to have a medical procedure performed.
PRESS RELEASES