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FDA rejects diabetes drug alogliptin; Takeda gives few CRL details

Takeda Pharmaceutical’s (TYO:4502) diabetes drug alogliptin failed to secure U.S. Food and Drug Administration approval. The agency issued a complete response letter for new drug applications of alogliptin and a combination drug that pairs alogliptin with another Takeda drug, Actos. “We will immediately request a meeting with the FDA to determine the appropriate next steps […]

Pharma

Takeda, Furiex await FDA approval decision on diabetes drug Nesina

Today we might glimpse the U.S. Food and Drug Administration’s thoughts on approving new type 2 diabetes drugs in a post-Avandia world. Nesina, a Takeda Pharmaceutical (TYO:4502) compound licensed from Furiex Pharmaceuticals (NASDAQ:FURX), is set for a prescription drug user fee act (PDUFA) decision today. The drug candidate, also known as alogliptin, was developed to […]

Pharma

FDA delays Takeda diabetes drug decision; FURX awaits $25M milestone

Furiex Pharmaceuticals (NASDAQ:FURX) must wait until April to learn whether the type 2 diabetes compound it licensed to a drug partner  will secure regulatory approval and a $25 million milestone payment for the company. The U.S. Food and Drug Administration has notified drug partner Takeda Pharmaceuticals that review of investigational diabetes drug alogliptin has been […]

Pharma

Furiex Pharmaceuticals lands $15M for drug pipeline R&D

Furiex Pharmaceuticals (NASDAQ:FURX) has secured $15 million to finance R&D for three compounds in its drug pipeline. The Morrisville, North Carolina drug development company has entered into a loan agreement with MidCap Financial and Silicon Valley Bank (NASDAQ:SIVB). Furiex has already received the first tranche, $10 million. The second tranche of $5 million will only […]

Pharma

Takeda, Furiex try again in a post-Avandia diabetes drug world

A type 2 diabetes drug hopefully thought of as a potential blockbuster before stalling amid safety concerns is now taking another shot at approval. Takeda Pharmaceuticals (TYO:4502), which is partnered with Morrisville, North Carolina-based Furiex Pharmaceuticals (NASDAQ:FURX) on the diabetes drug candidate alogliptin, has filed two new drug applications  for the compound with the U.S. […]

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Furiex licenses antibiotic targeting MRSA infections

Drug development company Furiex Pharmaceuticals (NASDAQ:FURX) has licensed an antibiotic compound that could be developed into a new weapon against antibiotic-resistant strains such as Methicillin-Resistant Staphylococcus aureus, or MRSA. Morrisville, North Carolina-based Furiex said it has acquired exclusive licensing rights to develop and commercialize JNJ-Q2 through its existing development and license agreement with Janssen Pharmaceutica. […]

Pharma

Furiex IBS drug gets FDA fast track designation

Furiex Pharmaceuticals is on a faster path for regulatory review of its treatment for irritable bowel syndrome. The Morrisville, North Carolina-based company has received fast track designation on its drug candidate, a status reserved for drugs that address serious diseases and fill an unmet medical need.