The FDA issued a complete response letter to Takeda Pharmaceutical Co. Ltd. last week regarding new drug applications for alogliptin and fixed-dose combinations of alogliptin and pioglitazone for Type II diabetes, products partnered with Furiex Pharmaceuticals Inc.
A new license agreement between Tolero Pharmaceuticals Inc., of Salt Lake City, and MannKind Corp., of Valencia, Calif., will grant Tolero exclusive worldwide rights to some of MannKind's Bruton's tyrosine kinase (Btk) compounds, which have potential for hematological malignancies and inflammatory disease.
The privately held UK specialty oncology firm EUSA Pharma Ltd. is to be acquired by Jazz Pharmaceuticals Inc. in a $700 million cash deal that is motivated by the early commercial success of EUSA's Erwinaze treatment for pediatric acute lymphoblastic leukemia (ALL), approved by the FDA in November 2011.
The FDA issued a complete response letter to Takeda Pharmaceutical Co. Ltd. regarding new drug applications for alogliptin and fixed-dose combinations of alogliptin and pioglitazone for Type II diabetes, products partnered with Furiex Pharmaceuticals Inc.
Amgen Inc.'s quarterly earnings conference call began on a bittersweet note, as outgoing CEO Kevin Sharer made his farewells and paid tribute to George Rathman, Amgen's first CEO, who passed away last weekend.
miRagen Therapeutics Inc., of Boulder, Colo., completed a $20 million Series B financing that will help advance its unpartnered compounds toward clinical development.
Pharmaceutical companies rich in cash and facing multiple looming drug patent expirations are getting serious about refilling their pipelines with late-stage biotech products, in many cases through acquisitions valued at $1 billion or more. Having weathered a period of caution and austerity triggered by the worldwide economic downturn, the pharma industry is on a full-out shopping spree for biotech pipeline value.
Three smashing clinical successes by Gilead Sciences Inc.'s nuc drug GS-7977 for hepatitis C virus (HCV) have lit up the 2012 International Liver Congress of the European Association for the Study of the Liver, sending the company's stock up 12 percent Thursday.
Inspiration Biopharmaceuticals Inc., of Cambridge, Mass., submitted a biologics license application (BLA) to the FDA for IB1001, a recombinant Factor IX therapy for hemophilia B. If approved, IB1001 would be the first new recombinant therapy for the disease in 15 years.
Four months after acquiring Intellikine Inc. for $320 million, and less than a year after its major purchase of Nycomed GmbH for $13.7 billion, Takeda Pharmaceutical Co. Ltd. said it will add another new asset to its portfolio.
