August could be the month when all patients suffering from rheumatoid arthritis (RA) have a new treatment alternative to injectable TNF-inhibitors, such as Humira (adalimumab, Abbott), Enbrel (etanercept, Amgen Inc.) and Remicade (infliximab, Johnson & Johnson).
It has been a long and turbulent road for Marqibo (vincristine sulfate liposome injection), but South San Francisco-based Talon Therapeutics Inc. finally brought it over the goal line. The product received FDA accelerated approval Thursday based on a single-arm study for the treatment of adult patients with Philadelphia chromosome negative (Ph-) acute lymphoblastic leukemia (ALL) in second or greater relapse or whose disease has progressed following two or more anti-leukemia therapies.
To help fuel its clinical trials programs on lead product candidate, cabozantinib, Exelixis Inc. (NASDAQ:EXEL) said it is planning an underwritten debt offering of $225 million convertible senior subordinated notes due 2019 and a concurrent sale of 20 million shares of its common stock.
The field of research surrounding antibody-drug conjugates (ADCs) and other peptide and small-molecule drug conjugates has heated up in the last 12 months following the approval of Seattle Genetics Inc.'s Adcetris (brentuximab vedotin), an ADC directed to CD30, to treat Hodgkin lymphoma and a rare lymphoma known as systemic anaplastic large-cell lymphoma. It was the first ADC to gain approval. (See BioWorld Today, Aug. 22, 2011.)
According to the American Cancer Society an estimated 1.6 million new cancer cases and 577,190 deaths from cancer are projected to occur in the U.S. in 2012. It is not surprising then that recent studies have found that there are more ongoing clinical trials focusing on cancer indications than any other disease. However, costs are rising in cancer treatment, putting tremendous strains on the health care system.
Commenting on his company's second-quarter financial results in an investor call, Dendreon Corp. CEO John Johnson said, "I'm not satisfied with the commercial performance of Provenge and believe that more men with advanced prostate cancer should be benefiting from the product."
As expected, the FDA gave the green light last Thursday to Amarin Corp. plc's Vascepa (icosapent ethyl) capsules (formerly known as AMR101) as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (TG greater than or equal to 500 mg/dL) hypertriglyceridemia.
Fifteen years have elapsed since the former U.S. president Bill Clinton predicted in 1997 the introduction of a vaccine for AIDS "within a decade." Unfortunately, instead of the prediction becoming a reality, 2007 represented a particularly low point for HIV vaccine research. During that year Merck & Co. Inc. announced that it was discontinuing its HIV vaccine trial. Merck, along with the AIDS community had high hopes for the drug, which had been in development for almost a decade. Its failure caused researchers to become pessimistic about the prospects of ever achieving an effective HIV vaccine in the foreseeable future.
As expected, the FDA gave the green light on Thursday to Amarin Corp. plc's Vascepa (icosapent ethyl) capsules (formerly known as AMR101) as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (TG greater than or equal to 500 mg/dL) hypertriglyceridemia.
Biogen Idec Inc. soundly beat earnings estimates for the quarter by more than 16 percent. The company reported adjusted net income of $1.82 per share and Wall Street was looking for $1.56 per share.
