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Home » Authors » Peter Winter

Articles by Peter Winter

Will New RA Therapies Cause a Paradigm Shift?

Aug. 10, 2012
By Peter Winter

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).


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FDA Grants Accelerated Approval for Talon's Marqibo

Aug. 10, 2012
By Peter Winter
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.
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Exelixis Looking to Complete Public and Debt Financings

Aug. 7, 2012
By Peter Winter
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.
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Next-Gen Drug Conjugates Attracting Funds, Partners

Aug. 6, 2012
By Peter Winter
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.)
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Boom in Oncology Research Raises Concerns About Costs

Aug. 6, 2012
By Peter Winter
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.
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Dendreon CEO Not Happy with Sales of Provenge

Aug. 1, 2012
By Peter Winter
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."
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Amarin Hooks FDA Approval for Prescription-Grade Fish Oil

July 31, 2012
By Peter Winter
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.
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HIV Vaccine Research Gets its Second Wind

July 30, 2012
By Peter Winter
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.
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Amarin Hooks FDA Approval for Prescription-Grade Fish Oil

July 27, 2012
By Peter Winter
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.
Read More

Biogen Reports Strong 2Q; Avonex Sales Beat Estimates

July 25, 2012
By Peter Winter
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.
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