ASCO GU: Some Object to Cancer Society’s Prostate Screening Update

SAN FRANCISCO (MedPage Today) — Reactions to the American Cancer Society’s guideline update calling for shared decision making in prostate cancer screening have been mixed among urologists here at the Genitourinary Cancers Symposium, as a leading oncologist explains in this exclusive InFocus™ report.

FDA Okays First Skin-Injection Immunodeficiency Treatment

WASHINGTON (MedPage Today) — The FDA has approved the first 20% subcutaneous primary immunodeficiency treatment, immune globulin subcutaneous 20% liquid (Hizentra), as a once-weekly replacement therapy.

FDA Reminds Unapproved Morphine Makers to Cease Production

WASHINGTON (MedPage Today) — The FDA issued follow-up warning letters to six unapproved oral morphine sulfate manufacturers with one message: be ready for when the enforcement discretion lifts.

FDA Recalls Catheter Sheath That May Block Arteries

WASHINGTON (MedPage Today) — The FDA has initiated a class I recall on transseptal sheath introducer kits (HeartSpan, CHANNEL FX, Torflex, Braided Guiding Introducer Kit) because of potential sheath breakage that may lead to injury or death.

Poniard Pharmaceuticals reports net loss of $13.2M for fourth-quarter 2009

Poniard Pharmaceuticals, Inc., a biopharmaceutical company focused on innovative oncology therapies, today reported financial results for the fourth quarter and year ended December 31, 2009.

Rexahn Pharmaceuticals granted Japanese patent for Archexin

Rexahn Pharmaceuticals, Inc, a clinical stage pharmaceutical company commercializing potential best in class oncology and CNS therapeutics, today announced that the Japanese Patent Office has issued a patent for its novel anti-cancer compound, Archexin®.

Positive Phase 2 data from Nektar Therapeutics’ NKTR-102 study in women with platinum-resistant ovarian cancer

Nektar Therapeutics today announced preliminary progression-free survival data from the first stage of a two-stage Phase 2 clinical study evaluating single-agent treatment with NKTR-102 in women with platinum-resistant ovarian cancer. In the first stage of the study, 39 patients were enrolled with platinum-resistant disease and were evaluable for the secondary endpoint of progression-free survival [...]

NOVAVAX’ Stage B 2009 H1N1 VLP pandemic influenza vaccine study in Mexico: Enrollment complete

Novavax, Inc. announced today that the enrollment of over 3,500 subjects in Mexico has been completed in Stage B of its pivotal 2009 H1N1 virus-like-particle (VLP) pandemic influenza vaccine study. With the 1,000 subjects already enrolled in Stage A of the trial, the enrollment in this pivotal trial is now complete with over 4,500 [...]

Positive data from Argos Therapeutics’ AGS-003 Phase 2 trial for mRCC

Argos Therapeutics today announced the presentation of positive data from a Phase 2 trial that evaluated the safety, clinical response and immune response of AGS-003 treatment in newly diagnosed patients with metastatic renal cell carcinoma (mRCC). The data were discussed March 7 in a poster presentation at the ASCO Genitourinary Cancers Symposium.

VIVUS granted three additional patents for Qnexa

VIVUS, Inc. today announced the issuance of three additional patents by the U.S. Patent and Trademark Office (USPTO) covering Qnexa, an investigational new drug candidate for the treatment of obesity. The three new patents are the second, third, and fourth patents to be granted in a series of patent applications VIVUS has filed that [...]