Breaking News in Biotech
Discovery Labs Shares Fall on FDA Delay of Surfaxin
Shares in Discovery Labs spiraled downward 52 percent Monday on news that the FDA has again delayed a decision on the company’s application to market Surfaxin for the prevention of respiratory distress syndrome in premature infants. For the fourth time, the agency has issued a complete response letter, this time indicating that the company needs to confirm the biological activity test of the drug’s stability and release. But Warrenton, Pa.-based Discovery Labs said that it believes that its tests for monitoring Surfaxin’s shelf-life are adequate, and it plans to seek an end-of-review meeting with the FDA as soon as possible. If the meeting is successful, Discovery Labs anticipates that Surfaxin may be approved some time this year.
Pharmasset Dropping HBV Drug Due to Safety Concerns
Postmarketing studies in South Korea showing several cases of severe myopathy in hepatitis B patients taking clevudine prompted Pharmasset Inc. to terminate Phase III trials of the drug, with no further plans to seek U.S. or European approval. Instead, the Princeton, N.J.-based firm plans to refocus its recently bolstered cash resources on its earlier-stage hepatitis C pipeline, a space that has garnered greater investor interest. Pharmasset’s HCV compounds include a Phase II-stage program partnered with F. Hoffmann-La Roche Ltd. and an unpartnered Phase I program that entered the clinic earlier this year.
AACR Roundup: Dendreon Data on Earlier-Stage Prostate Cancer Patients
Investors are eagerly awaiting the data from Dendreon Corp.’s confirmatory Phase III IMPACT trial, expected at the American Urological Association’s annual meeting. But in the meantime, the company presented data at AACR from its ongoing Phase III PROTECT trial, which evaluates the prostate cancer vaccine Provenge (sipuleucel-T) in men with earlier stage, nonmetastatic, androgen-dependent disease.
NCI Director: New Funds will Change, Speed Cancer Research
After several years of a flat budget, the National Cancer Institute received a nearly 3 percent budget increase this fiscal year and $1.3 billion from the economic stimulus package, which will fund more grants, aid in the development of a platform for personalized cancer care and accelerate its cancer genetics program, Director John Niederhuber said Monday at the annual meeting of the American Association for Cancer Research in Denver.
Also in the News:
Abraxis BioScience, Agilent Technologies, Allos Therapeutics, Alnylam, Apro Bio Pharmaceutical, ArQule, Array BioPharma, AVEO, BiOasis Technologies, Biolex Therapeutics, Bionovo, Caris Diagnostics, Cortex, Cytokinetics, Epistem, Expression Analysis, Expression Pathology, Genomic Health, Gilead Sciences, Hadasit, Halozyme, Illumina, Immune System Therapeutics, Immunomedics, InNexus, IntelGenx, Lorus Therapeutics, Lpath, Medarex, Mersana, MolecularMD, Momenta Pharmaceuticals, NextGen Sciences, Novelos Therapeutics, Novogen, Paion, Palau Pharma, Pantec Biosolutions, Peregrine Pharmaceuticals, Poniard, Psylin Neurosciences, QRxPharma, Santaris, Sunesis Pharmaceuticals, Threshold Pharmaceuticals, Tolarex, Viralytics.