Celgene’s first-quarter non-GAAP total revenue up 31% to $789 million

Celgene Corporation announced non-GAAP net income of $294.6 million, or non-GAAP diluted earnings per share of $0.63 for the quarter ended March 31, 2010. Non-GAAP net income for the first quarter of 2009 was $205.1 million or non-GAAP diluted earnings per share of $0.44. Based on U.S. GAAP, Celgene reported net income of $234.4 million, [...]

Provectus reports on end-of-Phase 2 meeting with FDA on licensure of PV-10 for metastatic melanoma

Provectus Pharmaceuticals, Inc., a development-stage oncology and dermatology biopharmaceutical company, announced today that it has held an end-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) to seek consensus on clinical program scope and endpoints for licensure of PV-10 for metastatic melanoma. The meeting was held at the Agency’s White Oak Campus in [...]

Human Genome Sciences reports net loss of $47.9M for first-quarter 2010

Human Genome Sciences, Inc. today announced financial results for the quarter ended March 31, 2010, and provided highlights of recent key developments.

AVEO Pharmaceuticals reports net loss of $14.4 million for first-quarter 2010

AVEO Pharmaceuticals, Inc., a biopharmaceutical company focused on discovering, developing and commercializing cancer therapeutics, today announced financial results for the quarter ended March 31, 2010, provided an update on progress towards achievement of 2010 goals as well as 2010 financial guidance.

Incorporation of NexACT technology helps reduce dose of Å6 compound for ovarian cancer treatment

NexMed, Inc., a specialty CRO with a pipeline of products based on the NexACT® technology, today announced that results from a pre-clinical study showed significant improvement in the delivery and half life of Å6, a proprietary peptide treatment for ovarian cancer currently in Phase 2 development by Angstrom Pharmaceuticals. Specifically, the incorporation of NexACT® enabled [...]

Gilead announces bioequivalence of Truvada in combination with Tibotec Pharmaceuticals’ TMC278 NNRTI

Gilead Sciences, Inc. announced today it has obtained data supporting bioequivalence of a formulation of the fixed-dose combination of Truvada® (emtricitabine and tenofovir disoproxil fumarate) and Tibotec Pharmaceuticals’ investigational non-nucleoside reverse transcriptase inhibitor (NNRTI) TMC278 (rilpivirine hydrochloride, 25 mg).

FDA Urges Industry To Take Additional Steps To Prevent Cargo Theft

The U.S. Food and Drug Administration sent a letter to companies and a wide range of other key stakeholders detailing the agency’s concern over cargo and warehouse thefts of FDA-regulated products. The products stolen have included prescription and over-the counter medicines, medical devices, and infant formula…

Overhaul May Cost Drugmakers More Than Expected

Bloomberg BusinessWeek: The health overhaul legislation will likely cost drugmakers $25 billion more than the $80 billion the industry anticipated when it agreed to back the Democratic-led effort, according to Wall Street analysts. “The extra costs will come from expanding drug rebates through Medicaid, the U.S. insurance program for the poor, [Leerink Swann & Co [...]

AstraZeneca Settles Drug Marketing Lawsuit, Plea Deal Rejected For Possibly Defective Heart Device Maker

The New York Times: AstraZeneca has settled a case and agreed to pay $520 million after federal investigations into its marketing practices for a schizophrenia drug, Seroquel. The announcement came Tuesday from Attorney General Eric Holder…

Celladon Corp. Announces That MYDICAR(R) Meets Primary Endpoint In Phase 2 Trial For Treatment Of Advanced Heart Failure

Celladon Corp., a biopharmaceutical company focused on the discovery and development of innovative treatments for cardiovascular diseases, announced that its first Phase 2 trial with MYDICAR® for the treatment of advanced heart failure has met the prospectively defined safety and efficacy endpoints for the trial as defined in the Phase 2 clinical trial protocol…