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AdvanDx's 90 minutes protocol for Yeast Traffic Light PNA FISH test receives FDA 510(k) clearance

AdvanDx today announced that it has received FDA 510(k) clearance for a fast, 90 minutes protocol for its Yeast Traffic Light® PNA FISH® test. The faster protocol reduces the PNA FISH turn-around time from the original 2.5 hours to 90 minutes by reducing PNA probe hybridization from 90 minutes to 30 minutes.

30 Jul 2010

Immunosuppressive properties of TNF blockers may increase risk of malignancy in children

The Food and Drug Administration (FDA) received reports of malignancies in children using tumor necrosis factor (TNF) blockers, raising concerns of an associated risk and prompting an investigation. Researchers from the FDA set out to identify all reports of malignancy in children using infliximab, etanercept, and adalimumab and their report is published in the August issue of Arthritis & Rheumatism, a journal of the American College of Rheumatology.

30 Jul 2010

Medtronic launches Defeat-HF clinical trial to evaluate SCS for heart failure

Medtronic, Inc. today announced the global launch of the Defeat-HF (Determining the Feasibility of Spinal Cord Neuromodulation for the Treatment of Chronic Heart Failure) clinical trial. It is the industry's first prospective, randomized study evaluating the clinical feasibility of spinal cord stimulation, or neurostimulation, to improve clinical signs and symptoms of heart failure.

30 Jul 2010

Amgen second-quarter total revenue increases 2% to $3,804 million

Amgen reported adjusted earnings per share (EPS) of $1.38 for the second quarter of 2010, an increase of 7 percent compared to $1.29 for the second quarter of 2009. Adjusted net income increased 1 percent to $1,326 million for the second quarter of 2010 compared to $1,311 million for the second quarter of 2009.

30 Jul 2010

Orexigen's Contrave COR-I trial results published online in journal Lancet

Orexigen® Therapeutics, Inc. announced that results from its COR-I trial of Contrave® were published online today in the journal Lancet. COR-I was the largest of the four, 56-week, Phase 3 trials supporting the New Drug Application for Contrave, currently under review by the U.S. Food and Drug Administration. Results show that patients taking Contrave were two to three times more likely to lose at least 5% or 10% of their body weight compared to those taking placebo, on both an intent-to-treat (ITT) and completers basis.

30 Jul 2010

Life Technologies second-quarter Non-GAAP revenue increases 8% to $906 million

Life Technologies Corporation today announced results for its second quarter ending June 30, 2010. Non-GAAP revenue for the second quarter was $906 million, an increase of 8 percent over the $839 million reported for the second quarter of 2009. Excluding the impact of currency and prior acquisitions and divestitures, organic revenue for the quarter grew 6 percent over the same period in the previous year.

30 Jul 2010

NMT Medical reports $2.6 million net income for second-quarter 2010

NMT Medical, Inc., an advanced medical technology company that designs, develops, manufactures and markets proprietary implant technologies that allow interventional cardiologists to treat structural heart disease through minimally invasive, catheter-based procedures, today announced financial results for the quarter ended June 30, 2010.

30 Jul 2010

ACADIA initiates new pimavanserin Phase III trial for Parkinson's disease psychosis

ACADIA Pharmaceuticals Inc., a biopharmaceutical company utilizing innovative technology to fuel drug discovery and clinical development of novel treatments for central nervous system disorders, today announced that it has initiated a new Phase III trial designed to evaluate the efficacy, tolerability and safety of pimavanserin as a treatment for patients with Parkinson's disease psychosis (PDP).

30 Jul 2010

Geron second-quarter net loss decreases to $17.0 million

Geron Corporation today reported financial results for the three and six months ended June 30, 2010.

30 Jul 2010

TNF blockers may increase the risk of malignancy in children

The Food and Drug Administration (FDA) received reports of malignancies in children using tumor necrosis factor a (TNF) blockers, raising concerns of an associated risk and prompting an investigation.

29 Jul 2010

$Postmenopausal women with diabetes taking TZDs at increased fracture risk$

Postmenopausal women with diabetes taking TZDs at increased fracture risk

Postmenopausal women with diabetes taking thiazolidinediones (TZDS), including rosiglitazone and pioglitazone, may be at increased risk for fractures according to a new study accepted for publication in The Endocrine Society's Journal of Clinical Endocrinology & Metabolism (JCEM). Men with diabetes taking both loop diuretics and TZDs may also be at increased risk of fractures.

29 Jul 2010

Gentiva Health Services second-quarter total net revenues increase 4% to $297.1 million

Gentiva Health Services, Inc., a leading provider of home health and hospice services, today reported second quarter 2010 results.

29 Jul 2010

BCBSNC receives CEO Cancer Gold Standard certification

Blue Cross and Blue Shield of North Carolina has received CEO Cancer Gold Standard accreditation, recognizing the organization's commitment to reducing the risk of cancer for employees and their families by promoting healthy lifestyle choices, encouraging early detection through cancer screenings, and ensuring access to quality treatment.

29 Jul 2010

Celgene second-quarter non-GAAP total revenue increases 36% to $850 million

Celgene Corporation announced non-GAAP net income of $323.3 million, or non-GAAP diluted earnings per share of $0.69 for the quarter ended June 30, 2010. Non-GAAP net income for the second quarter of 2009 was $216.0 million or non-GAAP diluted earnings per share of $0.46.

29 Jul 2010

Antigenics second-quarter net loss attributable to common stockholders decreases to $5.2 million

Antigenics Inc. reported today its results for the quarter ended June 30, 2010.

29 Jul 2010

Natus Medical second-quarter revenue increases to $52.7 million

Natus Medical Incorporated today announced financial results for the three and six months ended June 30, 2010.

29 Jul 2010

First Edition: July 29, 2010

In today's headlines, a new poll shows opposition to health reform declining, and Peter Orszag makes his exit as budget chief -- still pressing lawmakers to make tough budget choices while implementing the new law.

29 Jul 2010

AVEO second-quarter total revenues increase to $15.6 million

AVEO Pharmaceuticals, Inc., a biopharmaceutical company focused on discovering, developing and commercializing cancer therapeutics, today provided an update on recent research and development (R&D) and business accomplishments, and announced financial results for the quarter ended June 30, 2010.

29 Jul 2010

Bionovo receives EMA final guidance for advancing Menerba to Phase 3 clinical trials

Bionovo, Inc. announced today that it has received final guidance from the European Medicines Agency (EMA) in order to advance Menerba, the company's lead drug candidate for menopausal symptoms, to Phase 3 clinical trials in Europe. The guidance defines the clinical and regulatory pathway to a European marketing authorization for Menerba.

29 Jul 2010

New Zealand MEDSAFE approves ABRAXANE for metastatic breast cancer

Abraxis BioScience, Inc., a fully integrated, global biotechnology company, and Specialised Therapeutics Ltd. today announced that MEDSAFE, the New Zealand Medicines and Medical Devices Safety Authority, has approved for marketing ABRAXANE® (nanoparticle albumin-bound paclitaxel) for the treatment of metastatic breast cancer after failure of anthracycline therapy.

29 Jul 2010