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FDA awards 84 grants worth $18.5 million to boost food and feed safety initiatives

The U.S. Food and Drug Administration awarded 84 grants worth $18.5 million in fiscal year 2010 to help state and local regulatory agencies defend against and respond quickly to threats to the food supply and to outbreaks of foodborne diseases.

29 Oct 2010

ACRO responds to government report on FDA's Overseas Offices

The Association of Clinical Research Organizations, which represents the global CRO industry, issued the following statement in response to the Government Accountability Office's report on the Food and Drug Administration's Overseas Offices.

29 Oct 2010

Coherex achieves two milestones in structural heart disease field

In honor of World Stroke Day (October 29, 2010), Coherex Medical, Inc. today announced it has achieved two milestones that further strengthen its position as an emerging medical device company in the field of structural heart disease.

29 Oct 2010

Phytonutrient Report says Americans do not consume enough fruits and vegetables

The majority of Americans report getting a cold or flu in the past year, and more than a third say they'll make lifestyle changes to prevent getting sick again this year. However, 40 percent of Americans don't plan to take what is arguably the easiest and tastiest step to help potentially prevent illness this cold and flu season eat more fruits and vegetables daily.

29 Oct 2010

Coadministration of INTUNIV tablets with stimulant reduces ADHD symptoms

Shire plc the global specialty biopharmaceutical company, today presented research results of once-daily INTUNIV (guanfacine) Extended-Release Tablets, coadministered with stimulants in children and adolescents diagnosed with Attention Deficit Hyperactivity Disorder (ADHD) who had suboptimal response to treatment with a long-acting stimulant alone.

29 Oct 2010

SPRYCEL receives FDA approval for treating adult patients with Ph+ CML in chronic phase

After receiving a priority review, Bristol-Myers Squibb Company and Otsuka Pharmaceutical Co., Ltd. today announced that the U.S. Food and Drug Administration (FDA) has approved SPRYCEL (dasatinib) 100 mg once daily for the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase.

29 Oct 2010

Prominent scientist in mitochondrial genetics joins Children's Hospital to establish CMEM

Douglas C. Wallace, Ph.D., a pioneer and internationally prominent scientist in the field of human mitochondrial genetics, has joined The Children's Hospital of Philadelphia to continue his investigations into the role of mitochondrial energy in health and disease.

29 Oct 2010

Research on sheep population could help explain variation in vaccine protection

Strong immunity may play a key role in determining long life, but may do so at the expense of reduced fertility, a Princeton University study has concluded.

29 Oct 2010

VIVUS receives FDA CRL for QNEXA NDA

VIVUS, Inc. announced today that it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for the investigational new drug QNEXA® (phentermine/topiramate) Controlled-Release Capsules. The FDA issued the CRL to communicate its decision that the NDA cannot be approved in its present form.

29 Oct 2010

FDA approves Sprycel for treatment of adults with Ph+ CP-CML

The U.S. Food and Drug Administration today approved a new indication for Sprycel (dasatinib) for the treatment of a rare blood cancer when it is first diagnosed. The cancer, called Philadelphia chromosome positive chronic phase chronic myeloid leukemia (Ph+ CP-CML), is a slowly progressing blood and bone marrow disease linked to a genetic abnormality.

29 Oct 2010

Agweek examines USAID's food aid purchases

Agweek examines USAID's approach to purchasing food aid. The piece notes USAID Administrator Rajiv Shah's comments from his Oct. 15 remarks at the World Food Prize symposium in Des Moines, Iowa, when he explained that USAID has used $250 million to purchase foodstuffs in developing countries this year.

29 Oct 2010

Talecris third quarter net revenue increases 2.8% to $407.0 million

Talecris Biotherapeutics Holdings Corp. today announced its financial results for the three and nine months ended September 30, 2010 and filed its Quarterly Report on Form 10-Q with the U.S. Securities and Exchange Commission (SEC).

29 Oct 2010

Geron 2010 third quarter revenue increases from $494,000 to $546,000

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

29 Oct 2010

Latuda tablets receive FDA approval for treatment of adults with schizophrenia

The U.S. Food and Drug Administration today approved Latuda (lurasidone HCl) tablets for the treatment of adults with schizophrenia.

29 Oct 2010

Gen-Probe third quarter research revenue increases 70% to $3.4 million

Gen-Probe Incorporated today reported financial results for the third quarter of 2010, highlighted by 19% growth in non-GAAP earnings per share (EPS) and 8% growth in product sales and total revenues.

29 Oct 2010

Chillies for diabetes: Study

Researchers from Tasmania, Australia are recruiting volunteers in a study to explore if eating chillies can help control lifestyle-related diabetes. At present they need 35 people with type 2 diabetes or glucose intolerance.

28 Oct 2010

POZEN reports net loss of $8.6M for third quarter 2010 vs. net income of $6.7M for third quarter 2009

POZEN Inc., a pharmaceutical company committed to transforming medicine that transforms lives, today announced results for the third quarter ended September 30, 2010.

28 Oct 2010

FDA clears ArthroCare's Spartan PEEK Suture Implant system

ArthroCare Corp., a leader in developing state-of-the-art, minimally invasive surgical products, announced today that it has received clearance from the U.S. Food and Drug Administration (FDA) for its Spartan PEEK Suture Implant system (Spartan™). Spartan is a preloaded PEEK threaded anchor indicated for use in fixation of soft tissue to bone, such as during a rotator cuff repair.

28 Oct 2010

Celgene third quarter non-GAAP total revenue increases 31% to $908 million

Celgene Corporation announced non-GAAP net income of $349.9 million, or non-GAAP diluted earnings per share of $0.75 for the quarter ended September 30, 2010.

28 Oct 2010

Octapharma initiates Human-cl rhFVIII clinical study for severe hemophilia A

Octapharma, one of the largest human protein products manufacturers in the world, today announced that patients diagnosed with severe hemophilia A have started treatment with the first recombinant Factor VIII derived from a human cell line (Human-cl rhFVIII). Researchers are investigating pharmacokinetics, efficacy, safety and immunogenicity of Human-cl rhFVIII for previously treated patients with severe hemophilia A.

28 Oct 2010