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Lack of tracking of medical devices' performance raises questions about safety and efficacy

"Amid the booming use of artificial joints in the United States, the breakup between Dr. Berger and Zimmer highlights what experts say is a troubling situation for patients and doctors: when disputes arise about orthopedic implant safety, there are no independent referees or sources of information because no one tracks the performance of the devices.

22 Jun 2010

Star Scientific seeks FDA approval of Stonewall-BDL as "modified risk tobacco product"

Star Scientific, Inc. announced that on Friday, June 18 the company filed an application with the Food & Drug Administration for approval to market Stonewall-BDL™ as a "modified risk tobacco product" under the Family Smoking Prevention and Tobacco Control Act of 2009. This is Star's second such application to the Tobacco Products Center of the FDA, which has been established to oversee all aspects of tobacco regulation outlined in the 2009 Act.

22 Jun 2010

Women with PCOS may be more vulnerable to BPA exposure: Study

Women with the polycystic ovary syndrome, the most common hormone imbalance in women of reproductive age, may be more vulnerable to exposure to the chemical bisphenol A, found in many plastic household items, according to a new study. The results will be presented Sunday at The Endocrine Society's 92nd Annual Meeting in San Diego.

22 Jun 2010

FDA grants approval for newest version of OnGuard Chest X-ray CAD technology

Riverain Medical announced today that the U.S. Food and Drug Administration has granted approval for the newest version of the OnGuard Chest X-ray Computer-Aided Detection technology. OnGuard identifies solitary pulmonary nodules that may represent early-stage lung cancer on an existing chest X-ray. This improved performance demonstrates a 73% reduction in false positive marks and 50% higher relative sensitivity compared to the original product.

22 Jun 2010

Pfizer announces voluntary withdrawal of Mylotarg from U.S. market following FDA request

Pfizer Inc. today announced the voluntary withdrawal from the U.S. market of the drug Mylotarg (gemtuzumab ozogamicin) for patients with acute myeloid leukemia (AML), a bone marrow cancer. The company took the action at the request of the U.S. Food and Drug Administration after results from a recent clinical trial raised new concerns about the product's safety and the drug failed to demonstrate clinical benefit to patients enrolled in trials.

22 Jun 2010

Hunger hormone ghrelin heightens the appeal of high-calorie foods over low-calorie foods: Study

The "hunger" hormone ghrelin, which acts in the brain to stimulate hunger and increase food intake, heightens the appeal of high-calorie foods over low-calorie foods, according to a study that will be presented Tuesday at The Endocrine Society's 92nd Annual Meeting in San Diego.

22 Jun 2010

Exposure to BPA in early life may affect testis function into adulthood

Exposure to environmental levels of the industrial chemical bisphenol A, or BPA, in the womb and early life may cause long-lasting harm to testicular function, according to a new study conducted in animals. The results are being presented Monday at The Endocrine Society's 92nd Annual Meeting in San Diego.

22 Jun 2010

Celator announces expansion of research agreement with Cephalon

Celator Pharmaceuticals today announced that it has expanded its research agreement with Cephalon, Inc.. The research agreement provides for the utilization of Celator's proprietary technology in an ongoing drug development and life-cycle management program at Cephalon.

22 Jun 2010

Incline acquires IONSYS, announces $43 million Series A financing

Incline Therapeutics, Inc., a privately-held, hospital-focused specialty pharmaceutical company, announced today that it has entered into an agreement to acquire the rights to IONSYS™ (fentanyl iontophoretic transdermal system) from ALZA Corporation and completed a $43 million Series A financing.

22 Jun 2010

FDA approves NAMENDA XR for treatment of Alzheimer's type dementia

Forest Laboratories, Inc. and Merz Pharmaceuticals GmbH announced today that NAMENDA XR(TM) (memantine hydrochloride) was approved by the U.S. Food and Drug Administration for the treatment of moderate to severe dementia of the Alzheimer's type. NAMENDA XR is a 28 mg once-daily extended-release formulation of NAMENDA.

22 Jun 2010

Cadence Pharmaceuticals to acquire Incline Therapeutics

Cadence Pharmaceuticals, Inc., a biopharmaceutical company focused on in-licensing, developing and commercializing proprietary product candidates principally for use in the hospital setting, announced today that it has signed an agreement providing Cadence with an exclusive option to acquire Incline Therapeutics, Inc., a privately held specialty pharmaceutical company.

22 Jun 2010

FDA approves ARCHITECT HIV Ag/Ab Combo assay to aid in diagnosis of HIV-1/HIV-2 infection

The U.S. Food and Drug Administration today approved the first assay to detect both antigen and antibodies to Human Immunodeficiency Virus. This assay is approved for use as an aid in the diagnosis of HIV-1/HIV-2 infection in adults including pregnant women. It is also the first assay for use as an aid in the diagnosis of HIV-1/HIV-2 infection in children as young as two years old.

22 Jun 2010

Patel had the patient’s best interests in mind: Defense says

The manslaughter trial against the Bundaberg based surgeon Dr. Jayant Patel that has been going on for 13 weeks now, is in its final phases now. In Dr. Patel’s defense barrister, Michael Byrne QC completed his final address to the jury in the Queensland Supreme Court.

21 Jun 2010

CardioGenics announces clinical test sites for QL Care portable blood analyzer

CardioGenics Holdings Inc., developer of the ultra-sensitive QL Care™ Point-Of-Care (POC) analyzer and products for the immunoassay segment of the In-Vitro Diagnostics market, announced the selection of four sites for clinical testing of its patented QL Care™ Analyzer, a portable diagnostic platform designed to produce test results with central lab-like accuracy in 15 minutes using whole blood.

21 Jun 2010

FDA approves Abbott's ARCHITECT HIV Ag/Ab Combo assay

Every nine and a half minutes, someone in the United States is infected with HIV, and one out of every five of these individuals doesn't know it. To help stem the spread of this disease, the U.S. Food and Drug Administration (FDA) today approved an innovative new diagnostic tool, which will allow patients to be diagnosed earlier than ever before.

21 Jun 2010

Ferring announces availability of LYSTEDA for cyclic heavy menstrual bleeding in U.S.

Ferring Pharmaceuticals Inc. announced today the U.S. commercial availability of LYSTEDA™ (tranexamic acid) tablets, the only non-hormonal and non-surgical therapy indicated specifically for the treatment of women with cyclic heavy menstrual bleeding (HMB). In clinical studies, LYSTEDA significantly reduced menstrual blood loss (MBL) over three and six cycles of use with the reduction seen as early as the first cycle of use.

21 Jun 2010

"Lap Band" weight loss surgery improves physical, psychological health in extremely obese adults

One year after weight loss surgery with laparoscopic gastric banding, extremely obese adults demonstrate not only better physical health but also improved psychological health, a new study shows. The results will be presented Monday at The Endocrine Society's 92nd Annual Meeting in San Diego.

21 Jun 2010

BioSante announces $15 million registered direct offering

BioSante Pharmaceuticals, Inc. today announced that it has received commitments from several institutional investors to purchase $15 million of securities in a registered direct offering. The investors are Deerfield Management Company and other institutional investors. BioSante expects to receive net proceeds of approximately $14.2 million after deducting placement agent fees and other offering expenses.

21 Jun 2010

Palatin reports preclinical study results of PL-3994 in respiratory tissue for asthma indications

Palatin Technologies, Inc. today announced results of preclinical studies in respiratory tissue with PL-3994. In rat, guinea pig and human tissues, PL-3994 produced potent relaxation of isolated airway smooth muscle, indicating that PL-3994 may be a potent bronchodilator in humans.

21 Jun 2010

FDA grants Pathway 510(k) clearance for JETSTREAM G3 SF peripheral revascularization catheter for PVD

Pathway Medical Technologies, Inc., an innovator of endovascular treatments for peripheral vascular disease (PVD), today announced that the U.S. Food & Drug Administration (FDA) has granted the company 510(k) clearance to market JETSTREAM G3™ SF (Small Fixed), the newest version of its peripheral revascularization catheter for the treatment of PVD.

21 Jun 2010

Food News and Research

Lack of tracking of medical devices' performance raises questions about safety and efficacy

Star Scientific seeks FDA approval of Stonewall-BDL as "modified risk tobacco product"

Women with PCOS may be more vulnerable to BPA exposure: Study

FDA grants approval for newest version of OnGuard Chest X-ray CAD technology

Pfizer announces voluntary withdrawal of Mylotarg from U.S. market following FDA request

Hunger hormone ghrelin heightens the appeal of high-calorie foods over low-calorie foods: Study

Exposure to BPA in early life may affect testis function into adulthood

Celator announces expansion of research agreement with Cephalon

Incline acquires IONSYS, announces $43 million Series A financing

FDA approves NAMENDA XR for treatment of Alzheimer's type dementia

Cadence Pharmaceuticals to acquire Incline Therapeutics

FDA approves ARCHITECT HIV Ag/Ab Combo assay to aid in diagnosis of HIV-1/HIV-2 infection

Patel had the patient’s best interests in mind: Defense says

CardioGenics announces clinical test sites for QL Care portable blood analyzer

FDA approves Abbott's ARCHITECT HIV Ag/Ab Combo assay

Ferring announces availability of LYSTEDA for cyclic heavy menstrual bleeding in U.S.

"Lap Band" weight loss surgery improves physical, psychological health in extremely obese adults

BioSante announces $15 million registered direct offering

Palatin reports preclinical study results of PL-3994 in respiratory tissue for asthma indications

FDA grants Pathway 510(k) clearance for JETSTREAM G3 SF peripheral revascularization catheter for PVD

The future is bioengineered: Synthetic biology and global sustainability eBook

Bringing real-time analytics to downstream bioprocess monitoring

Designing fluidic architecture for scalable diagnostic platforms

Evaluating new approaches for rare disease genomics

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