Recently, Bristol-Myers Squibb Co. (BMY) received approval from the U.S. Food and Drug Administration (FDA) to market Abilify (aripiprazole) for the treatment of irritability in pediatric patients having autistic disorder. Abilify can be used to treat children aged 6 to 17 years for symptoms of aggression toward others, deliberate self injury, temper tantrums and quick mood swings.  Bristol-Myers and Otsuka Pharmaceutical Co. jointly develop and distribute the drug in the U.S. and Europe. The FDA approval of Abilify for treating irritation in pediatric patients with autistic disorder is based on data from two eight-week late-stage studies in which Abilify significantly improved scores on the irritability subscale of the caregiver-rated Aberrant Behavior Checklist (ABC-I), compared to placebo.  The most common adverse affects were sedation, fatigue, vomiting, somnolence, tremor and pyrexia. However, the efficacy of Abilify for the maintenance treatment of irritability associated with autistic disorder was not ...

Recently, Merck (MRK) and Schering-Plough (SGP) received approval from the US Federal Trade Commission (FTC), the Swiss Competition Commission and the Canadian Competition Bureau for their proposed merger. However, the transaction has yet to receive approval from other regulators, including China and Mexico. The deal was approved by the European Union antitrust regulators last week. Shareholders of both the companies have already approved the deal in August. Merck expects to close the proposed merger by year end. The FTC approval has come with the condition that both companies will sell some assets. As a result, Schering-Plough has agreed to sell its rolapitant drug, meant to be used for the treatment for nausea and vomiting in chemotherapy patients to Opko Health Inc. In addition, Merck agreed to sell its interest in Merial Ltd, an animal health joint venture, to its French partner, Sanofi-Aventis ...

Yesterday, GlaxoSmithKline (GSK) received some good news with the US Food and Drug Administration’s (FDA) approval of Votrient (pazopanib) for the treatment of patients with advanced renal cell carcinoma (RCC), a form of kidney cancer. However, the FDA approval does not come as a surprise to us as earlier this month the FDA’s Oncologic Drugs Advisory Committee (ODAC) had voted unanimously in favor of the drug.  The favorable recommendation was based on encouraging results from a phase III trial of Votrient, in which the drug reduced the risk of tumor progression or death by 54% compared to placebo, regardless of prior treatment. The overall median progression-free survival (PFS) was 9.2 months with Votrient and 4.2 months with placebo.  For both treatment naïve patients and those who received cytokine-based treatment, the median PFS was better with Votrient – 11.1 months versus 2.8 months with placebo, and 7.4 ...

Recently, Schering-Plough Corporation (SGP) and Opko Health Inc. (OPK) entered into a deal which would enable Opko to acquire the assets of Schering's neurokinin-1 (NK-1) receptor antagonist program. The companies did not disclose the terms of the agreement. NK-1 receptors are mostly found in the brain.  However, they are also found in other tissues of the body. Their activation causes a release of neurotransmitters and other signaling molecules that play a key role in controlling nausea and vomiting amongst other functions.  The U.S. market for nausea and vomiting drugs is estimated to be in excess of $2 billion. Rolapitant, Schering's lead neurokinin, recently completed mid-stage studies for the prevention of nausea and vomiting due to cancer chemotherapy, surgery and other indications. The company has initiated early-stage studies for another compound in the same class.  As a result of Schering’s $41.1 billion merger agreement with ...

Results from Arena’s (ARNA) phase III BLOSSOM study are strikingly similar to the BLOOM study, with mean total weight loss for the 10mg lorcaserin BID group coming in at 17.0 lbs in BLOSSOM vs. 17.9 lbs in BLOOM. These equated to 7.9% and 8.2% mean absolute weight loss. The placebo was 3.9% and 3.4% in each trial, respectively, putting the mean placebo-adjusted weight loss for each trial at 4.0% and 4.8%. Total categorical weight loss for the completer analysis was 63.2% in BLOSSOM and 66.4% in BLOOM, vs. 34.9% and 32.1% for the placebo. Per the FDA draft guidance: “A product can be considered effective for weight management if after one year of treatment either of the following occurs: (1) the difference in mean weight loss between the active-product and placebo-treated groups is at least 5% and the difference is statistically significant, or (2) the proportion of subjects who lose ...

Google (NASDAQ:GOOG) just beat earnings estimates. The numbers were jaw-dropping. Over the last three months the internet search-engine company earned $1.35 billion, or $4.92 a share. But Andrew Snyder says the party could soon be over for Google. Management at the company are overconfident…and that’s always a a recipe for disaster.

This from Today’s Financial News:

All across the nation, companies that rely on advertising dollars to stay in business are desperately searching for the nearest trash can. They are so nervous about what the next few months will bring that they already feel their stomachs twisting and convulsing. They know gut-wrenching vomiting is on the way.

But that is not the case at Google.

In fact, the only way the search-engine giant’s executives will be praying to the porcelain god is if they drank too much champagne while celebrating their company’s third-quarter earnings results.

While, Google did not flat-out destroy Wall Street expectations like

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A.P. Pharma, Inc. (NASDAQ: APPA) is a specialty pharmaceutical company focused on the development and commercialization of innovative medical treatments utilizing their proprietary polymer-based drug delivery systems.

The company’s proprietary Biochronomer™ technology, featuring bioerodible polymers intended to create controlled-release pharmaceuticals that improve treatments for diseases or health-threatening conditions, is their primary focus as they continue to advance the technology. The company’s lead product candidate is APF530, which is currently in a pivotal Phase III clinical trial for the prevention of acute and delayed onset chemotherapy-induced nausea and vomiting, or CINV.

The company has made significant investments in the development of their bioerodible drug delivery technologies, which have produced tangible results. Specifically, A.P. Pharma has developed a broad family of polymers consisting of unique attributes referred to as poly (ortho esters), under the trade name Biochronomer. This technology has been designed for use in drug delivery applications

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A cancer diagnosis is devastating, and oftentimes the treatment following such diagnosis can be just as mentally and physically debilitating. The majority of patients receiving treatment experience some degree of emesis, or nausea and vomiting, associated with chemotherapy. The prevention and control of emesis is very important for the patient, and chemotherapy patients are typically administered an anti-emetic prior to treatment.

Specialty pharmaceutical company A.P. Pharma Inc. (Nasdaq: APPA) today announced positive results from its pivotal phase III study that compares the efficacy of the company’s lead product, APF530, with Aloxi for the prevention of emesis, also known as chemotherapy-induced nausea and vomiting (CINV).

The phase III trial is based on the participation of 1,395 patients, treated at 103 centers in the United States, Poland and India. The patients were classified according to their level of emetogenic chemotherapy to demonstrate the safety and efficacy of APF530.

According to the

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Dyax Corp. (Nasdaq: DYAX) focuses on the advancement of novel biotherapeutics, such as those for the treatment of hereditary angiodema (HAE), a rare and potentially life-threatening condition that occurs in about one in every 10,000 to 50,000 people. The condition is associated with swelling in various parts of the body (including hands, feet, face and airway), abdominal pain, and nausea and vomiting.

Dyax today announced the completion of its Biologics License Application (BLA) with the U.S. Food and Drug Administration (FDA) for approval of Dyax’s flagship product, DX-88 (ecallantide), for the treatment of HAE.

“The submission of the DX-88 BLA is a major milestone for Dyax,” Henry E. Blair, chairman, president and CEO of Dyax stated in the press release. “We believe DX-88, a recombinant, subcutaneously administered therapy, has many characteristics that match well with the needs of HAE patients and physicians for a therapeutic option. We look forward to working

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