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 ...

Yesterday, Merck (MRK) updated the status of two of its pipeline candidates, both used to treat migraine. While the company abandoned MK-3207, it will continue to develop telcagepant (MK-0974). Although MK-3207 was found to be effective, it caused liver abnormalities in some patients on discontinuing the drug. Due to this, Merck has decided to abandon any further studies of the drug. The phase III trial conducted by Merck for telcagepant found it to be more effective than placebo for acute treatment of multiple migraine attacks. In another study, the safety of the product was compared to another migraine drug of Merck, Maxalt (rizatriptan). The company presented data from both trials at the International Headache Congress and plans to initiate discussions regarding the next steps with the US Food and Drug Administration (FDA) later this year. The telcagepant trial was carried out on 1677 patients who ...

In a positive development yesterday, Forest Laboratories (FRX) and Nycomed announced that encouraging data from a phase III clinical trial of their lung drug was published in a prestigious medical journal. We are pleased to hear that the drug, Daxas (a phosphodiesterase, PDE 4 inhibitor), improved lung function and reduced exacerbations in chronic obstructive pulmonary disease (COPD).

The placebo-controlled trials were carried out in 4,500 patients spanning 10 countries. It evaluated the treatment in two studies, each of which covered a time span of 12 months and 6 months. Results showed that Daxas reduced COPD attacks by 17% per patient every year compared with a placebo and improved the volume of air that patients breathe out each second, a measure known as FEV1 by 48 millilitres.

Studies also showed additional benefits when Daxas was used with other treatments such as Pfizer’s (PFE) Spiriva and GlaxoSmithKline's (GSK)

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Today, Nutra Pharma Corp., a biotechnology company that develops treatments for AMN, HIV and Multiple Sclerosis, announced the launch of an over-the-counter pain reliever, Cobroxin, for the treatment of Stage 2 chronic pain. Cobroxin is the first clinically approved OTC pain reliever for Stage 2 pain.

The drug, developed by Nutra Pharma’s subsidiary, ReceptoPharm, will be available as an oral spray. It is designed to treat lower back pain, migraines, neck aches, shoulder pain, cramps and neuralgia. It will also be available as a topical gel for treating repetitive stress, arthritis, and joint pain.

Rik J Deitsch, Chairman and CEO of Nutra Pharma Corporation, commented, “Cobroxin is a next generation pain reliever that addresses physician and consumer demand for a safer and less costly treatment for chronic pain. Cobroxin provides affordable and accessible pain relief for those without healthcare coverage, for those looking for a safer and effective treatment for pain,

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“Little else is required,” Adam Smith, author of The Wealth of Nations, once remarked, “to carry a state to the highest degree of affluence from the lowest barbarism but peace, easy taxes and a tolerable administration of justice; all the rest being brought about by the natural course of things.”

But this quintessentially laissez-faire perspective gains very little traction in modern-day America. In fact, it gains no traction whatsoever, except in a few fringey financial publications. Instead, America’s political elite conspires with the Wall Street bourgeoisie to lead the nation from the highest degree of affluence to the lowest barbarism.

The process begins innocently enough in the name of “crisis management,” as the political elite provides multi-trillion-dollar guarantees and bailouts to the Wall Street bourgeoisie. The proletariat embraces these bizarre, counterintuitive remedies because they genuinely believe these “remedies” contain curative powers. In other words, the proletariat believes that bureaucrats and politicians, following

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“Little else is required,” Adam Smith, author of The Wealth of Nations, once remarked, “to carry a state to the highest degree of affluence from the lowest barbarism but peace, easy taxes and a tolerable administration of justice; all the rest being brought about by the natural course of things.”

But this quintessentially laissez-faire perspective gains very little traction in modern-day America. In fact, it gains no traction whatsoever, except in a few fringey financial publications. Instead, America’s political elite conspires with the Wall Street bourgeoisie to lead the nation from the highest degree of affluence to the lowest barbarism.

The process begins innocently enough in the name of “crisis management,” as the political elite provides multi-trillion-dollar guarantees and bailouts to the Wall Street bourgeoisie. The proletariat embraces these bizarre, counterintuitive remedies because they genuinely believe these “remedies” contain curative powers. In other words, the proletariat believes that bureaucrats

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Shares of MAP Pharmaceuticals Inc. (MAPP) more than tripled in value on Tuesday after the company said its experimental migraine candidate accomplished the rare feat of meeting all four targets in the last stage of clinical trials.

The drug Levadex showed a significant number of patients got relief from severe headache within 30 minutes of taking the inhaled formula. Compared with a dummy drug at 2 hours, Levadex also proved more efficient in relieving all common symptoms of migraine such as pain, nausea, and sensitivity to light and sound. The drug did not lead to any serious adverse events in the study.

These results could mark a turning point for the company that saw its shares slumping in February as its late-stage pediatric asthma drug failed to show any significant improvement compared with a placebo.

If the drug gets approved by the US Food and Drug

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