NVS

NVS

Pfizer Halts Trial of Pain Drug: Biotech's Latest Mishaps

The Burrill Report submits: Pfizer (PFE) said it was halting a trial of its experimental drug tanezumab to treat chronic low back pain and diabetic peripheral neuropathy at the request of the U.S. Food and Drug Administration. Investigation of the compound continues in some areas of high unmet medical need, including cancer pain, the pharmaceutical company said. The FDA's request follows reports of adverse events in osteoarthritis patients taking tanezumab, and the agency's concerns regarding the potential for such events in other patient populations in which the compound is being studied. Pfizer said it will continue to work with the FDA to reach a common understanding about the appropriate scope of continued clinical investigation of tanezumab. A U.S. Food and Drug Administration panel is advising the agency to revoke Roche's (RHHBY.PK) right to market Avastin as a treatment for metastatic breast cancer after additional trial data convinced it that the biologic's risks might outweigh its benefits. The recommendation could put a $1 billion dent in Avastin's global sales some reports say, slicing as much as a sixth off Roche's $6 billion take from the drug in 2009 and opening up fears that European regulators may also revisit their approval of the drug's use in treating advanced breast cancer. Complete Story »

Hedge Fund East Coast on Consensus vs. Variant Perception Investing

Market Folly submits:We're pleased to present the second quarter 2010 commentary from East Coast Asset Management. The letter, penned by Chief Investment Officer Christopher Begg, touches on a number of intriguing and hotly debated topics, including inflation. Some of you will recall that we featured some past commentary from East Coast where the hedge fund examined the deflation-reflation continuum. East Coast is decisively in the inflationist camp. It believes that central banks armed with printing presses can only lead to one outcome. Its portfolio is positioned to mitigate the effects of any tail risk events such as hyperinflation, a bond bubble, a spike in interest rates, paper currency debasement, and a double dip recession. You'll recall that Baupost Group's Seth Klarman has also protected his portfolio from tail risk events as a form of cheap insurance. Complete Story »

Hedge Fund East Coast on Consensus vs. Variant Perception Investing

Market Folly submits:We're pleased to present the second quarter 2010 commentary from East Coast Asset Management. The letter, penned by Chief Investment Officer Christopher Begg, touches on a number of intriguing and hotly debated topics, including inflation. Some of you will recall that we featured some past commentary from East Coast where the hedge fund examined the deflation-reflation continuum. East Coast is decisively in the inflationist camp. It believes that central banks armed with printing presses can only lead to one outcome. Its portfolio is positioned to mitigate the effects of any tail risk events such as hyperinflation, a bond bubble, a spike in interest rates, paper currency debasement, and a double dip recession. You'll recall that Baupost Group's Seth Klarman has also protected his portfolio from tail risk events as a form of cheap insurance. Complete Story »

Drug Pipeline Pulse Check: High Expectations for Novartis

Research Recap submits:
NOVARTIS (NVS)A string of promising new drugs and broad treatment range make Novartis an attractive buy for those willing to wait out short-term weakness caused by a pending bid to complete its buyout of Alcon (ACL), according to Reuters. Some analysts say the stock has been trading below its potential but others note that share overhang from an Alcon deal could dilute Novartis’ stock.Complete Story »

FDA Approval Positions Novartis in the Lead to Bring Oral MS Treatment to Market

The Burrill Report submits: By Michael Fitzhugh A Food and Drug Administration panel has unanimously backed the safety and effectiveness of Novartis' (NVS) multiple sclerosis treatment fingolimod. The panel voted 25-0 in support of fingolimod's “substantial evidence of effectiveness” in treating patients with relapsing remitting multiple sclerosis. That makes it likely the drug will be the first oral MS treatment to gain FDA approval, beating Merck (MRK), Sanofi (SNY) and Teva (TEVA) - all of which are developing their own oral MS drugs - to the punch.Complete Story »

38 Foreign Dividend Stocks Traded in the U.S.

David Hunkar submits: Investing in foreign stocks is an integral part of a well-diversified portfolio. There are many reasons for this strategy. Some of them are noted below:

  • The total market capitalization of all stocks listed in the New York Stock Exchange is about $11.8 Trillion as of Dec 31,2009. Over 400 foreign stocks account for a significant portion of this total market capitalization
  • Last year in US dollar terms the market capitalization of Shanghai, Bombay, Bovepsa exchanges grew by 89%, 101% and 125% respectively while the market cap of NYSE grew by only 28%
  • More capital for IPOs and secondary market issues is raised in foreign markets than in the US exchanges

(Source: World Federation of Exchanges)Complete Story »

Preview of AspenBio's Potentially Blockbuster Clinical Trials

Dan Weiss submits:
When: Clinical trial results are anticipated to be released by AspenBio (APPY) for its appendicitis detector, AppyScore, anytime between May 4- May 18 according to a March 23 press release from the company. What: The clinical trial was completed in late March at 12 hospitals throughout the United States to measure the effectiveness of AspenBio’s rapid blood test, AppyScore, in combination with other common blood tests to detect appendicitis. The current care of conduct for suspected appendicitis is a clinical diagnosis with an abdominal CT scan which can be very expensive and in the case of unnecessary CT’s can expose patients to potential risks from radiation. Complete Story »

Fanapt First Quarter Sales Bode Well for Vanda, Novartis

VFC submits: Vanda Pharmaceuticals (VNDA) and marketing partner Novartis (NVS) announced the commercial launch of Vanda's schizophrenia drug Fanapt in early January, and this week Novartis released first quarter sales results for the product that at one point was issued a non-approvable letter from the FDA.According to a Novartis media release dated April 20th, Fanapt raked in a total of $21 million for the quarter, a solid start for a new drug entering a $14-$20 billion market. Complete Story »

Novartis Presents Positive Data on MS Treatment

Zacks.com submits:
Novartis (NVS) presented encouraging data on one of its investigational candidates, Gilenia at the annual meeting of the American Academy of Neurology (AAN). The drug is meant to treat relapsing forms of multiple sclerosis (MS) orally. Novartis conducted two pivotal phase III clinical trials – TRANSFORMS and FREEDOMS. The two-year FREEDOMS study showed that Gilenia (dosage of 0.5 mcg) reduced annual relapse rates (ARR) by 62% in treatment naïve patients compared to placebo. Additionally, ARR came down by 44% for patients undergoing treatment. Complete Story »

Cell Therapeutics Still Waiting on Its Diagnosis

The Burrill Report submits: Cell Therapeutics (CTIC) got a momentary reprieve from potentially bad news Friday as the US Food and Drug Administration postponed a meeting about pixantrone, an experimental treatment for refractory aggressive non-Hodgkin’s lymphoma, due to blustery weather. It's the company's best hope at generating any substantial revenue and an important bet to win for Cell Therapeutics and, among others, the two institutional investors that put a fresh $30 million into the company in January.Doubt about the drug's approval was cast by an FDA brief questioning pixantrone's efficacy February 8. That sparked investors to drive Cell Therapeutics' shares off a cliff, denting their value by 40 percent, briefly. It also called into question the likelihood of Novartis (NVS) acting on its option to license the drug, an event that could deliver as much as $104 million in registration and sales milestones should it pan out.Complete Story »

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