| Three Extreme FDA Medical Device / Diagnostic Trades Mike Havrilla submits:Below is a selection of companies with stock prices below $5 per share and upcoming binary events in the form of FDA decisions for medical device /diagnostic submissions to the Agency. A common strategy used by many investors is to buy a basket of several small or micro-cap companies (generally less than $1 billion market cap stocks) with pending binary events approximately 3-6 months ahead of the expected catalyst date and sell into the expected upward momentum in both stock price and trading volume. Medical device and diagnostic submissions for FDA marketing clearance represent a unique niche within the space of trading binary events since there are no firm decision deadlines for decisions by the Agency and there is often a great deal of variability in the review periods. For example, Cambridge Medical (CAMH.OB) received marketing clearance for its Microvolt T-Wave Alternans OEM module used in cardiac stress testing systems in less than three months while other companies such as Nephros [NEPH.OB] ($0.54, $22 million market cap) have been waiting for over one year.Complete Story » seekingalpha.com |
Affymax Tanks as Investors Worry About Safety of Anemia Drug: Biotech's Latest Mishaps The Burrill Report submits: Shares of Affymax (AFFY) tumbled 65 percent on news that despite a set of late-stage trials of its anemia drug Hematide that showed it was not inferior to Amgen’s (AMGN) Epogen or Aranesp, a subgroup of pre-dialysis patients had a statistically significant increase in cardiovascular events. That raised concerns among some investors that it could delay approval of the drug or prevent approval of its use in that population of patients. Affymax CEO Arlene Morris called the completion of the late-stage studies a “key milestone.” She said the company is continuing to evaluate the data, in particular the non-dialysis studies, and the impact on the timing of when it would submit an application to the U.S. Food and Drug Administration for approval to market the drug. Pfizer (PFE) said it is removing its leukemia drug Mylotarg from the market after a study found higher death rates and no benefit for patients using the drug. The approval of Mylotarg in the United States was granted under FDA's accelerated approval regulations based on overall response rate in three non-comparative studies and required submission of additional data to confirm clinical benefit. The required post-approval study combining chemotherapy and Mylotarg did not demonstrate improved survival compared with chemotherapy alone in patients with previously untreated acute myeloid leukemia. Pfizer said it has suspended development of tanezumab, a monoclonal antibody for the treatment of osteoarthritis. The decision followed a request by the U.S. Food and Drug Administration and comes after reports of a small number of tanezumab patients experiencing the worsening of osteoarthritis leading to joint replacement. To date, this adverse event has not been observed in non-osteoarthritis patient populations taking tanezumab, the company said. The clinical hold includes both the suspension of recruitment of new patients and the dosing of existing patients in the osteoarthritis program, as well as patients with osteoarthritis in other studies. The FDA has asked Pfizer to present its assessment of the potential implications of the adverse events in the osteoarthritis program for the other tanezumab clinical programs involving non-osteoarthritis patients, which include patients with cancer pain, interstitial cystitis, chronic low back pain and painful diabetic peripheral neuropathy. The company is working with the agency to determine the appropriate course of action. Basilea Pharmaceutica (BPMUF.PK) said that following a request for re-examination from the Johnson & Johnson (JNJ) subsidiary Janssen-Cilag International, the European Committee for Medicinal Products for Human Use confirmed its previous rejection of the Marketing Authorization Application for ceftobiprole for the treatment of complicated skin and soft tissue infections. The agency indicated that, although the study results suggested that the medicine was beneficial to patients, it was concerned about the reliability of the results. The committee recommended that, in light of the uncertainty surrounding the results, ceftobiprole should not be granted marketing authorization. In February, the agency said that inspections had shown that the late-stage studies supporting the application had not been conducted in compliance with good clinical practice in some sites. Full rights to ceftobiprole will be transferred from Cilag back to Basilea.Complete Story » seekingalpha.com |
Trident & Smiles Across America - Video More Than One Million Sealants Delivered to Date but Survey Reveals Parents Still Underestimate the Impact of Tooth Decay feedproxy.google.com |
New Ad Targets McDonald's McDonald's is the target of a new television commercial set to air in Washington, D.C., Thursday that blames the burger giant for heart disease. online.wsj.com |
PAREXEL International to Present at Piper Jaffray Healthcare Conference [PR Newswire] - PAREXEL International Corporation announced today it will be presenting at the Piper Jaffray Healthcare Conference in New York. Â James Winschel, Sr. Vice President and Chief Financial Officer will be making a presentation on PAREXEL at 2:30 pm E.T. on Tuesday, November 30, 2010. us.rd.yahoo.com |