As the only company to receive a positive United States Food and Drug Administration [FDA] Advisory Committee [AdCom] recommendation for a product candidate to treat obesity in 2010, Orexigen Therapeutics, Inc. (OREX) appeared well positioned to receive marketing approval for Contrave® [naltrexone HCl/bupropion HCI]. However, on January 31, 2011, Orexigen and its partner Takeda Pharmaceutical … Read moreFDA Advisory Panels: No Means No, Yes Means Maybe
At the start of the year, we provided a favorable outlook for the biotechnology industry in 2010 that was based on the same six drivers we proposed for 2009, which included the following: Sector’s defensive characteristics and impact on future economic growth Highest number of annual new product approvals since 2004 Record number of products … Read moreBiotech’s Top and Bottom Ten from 2010
Acute myelogenous leukemia [AML] is a fast-growing cancer of the blood and bone marrow. Unformed cells called myeloblasts, or “blasts,” reside in the bone marrow and normally become a particular kind of cell – a white blood cell, red blood cell, or platelet. In AML, abnormal blasts produce white blood cells that do not function … Read moreInvestment Opportunities with Five Frontline Therapies for AML
Monoclonal antibodies, which have been approved for immunological, anti-infective, ophthalmic, cancer and other categories, represent one of the most successful therapeutic drug classes. Ten monoclonal antibodies have been approved for cancer therapy alone, including three blockbuster products sold by the Roche Group (RHHBY) – Avastin® [bevacizumab], Rituxan® [rituximab], and Herceptin® [trastuzumab] that collectively represented nearly … Read moreMonoclonal Antibody Companies Command Premiums
Shares of Dendreon Corporation (DNDN) have declined significantly from an all-time high of $57.67 in late April 2010 when the company received U.S. Food and Drug Administration [FDA] approval for Provenge® [sipuleucel-T], the first active immunotherapy approved for the treatment of cancer in the U.S. Today, shares of Dendreon traded as low as $28.01, down … Read moreFive Key Factors Weighing on Dendreon
“It’s déjà vu all over again” – Yogi Berra With Opening Day less than a month away, it seems only fitting to reference one of the most quoted personalities of our time to describe our analysis of the biotechnology sector in 2010. In this article, we review our favorable outlook for the industry, draw comparisons … Read moreFor Biotechnology in 2010, it’s Déjà vu All over Again
* MD Becker Partners reporting live from the JP Morgan Healthcare Conference This week, nearly 6,500 registrants gathered in San Francisco, California for the JP Morgan Healthcare Conference to hear 25-minute presentations from 338 life science companies. For industry executives and investors, the annual event serves as a good barometer for the rest of the … Read moreBiotech Deal Activity Declines…The Pause that Refreshes?
According to the American Cancer Society [ACS], non-Hodgkin lymphoma [also known as non-Hodgkin’s lymphoma, NHL, or sometimes just lymphoma] is a cancer that starts in cells of the lymph system, which is part of the body’s immune system. NHL is the fifth most common cancer in both men and women in the United States [not … Read moreSpectrum Pharmaceuticals to Benefit from FDA Action on Zevalin?
Last week, the NASDAQ Biotech Index (NBI) declined more than 10 percent compared to an approximate 4.5 percent decline for the S&P 500. Since the NBI has been outperforming the broader market since mid-2008, this week’s relative underperformance came as quite a shock to many investors. Trying to explain the decline, most industry pundits pointed … Read moreChink in the Biotechnology Armor
At the start of the year I provided a positive outlook for the biotechnology industry in 2009, citing the sector’s defensive characteristics, favorable technical aspects, and improving fundamentals, such as the number of new product approvals, products in clinical trials and the brisk pace of industry consolidation and licensing transactions. With January officially on the … Read moreBullish Thesis for Biotechnology Remains Intact