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The Week In Review: International Initiatives

Sat, 24 Oct 2009 17:19:11 GMT

Boehringer Ingelheim will invest $149 million in China for new facilities including an R&D center; Simcere Pharma[More...]

FDA Calendar Updates: ABII, BMRN, JNJ, OSIP, Roche

Mon, 13 Jul 2009 19:24:05 GMT

Below is a summary of updates to the BioMedReports.com FDA Calendar, which includes a database of 254 entries as of 7/13/09. The calendar was originally created by Mike Havrilla to track companies with pending new drug, biological agent, or medical device new product decisions at the FDA. With the launch of BioMedReports.com, the FDA Calendar has expanded to include the following categories: pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), pending complete respo (...)[More...]

BioMedReports FDA Calendar: Seven Laggard Trades

Wed, 17 Jun 2009 20:29:05 GMT

Below are seven companies from the BioMedReports.com FDA Calendar database of over 200 entries, which have pending new drug decision(s) at the FDA combined with a stock price that is below its 200-day moving average (200-DMA). The list includes a balanced mix of two large-caps, two mid-caps, and three small-cap stocks which have been laggards in the overall market rally with looming regulatory catalysts in the form of FDA new drug decisions serving as potential upside catalysts. Data Source: Yah (...)[More...]

The Winner Of ASCO 2009

Tue, 16 Jun 2009 01:06:38 GMT

This year’s ASCO was packed with promising early stage trials, but very few positive late stage trials with an impact on medical practice.[More...]

Pharmaceuticals & Biotech - Industry Outlook

Tue, 09 Jun 2009 12:05:35 GMT

The pharmaceutical industry is entering a period of substantial change in 2009. Most of the names in the industry are facing significant patent challenges in the years to come. U.S.-based firms are facing foreign exchange headwinds, as well. Revenue growth is non-existent, and earnings growth is being driven primarily by mergers, cost-cutting and share buybacks. Knowing that investors rarely pay-up for this type of manufactured earnings growth, we struggle to see a broad-based out-performance for the large-cap pharmaceutical sector in 2009. Valuations, however, are attractive, with several of the largest players trading at PEs below 10x, including: Pfizer (PFE, 7.5x), Eli Lilly (LLY,[More...]

Top Picks For ASCO 2009

Tue, 26 May 2009 11:44:28 GMT

The ASCO annual meeting, one of the most important events in the pharmaceutical industry will take place in Orlando next weekend. With over 4,000 abstracts to be presented this year, separating the wheat from the chaff is difficult, but below is an incomp[More...]

Pharmaceuticals

Tue, 10 Feb 2009 18:38:00 GMT

Large pharmaceutical companies all seem to be in a similar boat heading into 2009. Most of the names in the industry are facing significant patent challenges in the years to come. U.S.-based firms are facing foreign exchange headwinds as well. Revenue growth is non-existent, and earnings growth is being driven primarily by cost-cutting and share buybacks. Knowing that investors rarely pay-up for this type of manufactured earnings growth, we struggle to see a broad-based out-performance for the large-cap pharmaceutical sector in 2009. Valuations, however, are attractive, with several of the largest players trading at PEs below 10x, including Pfizer (PFE, 7x), Eli Lilly (LLY, 9x), Merck ([More...]

Pharmaceuticals Industry

Fri, 21 Nov 2008 20:17:00 GMT

Names that were previously viewed as safe and stable investments, large-cap pharmaceuticals, are now trading at levels not seen since 2002.? And, for some such as Pfizer, Inc. (PFE) and Eli Lilly & Co. (LLY), these are prices not seen since the past decade. This is clearly a sell-first, ask questions later market. After all, believing that patients are going to stop taking Bristol-Myers Squibb Co. (BMY) blood-thinner Plavix or Pfizer's anti-cholesterol agent Lipitor because of the credit crunch is the epitome of irrational anxiety. [More...]

Notable Earnings After Market Close (10/22/2008) - Part 2

Wed, 22 Oct 2008 14:21:00 GMT

Stock Symbols: BSMD,CDNS,CNS,CNW,CRUS,CYBE,FFIV,FNF,GDI,IRBT,KAI,LSI,MCRI,MOH,MRCY,NTRI,PHM,ROL,RYL,SCSS,SKX,TLGD,TSCO,BIDU,CMG,EQIX,NARA,OMTR,OSIP,SJW,PRE,BCR,CVGI,WIRE[More...]

Analyst Comments: AGIX, Scientific Games, Sohu.com, Barclays, COSI, Cleveland-Cliffs,Potash Corp, Freddie Mac, OSI Pharma

Wed, 08 Oct 2008 12:39:00 GMT

For those of you still holding onto AtheroGenics (AGIX), the research-based pharmaceutical company with two clinical-stage drug development programs (according to Zacks senior drug industry analyst Jason Napodano, CFA, who published a report on AGIX last week), the company has just announced today it has filed for Chapter 11 bankruptcy. The question now seems to be who, if anyone, will pick up the pieces of the late-phase candidates AGIX had been developing.? But for anyone shocked by today's announcement, they shouldn't be.? From the same AGIX report: "The company recently released phase III data on lead compound AGI-1067 that did not meet the primary end point." And this: "In September 2008 AtheroGenics announced it will not repay the its 4.5% Convertible Notes due September 2, 2008, nor will it make its scheduled[More...]

Movers: Wells Fargo, Wachovia, Citigroup, ImClone, eBay

Tue, 07 Oct 2008 14:50:00 GMT

Citigroup (C) files a complaint against Wachovia (WB) and Wells Fargo (WFC) and the directors of both companies.
Citi seeking more than $20 billion in compensatory damages and more than $40 billion in punitive damages from WFC for tortious interference with Citi's contract with WB. Citi is seeking relief from WB for its bad faith breach of that contract.
ImClone Systems (IMCL) and Eli Lilly (LLY) announce that the boards of directors of both companies have approved a definitive agreement under which LLY will acquire IMCL through all cash tender offer of $70 per share, or about $6.5 billion.

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OSI Pharmaceuticals, Inc. Announces Third Quarter 2009 Financial Results

Wed, 21 Oct 2009 20:46:00 GMT

OSI Pharmaceuticals, Inc. (NASDAQ: OSIP) announced today its financial results for the Company's third quarter ended September 30, 2009.
Total worldwide net sales of Tarceva for the three and nine months ended September 30, 2009, as reported to the Company by its collaborator Roche, were approximately $301 million and $870 million, respectively.
The Company reported net income from continuing operations of $17.9 million (or $0.30 per share) for the three months ended September 30, 2009, compared to $31.4 million (or $0.53 per share) for the three months ended September 30, 2008.

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New Data from Phase III SATURN Study Showed Tarceva Extended Survival in Patients with Advanced Non-Small Cell Lung Cancer When Used Immediately after Initial Chemotherapy

Sat, 01 Aug 2009 16:56:00 GMT

OSI Pharmaceuticals, Inc. (NASDAQ: OSIP) today announced further results from the Phase III SATURN study showing that Tarceva® (erlotinib) extended the survival of patients with advanced non-small cell lung cancer (NSCLC) when used as single agent, maintenance therapy in patients who did not progress following first-line treatment with platinum-based chemotherapy. As previously announced, the safety results in this study were consistent with what has been seen previously and there were no new or unexpected safety signals. Overall survival was a key secondary endpoint of the study and these new data were presented today at the 13th World Conference on Lung Cancer being held in San Francisco.[More...]

OSI Pharmaceuticals to Present at the BMO Capital Markets 9th Annual Focus on Healthcare Conference on Wednesday, August 5, 2009

Wed, 29 Jul 2009 17:05:00 GMT

OSI Pharmaceuticals, Inc. (NASDAQ: OSIP) announced today that OSI Management will present at the BMO Capital Markets Healthcare Conference in New York, NY on Wednesday, August 5, 2009 at 8:00am (Eastern Time) and will provide an overview on the Company’s product portfolio and business developments.[More...]

Hercules Technology Growth Capital Announces Successful Fund Raising Activities From Select Life Sciences Portfolio Companies Despite Challenging Economy

Mon, 27 Jul 2009 13:54:00 GMT

Hercules Technology Growth Capital, Inc. (NASDAQ:HTGC), the leading specialty finance company providing venture debt and equity to venture capital and private equity-backed technology and life science companies at all stages of development, today announced that a select group of its Life Sciences portfolio companies, Novasys Medical and AVEO Pharmaceuticals have each successfully raised additional equity capital.
Additionally, Portola Pharmaceuticals and Merck & Co. entered into a worldwide license agreement.
Summary of Portfolio Companies Securing Additional Capital:

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StockPreacher.com Issues Trading Outlook for Onyx Pharmaceuticals Inc. (ONXX)

Mon, 27 Jul 2009 10:46:00 GMT

StockPreacher.com announces an investment report featuring biopharmaceutical company Onyx Pharmaceuticals Inc. . The report includes financial and investment analysis, analyst consensus, and pertinent industry information you need to know to make an educated investment decision.[More...]

OSI Pharmaceuticals, Inc. Announces Second Quarter 2009 Financial Results

Wed, 22 Jul 2009 20:49:00 GMT

OSI Pharmaceuticals, Inc. (NASDAQ: OSIP) announced today its financial results for the Company's second quarter ended June 30, 2009.
The Company reported total revenues from continuing operations of $99 million for the second quarter of 2009 compared to revenues of $96 million for the second quarter of 2008.
Total worldwide net sales of Tarceva for the three and six months ended June 30, 2009, as reported to the Company by its collaborator Roche, were approximately $290 million and $569 million, respectively.

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OSI Pharmaceuticals and AVEO Pharmaceuticals Expand Oncology Discovery and Translational Research Collaboration

Tue, 21 Jul 2009 11:27:00 GMT

OSI Pharmaceuticals, Inc. (NASDAQ:OSIP) and AVEO Pharmaceuticals, Inc. today announced that they have expanded the drug discovery and translational research collaboration announced in October of 2007. The alliance is anchored around developing molecular targeted therapies to target the underlying mechanisms of epithelial-mesenchymal transition (EMT) in cancer and to develop proprietary datasets of associated patient selection biomarkers to support OSI’s targeted medicine pipeline. EMT is a process of emerging significance in tumor development and disease progression and the focal point of OSI’s proprietary oncology research efforts. The companies are expanding their efforts to validate cancer targets and to deploy key elements of AVEO’s proprietary translational research platform in support of OSI’s clinical development programs.[More...]

New Data from Phase III SATURN Study Showed Tarceva Improved Overall Survival When Used Immediately After Initial Chemotherapy in Patients with Advanced Non-Small Cell Lung Cancer

Mon, 13 Jul 2009 04:56:00 GMT

OSI Pharmaceuticals, Inc. (NASDAQ: OSIP) and Genentech, Inc. today announced that SATURN, a pivotal Phase III study of Tarceva® (erlotinib), met a key secondary endpoint of extending overall survival in patients with advanced non-small cell lung cancer (NSCLC) who received Tarceva immediately after initial chemotherapy. A statistically significant improvement in overall survival was seen in this pre-planned final analysis of the total patient population. The new data will be presented during the 13th World Conference on Lung Cancer to be held July 31 to August 4, 2009 in San Francisco.[More...]

OSI Pharmaceuticals to Announce Second Quarter 2009 Financial Results on July 22, 2009

Wed, 08 Jul 2009 14:43:00 GMT

OSI Pharmaceuticals, Inc. (Nasdaq: OSIP) announced today that its second quarter 2009 financial results will be released on July 22, 2009, after the markets close. Following the announcement, OSI’s management will host a live conference call and webcast at 5:00p.m. Eastern Time to review the Company’s financial results, product portfolio and business developments.[More...]

OSI Pharmaceuticals Announces Consolidation of U.S. Operations

Tue, 07 Jul 2009 20:00:00 GMT

OSI Pharmaceuticals, Inc. (NASDAQ: OSIP) announced today plans to consolidate its U.S. operations onto a single campus located in Ardsley, a community located in the town of Greenburgh in Westchester County, New York. The Company has signed an agreement to purchase a 43 acre site, which consists of ~400,000 sq.ft. of existing office and laboratory space for $27 million. Additional capital and one time expenses will be incurred, mainly during the latter part of 2009 and first half of 2010.[More...]