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FDA Calendar Updates: DDSS, HGSI, OREX, SPPI, TRIB

Tue, 21 Jul 2009 16:55:28 GMT

Below is a summary of updates to the BioMedReports.com FDA Calendar, which includes a database of 263 entries as of 7/20/09. 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...]

Extreme FDA Calendar Trades: 20 Stocks Under $5

Tue, 21 Jul 2009 12:47:00 GMT

Below are extreme trades among 20 companies with stock prices under $5 from the BioMedReports.com FDA Calendar, which includes 264 entries as of 7/20/09. 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 fil (...)[More...]

FDA Extreme Trades: 16 Stocks Under $5

Sat, 27 Jun 2009 20:50:19 GMT

Below are FDA extreme trades among 16 companies with stock prices under $5 from the BioMedReports.com FDA Calendar (database includes 225 entries as of 6/27/09) which have pending FDA decisions for either new drug products, biological agents, medical devices, or diagnostic tests that may have a major impact on each of the underlying stock prices. A high risk/reward trading approach to consider for speculative traders is investing a small amount of money that you can afford to lose in a basket of (...)[More...]

BioMedReports FDA Calendar: 19 Hot Summer Trades

Wed, 17 Jun 2009 12:13:04 GMT

Below is a sample of entries from the BioMedReports.com FDA Calendar, which includes a database of over 200 entries. The companies outlined below have expected FDA new drug product decisions or clinical trial results expected over the next three months of summer. The list also includes some Extreme Trades of companies with market caps below $250 million that have pending clinical trial results or FDA decisions that could have a major stock price impact. Rigel Pharma (NASDAQ:RIGL): On 5/5/09, (...)[More...]

Updated Calendar Of 12 Extreme Trades On Pending FDA Decisions

Tue, 19 May 2009 17:08:30 GMT

Below are 12 extreme FDA trades of companies with market caps below $200M which have pending new drug product decisions or other meetings/milestones scheduled with the FDA that are expected to have a major impact on each of the underlying stock prices as the PDUFA decision dates approach and the decision is ultimately announced. A high risk/reward trading approach to consider for speculative traders is investing a small amount of money that you can afford to lose in a basket of stocks included i (...)[More...]

Trading FDA Decisions: 14 Extreme Trades

Wed, 11 Mar 2009 16:25:00 GMT

Below is a summary of companies from the BioMedReports.com FDA Decision Date Calendar which have market caps below $200M, making them ideal candidates for extreme stock price volatility trades as their decision dates become imminent. Dyax Corp. (DYAX) secured a narrow approval from a FDA Advisory Panel in early February (with a 6-5-2 vote) for its Kalbitor (ecallantide or DX-88) BLA with a PDUFA date of 3/23/09, which is designated for priority review in the treatment of acute attacks of hereditary angioedema (HAE is a rare disorder marked by severe swelling which can be fatal if the throat area is involved). The panel debated the need for an effective treatment for this rare, potentially dangerous condition against the 3% higher incidence of allergic reactions (13% versus 10%) in patients taking[More...]

FDA Decision Calendar: 16 Extreme Trades

Wed, 04 Feb 2009 18:49:00 GMT

Click here for a link to my previous FDA calendars and the list below highlights 16 companies with pending new product decisions at the agency + market caps below $150M, making them ideal candidates for extreme stock price volatility trades. BioDelivery Sciences (BDSI) – Onsolis approval is possible by mid-2009 and the Company raised $6M in cash from partner Meda AB, representing a $3M expanded licensing agreement + a $3M advance of the $30M milestone payment upon FDA approval. The remaining $27M cash milestone payment on FDA approval for Onsolis represents nearly one-half of the Company's current market cap, in addition to royalties that will be received on product sales once the breakthrough cancer pain drug is on the market. Discovery Labs (DSCO) has a 4/17/09 PDUFA[More...]

FDA Decision Calendar: Extreme Trades

Sun, 18 Jan 2009 03:45:00 GMT

The accompanying table (click to enlarge) includes an updated calendar of 78 expected FDA new product decisions with more detailed comments for each entry. Click here for a link to my previous FDA calendars and the list below highlights companies with pending decisions + market caps below $100M, making them ideal candidates for extreme trading opportunities. [More...]

Buyout Binge Begins for Bio-Pharma, Diagnostics

Sat, 10 Jan 2009 18:09:00 GMT

With news late Friday that Roche (RHHBY) is prepared to up its bid for complete control of Genentech (DNA) to $95 from a previous offer of $89 per share and a $41M ($1.50 per share) all-stock takeover offer by Sequenom (SQNM) for EXACT Sciences (EXAS); 2009 is off to a strong start for M&A activity in the bio-pharma and diagnostic[More...]

10 Stocks That You Absolutely Positively Definitely Have To Know About

Tue, 30 Dec 2008 17:27:00 GMT

The following was sent to TIMalert subscribers at 3AM EST..yah nobody works as hard as me…100 hour workweek baby! Don’t forget this is your second to last day to take advantage of the holiday... Visit TimothySykes.com to read full article with comments [More...]

Labopharm Reports Results for Third Quarter Fiscal 2009

Fri, 06 Nov 2009 13:49:00 GMT

Company Advances Plans to Realize the Benefits of Commercialization:
LAVAL, QC, Nov. 6 /CNW/ - Labopharm Inc. (TSX: DDS; NASDAQ: DDSS) today reported its financial results for the third quarter ended September 30, 2009.
Revenue from sales of the Company's once-daily tramadol product for the third quarter of fiscal 2009 increased to $5.2 million from $3.9 million for the third quarter of fiscal 2008 and was composed of product sales outside of the U.S. of $4.5 million and product sales in the U.S. of $0.7 million.

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Labopharm Receives Notice of ANDA Submission With Paragraph IV Certification for Generic of Ryzolt(TM)

Wed, 30 Sep 2009 11:48:00 GMT

LAVAL, QC, Sept. 30 /CNW/ - Labopharm Inc. (TSX: DDS; NASDAQ: DDSS) today announced it has received notice from Sun Pharma Global FZE advising that Sun has submitted an Abbreviated New Drug Application (ANDA) to the U.S. Food and Drug Administration (FDA) for approval to market 100, 200 and 300 mg generic versions of Ryzolt(TM) (tramadol hydrochloride extended-release 100, 200 and 300 mg tablets) in the United States.
Under the Drug Price Competition and Patent Term Restoration Act (known as the Hatch-Waxman Act), Ryzolt has a new dosage form market exclusivity period that prevents final approval of Sun's ANDA until the exclusivity period expires on December 31, 2011.
U.S. Patent Nos.

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Labopharm Reports Results for Second Quarter Fiscal 2009

Fri, 07 Aug 2009 11:48:00 GMT

Quarter Marked by Launch of RYZOLT(TM) in U.S. -
LAVAL, QC, Aug. 7 /CNW/ - Labopharm Inc. (TSX: DDS; NASDAQ: DDSS) today reported its financial results for the second quarter ended June 30, 2009.
"The second quarter of 2009 was highlighted by the U.S. commercial launch of RYZOLT(TM) by our marketing partner, Purdue Pharma," said James R. Howard-Tripp, President and Chief Executive Officer, Labopharm Inc. "We are encouraged by a number of aspects since the launch, including the growth of new prescriptions and the migration of patients to higher dosage strengths, which shows the product is being used as intended.

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Hercules Technology Growth Capital Announces Three Portfolio Companies That Reached Multi-Million Dollar Milestones

Tue, 20 Oct 2009 18:46:00 GMT

In October 2009, Gomez, Inc., (www.gomez.com)
a leader in Web application management and one of Hercules' early portfolio companies -- has entered into a definitive agreement to be acquired by Compuware in a $295 million cash transaction.
The statements contained in this release that are not purely historical are forward-looking statements.

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Labopharm's response for novel trazodone formulation accepted by FDA as complete - Designated as Class 2 resubmission

Tue, 25 Aug 2009 20:26:00 GMT

- New PDUFA action date assigned -[More...]

Labopharm comments on judgment in Purdue patent litigation

Mon, 17 Aug 2009 12:46:00 GMT

LAVAL, QC, Aug. 17 /PRNewswire-FirstCall/ - Labopharm Inc. today commented on the outcome of patent-infringement litigation initiated by Purdue Pharma Products L.P. against Par Pharmaceutical Companies, Inc. relating to Ultram ER . The patents-in-suit are owned by Purdue and are licensed to Ortho-McNeil, Inc., the marketer of Ultram ER. In his decision, Circuit Judge Kent Jordan entered judgment in favor of Purdue and against Par on the issue of infringement and rejected Par's claim that the patents were unenforceable for inequitable conduct. Judge Jordan, however, entered judgment in favor of Par and against Purdue on the issue of validity, citing obviousness.[More...]

Labopharm submits response to FDA for novel antidepressant

Tue, 11 Aug 2009 16:20:00 GMT

LAVAL, QC, Aug. 11 /PRNewswire-FirstCall/ - Labopharm Inc. today announced that it has submitted its response to the U.S. Food and Drug Administration's complete response letter regarding the Company's novel formulation of the antidepressant trazodone.[More...]

Labopharm files New Drug Submission with Health Canada for novel antidepressant

Wed, 05 Aug 2009 10:56:00 GMT

LAVAL, QC, Aug. 5 /PRNewswire-FirstCall/ - Labopharm Inc. today announced it has filed a New Drug Submission with the Therapeutic Products Directorate of Health Canada for its novel formulation of the antidepressant trazodone.[More...]

Labopharm to present at Canaccord Adams 29th Annual Global Growth Conference

Thu, 30 Jul 2009 10:55:00 GMT

LAVAL, QC, July 30 /CNW/ - Labopharm Inc. (TSX: DDS; NASDAQ: DDSS) today announced that James R. Howard-Tripp, Chief Executive Officer of the Company, will present at the Canaccord Adams 29th Annual Global Growth Conference at the InterContinental Boston, on Tuesday, August 11, 2009 at 3:30 p.m. ET.[More...]

Labopharm to host conference call Friday, August 7, 2009 at 8:30 a.m. (ET)

Mon, 27 Jul 2009 10:55:00 GMT

- Management to discuss second quarter financial results - LAVAL, QC, July 27 /CNW/ - Labopharm Inc. (TSX: DDS; NASDAQ: DDSS) today announced that it will host a conference call on Friday, August 7, 2009 at 8:30 a.m. (ET) to discuss its second quarter 2009 financial results. Labopharm will report its second quarter 2009 financial results via news release at approximately 7:00 a.m. the same day.[More...]

InvestorSoup.com Issues Trading Outlook for Labopharm Inc.

Wed, 22 Jul 2009 10:46:00 GMT

InvestorSoup.com announces an investment report featuring specialty pharmaceutical company Labopharm 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...]

Labopharm receives complete response letter from the U.S. FDA for novel antidepressant

Mon, 20 Jul 2009 13:20:00 GMT

LAVAL, QC, July 20 /CNW/ - Labopharm Inc. (TSX: DDS; NASDAQ: DDSS) today announced it has received a complete response letter from the U.S. Food and Drug Administration (FDA) for the new drug application (NDA) submission of its novel formulation of the antidepressant trazodone.[More...]

Labopharm amends debt facility agreement with Hercules

Thu, 25 Jun 2009 10:55:00 GMT

- Company Improves Financial Flexibility - LAVAL, QC, June 25 /CNW/ - Labopharm Inc. (TSX: DDS; NASDAQ: DDSS) today announced it has amended its debt facility agreement with Hercules Technology Growth Capital, Inc. (NASDAQ: HTGC).[More...]