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FDA Calendar Extreme Trades: 85 Single Digit Stocks

Tue, 13 Oct 2009 16:29:25 GMT

The BioMedReports.com FDA Calendar database includes over 400 entries of (1) pending new drug, biological agent, or medical device new product decisions at the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, and sBLA filings); (2) pending new submissions to the FDA; (3) pending complete response letter (CRL) re-submissions to the FDA; and (4) pending clinical trial results.[More...]

Momenta Pharma (MNTA): Timing Uncertain, Approval Likely for M-Enoxaparin

Tue, 06 Oct 2009 21:44:54 GMT

Momenta Pharma (NASDAQ: MNTA) presented at the 2009 UBS Global Life Sciences Conference about two weeks ago and outlined several key developments for the Company, including an update on the FDA status for M-Enoxaparin.[More...]

Teva Pharmaceutical Industries Limited (NASDAQ:TEVA): A Good Buy

Fri, 02 Oct 2009 16:55:00 GMT

On September 30, Teva Pharmaceutical Industries Ltd (TEVA), sold the worldwide rights to a generic version of the white blood-cell boosting drug filgrastim to Hospira Inc (NYSE:HSP).[More...]

Beyond Stem Cells: Healthcare Hot Spots

Mon, 26 Jan 2009 18:09:00 GMT

With the surprise announcement last week by Geron (GERN) that the FDA would allow human clinical trials for embryonic stem cells, all companies in the underlying ETF Innovators Index to track the space are screaming higher again today – led by the company with the biggest gains over the past year, StemCells (STEM). Below are three additional areas and associated companies for investors to consider in the search of the next hot spots in the healthcare sector, including a focus on small/mid-cap companies which have the added potential to be acquired as part of renewed M&A in the sector this year. Molecular Diagnostics EXACT Sciences (EXAS) has rejected the hostile $1.50 all-stock offer from[More...]

Nine For '09: Stock Picks For The New Year

Thu, 11 Dec 2008 03:18:00 GMT

Below are nine stock picks for 2009, which are taken from the 1,000 company database of ETF Innovators (ETFI) Indexes, and which I own in my personal brokerage account. Given my cautious stance toward the economy and stock market, the picks have a defensive theme favoring the healthcare sector as a source of defensive growth companies. 1.) Consumer Staples – Tobacco: Altria Group (MO) has lost about 30% of its market value since spinning off the international tobacco operations into a separate public company as Philip Morris International (PM), resulting in a dividend yield of 8.5% with a stock price near 15 bucks as of today. Altria declared its quarterly dividend of 32 cents today, with an ex-dividend date of 12/22/08 which is payable on 1/9/09. 2.) Consumer Staples – Packaged Food: Kraft Foods (KFT) is trading with a historically high dividend yield over 4% since losing about 23% of its market value in the past year. Profit margins[More...]

Generic Cardio Drugs Equal Brands

Tue, 02 Dec 2008 22:24:00 GMT

A meta-analysis review of clinical studies published in peer-reviewed journals was featured today in The Journal of the American Medical Association (JAMA) and concluded that cost-saving generics used to treat a variety of cardiovascular conditions produced equivalent clinical outcomes to higher cost brand name drugs. Despite this clinical evidence, the review notes that a majority (53%) of the 43 editorials analyzed had a negative opinion on generic substitution. While there are currently no ETFs on the market which feature generic drug companies, the ETF Innovators (ETFI)[More...]

Health Cost Containment Index: Expanding Into India, Impax Labs Set to Re-List

Thu, 27 Nov 2008 04:50:00 GMT

The ETF Innovators (ETFI) Global Healthcare Cost Containment Index profiled in the accompanying table is updated and expanded to include more companies from my recent Analysis of Generic Drug Companies from India. The index is structured to include companies with market caps between $150M-$60B, which are involved in producing generic healthcare products such as generic drugs and pharmacy benefit managers which do not have retail store and insurance components. [More...]

Stock Picks For Healthy Returns

Tue, 25 Nov 2008 14:14:00 GMT

Abbott Labs (ABT) is a consistent performer with diversified healthcare operations, including pharmaceuticals, diagnostics, medical nutrition products, and medical devices/stents. ABT is back to the lower end of its trading range near 50 bucks, presenting an excellent entry point with a 2.8% dividend yield and forward PE of about 14X. Celgene (CELG) is also trading at the low end of its trading range around 50 bucks as a large-cap growth stock focused on cancer biotech products and research with an estimated PEG ratio below one. China Medical (CMED) is trading near its IPO levels of August 2005 despite excellent growth prospects and is a buy below 20 bucks with a dividend yield of 2.5% and market cap of $540M as uncertainty over a $345M acquisition has spooked some investors, sending the stock down sharply by over 50% in the past three months. The acquisition provides CMED with a molecular diagnostics platform for HPV, including strains[More...]

Teva Beats On Profits: A Biogeneric Boon In '09?

Thu, 06 Nov 2008 13:51:00 GMT

Teva Pharma (TEVA) posted 3Q08 results this morning which beat consensus profit estimates by a penny at 72 cents per share on an adjusted basis with record sales coming in slightly below estimates at $2.84B versus $2.9B expected. Revenue increased by 20% while GAAP net income of $637M rose by 21% from the year-ago period. Results were driven by the proprietary multiple sclerosis drug Copaxone, which posted sales of $562M, representing a 28% increase from the year-ago period. Cash flow from operations more than doubled from 3Q07 at $710M. Teva also expects to close its acquisition of Barr Pharma (BRL) by[More...]

An Overview and Analysis of the Global Generic Drug Industry

Sat, 16 Aug 2008 17:24:00 GMT

Global Generic Drug Industry: Benchmark Comps Global Generic Drug Industry: Top 5 Companies by Market Cap[More...]

Teva files amended complaint against Momenta and Sandoz

Thu, 12 Nov 2009 10:49:00 GMT

Teva Pharmaceutical Industries, an Israeli pharmaceutical company, has reported that it is seeking to amend its existing complaint against Momenta Pharmaceuticals and Sandoz to include patent infringement of three additional patents related to the characterization of Copaxone.
The proposed updated complaint has been filed under seal with the US District Court for the Southern District of New York along with a motion requesting that the court grant Teva leave to amend.
Teva originally filed suit against Momenta and Sandoz in August 2008 for infringement of multiple patents, covering the chemical composition of Copaxone, pharmaceutical compositions containing it and methods of using it.

[More...]

U.S. drug approval head conflict probed

Wed, 12 Aug 2009 15:58:00 GMT

U.S. drug approval head conflict probed[More...]

Teva Files Amended Complaint Against Momenta/Sandoz to Include Infringement of Three COPAXONE®-Related Patents

Tue, 10 Nov 2009 07:48:00 GMT

Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) announced today it is seeking to amend its existing complaint against Momenta Pharmaceuticals, Inc./Sandoz Inc. to include patent infringement of three additional patents related to the characterization of COPAXONE® (glatiramer acetate injection).
The proposed updated complaint has been filed under seal with the U.S. District Court for the Southern District of New York along with a motion requesting that the Court grant Teva leave to amend.
is a highly-complicated product to develop and manufacture, and given the inability to fully characterize the active ingredients of COPAXONE®, Teva has serious doubts about any generic applicant's ability to demonstrate conclusively that the composition of its product is identical to that of COPAXONE®.

[More...]

Teva Comments on Mylan Paragraph IV Filing for COPAXONE®; Files Lawsuit Against Generic Filer for Patent Infringement

Fri, 16 Oct 2009 21:47:00 GMT

Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) commented today on the abbreviated new drug application (ANDA) containing a Paragraph IV certification for COPAXONE® (glatiramer acetate injection), filed by Mylan Pharmaceuticals Inc. Teva also announced that it has filed a lawsuit against Mylan Pharmaceuticals, Inc., Mylan Inc. and Natco Pharma Ltd. for patent infringement in the U.S. District Court for the Southern District of New York.
Teva remains committed to vigorously defending its COPAXONE® intellectual property rights against infringement wherever they are challenged and intends to pursue all relevant regulatory avenues via the FDA.
The lawsuit triggers a stay of FDA approval for the Mylan ANDA until the earlier of the expiration of a period of 30 months and a district court decision in its favor, and is also subject to the expiration of any exclusivity rights that may attach to earlier filed ANDAs.

[More...]

Momenta Pharmaceuticals, Inc. Announces Closing of Offering and Exercise of Over-Allotment Option

Mon, 28 Sep 2009 17:46:00 GMT

CAMBRIDGE, Mass., Sept. 28, 2009 (GLOBE NEWSWIRE) -- Momenta Pharmaceuticals, Inc. (Nasdaq:MNTA), a biotechnology company specializing in the characterization and engineering of complex drugs, today announced the closing of its underwritten public offering of 4,600,000 shares of its common stock, which includes the full exercise of the underwriter's over-allotment option of 600,000 shares.
After underwriting discounts and commissions and estimated offering expenses, Momenta received net proceeds of approximately $46.7 million.
Leerink Swann LLC acted as sole book-running manager for the offering.

[More...]

Momenta Pharmaceuticals Reports Financial Results for the Second Quarter of 2009

Thu, 06 Aug 2009 12:27:00 GMT

Momenta Pharmaceuticals, Inc. , a biotechnology company specializing in the characterization and engineering of complex drugs, today reported its financial results for the quarter ended June 30, 2009.[More...]

Momenta Pharmaceuticals Announces Date of Earnings Release and Conference Call for Second Quarter 2009 Financial Results

Thu, 23 Jul 2009 20:26:00 GMT

Momenta Pharmaceuticals, Inc. , a biotechnology company specializing in the characterization and engineering of complex drugs, will report its financial results for the second quarter ended June 30, 2009 before the U.S. financial markets open on Thursday, August 6, 2009.[More...]

Momenta Pharmaceuticals Announces Top-Line Results From the M118 EMINENCE Trial

Mon, 29 Jun 2009 20:24:00 GMT

Momenta Pharmaceuticals, Inc. , a biotechnology company specializing in the characterization and engineering of complex drugs, today announced top-line results from the EMINENCE phase 2 multicenter study of the intravenous formulation of M118.[More...]

Momenta Pharmaceuticals Announces Appointment of Bruce L. Downey to Board of Directors

Fri, 12 Jun 2009 11:56:00 GMT

Momenta Pharmaceuticals, Inc. , a biotechnology company specializing in the characterization and engineering of complex drugs, announced the appointment of Bruce L. Downey to its Board of Directors, effective June 11, 2009. Mr. Downey is the former Chairman and Chief Executive Officer of Barr Pharmaceuticals, Inc. and a former Chairman of the Generic Pharmaceutical Association . He succeeds Momenta co-founder Robert S. Langer, who is leaving the board after eight years of service. Dr. Langer will continue to serve as a scientific consultant to the company following his departure from the board.[More...]

Momenta Pharmaceuticals to Present At the Goldman Sachs 30th Annual Global Healthcare Conference

Wed, 03 Jun 2009 18:55:00 GMT

Momenta Pharmaceuticals, Inc. , a biotechnology company specializing in the characterization and engineering of complex drugs, today announced that Craig Wheeler, President and Chief Executive Officer, will deliver a corporate presentation at the Goldman Sachs 30th Annual Global Healthcare Conference on Tuesday, June 9th at 10:45 am EDT. The conference will be held at The Grand Hyatt Hotel in New York City.[More...]

Momenta Pharmaceuticals to Present At the Deutsche Bank 34th Annual Health Care Conference

Fri, 15 May 2009 20:25:00 GMT

Momenta Pharmaceuticals, Inc. , a biotechnology company specializing in the characterization and engineering of complex drugs, today announced that Craig Wheeler, Chief Executive Officer, will deliver a corporate presentation at the Deutsche Bank 34th Annual Health Care Conference on Tuesday, May 19th at 3:55 pm EDT. The conference will be held at the InterContinental Hotel in Boston.[More...]

Momenta Pharmaceuticals to Present At the Deutsche Bank 34th Annual Health Care Conference

Tue, 12 May 2009 18:45:00 GMT

Momenta Pharmaceuticals, Inc. , a biotechnology company specializing in the characterization and engineering of complex drugs, today announced that Richard Shea, Chief Financial Officer, will deliver a corporate presentation at the Deutsche Bank 34th Annual Health Care Conference on Tuesday, May 19th at 3:55 pm EDT. The conference will be held at the InterContinental Hotel in Boston.[More...]