New Drug Application News and Research

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FDA approves Abbott's CREON sNDA including dosing guidance for treating EPI due to CP, pancreatectomy

Abbott announced that the U.S. Food and Drug Administration (FDA) approved the supplemental New Drug Application (sNDA) for CREON® (pancrelipase) Delayed-Release Capsules that now includes dosing guidance in the prescribing information specific to patients with limited production of enzymes in the pancreas (exocrine pancreatic insufficiency) due to chronic pancreatitis (CP) or removal of the pancreas (pancreatectomy). Prior to this FDA approval, dosing guidance for medications such as CREON was based on patients with cystic fibrosis.

3 May 2010

Watson Pharmaceuticals sued in connection with filing ANDA for generic equivalent of Trilipix

Watson Pharmaceuticals, Inc. today confirmed that its subsidiary, Watson Laboratories, Inc. - Florida, has been sued by Abbott Laboratories and Fournier Laboratories Ireland Ltd. in connection with the filing of Watson's Abbreviated New Drug Application for choline fenofibrate delayed-release capsules in the 45 mg and 135 mg strengths.

3 May 2010

ZIOPHARM reports a net loss of $17.7 million in first quarter 2010

ZIOPHARM Oncology, Inc., a biopharmaceutical company that is seeking to develop and commercialize a diverse, risk sensitive portfolio of in-licensed cancer drugs addressing unmet medical needs, today reported its financial results for the three months ended March 31, 2010 and updated the Company's continued progress with its clinical programs.

3 May 2010

VIMOVO delayed-release tablets receive FDA approval

AstraZeneca and POZEN Inc. today announced the U.S. Food and Drug Administration has approved VIMOVO (naproxen and esomeprazole magnesium) delayed-release tablets for the relief of signs and symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis, and to decrease the risk of developing gastric ulcers in patients at risk of developing NSAID-associated gastric ulcers.

3 May 2010

ADVENTRX reports first-quarter net loss applicable to common stock of $4.9 million

ADVENTRX Pharmaceuticals, Inc. today reported financial results for the three months ended March 31, 2010.

30 Apr 2010

ISTA Pharmaceuticals first-quarter net revenues up 39%

ISTA Pharmaceuticals, Inc., today reported financial results for the quarter ended March 31, 2010. First quarter 2010 net revenues were $28.3 million, an increase of 39% from the first quarter of 2009. Net income for the first quarter ended March 31, 2010, was $0.5 million, or $0.01 per share, compared to a net loss of $19.6 million, or $0.59 per share, for the first quarter ended March 31, 2009.

30 Apr 2010

pSivida announces presentations on bioerodible technologies for degenerative eye disease

pSivida Corp., a leader in the development of back of the eye drug delivery systems, today announced that two poster presentations will be made at the upcoming ARVO meeting on one of pSivida's next generation bioerodible technologies for degenerative eye disease. It marks a key step toward the ability to use pSivida's bioerodible technologies to develop treatments for glaucoma and other degenerative eye diseases, diseases that affect millions of Americans.

30 Apr 2010

Acorda Therapeutics reports AMPYRA gross sales of $3.4 million for first-quarter 2010

Acorda Therapeutics, Inc. today announced its financial results for the first quarter of 2010.

30 Apr 2010

Johnson & Johnson subsidiaries agree to pay over $81M to resolve Topamax illegal promotion allegations

American pharmaceutical manufacturers Ortho-McNeil Pharmaceutical LLC and Ortho-McNeil-Janssen Pharmaceuticals Inc., both subsidiaries of Johnson & Johnson, have agreed to pay more than $81 million to resolve criminal and civil liability arising from the illegal promotion of the epilepsy drug Topamax, the Justice Department announced today.

30 Apr 2010

Impax initiates challenge of patent listed by Shionogi Pharma concerning Fenoglide

Impax Laboratories, Inc. today confirms that it has initiated a challenge of a patent listed by Shionogi Pharma, Inc. in connection with its Fenoglide® (fenofibrate) tablets, 40 and 120 mg.

30 Apr 2010

Depomed attributes 56% increase in first-quarter revenue to $5.8M increase in Glumetza product sales

Depomed, Inc. today reported financial results for the first quarter ended March 31, 2010.

30 Apr 2010

Bristol-Myers Squibb reports 11% increase in first-quarter 2010 revenue

Bristol-Myers Squibb Company today reported strong sales and earnings growth for the first quarter of 2010.

30 Apr 2010

Investment report on Somaxon Pharmaceuticals from MicroStockProfit.com

MicroStockProfit.com announces an investment report featuring Somaxon Pharmaceuticals Inc. The report includes financial, comparative and investment analyses, and industry information you need to know to make an educated investment decision.

29 Apr 2010

Gilead announces bioequivalence of Truvada in combination with Tibotec Pharmaceuticals' TMC278 NNRTI

Gilead Sciences, Inc. announced today it has obtained data supporting bioequivalence of a formulation of the fixed-dose combination of Truvada® (emtricitabine and tenofovir disoproxil fumarate) and Tibotec Pharmaceuticals' investigational non-nucleoside reverse transcriptase inhibitor (NNRTI) TMC278 (rilpivirine hydrochloride, 25 mg).

29 Apr 2010

Pain Therapeutics reports net loss of $1.0 million for first-quarter 2010

Pain Therapeutics, Inc., a biopharmaceutical company, today reported first quarter 2010 financial results. Net loss for Q1 2010 was $1.0 million, or $0.02 per share, compared to a net loss of $1.8 million, or $0.04 per share, for Q1 2009.

29 Apr 2010

Watson Laboratories sued in connection with filing of ANDA for generic version of Rapamune tablets

Watson Pharmaceuticals, Inc. today confirmed that its subsidiary, Watson Laboratories, Inc. - Florida, has been sued by Pfizer Inc. and Wyeth Pharmaceuticals Inc. in connection with the filing of Watson's Abbreviated New Drug Application for sirolimus tablets in the 1 mg and 2 mg strengths.

29 Apr 2010

Salix Pharmaceuticals receives FDA complete response letter for GIAZO Tablets NDA

Salix Pharmaceuticals, Ltd. today announced the Food and Drug Administration (FDA) has issued a complete response letter regarding the New Drug Application (NDA) for GIAZO™ (balsalazide disodium) Tablets 1.1 g. for the treatment of mild-to-moderate active ulcerative colitis in patients 18 years and older.

29 Apr 2010

Neoprobe reports revenues of $2.7M for first-quarter 2010

Neoprobe Corporation, a diversified developer of innovative biomedical surgical oncology products, today announced consolidated results for the first quarter of 2010. First quarter 2010 revenues were $2.7 million, consistent with the record revenue reported for the first quarter of 2009.

29 Apr 2010

Mylan Pharmaceuticals' ANDA for generic version of Flomax receives FDA approval

Mylan Inc. today announced that its subsidiary Mylan Pharmaceuticals Inc. received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for Tamsulosin Hydrochloride Capsules USP, 0.4 mg, the generic version of Boehringer Ingelheim's benign prostatic hyperplasia treatment, Flomax.

29 Apr 2010

Seattle Genetics reports revenues of $46.5M for first-quarter 2010

Seattle Genetics, Inc. today reported financial results for the first quarter ended March 31, 2010. The company also highlighted recent product development activities and planned milestones.

28 Apr 2010

New Drug Application News and Research

FDA approves Abbott's CREON sNDA including dosing guidance for treating EPI due to CP, pancreatectomy

Watson Pharmaceuticals sued in connection with filing ANDA for generic equivalent of Trilipix

ZIOPHARM reports a net loss of $17.7 million in first quarter 2010

VIMOVO delayed-release tablets receive FDA approval

ADVENTRX reports first-quarter net loss applicable to common stock of $4.9 million

ISTA Pharmaceuticals first-quarter net revenues up 39%

pSivida announces presentations on bioerodible technologies for degenerative eye disease

Acorda Therapeutics reports AMPYRA gross sales of $3.4 million for first-quarter 2010

Johnson & Johnson subsidiaries agree to pay over $81M to resolve Topamax illegal promotion allegations

Impax initiates challenge of patent listed by Shionogi Pharma concerning Fenoglide

Depomed attributes 56% increase in first-quarter revenue to $5.8M increase in Glumetza product sales

Bristol-Myers Squibb reports 11% increase in first-quarter 2010 revenue

Investment report on Somaxon Pharmaceuticals from MicroStockProfit.com

Gilead announces bioequivalence of Truvada in combination with Tibotec Pharmaceuticals' TMC278 NNRTI

Pain Therapeutics reports net loss of $1.0 million for first-quarter 2010

Watson Laboratories sued in connection with filing of ANDA for generic version of Rapamune tablets

Salix Pharmaceuticals receives FDA complete response letter for GIAZO Tablets NDA

Neoprobe reports revenues of $2.7M for first-quarter 2010

Mylan Pharmaceuticals' ANDA for generic version of Flomax receives FDA approval

Seattle Genetics reports revenues of $46.5M for first-quarter 2010

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