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Hercules Technology Growth Capital commits over $52.0M in structured debt financing

Hercules Technology Growth Capital, Inc., 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 it has committed over $52.0 million in structured debt financing to new and existing portfolio companies.

19 Mar 2010

InvestorSoup.com announces investment report featuring Somaxon Pharmaceuticals

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

19 Mar 2010

FDA approves Somaxon Pharmaceuticals' Silenor for treatment of insomnia

Somaxon Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for Silenor® (doxepin) for the treatment of insomnia characterized by difficulty with sleep maintenance.

19 Mar 2010

ZIOPHARM Oncology reports fourth quarter net income of $1.0M against loss last year

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, announced today its financial results for the fourth quarter and full year 2009, and the filing of its Annual Report on Form 10-K with the Securities and Exchange Commission.

18 Mar 2010

Acurox NDA: FDA schedules Advisory Committee meeting

Acura Pharmaceuticals, Inc. and King Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration ("FDA") has publically announced the scheduling of an April 22, 2010 Advisory Committee meeting to discuss the New Drug Application ("NDA") for Acurox® (oxycodone HCl and niacin) Tablets and the results of studies evaluating the addition of niacin for the purpose of reducing the misuse of oxycodone.

18 Mar 2010

Nabi Biopharmaceuticals commences second Phase III study of NicVAX for treating nicotine addiction

Nabi Biopharmaceuticals announced that it has initiated the second of two pivotal Phase III clinical trials for NicVAX® (Nicotine Conjugate Vaccine), the company's innovative and proprietary vaccine to treat nicotine addiction and prevent smoking relapse. The FDA has agreed with Nabi on the study design, protocol and end points through a Special Protocol Assessment (SPA). The SPA forms a basic foundation to support approval of a New Drug Application. The Company also received scientific advice from the European Medicines Agency (EMEA) that confirms and supports the trial protocol.

17 Mar 2010

ONGLYZA-metformin combination: FDA accepts NDA for review

Bristol-Myers Squibb Company and AstraZeneca today announced that the U.S. Food and Drug Administration (FDA) has accepted for review a New Drug Application (NDA) for an investigational fixed dose combination of ONGLYZA™ (saxagliptin), a dipeptidyl peptidase-4 (DPP4) inhibitor, and metformin HCl extended-release tablets as a once-daily treatment for type 2 diabetes mellitus in adults.

17 Mar 2010

Abraxis BioScience's Phase 3 trial comparing ABRAXANE with Taxol injection meets primary endpoint

Abraxis BioScience, Inc. today announced that its randomized registrational Phase 3 clinical trial comparing ABRAXANE® (protein-bound paclitaxel) with Taxol® (paclitaxel) injection, both in combination with carboplatin, met the study’s primary endpoint by demonstrating that ABRAXANE showed a significant improvement in overall response rate as compared to Taxol, in the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC), as assessed by independent radiologist review.

17 Mar 2010

Protalix BioTherapeutics commences clinical trial of human acetylcholinesterase for biodefense indications

Protalix BioTherapeutics, Inc. announced today that it has initiated a phase I clinical trial of PRX-105, the Company's plant cell expressed pegylated recombinant human acetylcholinesterase product candidate in development for biodefense indications. The trial is designed to study the safety of PRX-105 by administering a bolus intravenous injection of PRX-105 in healthy volunteers.

17 Mar 2010

Shire receives Paragraph IV Notice Letter over generic INTUNIV ANDAs from Teva Pharmaceuticals

Shire plc, announces that it has received a Paragraph IV Notice Letter from Teva Pharmaceuticals USA, Inc. advising of the filing of an Abbreviated New Drug Application for a generic version of Shire's 1 mg, 2mg, 3 mg, and 4mg guanfacine hydrochloride extended release tablets, INTUNIV(TM).

17 Mar 2010

Actoplus Met and Actos: Mylan enters into settlement agreements with Takeda Pharmaceutical

Mylan Inc. today announced that it has entered into settlement agreements with Takeda Pharmaceutical Co. related to two treatments for type 2 diabetes: Actoplus Met®, 15 mg/500 mg and 15 mg/850 mg, known generically as Pioglitazone Hydrochloride (HCl) and Metformin HCl Tablets, and Actos®, 15 mg, 30 mg and 45 mg, known generically as Pioglitazone HCl Tablets.

16 Mar 2010

Clinical evaluation of benzodiazepine products is now allowed using Acura's Aversion Technology

Acura Pharmaceuticals, Inc. today announced clinical evaluation is now allowed under an Investigational New Drug application ("IND") filed with the U.S. Food and Drug Administration ("FDA") for a benzodiazepine product candidate utilizing our Aversion® Technology.

16 Mar 2010

FDA approves Watson Pharmaceuticals' ANDA for generic Cardizem LA

Watson Pharmaceuticals, Inc. today announced that its subsidiary, Watson Laboratories, Inc. – Florida, has received approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Diltiazem Hydrochloride Extended-Release tablets, the generic equivalent to Biovail Laboratories International SRL's Cardizem® LA product. Watson intends to launch its generic version of Cardizem® LA immediately.

16 Mar 2010

Lilly receives exclusive rights to commercialize Acrux's testosterone solution

Eli Lilly and Company and Acrux announced today that they have entered into an exclusive worldwide license agreement for the potential commercialization of Acrux's experimental underarm testosterone solution (proposed tradename AXIRON™).

16 Mar 2010

Impax Laboratories initiates challenge of patent over generic TRILIPIX

Impax Laboratories, Inc. today confirms that it has initiated a challenge of the patent listed by Abbott Laboratories and Fournier Laboratories Ireland Ltd. in connection with its TRILIPIX® (choline fenofibrate) delayed-release capsules, 135 mg and 45 mg.

15 Mar 2010

MannKind receives FDA Complete Response letter for AFREZZA NDA

MannKind Corporation today announced that it has received a Complete Response letter from the U.S. Food & Drug Administration (FDA) regarding the New Drug Application (NDA) for AFREZZA™ (insulin human [rDNA origin]) Inhalation Powder for the treatment of adult patients with type 1 and type 2 diabetes mellitus for the control of hyperglycemia.

15 Mar 2010

Hemispherx Biopharma reports net loss of $13,438,000 for fiscal year 2009

Hemispherx Biopharma, Inc., announced its financial results for the fiscal year ended December 31, 2009. The net loss for the year (including non-cash charges) was approximately $13,438,000 or $0.12 per share as compared to a net loss of $12,219,000 or $0.16 per share in 2008.

15 Mar 2010

GTx reacquires full rights to Ostarine

GTx, Inc. today provided a company update and reported financial results for the fourth quarter and full year 2009.

15 Mar 2010

CPF, PFF applaud PF patients' efforts to plead with FDA Advisory Panel regarding lack of treatment options

The Coalition for Pulmonary Fibrosis and the Pulmonary Fibrosis Foundation are applauding the efforts of Pulmonary Fibrosis (PF) patients and family members for their work to convey to the FDA and an FDA Advisory Committee the sense of urgency and desperation regarding the disease and the lack of treatment options.

15 Mar 2010

NDA for BYDUREON: FDA issues complete response letter

Amylin Pharmaceuticals, Inc., Eli Lilly and Company and Alkermes, Inc. today announced that the U.S. Food and Drug Administration has issued a complete response letter regarding the New Drug Application for BYDUREON™ (exenatide for extended-release injectable suspension).

15 Mar 2010

New Drug Application News and Research

Hercules Technology Growth Capital commits over $52.0M in structured debt financing

InvestorSoup.com announces investment report featuring Somaxon Pharmaceuticals

FDA approves Somaxon Pharmaceuticals' Silenor for treatment of insomnia

ZIOPHARM Oncology reports fourth quarter net income of $1.0M against loss last year

Acurox NDA: FDA schedules Advisory Committee meeting

Nabi Biopharmaceuticals commences second Phase III study of NicVAX for treating nicotine addiction

ONGLYZA-metformin combination: FDA accepts NDA for review

Abraxis BioScience's Phase 3 trial comparing ABRAXANE with Taxol injection meets primary endpoint

Protalix BioTherapeutics commences clinical trial of human acetylcholinesterase for biodefense indications

Shire receives Paragraph IV Notice Letter over generic INTUNIV ANDAs from Teva Pharmaceuticals

Actoplus Met and Actos: Mylan enters into settlement agreements with Takeda Pharmaceutical

Clinical evaluation of benzodiazepine products is now allowed using Acura's Aversion Technology

FDA approves Watson Pharmaceuticals' ANDA for generic Cardizem LA

Lilly receives exclusive rights to commercialize Acrux's testosterone solution

Impax Laboratories initiates challenge of patent over generic TRILIPIX

MannKind receives FDA Complete Response letter for AFREZZA NDA

Hemispherx Biopharma reports net loss of $13,438,000 for fiscal year 2009

GTx reacquires full rights to Ostarine

CPF, PFF applaud PF patients' efforts to plead with FDA Advisory Panel regarding lack of treatment options

NDA for BYDUREON: FDA issues complete response letter

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