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ARCA biopharma raises $6.8M through sale of 1,075,000 common stock shares

ARCA biopharma, Inc., a biopharmaceutical company developing genetically targeted therapies for heart failure and other cardiovascular diseases, today announced that during the first quarter of 2010, through its previously established equity distribution agreement, it raised net proceeds of approximately $6.8 million through the sale of 1,075,000 shares of ARCA common stock in open market.

1 Apr 2010

Investment report on ADVENTRX Pharmaceuticals

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

1 Apr 2010

Orexigen Therapeutics announces submission of Contrave NDA for treatment of obesity

Orexigen® Therapeutics, Inc. announced that the Company has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Contrave® (naltrexone SR/bupropion SR), its investigational drug for the treatment of obesity. The NDA is based on a substantial body of evidence gathered through the Contrave Obesity Research (COR) clinical program, which included over 4,500 patients.

1 Apr 2010

Positive results from Ardea Biosciences' Phase 2b study of RDEA594 for hyperuricemia and gout

Ardea Biosciences, Inc. announced positive, preliminary, top-line results from its Phase 2b monotherapy study of RDEA594, its lead product candidate for the treatment of hyperuricemia and gout. In this 28-day, randomized, double-blind, placebo-controlled, dose-escalation study, 123 gout patients with hyperuricemia (serum urate levels greater than or equal to 8 mg/dL) received 200 mg once-daily (qd) RDEA594, 400 mg qd RDEA594, 600 mg qd RDEA594 or matching placebo.

1 Apr 2010

FDA accepts filing of Lux Biosciences' NDA for Luveniq and grants application priority review

Lux Biosciences, Inc. today announced that the U.S. Food and Drug Administration has accepted the filing of the company's New Drug Application for Luveniq™ (oral voclosporin) and has granted the application priority review.

31 Mar 2010

Devicor offers to acquire EES Breast Care business

Ethicon Endo-Surgery, Inc. (EES), a Johnson & Johnson company, today announced it has received an irrevocable, unconditional offer from Devicor Medical Products (Devicor), a portfolio company of GTCR Golder Rauner, LLC, (GTCR), to acquire its Breast Care business. The EES Breast Care business sells products designed to help doctors diagnose breast cancer at early stages, while minimizing patient discomfort. Financial terms of the offer are not being disclosed.

31 Mar 2010

Depomed licensee submits DM-1796 NDA for management of PHN

Depomed, Inc. today announced that its licensee has submitted a New Drug Application (NDA) for DM-1796 to the U.S. Food and Drug Administration (FDA) for the management of postherpetic neuralgia (PHN), or pain after shingles. DM-1796 is an investigational, extended release, once-daily tablet formulation of gabapentin designed to reduce dosing frequency and have a low incidence of side effects.

31 Mar 2010

FDA grants priority review status for Isotechnika Pharma's voclosporin

Isotechnika Pharma Inc. today announced that the New Drug Application (NDA) for the Company's next generation calcineurin inhibitor, voclosporin, has been accepted for priority review as filed by the U.S. Food and Drug Administration (FDA). The application was submitted by Isotechnika's partner, Lux Biosciences, Inc.

31 Mar 2010

Patients switching to Victoza experience further reductions in A1c and weight loss

Diabetes Care published online the results of the Novo Nordisk LEAD™ 6 extension study, which evaluated the efficacy and safety of switching from exenatide, which is taken twice a day, to once-daily Victoza®. Results show that when added to oral antidiabetes drugs, patients who switched from exenatide to Victoza experienced further reductions in A1c and weight loss.

31 Mar 2010

QRxPharma initiates Phase 1 trial for evaluating PK profiles of morphine, oxycodone CR formulations

QRxPharma announced today initiation of the Company's first Phase 1 trial to evaluate the pharmacokinetic (PK) profiles of experimental controlled-release (CR) morphine and oxycodone formulations that will be incorporated into MoxDuo®CR. MoxDuo®CR contains a fixed 3:2 morphine:oxycodone combination and is intended to be dosed twice daily in patients experiencing chronic pain, an approximately US$7 billion dollar market worldwide.

31 Mar 2010

FDA issues Complete Response Letter for CERTRIAD NDA

AstraZeneca and Abbott announced today that the U.S. Food and Drug Administration (FDA) issued a complete response letter (CRL) for the New Drug Application (NDA) for CERTRIAD™ (rosuvastatin / fenofibric acid delayed release) Capsules.

31 Mar 2010

Ikaria Holdings acquires NDA and IND application for LUCASSIN drug

Ikaria Holdings, Inc. announced today that it has acquired the New Drug Application (NDA) and the Investigational New Drug (IND) application to LUCASSIN® (terlipressin for injection) from Orphan Therapeutics, assuming all future development and ownership of the drug in North America and Australia.

31 Mar 2010

FDA allows GeoVax Labs to commence phase 1 clinical trial for HIV/AIDS therapeutic vaccine

GeoVax Labs, Inc., a biotechnology company that creates, develops, and tests innovative HIV/AIDS vaccines, is now allowed by the FDA to begin a phase 1 clinical trial for GeoVax's therapeutic vaccine, which is intended as a treatment for individuals infected with HIV. The company will begin a non-blinded study in HIV infected individuals who started drug treatment during their first year of infection.

30 Mar 2010

Savient Pharmaceuticals' resubmission of BLA for KRYSTEXXA accepted for FDA review

Savient Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration has acknowledged receipt of and accepted for review the March 15, 2010 resubmission of the Biologics License Application for KRYSTEXXA™ (pegloticase), a treatment for chronic gout in patients refractory to conventional therapy.

30 Mar 2010

Cumberland Pharmaceuticals submits Acetadote sNDA for non-acetaminophen acute liver failure

Cumberland Pharmaceuticals Inc. has submitted a supplemental new drug application (sNDA) to the U.S. Food and Drug Administration for the use of Acetadote® (acetylcysteine) Injection in patients with non-acetaminophen acute liver failure. Acetadote was launched by Cumberland in 2004 as the first U.S.-approved injectable drug to treat acetaminophen overdose.

30 Mar 2010

GSK re-submits sNDA for Avodart to FDA

GlaxoSmithKline announced today that it has re-submitted the supplemental New Drug Application for Avodart® (dutasteride) for prostate cancer risk reduction among men at increased risk of developing the disease to the US Food and Drug Administration.

30 Mar 2010

Cephalon receives FDA Complete Response Letter for NUVIGIL supplemental new drug application

Cephalon, Inc. today announced the company has received a Complete Response letter from the U.S. Food and Drug Administration (FDA) for its supplemental new drug application for NUVIGIL® (armodafinil) Tablets [C-IV] in the treatment of patients with excessive sleepiness associated with jet lag disorder resulting from eastbound travel.

30 Mar 2010

Genta reports net loss of $11.7M for fourth-quarter 2009

Genta Incorporated today reported results for the quarter and year ended December 31, 2009. The Company also provided an overview of recent corporate highlights and anticipated milestones.

29 Mar 2010

FDA approves Graceway Pharmaceuticals' NDA for Zyclara

Graceway® Pharmaceuticals announced today that the Food and Drug Administration has approved the New Drug Application for Zyclara™, determining it to be safe and effective for the treatment of clinically typical, visible or palpable actinic keratoses.

27 Mar 2010

ARCA biopharma granted patent for methods of treating heart failure patients with bucindolol based on genetic testing

ARCA biopharma, Inc., a biopharmaceutical company developing genetically targeted therapies for heart failure and other cardiovascular diseases, today announced that the U.S. Patent and Trademark Office (USPTO) has issued a patent on methods of treating heart failure patients with bucindolol based on genetic testing.

26 Mar 2010

New Drug Application News and Research

ARCA biopharma raises $6.8M through sale of 1,075,000 common stock shares

Investment report on ADVENTRX Pharmaceuticals

Orexigen Therapeutics announces submission of Contrave NDA for treatment of obesity

Positive results from Ardea Biosciences' Phase 2b study of RDEA594 for hyperuricemia and gout

FDA accepts filing of Lux Biosciences' NDA for Luveniq and grants application priority review

Devicor offers to acquire EES Breast Care business

Depomed licensee submits DM-1796 NDA for management of PHN

FDA grants priority review status for Isotechnika Pharma's voclosporin

Patients switching to Victoza experience further reductions in A1c and weight loss

QRxPharma initiates Phase 1 trial for evaluating PK profiles of morphine, oxycodone CR formulations

FDA issues Complete Response Letter for CERTRIAD NDA

Ikaria Holdings acquires NDA and IND application for LUCASSIN drug

FDA allows GeoVax Labs to commence phase 1 clinical trial for HIV/AIDS therapeutic vaccine

Savient Pharmaceuticals' resubmission of BLA for KRYSTEXXA accepted for FDA review

Cumberland Pharmaceuticals submits Acetadote sNDA for non-acetaminophen acute liver failure

GSK re-submits sNDA for Avodart to FDA

Cephalon receives FDA Complete Response Letter for NUVIGIL supplemental new drug application

Genta reports net loss of $11.7M for fourth-quarter 2009

FDA approves Graceway Pharmaceuticals' NDA for Zyclara

ARCA biopharma granted patent for methods of treating heart failure patients with bucindolol based on genetic testing

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