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Noscira receives FDA approval for Tideglusib drug to treat PSP

Noscira, a Grupo Zeltia subsidiary specialized in research and development of drugs to treat neurodegenerative diseases, has announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track status to its neuroprotector drug Tideglusib (ZentylorTM) to treat Progressive Supranuclear Palsy (PSP), a fast-advancing fatal degenerative brain disorder.

10 Sep 2010

Questcor Pharmaceuticals provides update on sNDA for H.P. Acthar Gel

Questcor Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration has informed Questcor that the FDA will require additional time beyond the current action date of September 11, 2010 to complete its review of Questcor's supplemental new drug application for H.P. Acthar Gel (repository corticotropin injection) in the treatment of infantile spasms.

9 Sep 2010

Santarus, VeroScience enter agreement to commercialize CYCLOSET drug for type 2 diabetes

Santarus, Inc., S2 Therapeutics, Inc. and VeroScience LLC today announced that they have entered into a distribution and license agreement granting Santarus exclusive rights to manufacture and commercialize CYCLOSET (bromocriptine mesylate) tablets in the U.S.

9 Sep 2010

MAP Pharmaceuticals completes 12 months of treatment in LEVADEX open-label safety trial

MAP Pharmaceuticals, Inc. today announced that all non-asthmatic patients and a subset of asthmatic patients have completed 12 months of treatment in the open-label safety trial of LEVADEX™. In addition, the Company has completed patient treatment in a thorough QT trial, the last trial necessary to support a New Drug Application (NDA) for LEVADEX.

8 Sep 2010

MAP Pharmaceuticals reports results from PD trial that compares effects of LEVADEX, IV DHE

MAP Pharmaceuticals, Inc. today reported results from a pharmacodynamics trial comparing the acute effects on pulmonary artery pressure of LEVADEX, dihydroergotamine mesylate administered intravenously and placebo. In the trial, there was no statistically significant difference between the LEVADEX and placebo groups in the primary endpoint of pulmonary artery pressure over two hours after administration.

8 Sep 2010

Emergent BioSolutions initiates Phase I clinical trial for anthrax monoclonal antibody therapeutic

Emergent BioSolutions Inc. announced today that the Phase I clinical trial for its anthrax monoclonal antibody therapeutic has commenced with the dosing of the first subject. Emergent's fully human monoclonal antibody product candidate is being developed as a parenteral post-exposure therapeutic to treat symptoms of inhalational anthrax disease.

8 Sep 2010

Phase 3 REALIZE study shows milestone in treatment development for hepatitis C

Vertex Pharmaceuticals Incorporated today announced that 65% of people overall achieved a sustained viral response (SVR or viral cure) with a telaprevir-based regimen in the pivotal Phase 3 REALIZE study, as compared to 17% of people in the control arm who received pegylated-interferon and ribavirin alone.

8 Sep 2010

Onyx enters commercialization agreement with Ono for carfilzomib and ONX 0912 development program

Onyx Pharmaceuticals, Inc. today announced that it has entered into an exclusive agreement with Ono Pharmaceutical Co., Ltd. to develop and commercialize two compounds from Onyx's proteasome inhibitor development program, carfilzomib and ONX 0912. Under the terms of the agreement, Ono has exclusive rights to develop and commercialize both compounds for all oncology indications in Japan.

8 Sep 2010

Forest Laboratories' ceftaroline fosamil receives FDA Advisory Committee approval for CABP and cSSSI

Forest Laboratories, Inc. announced that the U.S. Food and Drug Administration's (FDA) Anti-Infective Drugs Advisory Committee voted 21 - 0 in favor of approval of ceftaroline fosamil for the treatment of community acquired bacterial pneumonia (CABP) and voted 18 - 0 in favor of approval for complicated skin and skin structure infections (cSSSI).

8 Sep 2010

Can-Fite BioPharma opens IND with US-FDA for CF101 Phase 3 study in Dry Eye Syndrome

Can-Fite BioPharma Ltd, a biotechnology company traded on the Tel Aviv Stock Exchange, announced today that it has opened an Investigational New Drug application (IND) with the US-FDA for a Phase 3 study of its lead drug, CF101, in patients with moderate to severe Dry Eye Syndrome.

8 Sep 2010

Watson Laboratories receives FDA approval for Zarah tablets

Watson Pharmaceuticals, Inc., today announced that its subsidiary, Watson Laboratories, Inc., has received approval from the United States Food and Drug Administration (FDA) for its Abbreviated New Drug Application for Zarah (drospirenone and ethinyl estradiol tablets) 3 mg/0.03 mg, the generic equivalent to Bayer's Yasmin.

7 Sep 2010

Celgene receives Paragraph IV Certification Letter on submission of ANDA for REVLIMID

Celgene Corporation today announced it has received a Paragraph IV Certification Letter advising that Natco Pharma Limited of Hyderabad, India, submitted an Abbreviated New Drug Application to the U.S. Food and Drug Administration. The application requests authorization to manufacture and market generic versions of REVLIMID (lenalidomide) 5, 10, 15 and 25 mg capsules in the United States.

3 Sep 2010

Gilead Sciences seeks MAA in Europe for fixed-dose combination of Truvada and TMC278 for HIV-1 infection

Gilead Sciences, Inc. today announced that it has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for marketing approval for the fixed-dose combination of Truvada® (emtricitabine and tenofovir disoproxil (as fumarate)) and Tibotec Pharmaceuticals' investigational non-nucleoside reverse transcriptase inhibitor TMC278 (rilpivirine (as hydrochloride)) for the treatment of HIV-1 infection in adults.

3 Sep 2010

Orexigen and Takeda partner to develop, commercialize Contrave in US, Canada and Mexico

Orexigen® Therapeutics, Inc. and Takeda Pharmaceutical Company Limited, today announced that they have entered into an exclusive partnership to develop and commercialize Contrave® (naltrexone SR/bupropion SR), Orexigen's investigational drug for the treatment of obesity, in the United States, Canada and Mexico.

2 Sep 2010

Biodel replaces Linjeta with trade name VIAject

Biodel Inc. announced today that Linjeta™ (pronounced lin-JET-uh) will replace VIAject as the proposed trade name for Biodel's most advanced product candidate.

2 Sep 2010

QRxPharma announces interim analysis of MoxDuo IR clinical program

QRxPharma announced today a successful interim analysis of its final MoxDuo IR pivotal Phase 3 study required for New Drug Application (NDA) submission.

2 Sep 2010

Pfizer enters agreement to acquire FoldRx Pharmaceuticals

Pfizer Inc. and FoldRx Pharmaceuticals, Inc., a privately held drug discovery and clinical development company, today announced that they have entered into an agreement under which Pfizer will acquire FoldRx.

2 Sep 2010

USFDA grants Sun Pharma subsidiary approval for generic Strattera capsules ANDA

Sun Pharmaceutical Industries Ltd. announced that USFDA has granted its subsidiary an approval for its Abbreviated New Drug Application (ANDA) to market a generic version of Strattera ®, atomoxetine hydrochloride capsules.

2 Sep 2010

pSivida announces FDA Priority Review status for Iluvien NDA

pSivida Corp., a leader in the development of sustained release back of the eye drug delivery systems for difficult-to-treat conditions, today announced that its licensee, Alimera Sciences has been notified that the U.S. Food and Drug Administration (FDA) has granted Priority Review status for the New Drug Application (NDA) filed for Iluvien for the treatment diabetic macular edema (DME).

31 Aug 2010

ESC issues revised practice guidelines for management of AF

The European Society of Cardiology today issued revised practice guidelines for the management of atrial fibrillation, including guidance on the role of a novel oral treatment, dabigatran etexilate, for the prevention of stroke and systemic embolism in patients with atrial fibrillation.

31 Aug 2010

New Drug Application News and Research

Noscira receives FDA approval for Tideglusib drug to treat PSP

Questcor Pharmaceuticals provides update on sNDA for H.P. Acthar Gel

Santarus, VeroScience enter agreement to commercialize CYCLOSET drug for type 2 diabetes

MAP Pharmaceuticals completes 12 months of treatment in LEVADEX open-label safety trial

MAP Pharmaceuticals reports results from PD trial that compares effects of LEVADEX, IV DHE

Emergent BioSolutions initiates Phase I clinical trial for anthrax monoclonal antibody therapeutic

Phase 3 REALIZE study shows milestone in treatment development for hepatitis C

Onyx enters commercialization agreement with Ono for carfilzomib and ONX 0912 development program

Forest Laboratories' ceftaroline fosamil receives FDA Advisory Committee approval for CABP and cSSSI

Can-Fite BioPharma opens IND with US-FDA for CF101 Phase 3 study in Dry Eye Syndrome

Watson Laboratories receives FDA approval for Zarah tablets

Celgene receives Paragraph IV Certification Letter on submission of ANDA for REVLIMID

Gilead Sciences seeks MAA in Europe for fixed-dose combination of Truvada and TMC278 for HIV-1 infection

Orexigen and Takeda partner to develop, commercialize Contrave in US, Canada and Mexico

Biodel replaces Linjeta with trade name VIAject

QRxPharma announces interim analysis of MoxDuo IR clinical program

Pfizer enters agreement to acquire FoldRx Pharmaceuticals

USFDA grants Sun Pharma subsidiary approval for generic Strattera capsules ANDA

pSivida announces FDA Priority Review status for Iluvien NDA

ESC issues revised practice guidelines for management of AF

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