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Shire receives Paragraph IV Notice Letter from Watson for INTUNIV tablet

Shire plc , the global specialty biopharmaceutical company, announces that it has received a Paragraph IV Notice Letter from Watson Laboratories, Inc. advising of the filing of an Abbreviated New Drug Application for a generic version of Shire's 4 mg guanfacine hydrochloride extended release tablet, INTUNIV.

26 Oct 2010

Bristol-Myers Squibb 2010 third quarter U.S. net sales increases 4% to $3.1 billion

Bristol-Myers Squibb Company today reported results for the third quarter of 2010. Highlights in the quarter included: the presentation of new data on investigational compounds in the diabetes and cardiovascular disease franchises at major medical meetings; the completion of important regulatory milestones in the oncology, diabetes and immunoscience franchises; the acquisition of ZymoGenetics; and double-digit EPS growth. The company also confirmed guidance for 2010.

26 Oct 2010

Neurologix holds license for gene therapy to treat severe depression

Neurologix, Inc. today announced that a landmark paper, published on October 20th in Science Translational Medicine demonstrating the importance of the p11 gene in modulating depression in mice, utilized a gene therapy approach to reverse depression in mice for which the Company holds exclusive development rights. Based on the findings reported in the paper, gene therapy may have potential as a new treatment option for people who suffer from severe depression.

26 Oct 2010

Vertex initiates OPTIMIZE Phase 3b study in patients infected with genotype 1 HCV

Vertex Pharmaceuticals Incorporated today announced the initiation of a Phase 3b study called OPTIMIZE that will evaluate twice-daily (BID) dosing of a telaprevir-based combination regimen in people chronically infected with genotype 1 hepatitis C virus (HCV) who have not been treated previously. This is the first Phase 3 study to evaluate twice-daily dosing of a protease inhibitor for the treatment of hepatitis C. OPTIMIZE will not include a control arm of pegylated-interferon and ribavirin alone.

26 Oct 2010

Essentialis, FDA enter agreement on SPA for DCCR Phase 3 efficacy study in patients with high triglycerides

Essentialis, Inc. announced today that the company has reached agreement with the U.S. Food and Drug Administration (FDA) on a Special Protocol Assessment (SPA) for a Phase 3 efficacy study required for product registration for its product candidate, Diazoxide Choline Controlled Release Tablet (DCCR), for the treatment of patients with very high triglycerides.

25 Oct 2010

Arena's NDA receives Complete Response Letter for lorcaserin

Arena Pharmaceuticals, Inc. and Eisai Inc. announced that the US Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) regarding Arena's New Drug Application (NDA) for lorcaserin. Lorcaserin is intended for weight management, including weight loss and maintenance of weight loss, in patients who are obese

25 Oct 2010

Inspire presents data on denufosol therapy for cystic fibrosis at NACFC conference

Inspire Pharmaceuticals, Inc. announced today that data will be presented on denufosol tetrasodium, an investigational therapy for cystic fibrosis (CF), during oral and poster presentations at the 24th Annual North American Cystic Fibrosis Conference (NACFC) October 21-23, 2010 in Baltimore, Maryland.

22 Oct 2010

Cephalon signs convertible note subscription agreement with ChemGenex Pharmaceuticals

Today, Cephalon, Inc. announced the signing of a convertible note subscription agreement with ChemGenex Pharmaceuticals Limited, an Australian-based oncology focused biopharmaceutical company.

22 Oct 2010

Mylan receives final FDA approval for Pramipexole Dihydrochloride Tablets

Mylan Inc. today announced that its subsidiary Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Pramipexole Dihydrochloride Tablets, 0.125 mg, 0.25 mg, 0.5 mg, 1 mg and 1.5 mg, the generic version of Boehringer Ingelheim's Mirapex Tablets, a Parkinson's disease treatment.

21 Oct 2010

MAP Pharmaceuticals to present nine analyses on LEVADEX for migraine therapy at 2010 EHMTIC congress

MAP Pharmaceuticals, Inc. today announced that the Company will present nine analyses relating to its LEVADEX™ orally inhaled migraine therapy product candidate, including analysis from the FREEDOM-301 Phase 3 trial, at the 2010 European Headache and Migraine Trust International Congress (EHMTIC) in Nice, France.

21 Oct 2010

FDA issues complete response letter for BYDUREON NDA

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

21 Oct 2010

Alexza reacquires U.S. and Canadian rights for Staccato Loxapine from BLS

Alexza Pharmaceuticals, Inc. announced today that it has reacquired the U.S. and Canadian rights for AZ-004 (Staccato® loxapine) from Biovail Laboratories International SRL, a wholly-owned subsidiary of Valeant Pharmaceuticals International, Inc.. AZ-004 is being developed for the rapid treatment of agitation in schizophrenia or bipolar disorder patients.

20 Oct 2010

Forest Laboratories second quarter net sales increase 7.7% to $1,037.3 million

Forest Laboratories, Inc., an international pharmaceutical manufacturer and marketer, announced that diluted earnings per share equaled $1.00 in the second quarter of fiscal 2011.

19 Oct 2010

Transcept announces Intermezzo tablet preliminary data for insomnia

Transcept Pharmaceuticals, Inc. today announced its preliminary analysis of data from the recently completed Intermezzo 3.5 mg (zolpidem tartrate sublingual tablet) highway driving study.

19 Oct 2010

Salix presents two Phase 3 pivotal clinical trials data for non-C IBS at ACG Meeting

Salix Pharmaceuticals, Ltd. today announced the presentation of two analyses of data from its Phase 3 pivotal clinical trials, TARGET 1 and 2, demonstrating a 14-day course of XIFAXAN 550 mg (rifaximin) taken three times daily achieved adequate relief of symptoms of non-constipation irritable bowel syndrome (non-C IBS) in a significantly greater proportion of patients compared with placebo.

19 Oct 2010

NeurogesX plans U.S. label expansion for Qutenza in HIV-associated neuropathy

NeurogesX, Inc., a biopharmaceutical company focused on developing and commercializing novel pain management therapies, today announced plans to pursue a U.S. label expansion for Qutenza® (capsaicin) 8% patch to include patients with painful HIV-associated neuropathy (HIV-AN, also referred to as HIV-distal sensory polyneuropathy (HIV-DSP)).

19 Oct 2010

Somaxon announces nonreceipt of Paragraph IV certification for generic Silenor ANDA

Somaxon Pharmaceuticals, Inc., a specialty pharmaceutical company focused on the in-licensing, development and commercialization of proprietary branded pharmaceutical products and late-stage product candidates for the treatment of diseases and disorders in the central nervous system therapeutic area, today announced that the website of the U.S. Food and Drug Administration (FDA) indicates that an Abbreviated New Drug Application (ANDA) for a generic version of Silenor® (doxepin) 3 mg and 6 mg was submitted on September 16, 2010.

19 Oct 2010

BARACLUDE sNDA receives FDA approval for treatment of CHB patients with decompensated liver disease

Bristol-Myers Squibb Company announced today that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) of BARACLUDE for the treatment of chronic hepatitis B (CHB) in adult patients with decompensated liver disease.

18 Oct 2010

Vertex commences VX-770 and VX-809 combination Phase 2a clinical trial for cystic fibrosis

Vertex Pharmaceuticals Incorporated today announced the initiation of a Phase 2a clinical trial that will evaluate multiple combinations of VX-770 and VX-809, investigational oral cystic fibrosis transmembrane conductance regulator (CFTR) modulators for the treatment of cystic fibrosis (CF). The trial is designed to evaluate the safety and tolerability of VX-809 dosed alone for 14 days followed by dosing of VX-809 in combination with VX-770 for 7 days.

18 Oct 2010

Lannett announces launch of Fluphenazine HCl Tablets

Lannett Company, Inc., a manufacturer of generic pharmaceuticals, today announced that it has commenced shipping Fluphenazine HCl Tablets USP, the generic equivalent of Prolixin®, in 1 mg, 2.5 mg, 5 mg and 10 mg dosages. For the 12 months ended September 2010, Fluphenazine HCl Tablets USP, 1 mg, 2.5 mg, 5 mg, & 10 mg had U.S. sales of approximately $28 million at Average Wholesale Price.

18 Oct 2010

New Drug Application News and Research

Shire receives Paragraph IV Notice Letter from Watson for INTUNIV tablet

Bristol-Myers Squibb 2010 third quarter U.S. net sales increases 4% to $3.1 billion

Neurologix holds license for gene therapy to treat severe depression

Vertex initiates OPTIMIZE Phase 3b study in patients infected with genotype 1 HCV

Essentialis, FDA enter agreement on SPA for DCCR Phase 3 efficacy study in patients with high triglycerides

Arena's NDA receives Complete Response Letter for lorcaserin

Inspire presents data on denufosol therapy for cystic fibrosis at NACFC conference

Cephalon signs convertible note subscription agreement with ChemGenex Pharmaceuticals

Mylan receives final FDA approval for Pramipexole Dihydrochloride Tablets

MAP Pharmaceuticals to present nine analyses on LEVADEX for migraine therapy at 2010 EHMTIC congress

FDA issues complete response letter for BYDUREON NDA

Alexza reacquires U.S. and Canadian rights for Staccato Loxapine from BLS

Forest Laboratories second quarter net sales increase 7.7% to $1,037.3 million

Transcept announces Intermezzo tablet preliminary data for insomnia

Salix presents two Phase 3 pivotal clinical trials data for non-C IBS at ACG Meeting

NeurogesX plans U.S. label expansion for Qutenza in HIV-associated neuropathy

Somaxon announces nonreceipt of Paragraph IV certification for generic Silenor ANDA

BARACLUDE sNDA receives FDA approval for treatment of CHB patients with decompensated liver disease

Vertex commences VX-770 and VX-809 combination Phase 2a clinical trial for cystic fibrosis

Lannett announces launch of Fluphenazine HCl Tablets

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