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FDA approves Mylan's ANDA for Fenofibrate Tablets

Mylan Inc. today announced that its subsidiary Mylan Pharmaceuticals Inc. has shipped Fenofibrate Tablets, 48 mg and 145 mg.

17 May 2013

FDA clears Oramed Pharmaceuticals' IND for ORMD-0801

Oramed Pharmaceuticals Inc., a developer of oral drug delivery systems, announced today that the United States Food and Drug Administration has cleared the Company's Investigational New Drug application for ORMD-0801, its oral insulin capsule.

17 May 2013

FDA OKs TWi Pharmaceuticals' tentative ANDA for Guanfacine Hydrochloride Extended Release Tablets

TWi Pharmaceuticals, Inc. today announced that it has received tentative approval for its Abbreviated New Drug Application for Guanfacine Hydrochloride Extended Release Tablets 1mg, 2mg, 3mg and 4mg from the United States Food and Drug Administration.

14 May 2013

FDA approves Arbor Pharmaceuticals' NDA for Nymalize oral solution

Arbor Pharmaceuticals announced today that the U.S. Food and Drug Administration has approved its New Drug Application for Nymalize (nimodipine) oral solution.

14 May 2013

FDA grants priority review for Janssen's simeprevir

Medivir AB today announces that the U.S. Food and Drug Administration has granted Priority Review to the New Drug Application by Janssen for simeprevir (TMC435), an investigational NS3/4A protease inhibitor administered as a 150 mg capsule once daily with pegylated interferon and ribavirin for the treatment of genotype 1 chronic hepatitis C in adult patients with compensated liver disease.

14 May 2013

InSite Vision starts patient enrollment in confirmatory Phase 3 clinical trial of BromSite

InSite Vision Incorporated today announced that patient enrollment has begun in the confirmatory Phase 3 clinical trial of BromSite (ISV-303) for the reduction of inflammation and pain after cataract surgery.

10 May 2013

Mathematical model with prognostic factors predicts treatment effect with bevacizumab in colorectal cancer patients

Certara-, a leading provider of software and scientific consulting services to improve productivity and decision-making from drug discovery through drug development, announced that its Pharsight Consulting Services has developed a mathematical model of tumor growth inhibition, which when combined with baseline prognostic factors, predicts treatment effect with bevacizumab for patients with metastatic colorectal cancer.

9 May 2013

POZEN announces revenue of $1.4 million for first quarter 2013

POZEN Inc., a pharmaceutical company committed to transforming medicine that transforms lives, today announced results for the first quarter ended March 31, 2013.

8 May 2013

Biocryst reports financial results for first quarter 2013

BioCryst Pharmaceuticals, Inc. announced financial results for the first quarter ended March 31, 2013.

7 May 2013

Akorn reports record consolidated revenue of $73.9 million in first quarter 2013

Akorn, Inc., a niche generic pharmaceutical company, today reported financial results for its first quarter ended March 31, 2013.

7 May 2013

FDA approves sNDA for SUSTIVA for treatment of HIV-1 infected pediatric patients

Bristol-Myers Squibb Company today announced that the U.S. Food and Drug Administration has approved a supplemental new drug application for SUSTIVA (efavirenz), including dosing recommendations for HIV-1 infected pediatric patients three months to three years old and weighing at least 3.5 kg.

4 May 2013

Preclinical data of Emergent BioSolutions' ES414 in mCRPC presented at PEGS 2013

Emergent BioSolutions Inc. today announced that it presented preclinical data on its lead bispecific ADAPTIRTM (Modular Protein Technology) molecule, ES414, at the 9th Annual Protein and Antibody Engineering Summit, currently underway in Boston, MA.

3 May 2013

AcelRx Pharmaceuticals reports clinical results of Sufentanil NanoTab PCA System for acute pain treatment

AcelRx Pharmaceuticals, Inc., a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of acute and breakthrough pain, today reported additional clinical results for its lead product candidate, the Sufentanil NanoTab PCA System for the treatment of moderate-to-severe acute pain in the hospital setting.

2 May 2013

Oramed to report results of T1DM oral insulin formulation at Diabetes Summit 2013

Oramed Pharmaceuticals Inc., a developer of oral delivery systems of drugs currently administered by injection, announced today that its abstract, entitled "Oral insulin capsules toward management of Type 1 diabetes mellitus," will be presented at the Global Technology Community Diabetes Summit 2013.

29 Apr 2013

Actavis resolves patent litigation related to generic version of INTUNIV for treatment of ADHD

Actavis, Inc., a leading specialty pharmaceutical company, today announced that is has reached a settlement agreement with Shire plc resolving outstanding patent litigation related to Actavis' generic version of INTUNIV® (guanfacine hydrochloride) for the treatment of Attention Deficit Hyperactivity Disorder.

26 Apr 2013

Derma Sciences initiates patient screening in DSC127 pivotal program for treatment of diabetic foot ulcers

Derma Sciences, Inc., a medical device and pharmaceutical company focused on advanced wound care, announces that patient screening has begun in the second of two Phase 3 clinical trials with the investigational topical drug candidate DSC127 for the treatment of diabetic foot ulcers.

26 Apr 2013

Orexigen Therapeutics praises new research report on obesity prevention policies

Orexigen commends CEO as well as the author of the report, Alex Brill , and the Robert Wood Johnson Foundation (RWJF) who funded the report, for this new research illustrating the importance of long-term budget impact analyses on preventive health policies, specifically those aimed at obesity.

26 Apr 2013

Omeros presents clinical data of OMS302 on reducing pupil constriction during ILR at ASCRS meeting

Omeros Corporation today reported analyses of Phase 2 and Phase 3 clinical data showing the favorable impact of OMS302 on reducing the incidence of miosis (pupil constriction) during intraocular lens replacement.

25 Apr 2013

Janssen submits Marketing Authorization Application to EMA for simeprevir approval

Medivir AB today announces that Janssen-Cilag International NV today has submitted a Marketing Authorization Application to the European Medicines Agency seeking approval for simeprevir (TMC435).

25 Apr 2013

CytRx reaches agreement with FDA for aldoxorubicin Phase 3 trial for treatment of soft tissue sarcomas

CytRx Corporation, a biopharmaceutical research and development company specializing in oncology, announced today that it has reached an agreement with the U.S. Food and Drug Administration under a special protocol assessment for a global pivotal Phase 3 trial with aldoxorubicin as a treatment for patients with soft tissue sarcomas who have relapsed or were refractory following prior treatment with chemotherapy.

24 Apr 2013

New Drug Application News and Research

FDA approves Mylan's ANDA for Fenofibrate Tablets

FDA clears Oramed Pharmaceuticals' IND for ORMD-0801

FDA OKs TWi Pharmaceuticals' tentative ANDA for Guanfacine Hydrochloride Extended Release Tablets

FDA approves Arbor Pharmaceuticals' NDA for Nymalize oral solution

FDA grants priority review for Janssen's simeprevir

InSite Vision starts patient enrollment in confirmatory Phase 3 clinical trial of BromSite

Mathematical model with prognostic factors predicts treatment effect with bevacizumab in colorectal cancer patients

POZEN announces revenue of $1.4 million for first quarter 2013

Biocryst reports financial results for first quarter 2013

Akorn reports record consolidated revenue of $73.9 million in first quarter 2013

FDA approves sNDA for SUSTIVA for treatment of HIV-1 infected pediatric patients

Preclinical data of Emergent BioSolutions' ES414 in mCRPC presented at PEGS 2013

AcelRx Pharmaceuticals reports clinical results of Sufentanil NanoTab PCA System for acute pain treatment

Oramed to report results of T1DM oral insulin formulation at Diabetes Summit 2013

Actavis resolves patent litigation related to generic version of INTUNIV for treatment of ADHD

Derma Sciences initiates patient screening in DSC127 pivotal program for treatment of diabetic foot ulcers

Orexigen Therapeutics praises new research report on obesity prevention policies

Omeros presents clinical data of OMS302 on reducing pupil constriction during ILR at ASCRS meeting

Janssen submits Marketing Authorization Application to EMA for simeprevir approval

CytRx reaches agreement with FDA for aldoxorubicin Phase 3 trial for treatment of soft tissue sarcomas

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