New Drug Application News and Research

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USPTO issues patent to QRxPharma’s MoxDuo for treatment of acute and chronic pain

QRxPharma Limited announced today that the United States Patent and Trademark Office (USPTO) issued the Company U.S. Patent No. 8,182,837, which does not expire until 2023.

24 May 2012

EMA accepts MAA filing of Takeda’s alogliptin for type 2 diabetes

Furiex Pharmaceuticals, Inc. today confirmed that Takeda Global Research & Development Centre (Europe) Ltd. received confirmation on the acceptance of the submission of a Marketing Authorization Application, or MAA, from the European Medicines Agency for alogliptin, a selective dipeptidyl peptidase IV, or DPP-4, inhibitor for the treatment of type 2 diabetes.

24 May 2012

Gattex may represent new treatment approach for short bowel syndrome

NPS Pharmaceuticals, Inc., a specialty pharmaceutical company developing innovative therapeutics for rare gastrointestinal and endocrine disorders, today reported the presentation of data at the Digestive Disease Week (DDW) meeting held May 19-22 in San Diego.

22 May 2012

DCI receives FDA approval for PERTZYE NDA to treat EPI

Digestive Care, Inc. (DCI), announced that the company has received U.S. Food and Drug Administration (FDA) approval of its New Drug Application (NDA) for PERTZYE, indicated for the treatment of Exocrine Pancreatic Insufficiency (EPI) due to cystic fibrosis (CF) or other conditions.

19 May 2012

Janssen’s NUCYNTA ER tablets more effective in providing pain management in adults with DPN

Janssen Pharmaceuticals, Inc. today announced the results of an investigational Phase 3 study suggesting NUCYNTA ER (tapentadol) extended-release tablets were significantly more effective than placebo in providing pain management among adults with chronic moderate to severe, painful diabetic peripheral neuropathy.

18 May 2012

Medgenics’ EPODURE receives FDA clearance to proceed into clinical trials

Medgenics, Inc., developer of the novel Biopump technology for the sustained production and delivery of therapeutic proteins in patients using their own tissue, today announced receipt of clearance from the U.S. Food and Drug Administration to proceed with a Phase IIb clinical trial of EPODURE for the treatment of anemia in patients undergoing renal dialysis.

18 May 2012

Mylan receives final FDA approval for Clopidogrel Tablets ANDA

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 Clopidogrel Tablets USP, 75 mg and 300 mg.

18 May 2012

Achaogen’s plazomicin and levofloxacin safe and effective in treating cUTI, acute pyelonephritis

Achaogen, Inc. announced today that all objectives were met in the company's multi-national Phase 2 study of plazomicin compared to levofloxacin for the treatment of complicated urinary tract infections (cUTI) and acute pyelonephritis in adults.

16 May 2012

FDA ADAC recommends approval of Quad for HIV-1 infection

Gilead Sciences, Inc. today announced that the Antiviral Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) has voted 13 to 1 in support of approval of the Quad, a complete single tablet regimen of elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil fumarate, for the treatment of HIV-1 infection in treatment-naïve adults.

14 May 2012

FDA advisory committee supports lorcaserin for weight management

Arena Pharmaceuticals, Inc. and Eisai Inc. announced today that the US Food and Drug Administration Endocrinologic and Metabolic Drugs Advisory Committee voted 18 to 4, with one abstention, that the available data demonstrate that the potential benefits of lorcaserin outweigh the potential risks when used long-term in a population of overweight and obese individuals.

11 May 2012

Aradigm first quarter total revenue increases to $0.3 million

Aradigm Corporation today announced financial results for the first quarter and three months ended March 31, 2012.

11 May 2012

Final results from Alnylam’s ALN-TTR01 Phase I trial on TTR-mediated amyloidosis

Alnylam Pharmaceuticals, Inc., a leading RNAi therapeutics company, announced today final results from its completed Phase I clinical trial with ALN-TTR01, an RNAi therapeutic targeting transthyretin (TTR) for the treatment of TTR-mediated amyloidosis.

11 May 2012

Eisai, Arena announce expansion of lorcaserin marketing and supply agreement

Arena Pharmaceuticals, Inc. and Eisai Inc. announced today the expansion of the lorcaserin marketing and supply agreement between Arena Pharmaceuticals, Inc.'s wholly owned subsidiary, Arena Pharmaceuticals GmbH, and Eisai Inc. Lorcaserin is an investigational drug candidate intended for weight management.

11 May 2012

FDA ADAC recommends approval of Gilead’s Truvada for HIV

Gilead Sciences, Inc. today announced that the Antiviral Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) has voted to support approval of once-daily oral Truvada(emtricitabine and tenofovir disoproxil fumarate) to reduce the risk of HIV-1 infection among uninfected adults, an HIV prevention strategy called pre-exposure prophylaxis or PrEP.

11 May 2012

EU and U.S. regulatory authorities accept Biogen Idec’s BG-12 NDA for review

Today Biogen Idec announced that U.S. and EU regulatory authorities have accepted the company's marketing applications for the review of BG-12 (dimethyl fumarate), an oral therapeutic candidate for the treatment of multiple sclerosis.

10 May 2012

Orexigen reports net loss of $10.4 million for first quarter 2012

Orexigen Therapeutics, Inc., a biopharmaceutical company focused on the treatment of obesity, today announced financial results for the first quarter of 2012.

10 May 2012

FDA AAC recommends approval of Pfizer’s tofacitinib for RA

Pfizer Inc. announced today that the Arthritis Advisory Committee to the U.S. Food and Drug Administration (FDA) voted 8-2 to recommend approval of the investigational agent tofacitinib for the treatment of adult patients with moderately to severely active rheumatoid arthritis.

10 May 2012

Janssen submits XARELTO sNDA with FDA to reduce risk of stent thrombosis in ACS patients

Janssen Research & Development, LLC announced today that it has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) seeking approval for the use of XARELTO, an oral anticoagulant, to reduce the risk of stent thrombosis in patients with Acute Coronary Syndrome.

10 May 2012

Shire, Cosmo and Giuliani International file suit against Watson over generic Lialda

Watson Pharmaceuticals, Inc. today confirmed that its subsidiary, Watson Laboratories, Inc. - Florida, filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market Mesalamine Delayed-release Tablets, 1.2g. Watson's ANDA product is a generic version of Shire Development LLC's Lialda.

10 May 2012

FDA approves Clinigen’s Foscavir sNDA to treat HIV/AIDS-related CMV infections and herpes

Clinigen Healthcare, the pharmaceutical products division of Clinigen Group, announced today that its supplemental new drug application (sNDA) for Foscavir (foscarnet sodium), a treatment for HIV/AIDS-related cytomegalovirus (CMV) infections and herpes, has been approved by the US Food and Drug Administration.

From Clinigen Group 8 May 2012

New Drug Application News and Research

USPTO issues patent to QRxPharma’s MoxDuo for treatment of acute and chronic pain

EMA accepts MAA filing of Takeda’s alogliptin for type 2 diabetes

Gattex may represent new treatment approach for short bowel syndrome

DCI receives FDA approval for PERTZYE NDA to treat EPI

Janssen’s NUCYNTA ER tablets more effective in providing pain management in adults with DPN

Medgenics’ EPODURE receives FDA clearance to proceed into clinical trials

Mylan receives final FDA approval for Clopidogrel Tablets ANDA

Achaogen’s plazomicin and levofloxacin safe and effective in treating cUTI, acute pyelonephritis

FDA ADAC recommends approval of Quad for HIV-1 infection

FDA advisory committee supports lorcaserin for weight management

Aradigm first quarter total revenue increases to $0.3 million

Final results from Alnylam’s ALN-TTR01 Phase I trial on TTR-mediated amyloidosis

Eisai, Arena announce expansion of lorcaserin marketing and supply agreement

FDA ADAC recommends approval of Gilead’s Truvada for HIV

EU and U.S. regulatory authorities accept Biogen Idec’s BG-12 NDA for review

Orexigen reports net loss of $10.4 million for first quarter 2012

FDA AAC recommends approval of Pfizer’s tofacitinib for RA

Janssen submits XARELTO sNDA with FDA to reduce risk of stent thrombosis in ACS patients

Shire, Cosmo and Giuliani International file suit against Watson over generic Lialda

FDA approves Clinigen’s Foscavir sNDA to treat HIV/AIDS-related CMV infections and herpes

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