New Drug Application News and Research

RSS

FDA completes review of compounded hydroxyprogesterone caproate products and APIs

FDA (or the Agency) approved Makena (hydroxyprogesterone caproate) in February 2011 for the reduction of the risk of certain preterm births in women who have had at least one prior preterm birth. Beginning many years before Makena was approved, a version of the active ingredient of Makena has been available to patients whose physicians requested the drug from a pharmacist who compounded the drug.

18 Jun 2012

Investigational Insomnia Medicine from Merck improved patients’ ability to fall and stay asleep according to new phase III Data

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced new data from two pivotal Phase III efficacy trials for suvorexant, the investigational medicine Merck is developing for the treatment of insomnia. In the studies, suvorexant significantly reduced the time it took patients to fall asleep and increased the time that patients stayed asleep as early as the first night and at the three-month time point compared to placebo. The investigational medicine met statistical significance for all primary endpoints except for one measurement at Month 3 in one of the trials. These late-breaking data were presented here today at SLEEP 2012, the 26th Annual Meeting of the Associated Professional Sleep Societies.

13 Jun 2012

Dapagliflozin more effective than sitagliptin for adult patients with type 2 diabetes

Bristol-Myers Squibb Company and AstraZeneca today announced results from a Phase 3 clinical study that showed the investigational compound dapagliflozin 10 mg demonstrated significant reductions in blood sugar levels (glycosylated hemoglobin levels, or HbA1c) compared with placebo at 24 weeks when either agent was added to existing sitagliptin therapy (with or without metformin) in adult patients with type 2 diabetes.

11 Jun 2012

Amylin, Alkermes announce results from BYDUREON clinical study on type 2 diabetes

Amylin Pharmaceuticals, Inc. and Alkermes plc today announced results from the long-term extension of the DURATION-1 study, which showed that BYDUREON (exenatide extended-release for injectable suspension), the first and only once-weekly treatment for type 2 diabetes, was associated with clinically significant and sustained improvements in glycemic control during four years of treatment in adults with type 2 diabetes.

11 Jun 2012

Mylan, Teva resolve generic Provigil litigation

Mylan Inc. today announced that its subsidiary Mylan Pharmaceuticals Inc. has resolved all disputes with Teva Pharmaceuticals USA, Inc. stemming from litigation brought by Mylan in federal court in the District of Columbia against the U.S. Food and Drug Administration (FDA) concerning Mylan's abbreviated new drug application (ANDA) for Modafinil Tablets, 100 mg and 200 mg.

8 Jun 2012

FDA issues complete response letter to Merck’s ridaforolimus NDA

Merck, known as MSD outside the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) has issued a complete response letter regarding the New Drug Application (NDA) for ridaforolimus.

6 Jun 2012

Exelixis reports data from cabozantinib phase 3 trial on MTC

Exelixis, Inc. today reported data from the phase 3 pivotal trial of cabozantinib in patients with progressive, unresectable, locally advanced or metastatic medullary thyroid cancer (MTC).

5 Jun 2012

Onyx announces data from regorafenib Phase 3 trial on GIST

Onyx Pharmaceuticals today announced data from the Phase 3 GRID (GIST – Regorafenib In Progressive Disease) trial evaluating the investigational drug regorafenib, a Bayer compound, in patients with metastatic and/or unresectable gastrointestinal stromal tumors (GIST) whose disease had progressed despite prior treatment with imatinib and sunitinib.

4 Jun 2012

KYTHERA receives U.S. patent allowance for ATX-101

KYTHERA Biopharmaceuticals, Inc. today announced that it has received a Notice of Allowance from the U.S. Patent and Trademark Office (USPTO) for a patent application that claims synthetic deoxycholic acid or pharmaceutically acceptable salts thereof, including the synthetic form that is used in ATX-101, a potential first-in-class, injectable drug under clinical investigation for the reduction of submental fat, which commonly presents as an undesirable "double chin."

1 Jun 2012

Janssen submits canagliflozin NDA with FDA for treatment of type 2 diabetes

Janssen Research & Development, LLC (Janssen), announced today that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for the use of canagliflozin, an investigational, oral, once-daily, selective sodium glucose co-transporter 2 (SGLT2) inhibitor, for the treatment of adult patients with type 2 diabetes.

1 Jun 2012

RXi’s RXI-109 IND receives FDA clearance to proceed into clinical trials

RXi Pharmaceuticals Corporation today announced that it has received clearance for its investigational new drug application (IND) from the U.S. Food and Drug Administration (FDA) to initiate clinical trials with RXI-109, a self-delivering RNAi compound that selectively targets Connective Tissue Growth Factor.

1 Jun 2012

Exelixis files NDA with FDA for cabozantinib to treat MTC

Exelixis, Inc. today announced that it has completed the filing of its rolling New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for cabozantinib as a treatment for patients with progressive, unresectable, locally advanced, or metastatic medullary thyroid cancer.

30 May 2012

Endo, Watson reach agreement to resolve two LIDODERM patent infringement lawsuits

Endo announced today that it has reached an agreement with Watson Pharmaceuticals (Watson) resolving two patent infringement lawsuits related to LIDODERM.

30 May 2012

Positive results from RedHill’s RHB-103 bioequivalence trial on acute migraine

RedHill Biopharma Ltd., an emerging Israeli biopharmaceutical company focusing primarily on development of late clinical-stage (Phase II/III), patent protected, new formulations and combinations of existing drugs, announces positive results in a pivotal bioequivalence clinical trial with RHB-103, an oral thin-film formulation of Rizatriptan for the treatment of acute migraine.

30 May 2012

Marshall Edwards initiates ME-344 Phase I trial in solid tumors

Marshall Edwards, Inc., an oncology company focused on the clinical development of novel therapeutics targeting cancer metabolism, announced today that the first cohort of patients has been dosed in a Phase I clinical trial of ME-344, the Company's lead mitochondrial inhibitor drug candidate, in patients with refractory solid tumors.

30 May 2012

FDA accepts NDA filing for KYNAMRO to treat HoFH

Genzyme, a Sanofi company, and Isis Pharmaceuticals Inc., announced today that the U.S. Food and Drug Administration has accepted for filing the New Drug Application for KYNAMRO (mipomersen sodium) for the treatment of patients with homozygous familial hypercholesterolemia (HoFH).

29 May 2012

FDA advisory committee votes in favor of Pfizer's tafamidis meglumine

Pfizer Inc. announced today that the United States Food and Drug Administration's (FDA) Peripheral and Central Nervous System Drugs Advisory Committee voted on Pfizer's clinical data package for tafamidis meglumine.

25 May 2012

Auxilium, FCB I file suit against Watson over generic Testim

Watson Pharmaceuticals, Inc. today confirmed that its subsidiary, Watson Laboratories, Inc., filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market Testosterone Gel, 1%. Watson's 1% testosterone gel product is a generic version of Auxilium Pharmaceuticals, Inc.'s Testim 1%.

25 May 2012

APP expands portfolio of injectable critical care products

APP Pharmaceuticals, LLC, a Fresenius Kabi Company, today announced it has acquired three products from Nexus Pharmaceuticals, Inc.

24 May 2012

Bayer submits regorafenib NDA with FDA for treatment of mCRC

Bayer HealthCare announced today that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for the oral multi-kinase inhibitor regorafenib for the treatment of patients with metastatic colorectal cancer.

24 May 2012