New Drug Application News and Research

RSS

Egalet announces business highlights, financial results for first quarter 2015

Egalet Corporation, a fully integrated specialty pharmaceutical company focused on developing, manufacturing and marketing innovative pain treatments, today reported business highlights and financial results for the three months ended March 31, 2015.

7 May 2015

Symbiomix closes $41 million Series A financing and reports positive results from SYM-1219 Phase 2 trial

Symbiomix Therapeutics today announced multiple milestones, including the closing of the third and final tranche of a $41 million Series A financing and positive results from a multi-center, randomized Phase 2 trial testing a single oral dose of SYM-1219 for the treatment of bacterial vaginosis (BV).

6 May 2015

Juniper's total revenues increase 19% to $8.3 million in first quarter 2015

Juniper Pharmaceuticals, Inc., today announced financial results for the three-month period ended March 31, 2015.

6 May 2015

Mylan releases generic version of Seasonale Tablets in the U.S.

Mylan N.V. today announced the U.S. launch of Levonorgestrel and Ethinyl Estradiol Tablets USP, 0.15 mg/0.03 mg, which is the generic version of Teva's Seasonale Tablets. Mylan's partner Famy Care Ltd. received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application (ANDA) for this product, which is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception.

5 May 2015

Indivior reports top-line results from RBP-7000 phase 3 trial for treatment of schizophrenia

Indivior PLC today announced top-line results from its phase 3 clinical trial of RBP-7000, an investigational drug in development for the treatment of schizophrenia. In this pivotal study, both doses of RBP-7000 tested, 90 mg and 120 mg administered once-monthly, met the primary endpoint with statistically and clinically significant reductions in the symptoms of acute schizophrenia over an 8-week treatment period.

5 May 2015

FDA grants tentative approval to Amerigen's ANDA for generic version of Toviaz

Amerigen Pharmaceuticals Limited today announced that the U.S. Food and Drug Administration has granted tentative approval to the Company's Abbreviated New Drug Application (ANDA) for a generic version of Toviaz (Fesoterodine Fumarate Extended-release Tablets, 4mg and 8mg).

30 Apr 2015

Neurocrine reports net loss of $1.2 million for first quarter 2015

Neurocrine Biosciences, Inc. today announced its financial results for the quarter ended March 31, 2015. For the first quarter of 2015, the Company reported a net loss of $1.2 million, or $0.01 loss per share, compared to a net loss of $11.8 million, or $0.17 loss per share, for the same period in 2014.

30 Apr 2015

Merrimack completes submission of MM-398 NDA for treatment of post-gemcitabine metastatic pancreatic cancer

Merrimack Pharmaceuticals, Inc. and Baxter International Inc. today jointly announced that Merrimack has completed the rolling submission of the New Drug Application (NDA) for MM-398 (irinotecan liposome injection), also known as "nal-IRI," to the U.S. Food and Drug Administration.

From Baxter International Inc. 27 Apr 2015

TWi signs Settlement Agreement with Takeda on patent litigation related to generic Dexilant

TWi Pharmaceuticals, Inc. today announced that it has entered into a Settlement Agreement with Takeda Pharmaceutical Company Limited, Takeda Pharmaceuticals U.S.A., Inc., Takeda Pharmaceuticals America, Inc. (individually and collectively, "Takeda") to settle and dismiss all outstanding patent litigation related to TWi's generic dexlansoprazole delayed release capsules for oral administration in 30 mg and 60 mg dosage strengths.

27 Apr 2015

AbbVie's all-oral, interferon-free therapy granted FDA priority review for treatment of GT4 HCV infection

AbbVie has announced that the U.S. Food and Drug Administration has accepted its New Drug Application (NDA) and granted priority review for the company's, all-oral, interferon-free, two direct-acting antiviral treatment of ombitasvir, paritaprevir, ritonavir (OBV/PTV/r), with ribavirin (RBV).

25 Apr 2015

Actavis reports positive results from phase 3 study of single-dose DALVANCE for treatment of ABSSSI

Actavis plc today announced positive top-line results for study DUR001-303, a phase 3 study comparing a single 1500 mg dose of DALVANCE with the same total dose given as two-doses one week apart, for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible Gram-positive bacteria, including methicillin resistant Staphylococcus aureus (MRSA).

25 Apr 2015

Data from pacritinib Phase 3 PERSIST-1 trial in patients with myelofibrosis to be highlighted at ASCO

CTI BioPharma Corp. and Baxter International Inc. today announced that data from the randomized Phase 3 PERSIST-1 trial evaluating the investigational agent pacritinib in patients with myelofibrosis will be highlighted in a late-breaking oral presentation at the upcoming American Society of Clinical Oncology 2015 Meeting (May 29-June 2, 2015 in Chicago, Ill).

From Baxter International Inc. 22 Apr 2015

Boehringer Ingelheim seeks FDA approval for Pradaxa to treat DVT and PE

Legal-Bay LLC, The Lawsuit Settlement Funding Company, announced today that Pradaxa's maker, Boehringer Ingelheim Pharmaceuticals, is seeking FDA approval for its blood thinner to treat DVT and PE.

21 Apr 2015

Baxter submits BAX 855 NDA to Japan's MHLW for treatment of hemophilia A patients

Nektar Therapeutics reported today that partner Baxter International Inc. announced that the company has submitted a new drug application (NDA) to Japan's Ministry of Health, Labour and Welfare for the approval of BAX 855, an investigational, extended half-life recombinant factor VIII (rFVIII) treatment based on ADVATE [Antihemophilic Factor (Recombinant)] for patients over 12 years of age with hemophilia A.

From Baxter International Inc. 16 Apr 2015

Japanese MHLW grants priority review for AbbVie's investigational hepatitis C treatment

AbbVie today announced that the Japanese Ministry of Health, Labour and Welfare has granted priority review for its investigational, two direct-acting antiviral treatment of ombitasvir/paritaprevir/ritonavir.

16 Apr 2015

Aeterna Zentaris plans to conduct Macrilen Phase 3 clinical study for AGHD

Aeterna Zentaris Inc. today announced plans to conduct a new, confirmatory Phase 3 clinical study to demonstrate the efficacy of Macrilen (macimorelin), a novel orally-active ghrelin agonist for use in evaluating adult growth hormone deficiency ("AGHD"), as well as a dedicated thorough QT study to evaluate the effect of Macrilen on myocardial repolarization.

13 Apr 2015

Eisai, Arena complete two Phase 1 registrational trials for once-daily formulation of lorcaserin

Eisai Inc. and Arena Pharmaceuticals, Inc. today announced the completion of two Phase 1 registrational clinical trials that Eisai and Arena believe demonstrate bioequivalence of an investigational once-daily extended release formulation of lorcaserin, as compared to the twice-daily immediate release formulation approved by the US Food and Drug Administration and marketed as BELVIQ.

13 Apr 2015

AstraZeneca selects Regulus' RG-125 as clinical candidate for treatment of NASH

Regulus Therapeutics Inc., a biopharmaceutical company leading the discovery and development of innovative medicines targeting microRNAs, announced today the selection of RG-125 (AZD4076), a GalNAc-conjugated anti-miR targeting microRNA-103/107 (“miR-103/107”) for the treatment of Non Alcoholic Steatohepatitis (“NASH) in patients with type 2 diabetes/pre-diabetes, as a clinical candidate by AstraZeneca under the companies’ strategic alliance to discover, develop and commercialize microRNA therapeutics.

9 Apr 2015

Mylan announces the U.S. launch of first generic version of Generess Fe tablets

Mylan N.V. today announced the U.S. launch of Norethindrone and Ethinyl Estradiol Tablets (Chewable) 0.8 mg/0.025 mg and Ferrous Fumarate Tablets, 75 mg (Chewable), which is the generic version of Warner Chilcott's Generess Fe Tablets.

7 Apr 2015

Personalized cancer vaccines can be used to marshal powerful immune response

Personalized melanoma vaccines can be used to marshal a powerful immune response against unique mutations in patients' tumors, according to early data in a first-in-people clinical trial at Washington University School of Medicine in St. Louis.

6 Apr 2015