New Drug Application News and Research

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FDA approves KALYDECO for people with cystic fibrosis

Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced the U.S. Food and Drug Administration (FDA) approved a supplemental New Drug Application (sNDA) for KALYDECOTM (ivacaftor) for people with cystic fibrosis (CF) ages 6 and older who have one of eight additional mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. KALYDECO was first approved in January 2012 for people with CF ages 6 and older who have at least one copy of the G551D mutation.

26 Feb 2014

FDA approves sNDA to include radiographic data updating label of Pfizer XELJANZ for treatment of RA

Pfizer Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) to update the current label of XELJANZ® (tofacitinib citrate) 5 mg tablets to include radiographic data from two Phase 3 studies, ORAL Scan (A3921044) and ORAL Start.

25 Feb 2014

Impax Laboratories records adjusted net loss of $1.6 million in fourth quarter 2013

Impax Laboratories, Inc. today reported fourth quarter and full year ended December 31, 2013 results.

21 Feb 2014

XenoPort reports net loss of $19.1 million for fourth quarter 2013

XenoPort, Inc. announced today its financial results for the fourth quarter and year ended December 31, 2013. Revenues for the fourth quarter were $2.9 million, compared to $0.5 million for the same period in 2012. Net loss for the fourth quarter was $19.1 million compared to net income of $3.0 million that resulted from a non-cash gain from XenoPort's litigation settlement with Glaxo Group Limited in the fourth quarter of 2012. At December 31, 2013, XenoPort had cash and cash equivalents and short-term investments of $58.7 million.

20 Feb 2014

Pharmacyclics total revenue for fourth quarter 2013 increases 113% to $123.6 million

Pharmacyclics, Inc. today reported financial results and recent developments for the quarter and year ended December 31, 2013.

20 Feb 2014

OTC asthma inhaler endangers patients by encouraging substandard treatment

An over-the-counter (OTC) asthma inhaler up for approval by the U.S. Food & Drug Administration (FDA) endangers patients by encouraging substandard treatment, according to Allergy & Asthma Network Mothers of Asthmatics (AANMA), a leading nonprofit patient education and advocacy organization.

20 Feb 2014

Jazz Pharmaceuticals' Versacloz now commercially available in the U.S. for schizophrenia

Jazz Pharmaceuticals plc today announced U.S. commercial availability of Versacloz (clozapine, USP) oral suspension, the first and only oral suspension clozapine for severely ill treatment-resistant schizophrenia patients or those at risk of recurrent suicidal behavior with schizophrenia or schizoaffective disorder.

11 Feb 2014

Ligand Pharmaceuticals' total revenues for Q4 2013 increase 8% to $14.7 million

Ligand Pharmaceuticals Incorporated today reported financial results for the three and 12 months ended December 31, 2013, and provided an operating forecast and program updates.

11 Feb 2014

Gilead submits NDA to FDA for fixed-dose combination of ledipasvir and sofosbuvir for hepatitis C infection

Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the company has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for a once-daily fixed-dose combination of the NS5A inhibitor ledipasvir (LDV) 90 mg and the nucleotide analog polymerase inhibitor sofosbuvir (SOF) 400 mg for the treatment of chronic hepatitis C genotype 1 infection in adults.

11 Feb 2014

CTI announces initiation of pacritinib Phase 2 trial in AML patients with FLT3 mutations

Cell Therapeutics, Inc. today announced the initiation of an international cooperative group Phase 2 clinical trial of pacritinib in adult patients with relapsed acute myeloid leukemia (AML) with mutations of the FLT3 gene. Mutation of the FLT3 gene is found in approximately one-third of AML patients and is an independent risk factor for poor prognosis.

30 Jan 2014

Oramed Pharmaceuticals' ORMD-0801 Phase 2a study meets primary and secondary endpoints

Oramed Pharmaceuticals Inc., a developer of oral drug delivery systems, announced today results from its Phase 2a clinical trial for its ORMD-0801 oral insulin capsule for the treatment of type 2 diabetes. The trial was conducted under a United States Food and Drug Administration IND (Investigational New Drug) protocol. The Phase 2a study met all primary and secondary endpoints.

30 Jan 2014

FDA approves Teva's sNDA for three-times-a-week COPAXONE 40mg/mL

Teva Pharmaceutical Industries Ltd. announced today that the U.S. Food and Drug Administration has approved the Company's supplemental new drug application for three-times-a-week COPAXONE 40mg/mL, a new dose of COPAXONE.

28 Jan 2014

Oramed to publish results of Phase 2a clinical trial for oral insulin capsule for treatment of type 2 diabetes

Oramed Pharmaceuticals Inc., a developer of oral drug delivery systems, announced today that it will announce the results of its Phase 2a clinical trial for the company's ORMD-0801 oral insulin capsule for the treatment of type 2 diabetes on January 30, 2014.

28 Jan 2014

Medac Pharma announces FDA acceptance of New Drug Application for MPI-2505

Medac Pharma, Inc., a privately held pharmaceutical company focused on the development of new molecules and improving the effectiveness of existing medicines, announced the FDA acceptance of its New Drug Application (NDA) for its lead product candidate, MPI-2505, a subcutaneous injectable methotrexate (MTX) in a ready-to-use injection device, for which the proposed indications are rheumatoid arthritis (RA), poly-articular-course juvenile RA and psoriasis.

28 Jan 2014

Bristol-Myers Squibb fourth quarter 2013 revenues increase 6% to $4.4 billion

Bristol-Myers Squibb Company today reported results for the fourth quarter and full year of 2013. The fourth quarter was highlighted by the company's announcement to sell its diabetes business as part of the continued evolution of its successful BioPharma strategy to a specialty care model. The company achieved important regulatory milestones in the quarter for Eliquis in the U.S., daclatasvir/asunaprevir in Japan, daclatasvir in Europe and Farxiga in the U.S. In addition, the company provided financial guidance for 2014.

24 Jan 2014

FDA gives final approval to Perrigo's ANDA for repaglinide tablets 1 mg and 2 mg

Perrigo Company plc today announced that it has received final approval from the U.S. Food & Drug Administration for its abbreviated new drug application for repaglinide tablets 1 mg and 2 mg, the generic equivalent to Prandin Tablets (repaglinide tablets) and has commenced shipment of product. Perrigo previously launched the 0.5 mg strength in 2013.

24 Jan 2014

Mylan Pharmaceuticals launches Repaglinide Tablets, 0.5 mg, 1 mg and 2 mg

Mylan Inc. today announced that its U.S.-based subsidiary Mylan Pharmaceuticals Inc. has launched Repaglinide Tablets, 0.5 mg, 1 mg and 2 mg. This product is the generic version of Novo Nordisk's Prandin, which is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

24 Jan 2014

FDA grants final approval for Hi-Tech Pharmacal's Bromfenac Ophthalmic Solution ANDA

Hi-Tech Pharmacal Co., Inc., a specialty pharmaceuticals company, announced today that the US Food and Drug Administration, granted final approval for the Company's Abbreviated New Drug Application, for Bromfenac Ophthalmic Solution, 0.09% (Once-A-Day), the generic for ISTA Pharmaceuticals' Bromday ophthalmic solution, 0.09%.

23 Jan 2014

$Japanese MHLW approves ADCETRIS for relapsed or refractory CD30-positive HL and ALCL$

Japanese MHLW approves ADCETRIS for relapsed or refractory CD30-positive HL and ALCL

Seattle Genetics, Inc. today announced that its collaborator, Takeda Pharmaceutical Company Limited, has received approval of ADCETRIS (brentuximab vedotin) from the Japanese Ministry of Health, Labour and Welfare for the treatment of patients with CD30-positive relapsed or refractory Hodgkin lymphoma and anaplastic large cell lymphoma.

18 Jan 2014

FDA approves New Drug Application for PENNSA 2%

Mallinckrodt today announced that the U.S. Food and Drug Administration has approved the New Drug Application for PENNSAID (diclofenac sodium topical solution) 2% w/w. PENNSAID 2% is a topical non-steroidal anti-inflammatory drug approved for use in the treatment of the pain of osteoarthritis of the knee(s).

17 Jan 2014

New Drug Application News and Research

FDA approves KALYDECO for people with cystic fibrosis

FDA approves sNDA to include radiographic data updating label of Pfizer XELJANZ for treatment of RA

Impax Laboratories records adjusted net loss of $1.6 million in fourth quarter 2013

XenoPort reports net loss of $19.1 million for fourth quarter 2013

Pharmacyclics total revenue for fourth quarter 2013 increases 113% to $123.6 million

OTC asthma inhaler endangers patients by encouraging substandard treatment

Jazz Pharmaceuticals' Versacloz now commercially available in the U.S. for schizophrenia

Ligand Pharmaceuticals' total revenues for Q4 2013 increase 8% to $14.7 million

Gilead submits NDA to FDA for fixed-dose combination of ledipasvir and sofosbuvir for hepatitis C infection

CTI announces initiation of pacritinib Phase 2 trial in AML patients with FLT3 mutations

Oramed Pharmaceuticals' ORMD-0801 Phase 2a study meets primary and secondary endpoints

FDA approves Teva's sNDA for three-times-a-week COPAXONE 40mg/mL

Oramed to publish results of Phase 2a clinical trial for oral insulin capsule for treatment of type 2 diabetes

Medac Pharma announces FDA acceptance of New Drug Application for MPI-2505

Bristol-Myers Squibb fourth quarter 2013 revenues increase 6% to $4.4 billion

FDA gives final approval to Perrigo's ANDA for repaglinide tablets 1 mg and 2 mg

Mylan Pharmaceuticals launches Repaglinide Tablets, 0.5 mg, 1 mg and 2 mg

FDA grants final approval for Hi-Tech Pharmacal's Bromfenac Ophthalmic Solution ANDA

Japanese MHLW approves ADCETRIS for relapsed or refractory CD30-positive HL and ALCL

FDA approves New Drug Application for PENNSA 2%

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