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Provectus’ PV-10 data for intralesional treatment of solid tumors presented at ASCO annual meeting

Provectus Biopharmaceuticals, Inc., a development-stage oncology and dermatology biopharmaceutical company, announced today that data on its investigational agent PV-10 for intralesional (IL) treatment of solid tumors were featured in two presentations in the Poster Highlights Session, Melanoma/Skin Cancers, on June 2, 2014 during the American Society of Clinical Oncology (ASCO) annual meeting in Chicago, IL.

4 Jun 2014

Forest publishes data from pivotal Phase III Study of Investigational FDC of nebivolol and valsartan

Forest Laboratories, Inc. (NYSE:FRX) today announced the publication of data from its pivotal Phase III Study of an Investigational Fixed-Dose Combination (FDC) of nebivolol and valsartan in the May 30, 2014 issue of The Lancet.

31 May 2014

FDA grants Angiochem’s ANG1005 fast track and orphan drug designation for treatment of glioblastoma multiforme

Angiochem announced today that the Food & Drug Association (FDA) has granted both orphan drug and fast track designation to ANG1005 a novel paclitaxel-peptide drug conjugate leveraging the low density lipoprotein receptor-related protein 1 (LRP-1) pathway to cross the blood-brain barrier (BBB) and enter cancer, for the treatment of glioblastoma multiforme (GBM).

31 May 2014

Newron Pharmaceuticals submits safinamide NDA to FDA

Newron Pharmaceuticals S.p.A. ("Newron"), a research and development company focused on novel CNS and pain therapies, and its partner Zambon S.p.A., an international pharmaceutical company strongly committed to the CNS therapeutic area with a long experience in respiratory disease therapies, woman care and primary care, announce that the New Drug Application (NDA) for safinamide was submitted today to the US Food and Drug Administration (FDA).

30 May 2014

Mylan launches generic version of GlaxoSmithKline's Malarone Tablets

Mylan Inc. today announced that it has launched Atovaquone and Proguanil Hydrochloride Tablets, 62.5 mg/25 mg and 250 mg/100 mg, the generic version of GlaxoSmithKline's Malarone® Tablets.

29 May 2014

Trimel announces top-line results of Phase II clinical trial evaluating efficacy of Tefina

Trimel Pharmaceuticals Corporation (TSX: TRL) announced today top-line results of its Phase II clinical trial evaluating the efficacy and safety of Tefina™, a "use-as-required" testosterone nasal gel for the treatment of Female Orgasmic Disorder (FOD).

28 May 2014

FDA issues Complete Response Letter to QRxPharma regarding Moxduo NDA

QRxPharma Limited announced today the United States Food and Drug Administration has issued a Complete Response Letter regarding the Moxduo New Drug Application for the treatment of moderate to severe acute pain.

27 May 2014

Shire intends to submit NDA for lifitegrast to treat dry eye disease

Following a May 15, 2014, meeting with the U.S. Food and Drug Administration (FDA), Shire plc, the global specialty biopharmaceutical company, announces today that it intends to submit a New Drug Application for lifitegrast as a treatment for the signs and symptoms of dry eye disease in adults in the first-quarter 2015, as we complete remaining chemistry and manufacturing work.

19 May 2014

Actavis reaches agreement to continue supplying authorized generic version of JPI's Concerta

Actavis plc today announced that it has reached an agreement with Janssen Pharmaceuticals, Inc. to continue supplying the authorized generic version of JPI's Concerta (methylphenidate hydrochloride extended-release tablets).

15 May 2014

Mylan releases generic version of Zyprexa Zydis Tablets

Mylan Inc. today announced that it has launched Olanzapine Orally Disintegrating Tablets (ODT), 5 mg, 10 mg, 15 mg and 20 mg, the generic version of Eli Lilly and Company's Zyprexa Zydis Tablets.

14 May 2014

Eagle Pharmaceuticals total revenue increases by $2.5 million for Q2 2014

Eagle Pharmaceuticals, Inc. today announced its financial results for the three-month period ended March 31, 2014. This marks the first period for which Eagle is reporting financial results as a public company.

14 May 2014

Perrigo receives final approval from FDA for azelastine hydrochloride nasal spray ANDA

Perrigo Company plc announced that it has received final approval from the U.S. Food and Drug Administration on its Abbreviated New Drug Application (ANDA) for azelastine hydrochloride nasal spray (0.15%).

12 May 2014

New Colombia Resources, Phoenix Tears Foundation to develop cannabis-based medicine for skin cancer

New Colombia Resources, Inc., a U.S. company with coal and other resource assets in Colombia, is pleased to announce an agreement of collaboration with the Phoenix Tears Foundation for the research and development of a cannabis based medicine to treat skin cancer in Colombia.

9 May 2014

AbbVie seeks marketing approval from EMA for all-oral, interferon-free therapy to treat HCV infection

AbbVie submitted marketing authorization applications (MAAs) to the European Medicines Agency seeking approval for the company’s investigational, all-oral, interferon-free regimen for the treatment of adult patients with chronic genotype 1 (GT1) hepatitis C virus (HCV) infection.

9 May 2014

Pharmaceutical Executive Magazine names COPAXONE therapy as 2014 "Brand of The Year"

Teva Pharmaceutical Industries Ltd., today announced that COPAXONE (glatiramer acetate injection), the #1 global therapy for relapsing multiple sclerosis, has been named the 2014 "Brand of The Year" by Pharmaceutical Executive Magazine, a leading print and online publication for the biopharmaceutical industry.

9 May 2014

Janssen submits sNDA to FDA for simeprevir in combination with sofosbuvir for treatment of HCV genotype 1 infection

Janssen Research & Development, LLC (Janssen) today announced it has submitted a Supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for simeprevir, an NS3/4A protease inhibitor marketed as OLYSIO™ in the United States, in combination with the nucleotide analog NS5B polymerase inhibitor sofosbuvir developed by Gilead Sciences, Inc.

8 May 2014

Ligand's total revenues increase 37% to $16.0 million in first quarter 2014

Ligand Pharmaceuticals Incorporated today reported financial results for the three months ended March 31, 2014, and provided an operating forecast and program updates.

7 May 2014

Ruthigen files IND Application to FDA for lead drug candidate RUT58-60

Ruthigen, Inc., a biopharmaceutical company focused on the discovery, development and commercialization of novel therapeutics designed to prevent and treat infection in invasive applications, today announced that the Company has submitted an Investigational New Drug (IND) Application to the U.S. Food and Drug Administration for its lead drug candidate RUT58-60.

2 May 2014

Acorda gets FDA Complete Response Letter for PLUMIAZ Nasal Spray NDA

Acorda Therapeutics, Inc. today announced that the U.S. Food and Drug Administration has issued a Complete Response Letter (CRL) for the New Drug Application (NDA) for PLUMIAZ (diazepam) Nasal Spray for the treatment of people with epilepsy who experience cluster seizures.

2 May 2014

FDA approves Parion’s investigational new drug application for treatment of dry eye disease

Parion Sciences, a company dedicated to the development of novel treatments for ocular and pulmonary diseases, announced today that it has received acceptance from the U.S. Food and Drug Administration (FDA) of its Investigational New Drug (IND) application for P-321 Ophthalmic Solution for the treatment of dry eye disease.

2 May 2014

New Drug Application News and Research

Provectus’ PV-10 data for intralesional treatment of solid tumors presented at ASCO annual meeting

Forest publishes data from pivotal Phase III Study of Investigational FDC of nebivolol and valsartan

FDA grants Angiochem’s ANG1005 fast track and orphan drug designation for treatment of glioblastoma multiforme

Newron Pharmaceuticals submits safinamide NDA to FDA

Mylan launches generic version of GlaxoSmithKline's Malarone Tablets

Trimel announces top-line results of Phase II clinical trial evaluating efficacy of Tefina

FDA issues Complete Response Letter to QRxPharma regarding Moxduo NDA

Shire intends to submit NDA for lifitegrast to treat dry eye disease

Actavis reaches agreement to continue supplying authorized generic version of JPI's Concerta

Mylan releases generic version of Zyprexa Zydis Tablets

Eagle Pharmaceuticals total revenue increases by $2.5 million for Q2 2014

Perrigo receives final approval from FDA for azelastine hydrochloride nasal spray ANDA

New Colombia Resources, Phoenix Tears Foundation to develop cannabis-based medicine for skin cancer

AbbVie seeks marketing approval from EMA for all-oral, interferon-free therapy to treat HCV infection

Pharmaceutical Executive Magazine names COPAXONE therapy as 2014 "Brand of The Year"

Janssen submits sNDA to FDA for simeprevir in combination with sofosbuvir for treatment of HCV genotype 1 infection

Ligand's total revenues increase 37% to $16.0 million in first quarter 2014

Ruthigen files IND Application to FDA for lead drug candidate RUT58-60

Acorda gets FDA Complete Response Letter for PLUMIAZ Nasal Spray NDA

FDA approves Parion’s investigational new drug application for treatment of dry eye disease

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