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Actavis to purchase four currently marketed products from Akorn

Actavis to purchase four currently marketed products from Akorn

Actavis plc, a leading global specialty pharmaceutical company, today announced that it has entered into agreements with Akorn, Inc. and Hi-Tech Pharmacal Co. Inc. to purchase four currently marketed products and one product under development [More]

FDA approves Lannett's ANDA for Diazepam Oral Solution

Lannett Company, Inc. today announced that it has received approval from the U.S. Food and Drug Administration of its Abbreviated New Drug Application (ANDA) for Diazepam Oral Solution (Concentrate), 5 mg/mL, a Schedule C-IV controlled drug. [More]
Johnson & Johnson's sales increase 3.5% to $18.1 billion in first quarter 2014

Johnson & Johnson's sales increase 3.5% to $18.1 billion in first quarter 2014

Johnson & Johnson today announced sales of $18.1 billion for the first quarter of 2014, an increase of 3.5% as compared to the first quarter of 2013. Operational results increased 5.3% and the negative impact of currency was 1.8%. Domestic sales increased 2.2%. International sales increased 4.5%, reflecting operational growth of 7.9% and a negative currency impact of 3.4%. [More]
Federal district court enforces settlement between Mylan and Endo Pharmaceuticals on generic FROVA

Federal district court enforces settlement between Mylan and Endo Pharmaceuticals on generic FROVA

Mylan Inc. today confirmed that a federal district court has granted its request to enforce a settlement agreement between Endo Pharmaceuticals and Mylan settling patent litigation in connection with Mylan's filing of an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration for Frovatriptan Succinate Tablets, 2.5 mg. [More]
Impax resubmits NDA for RYTARY providing updated safety and stability information

Impax resubmits NDA for RYTARY providing updated safety and stability information

Impax Pharmaceuticals, a division of Impax Laboratories, Inc. (NASDAQ: IPXL), announced today the resubmission of Impax's New Drug Application (NDA) for RYTARY (IPX066) to the U.S. Food and Drug Administration (FDA). [More]

Gilead Sciences announces positive results from LDV/SOF phase 2 studies on HCV infection

Gilead Sciences, Inc. (Nasdaq: GILD) today announced data from two Phase 2 studies evaluating investigational all-oral regimens containing the nucleotide analog polymerase inhibitor sofosbuvir (SOF) for the treatment of chronic hepatitis C virus (HCV) infection. [More]
Janssen submits supplemental New Drug Application for IMBRUVICA to the U.S. FDA

Janssen submits supplemental New Drug Application for IMBRUVICA to the U.S. FDA

Janssen Research & Development, LLC ("Janssen") today announced the submission of a supplemental New Drug Application (sNDA) for IMBRUVICA™ (ibrutinib) to the U.S. Food and Drug Administration (FDA) by its collaboration partner Pharmacyclics, Inc. [More]
Alkermes announces results from phase 3 clinical trial of aripiprazole lauroxil in patients with schizophrenia

Alkermes announces results from phase 3 clinical trial of aripiprazole lauroxil in patients with schizophrenia

Alkermes plc today announced positive topline results from a randomized, double-blind, placebo-controlled phase 3 clinical trial of aripiprazole lauroxil in patients with schizophrenia. Patients treated once monthly with either 441 mg or 882 mg of aripiprazole lauroxil demonstrated statistically significant reductions from baseline in Positive and Negative Syndrome Scale (PANSS) total scores at week 12, compared to placebo (p<0.001 aripiprazole lauroxil 441 mg, p<0.001 aripiprazole lauroxil 882 mg), which was the prespecified primary endpoint in the study. Based on the positive results from this phase 3 study, Alkermes plans to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in the third quarter of 2014. [More]
OncoSec Medical to re-launch Phase II cutaneous T-cell lymphoma trial under protocol amendment

OncoSec Medical to re-launch Phase II cutaneous T-cell lymphoma trial under protocol amendment

OncoSec Medical Inc., a company developing its ImmunoPulse DNA-based immunotherapy to treat solid tumors, will re-launch its Phase II cutaneous T-cell lymphoma (CTCL) trial under a protocol amendment. [More]
Astellas, Medivation submit European Marketing Authorization Application for XTANDI capsules

Astellas, Medivation submit European Marketing Authorization Application for XTANDI capsules

Astellas Pharma Inc. and Medivation Inc. today announced the submission of a variation to amend the European Marketing Authorization Application for XTANDI® (enzalutamide) capsules for the treatment of adult men with metastatic castration-resistant prostate cancer (mCRPC) who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy and in whom chemotherapy is not yet clinically indicated. [More]
FDA clears Omeros' OMS721 IND for inhibition of complement‑mediated TMAs

FDA clears Omeros' OMS721 IND for inhibition of complement‑mediated TMAs

Omeros Corporation today announced that its Investigational New Drug Application (IND) to evaluate OMS721 for the inhibition of complement‑mediated thrombotic microangiopathies (TMAs) has been cleared by the U.S. Food and Drug Administration. [More]
Cedars-Sinai earns grant to conduct clinical trial of gene therapy product for patients with Lou Gehrig's disease

Cedars-Sinai earns grant to conduct clinical trial of gene therapy product for patients with Lou Gehrig's disease

The Cedars-Sinai Regenerative Medicine Institute has received a $2.5 million grant from the Department of Defense to conduct animal studies that, if successful, could provide the basis for a clinical trial of a gene therapy product for patients with Lou Gehrig's disease, also called amyotrophic lateral sclerosis, or ALS. [More]

Teva granted certiorari petition related to Mylan's ANDA for Copaxone

Mylan Inc. announced that today the Supreme Court of the United States granted certiorari in Mylan's patent litigation against Teva relating to Mylan's Abbreviated New Drug Application (ANDA) for glatiramer acetate (Copaxone). [More]

Heron initiates SUSTOL Phase 3 clinical trial for CINV prevention associated with emetogenic chemotherapy

Heron Therapeutics, Inc., a specialty pharmaceutical company, today announced the initiation of a Phase 3 clinical trial of SUSTOL™ (APF530), the Company's lead product candidate for the prevention of chemotherapy-induced nausea and vomiting (CINV) associated with moderately and highly emetogenic chemotherapy. [More]

Prana Biotechnology releases top-line results of PBT2 Phase II Imaging trial in Alzheimer's disease

Prana Biotechnology has today released the top line results of the 12-month Phase II Imaging trial in Alzheimer's Disease ("IMAGINE" Trial), based on draft results. [More]
Concert Pharmaceuticals announces 2013 year-end results; posts record revenue of $25.4M

Concert Pharmaceuticals announces 2013 year-end results; posts record revenue of $25.4M

Concert Pharmaceuticals, Inc. today reported financial results for the year ended December 31, 2013 and provided an update on corporate activities. [More]
Forest Laboratories, Richter report positive results from cariprazine Phase IIb trial for bipolar depression

Forest Laboratories, Richter report positive results from cariprazine Phase IIb trial for bipolar depression

Forest Laboratories, Inc. and Gedeon Richter Plc. today announced positive topline results from a Phase IIb trial evaluating the efficacy and safety of the investigational antipsychotic cariprazine in patients with bipolar depression. [More]

Actavis gets favorable ruling in patent suit against generic Lialda

Actavis plc today confirmed that the United States Court of Appeals for the Federal Circuit has reversed a lower court ruling that Actavis' generic version of Shire's Lialda (mesalamine extended-release tablets) infringes United States Patent No. 6,773,720 (the '720 Patent). [More]

FDA accepts AVP-825 NDA for acute treatment of migraine

The U.S. Food and Drug Administration has accepted the New Drug Application (NDA) for AVP-825, an innovative closed-palate Breath Powered investigational drug-device combination product for the acute treatment of migraine. [More]

Jury returns verdict in favor of Mylan in breach of contract case against GSK

Mylan Inc. today announced that, after a trial in the United States District Court for the District of New Jersey, a jury returned a verdict in favor of Mylan in its breach of contract lawsuit against GlaxoSmithKline (GSK) relating to Paroxetine Hydrochloride Extended-release (ER) Tablets. [More]