New Drug Application News and Research

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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.

3 Apr 2014

Foundation Medicine, Clovis Oncology expand collaboration to develop novel companion diagnostic test

Foundation Medicine, Inc. and Clovis Oncology, Inc. today announced the expansion of their ongoing collaboration to incorporate a coordinated regulatory strategy for the development of a novel Premarket Approval (PMA) companion diagnostic test.

3 Apr 2014

Gilead reports topline results from sofosbuvir Phase 3 trial in Japan for treatment of HCV infection

Gilead Sciences, Inc. today announced topline results from a Phase 3 clinical trial (Study GS-US-334-0118) in Japan evaluating the once-daily nucleotide analog polymerase inhibitor sofosbuvir in combination with ribavirin (RBV) for the treatment of genotype 2 chronic hepatitis C virus (HCV) infection.

3 Apr 2014

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.

2 Apr 2014

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).

1 Apr 2014

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.

31 Mar 2014

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.

31 Mar 2014

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.

31 Mar 2014

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.

31 Mar 2014

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).

29 Mar 2014

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.

27 Mar 2014

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.

27 Mar 2014

pSivida resubmits New Drug Application for ILUVIEN

pSivida Corp., a leader in the development of sustained release, drug delivery products for treating eye diseases, today announced that the New Drug Application for ILUVIEN for the treatment of chronic Diabetic Macular Edema has been resubmitted to the U.S. Food and Drug Administration (FDA).

27 Mar 2014

Alimera Sciences resubmits New Drug Application for ILUVIEN

Alimera Sciences, Inc. (Alimera), a biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals, today announced that it has resubmitted its New Drug Application for ILUVIEN® to the U.S. Food and Drug Administration (FDA).

27 Mar 2014

Egalet provides business update, reports full year 2013 financial results

Egalet Corporation ("Egalet") today reported business highlights and financial results for the year ended December 31, 2013. This marks the first time that Egalet is reporting its operating results as a public company.

26 Mar 2014

Mast Therapeutics reports net loss of $5.7 million for fourth quarter 2013

Mast Therapeutics, Inc. today reported financial results for the fourth quarter and year ended December 31, 2013.

26 Mar 2014

Emmaus reports preliminary top-line results from Phase 3 clinical trial for treatment of sickle cell disease

Emmaus Life Sciences, Inc., a biopharmaceutical company dedicated primarily to the discovery, development and commercialization of innovative treatments and therapies for rare and orphan diseases, today announced that preliminary top-line results of its Phase 3 clinical trial evaluating the safety and efficacy of its treatment for sickle cell anemia and sickle beta-0 thalassemia met both the primary and secondary endpoints of the clinical trial.

20 Mar 2014

Daiichi Sankyo files NDA for development and marketing of Methylene Blue medicinal product in Japan

Provepharm, a French company specialized in the development of pharmaceutical applications, today announces that Daiichi Sankyo, Co. Ltd., a global pharmaceutical firm, has filed an NDA (New Drug Application) for the development and marketing of the injectable Methylene Blue medicinal product in Japan, made out of Provepharm’s Proveblue Methylene Blue active substance.

20 Mar 2014

Dartmouth, Aeras to jointly conduct trial of DAR-901 vaccine against TB

Dartmouth's Geisel School of Medicine and Aeras, a global nonprofit biotech, announced a collaboration to jointly conduct a trial of a new vaccine against tuberculosis (TB), one of the world's deadliest diseases. The vaccine, known as DAR-901, is related to the vaccine SRL-172, previously shown by Dartmouth investigators to decrease the risk of TB in a trial known as the DarDar Trial.

19 Mar 2014

Pierre Fabre Dermatologie receives FDA marketing authorization for pediatric drug Hemangeol

Pierre Fabre Dermatologie has obtained marketing authorization from the FDA for the pediatric drug Hemangeol (propranolol hydrochloride), which is the first and only approved treatment for "proliferating infantile hemangioma requiring systemic therapy".

18 Mar 2014

New Drug Application News and Research

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

Foundation Medicine, Clovis Oncology expand collaboration to develop novel companion diagnostic test

Gilead reports topline results from sofosbuvir Phase 3 trial in Japan for treatment of HCV infection

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

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

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

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

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

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

Actavis gets favorable ruling in patent suit against generic Lialda

FDA accepts AVP-825 NDA for acute treatment of migraine

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

pSivida resubmits New Drug Application for ILUVIEN

Alimera Sciences resubmits New Drug Application for ILUVIEN

Egalet provides business update, reports full year 2013 financial results

Mast Therapeutics reports net loss of $5.7 million for fourth quarter 2013

Emmaus reports preliminary top-line results from Phase 3 clinical trial for treatment of sickle cell disease

Daiichi Sankyo files NDA for development and marketing of Methylene Blue medicinal product in Japan

Dartmouth, Aeras to jointly conduct trial of DAR-901 vaccine against TB

Pierre Fabre Dermatologie receives FDA marketing authorization for pediatric drug Hemangeol

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