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Edison Pharmaceuticals begins EPI-743 clinical trial in children with Pearson syndrome

Edison Pharmaceuticals today announced the initiation of a phase 2 study entitled "A Phase 2 Safety and Efficacy Study of EPI-743 (Vincerinone™) in Children with Pearson Syndrome." The Investigative New Drug application (IND) was approved by the Food and Drug Administration, Office of Hematology and Oncology Products.

17 Mar 2014

FDA grants Fast Track designation to Edison’s lead drug EPI-743

Edison Pharmaceuticals today announced that the United States Food and Drug Administration granted Fast Track designation to EPI-743, the company's lead drug, for the treatment of Friedreich's ataxia. EPI-743 is being developed for pediatric and adult mitochondrial disease, including Friedreich's ataxia.

17 Mar 2014

Bristol-Myers Squibb, Pfizer announce FDA approval of Eliquis for DVT prophylaxis

Bristol-Myers Squibb Company and Pfizer Inc. today announced that the U.S. Food and Drug Administration approved a Supplemental New Drug Application (sNDA) for Eliquis (apixaban) for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), in patients who have undergone hip or knee replacement surgery.

16 Mar 2014

Derma Sciences' net sales increase 3% to $20.7 million in fourth quarter 2013

Derma Sciences, Inc., a tissue regeneration and burn care company focused on advanced wound care, today reported financial and operating results for the three months and year ended December 31, 2013.

14 Mar 2014

TFDA approves TaiGen's Taigexyn NDA for treatment of community-acquired bacterial pneumonia

TaiGen Biotechnology Company, Limited today announced that the Taiwan Food and Drug Administration has approved the new drug application (NDA) of Taigexyn (nemonoxacin) oral formulation (500 mg) for the treatment of community-acquired bacterial pneumonia (CAP). With this NDA approval, Taiwan is the first region to grant marketing approval to Taigexyn.

13 Mar 2014

Antares Pharma reports total revenue of $4.7 million for fourth quarter 2013

Antares Pharma, Inc. today reported operating and financial results for the fourth quarter and full year ended December 31, 2013.

13 Mar 2014

FDA accepts Lundbeck's carbamazepine NDA for review

Lundbeck LLC today announced that the U.S. Food and Drug Administration has accepted for review a New Drug Application (NDA) for its investigational therapy intravenous carbamazepine, an intravenous formulation of the anti-epileptic drug (AED) carbamazepine. An action letter is anticipated before the end of 2014. Carbella is the proposed U.S. trade name for intravenous carbamazepine.

10 Mar 2014

Alkermes initiates pivotal clinical development program for treatment of MDD

Alkermes plc today announced the initiation of the pivotal clinical development program for ALKS 5461, a once-daily, oral investigational medicine with a novel mechanism of action for the adjunctive treatment of major depressive disorder (MDD).

6 Mar 2014

Boehringer Ingelheim reports results from SVR12 Phase 3 trial in patients with HCV/HIV co-infection

Today Boehringer Ingelheim announced results from STARTVerso4 in patients with HCV/HIV co-infection. Hepatitis C viral cure 12 weeks after the conclusion of treatment (SVR12) was achieved by 72% of all patients in the trial. Patients were enrolled in either 120mg or 240mg faldaprevir dose groups.

6 Mar 2014

Tetraphase Pharmaceuticals reports net loss of $11.3 million for Q4 2013

Tetraphase Pharmaceuticals, Inc. today reported financial results for the quarter and full year ended December 31, 2013.

6 Mar 2014

Neos Therapeutics completes private financing round, raises $15.5M

Neos Therapeutics, Inc. ("Neos" or "the Company"), a highly differentiated oral drug delivery company with an exciting portfolio of proprietary technologies and a late-stage pipeline of innovative controlled release (CR) products for ADHD, announced today that it has completed an oversubscribed round of private financing, raising a total of $15.5 million.

4 Mar 2014

GTx provides clinical updates, reports financial results for fourth quarter and full year 2013

GTx, Inc. today provided a Company update and reported financial results for the fourth quarter and full year 2013.

4 Mar 2014

Rigel Pharmaceuticals reports net loss of $16.9 million for fourth quarter 2013

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

4 Mar 2014

Oramed to present detailed results from ORMD-0801 Phase 2a trial at 2014 GTC Diabetes Summit

Oramed Pharmaceuticals Inc., a clinical-stage pharmaceutical company focused on the development of oral drug delivery systems, announced today that it will be presenting detailed results from its recently completed Phase 2a FDA trial on ORMD-0801, its orally ingestible insulin capsule at the 2014 GTC Diabetes Summit taking place from April 23-25, 2014, in Boston, Massachusetts, USA.

4 Mar 2014

AcelRx Pharmaceuticals announces financial results for fourth quarter and full year 2013

AcelRx Pharmaceuticals, Inc., a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of acute and breakthrough pain, today reported financial results for the three and twelve months ended December 31, 2013.

4 Mar 2014

Naurex's GLYX-13 receives FDA Fast Track designation

Naurex Inc. today announced that the U.S. Food and Drug Administration has granted Fast Track designation to the investigation of GLYX-13, the company's rapid-acting antidepressant in Phase 2 clinical development, as adjunctive therapy in major depressive disorder.

4 Mar 2014

Akorn's consolidated revenue for fourth quarter 2013 increases 19% to $85 million

Akorn, Inc., a niche generic pharmaceutical company, today reported financial results for the fourth quarter and year-ended December 31, 2013.

3 Mar 2014

Cell Therapeutics initiates Phase 3 clinical trial to evaluate pacritinib in patients with myelofibrosis

Cell Therapeutics, Inc. (CTI) (NASDAQ and MTA: CTIC) today announced the initiation of a Phase 3 clinical trial, known as PERSIST-2, which will evaluate pacritinib, a novel, investigational JAK2/FLT3 inhibitor, in patients with myelofibrosis whose platelet counts are less than or equal to 100,000 per microliter (uL).

3 Mar 2014

Actavis files ANDA with FDA to market Colchicine Tablets USP

Actavis plc (NYSE: ACT) today confirmed that it has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market Colchicine Tablets USP, 0.6 mg.

3 Mar 2014

Astellas Pharma to exclusively commercialize isavuconazole in the U.S. and Canada

Astellas Pharma Inc. announced today that the company has amended the License, Co-Development and Co-Promotion Agreement on isavuconazole under co-development with Basilea Pharmaceutica Ltd.

28 Feb 2014

New Drug Application News and Research

Edison Pharmaceuticals begins EPI-743 clinical trial in children with Pearson syndrome

FDA grants Fast Track designation to Edison’s lead drug EPI-743

Bristol-Myers Squibb, Pfizer announce FDA approval of Eliquis for DVT prophylaxis

Derma Sciences' net sales increase 3% to $20.7 million in fourth quarter 2013

TFDA approves TaiGen's Taigexyn NDA for treatment of community-acquired bacterial pneumonia

Antares Pharma reports total revenue of $4.7 million for fourth quarter 2013

FDA accepts Lundbeck's carbamazepine NDA for review

Alkermes initiates pivotal clinical development program for treatment of MDD

Boehringer Ingelheim reports results from SVR12 Phase 3 trial in patients with HCV/HIV co-infection

Tetraphase Pharmaceuticals reports net loss of $11.3 million for Q4 2013

Neos Therapeutics completes private financing round, raises $15.5M

GTx provides clinical updates, reports financial results for fourth quarter and full year 2013

Rigel Pharmaceuticals reports net loss of $16.9 million for fourth quarter 2013

Oramed to present detailed results from ORMD-0801 Phase 2a trial at 2014 GTC Diabetes Summit

AcelRx Pharmaceuticals announces financial results for fourth quarter and full year 2013

Naurex's GLYX-13 receives FDA Fast Track designation

Akorn's consolidated revenue for fourth quarter 2013 increases 19% to $85 million

Cell Therapeutics initiates Phase 3 clinical trial to evaluate pacritinib in patients with myelofibrosis

Actavis files ANDA with FDA to market Colchicine Tablets USP

Astellas Pharma to exclusively commercialize isavuconazole in the U.S. and Canada

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