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Shire, ArmaGen partner to develop AGT-182 drug for treatment of Hunter syndrome

Shire, ArmaGen partner to develop AGT-182 drug for treatment of Hunter syndrome

Shire plc, the global specialty biopharmaceutical company, and ArmaGen, a US privately held biotechnology company, today announced a worldwide licensing and collaboration agreement for AGT-182, an investigational enzyme replacement therapy (ERT) for the potential treatment of both the central nervous system (CNS) and somatic manifestations in patients with Hunter syndrome (MPS II). [More]
Sinovac selected to supply seasonal influenza vaccine to Beijing citizens

Sinovac selected to supply seasonal influenza vaccine to Beijing citizens

Sinovac Biotech Ltd., a leading provider of biopharmaceutical products in China, announced today that it has been selected by the Beijing Centers for Disease Control and Prevention to be a supplier of the seasonal influenza vaccine to the citizens of Beijing for 2014. [More]
Johnson & Johnson sales increase 9.1% to $19.5 billion in second quarter 2014

Johnson & Johnson sales increase 9.1% to $19.5 billion in second quarter 2014

Johnson & Johnson today announced sales of $19.5 billion for the second quarter of 2014, an increase of 9.1% as compared to the second quarter of 2013. Operational results increased 9.4% and the negative impact of currency was 0.3%. [More]
Astellas seeks isavuconazole approval from FDA for treatment of life-threatening fungal infections

Astellas seeks isavuconazole approval from FDA for treatment of life-threatening fungal infections

Astellas today announced it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration seeking approval for isavuconazole for the treatment of invasive aspergillosis and invasive mucormycosis (also known as zygomycosis), life-threatening fungal infections predominantly occurring in immunocompromised patients. [More]
Perrigo receives final approval from FDA for congestion relief tablets

Perrigo receives final approval from FDA for congestion relief tablets

Perrigo Company today announced that it was the first to receive final approval from the U.S. Food and Drug Administration for its abbreviated new drug application for ibuprofen and phenylephrine hydrochloride tablets, 200 mg/10 mg (over-the-counter), the store brand equivalent to Advil Congestion Relief Tablets, 200 mg/10 mg. [More]
Mylan launches Telmisartan Tablets USP

Mylan launches Telmisartan Tablets USP

Mylan Inc. today announced that it has launched Telmisartan Tablets USP, 20 mg, 40 mg and 80 mg, the generic version of Boehringer Ingelheim's Micardis® Tablets. [More]
Forest Laboratories completes acquisition of Furiex Pharmaceuticals

Forest Laboratories completes acquisition of Furiex Pharmaceuticals

Actavis plc today announced that its subsidiary Forest Laboratories, LLC has successfully completed its acquisition of Furiex Pharmaceuticals, Inc. in an all-cash transaction valued at approximately $1.1 billion, and up to approximately $360 million in a Contingent Value Right (CVR) that may be payable based on the status of eluxadoline, Furiex's lead product, as a controlled drug following approval. [More]
Ipsen seeks marketing authorization from FDA for Somatuline Depot 120mg injection

Ipsen seeks marketing authorization from FDA for Somatuline Depot 120mg injection

Ipsen Biopharmaceuticals, Inc., the U.S. affiliate of Ipsen today announced that it has submitted a Supplemental New Drug Application to the U.S. Food and Drug Administration for Somatuline Depot 120mg injection for the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs). [More]
CTI completes recruitment in PERSIST-1 clinical trial of pacritinib for treatment of myelofibrosis

CTI completes recruitment in PERSIST-1 clinical trial of pacritinib for treatment of myelofibrosis

CTI BioPharma Corp. announced today that it has completed recruitment in the PERSIST-1 pivotal Phase 3 clinical trial of pacritinib, a novel oral JAK2/FLT3 inhibitor that is being evaluated for the treatment of myelofibrosis. [More]
Ipsen submits Supplemental New Drug Application to FDA for Somatuline Depot 120mg injection

Ipsen submits Supplemental New Drug Application to FDA for Somatuline Depot 120mg injection

Ipsen today announced that it has submitted a Supplemental New Drug Application to the U.S. Food and Drug Administration for Somatuline Depot 120mg injection for the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs). [More]
Merck reports results from global EMEND Phase 3 study for CINV prevention in pediatric cancer patients

Merck reports results from global EMEND Phase 3 study for CINV prevention in pediatric cancer patients

Merck, known as MSD outside the United States and Canada, today announced results from a global, investigational Phase 3 study to evaluate the safety and efficacy of EMEND (aprepitant) in the prevention of chemotherapy-induced nausea and vomiting (CINV) in pediatric cancer patients, aged 6 months to 17 years. [More]
Actavis seeks FDA ANDA approval for generic Zubsolv, confirms patent challenge

Actavis seeks FDA ANDA approval for generic Zubsolv, confirms patent challenge

Actavis plc 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 Buprenorphine Hydrochloride and Naloxone Hydrochloride Dihydrate Sublingual Tablets, Eq, 1.4 mg/0.36 mg and 5.7 mg/1.4 mg Base. Actavis' ANDA product is a generic version of Orexo's Zubsolv, which is a partial opioid agonist indicated for the maintenance treatment of opioid dependence. [More]
Forest Laboratories reports positive results from three Phase III trials of vilazodone for GAD treatment

Forest Laboratories reports positive results from three Phase III trials of vilazodone for GAD treatment

Forest Laboratories, Inc. today announced positive topline results from three Phase III trials evaluating the efficacy, safety and tolerability of vilazodone in adult patients with generalized anxiety disorder (GAD). [More]
Cubist Pharmaceuticals' SIVEXTRO receives FDA approval for treatment of ABSSSI

Cubist Pharmaceuticals' SIVEXTRO receives FDA approval for treatment of ABSSSI

Cubist Pharmaceuticals, Inc. announced today the U.S. Food and Drug Administration approved SIVEXTRO (tedizolid phosphate) for the treatment of adult acute bacterial skin and skin structure infections (ABSSSI). [More]
IGI Laboratories submits third ANDA in 2014 to FDA

IGI Laboratories submits third ANDA in 2014 to FDA

IGI Laboratories, Inc., a New Jersey based generic topical pharmaceutical company, today announced it has submitted its third abbreviated new drug application (ANDA) in 2014 to the U.S. Food and Drug Administration, which brings the Company's total number of ANDA submissions to sixteen, with fourteen now pending at the FDA. [More]
Alkermes reports data from aripiprazole lauroxil phase 3 clinical trial for treatment of schizophrenia

Alkermes reports data from aripiprazole lauroxil phase 3 clinical trial for treatment of schizophrenia

Alkermes plc today announced the presentation of data from its phase 3 clinical trial of aripiprazole lauroxil, an investigational drug candidate in development for schizophrenia, at the American Society of Clinical Psychopharmacology Annual Meeting in Hollywood, Fla. [More]
Novogen, CanTx believe Intra-Peritoneal Trx-1 could be utilized as first-line therapy for ovarian cancer

Novogen, CanTx believe Intra-Peritoneal Trx-1 could be utilized as first-line therapy for ovarian cancer

Australian oncology drug development company Novogen Limited and CanTx Inc., its joint venture with Yale University, today announced the success of proof-of-concept pre-clinical studies confirming the potency of experimental drug, Trx-1, in the treatment of primary ovarian cancer when delivered into the peritoneal cavity. [More]
FDA accepts Symplmed's Prestalia NDA for hypertension treatment

FDA accepts Symplmed's Prestalia NDA for hypertension treatment

Symplmed announced today that the U.S. Food and Drug Administration has accepted for review its New Drug Application (NDA) for investigational drug Prestalia, the first single-pill, fixed-dose combination (FDC) of perindopril arginine and amlodipine besylate for the treatment of hypertension in the U.S. Symplmed filed the application under section 505(b)(2) consistent with FDA's guidance. [More]
BIPI, Lilly announce resubmission of empagliflozin NDA to FDA for treatment of type 2 diabetes

BIPI, Lilly announce resubmission of empagliflozin NDA to FDA for treatment of type 2 diabetes

Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly and Company today announced the resubmission of a New Drug Application (NDA) for the investigational sodium glucose co-transporter-2 (SGLT2) inhibitor empagliflozin for the treatment of adults with type 2 diabetes (T2D) to the U.S. Food and Drug Administration (FDA). [More]

Breckenridge announces launch of Duloxetine Delayed-release Capsules

Breckenridge Pharmaceutical, Inc. announced today the immediate launch of Duloxetine Delayed-release Capsules. [More]