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Envarsus gets marketing authorization from EC for treatment of kidney and liver transplant patients

Envarsus gets marketing authorization from EC for treatment of kidney and liver transplant patients

Veloxis Pharmaceuticals A/S and Chiesi Farmaceutici S.p.A. today announced that the European Commission (EC) has granted marketing authorization for Envarsus for the prevention of organ rejection in adult kidney and liver transplant patients in the European Union. [More]
FDA issues Complete Response Letter for AcelRx's Zalviso NDA

FDA issues Complete Response Letter for AcelRx's Zalviso NDA

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 announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for the Company's new drug application (NDA) for Zalviso (sufentanil sublingual tablet system). [More]
Galmed reports net loss of $3.9 million for six months ended June 30, 2014

Galmed reports net loss of $3.9 million for six months ended June 30, 2014

Galmed Pharmaceuticals Ltd., a clinical-stage biopharmaceutical company focused on the development and commercialization of a once-daily, oral therapy for the treatment of liver diseases and cholesterol gallstones, today announced financial results for the period ended June 30, 2014. [More]
EMA recommends full marketing approval for IMBRUVICA in the European Union

EMA recommends full marketing approval for IMBRUVICA in the European Union

Pharmacyclics, Inc. today announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency issued a positive opinion recommending the granting of full marketing approval for IMBRUVICA (ibrutinib) in the European Union. [More]
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]
Ipsen’s Somatuline CLARINET Phase III study published online in NEJM

Ipsen’s Somatuline CLARINET Phase III study published online in NEJM

The U.S. affiliate of Ipsen today announced that the New England Journal of Medicine has published clinical trial results showing that Somatuline Autogel / Somatuline Depot (lanreotide) Injection 120 mg (referred to as Somatuline) achieved statistically significant prolongation of progression free survival (PFS) over placebo in patients with metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs). [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]
Pain control in osteoarthritis patients: an interview with Dr. Clarence Young, Chief Medical Officer and John Vavricka, President and CEO, Iroko Pharmaceuticals

Pain control in osteoarthritis patients: an interview with Dr. Clarence Young, Chief Medical Officer and John Vavricka, President and CEO, Iroko Pharmaceuticals

Osteoarthritis (OA) is one of the most common causes of disability, and inadequate pain control can lead to joint stiffness that may impair mobility for 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]