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Rigel Pharmaceuticals reports net loss of $22.3 million for fourth quarter 2014

Rigel Pharmaceuticals reports net loss of $22.3 million for fourth quarter 2014

Rigel Pharmaceuticals, Inc. today reported financial results for the fourth quarter and year ended December 31, 2014. For the fourth quarter of 2014, Rigel reported a net loss of $22.3 million, or $0.25 per share, compared to a net loss of $16.9 million, or $0.19 per share, in the fourth quarter of 2013. [More]
Taiho announces submission of TAS-102 MAA to EMA for treatment of mCRC

Taiho announces submission of TAS-102 MAA to EMA for treatment of mCRC

Taiho Pharma Europe Ltd., a subsidiary of Japan based Taiho Pharmaceutical Co., Ltd., announced that it has submitted a Marketing Authorisation Application to the European Medicines Agency for TAS-102 (nonproprietary names: trifluridine and tipiracil hydrochloride), an oral combination anticancer drug intended for use in the treatment of refractory metastatic colorectal cancer (mCRC). [More]
Neuroprotective compounds can limit damage to the brain during ischemic stroke

Neuroprotective compounds can limit damage to the brain during ischemic stroke

In the 1990s, neuroscientists identified a class of drugs that showed promise in the area of stroke. NMDA receptor antagonists could limit damage to the brain in animal models of stroke. But one problem complicated testing the drugs in a clinical setting: the side effects included disorientation and hallucinations. [More]
Chiasma closes $70 million Series E financing round

Chiasma closes $70 million Series E financing round

Chiasma, Inc., a U.S. privately-held biopharma company developing octreotide capsules, its lead product for the orphan condition acromegaly, today announced the closing of a $70 million Series E financing round. [More]
Actavis files ANDA to market Budesonide Extended-release Tablets

Actavis files ANDA to market Budesonide Extended-release Tablets

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 Budesonide Extended-release Tablets, 9 mg. [More]
Taiho Oncology announces acceptance of TAS-102 NDA for review by FDA

Taiho Oncology announces acceptance of TAS-102 NDA for review by FDA

Taiho Oncology, Inc., a subsidiary of Taiho Pharmaceutical Co., Ltd. (Japan), today announced the New Drug Application (NDA) for TAS-102 (nonproprietary names: trifluridine and tipiracil hydrochloride), has been accepted for review by the U.S. Food and Drug Administration. [More]
Actavis obtains final approval from FDA for generic Subutex

Actavis obtains final approval from FDA for generic Subutex

Actavis plc today announced that it has received final approval from the U.S. Food and Drug Administration on its Abbreviated New Drug Application for a generic version of Reckitt Benckiser's Subutex (Buprenorphine 2 mg and 8 mg sublingual tablets). [More]
Actavis provides overview of standalone global pharmaceutical development pipeline

Actavis provides overview of standalone global pharmaceutical development pipeline

Actavis plc, during its Investor Meeting in New York, today provided a detailed look into its standalone global pharmaceutical development pipeline that supports the Company's long-term organic growth. The Company provided details regarding key development programs, including clinical data, development milestones and an overview of potential market opportunities, as well as an updated look at Actavis' world-class generics pipeline, which continues to hold an industry-leading position in First-to-File opportunities in the U.S. [More]
Novartis’ heart failure medicine LCZ696 granted FDA priority review

Novartis’ heart failure medicine LCZ696 granted FDA priority review

LCZ696, a twice-a-day medicine being investigated for heart failure, acts to enhance the protective neurohormonal systems of the heart (NP system) while simultaneously suppressing the harmful effects of the overactive renin-angiotensin-aldosterone system (RAAS). [More]
Novartis receives priority review status from FDA for heart failure medicine LCZ696

Novartis receives priority review status from FDA for heart failure medicine LCZ696

Novartis announced today that the US Food and Drug Administration has granted priority review for LCZ696, an investigational medicine for the treatment of heart failure with reduced ejection fraction (HFrEF). The designation is intended to accelerate the review of therapies that offer a significant improvement in the safety or effectiveness of the treatment, prevention or diagnosis of a serious condition. [More]
Actavis releases generic version of Pulmicort RESPULES

Actavis releases generic version of Pulmicort RESPULES

Actavis plc today announced that it has launched its generic version of AstraZeneca's Pulmicort RESPULES® (budesonide inhalation suspension) 0.25 and 0.5 mg vials following a ruling from the United States District Court for the District of New Jersey that (i) United States Patent No. 7,524,834 is invalid, and (ii) AstraZeneca's request for a permanent injunction is denied. [More]
Jazz Pharmaceuticals to present defibrotide results for hepatic VOD at BMT Tandem meetings

Jazz Pharmaceuticals to present defibrotide results for hepatic VOD at BMT Tandem meetings

Jazz Pharmaceuticals plc announced today that researchers will present data on the use of defibrotide, an investigational medicine being studied in the United States (U.S.) for the treatment of hepatic veno-occlusive disease (VOD), a rare, potentially life-threatening, early complication in patients undergoing hematopoietic stem-cell transplantation (HSCT) therapy. [More]
AbbVie submits NDA in Japan for investigational, all-oral treatment of patients with chronic HCV infection

AbbVie submits NDA in Japan for investigational, all-oral treatment of patients with chronic HCV infection

AbbVie (NYSE: ABBV) submitted a New Drug Application (NDA) to the Japanese Ministry of Health, Labour and Welfare (MHLW) seeking approval for the company's investigational, all-oral, ribavirin (RBV) and interferon (IFN)-free, 12-week, two direct-acting antiviral treatment of ombitasvir/paritaprevir/ritonavir (OBV/PTV/r), dosed once daily. [More]
Chiasma announces publication of octreotide capsules Phase III study results in JCEM

Chiasma announces publication of octreotide capsules Phase III study results in JCEM

Chiasma Inc., a U.S. privately-held biopharma company, announced today that results from a multicenter Phase III study of the investigational new drug, octreotide capsules, were published online for early release on Feb. 9, ahead of print, by the Journal of Clinical Endocrinology & Metabolism. [More]
FDA accepts NDA filing for Inspirion Delivery Technologies' investigational drug, MorphaBond ER

FDA accepts NDA filing for Inspirion Delivery Technologies' investigational drug, MorphaBond ER

Inspirion Delivery Technologies, LLC, a specialty pharmaceutical company focused solely on the development of Abuse-Deterrent Formulations (ADFs) of opioid products, together with its financial partner Trygg Pharma Group, announced that the U.S. Food & Drug Administration has accepted for filing the New Drug Application ("NDA") submitted on November 21, 2014 for its investigational drug, MorphaBond ER, an extended-release (ER), abuse-deterrent formulation of morphine. [More]
Regulus Therapeutics reports top-line results from RG-101 clinical study for HCV treatment

Regulus Therapeutics reports top-line results from RG-101 clinical study for HCV treatment

Regulus Therapeutics Inc., a biopharmaceutical company leading the discovery and development of innovative medicines targeting microRNAs, today announced top-line results from the 4 mg/kg cohort and additional results from the 2 mg/kg cohort in a completed clinical study evaluating RG-101, a wholly-owned, GalNac-conjugated anti-miR targeting microRNA-122 ("miR-122"), for the treatment of hepatitis C virus infection ("HCV"). [More]
Janssen granted Priority Review from FDA for YONDELIS (trabectedin) NDA to treat STS patients

Janssen granted Priority Review from FDA for YONDELIS (trabectedin) NDA to treat STS patients

Janssen Research & Development, LLC announced today that the U.S. Food and Drug Administration has granted Priority Review for the New Drug Application (NDA) for YONDELIS (trabectedin) to treat patients with advanced soft tissue sarcoma (STS), including liposarcoma and leiomyosarcoma subtypes, who have received prior chemotherapy including an anthracycline. [More]
Theravance Biopharma, Mylan partner to develop and commercialize TD-4208 for COPD treatment

Theravance Biopharma, Mylan partner to develop and commercialize TD-4208 for COPD treatment

Theravance Biopharma, Inc. and Mylan Inc. today announced that the two companies will partner on the development and, subject to FDA approval, commercialization of TD-4208, a novel investigational once-daily nebulized long-acting muscarinic antagonist (LAMA) for chronic obstructive pulmonary disease (COPD) and other respiratory diseases. [More]
Shire announces FDA approval of Vyvanse Capsules for binge eating disorder

Shire announces FDA approval of Vyvanse Capsules for binge eating disorder

Shire plc announced today that the U.S. Food and Drug Administration approved Vyvanse (lisdexamfetamine dimesylate) Capsules (CII), the first and only medication for the treatment of moderate to severe binge eating disorder (B.E.D.) in adults, shown to significantly reduce the mean number of binge days per week. [More]
Celator Pharmaceuticals' CPX-351 receives FDA Fast Track designation for secondary AML treatment

Celator Pharmaceuticals' CPX-351 receives FDA Fast Track designation for secondary AML treatment

Celator Pharmaceuticals, Inc., a biopharmaceutical company that is transforming the science of combination therapy and developing products to improve patient outcomes in cancer, today announced that the U.S. Food and Drug Administration granted Fast Track designation for CPX-351 (cytarabine:daunorubicin) for the treatment of elderly patients with secondary Acute Myeloid Leukemia (AML). [More]