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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.

23 Feb 2015

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).

21 Feb 2015

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.

18 Feb 2015

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).

16 Feb 2015

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.

16 Feb 2015

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.

13 Feb 2015

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.

13 Feb 2015

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.

12 Feb 2015

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.

10 Feb 2015

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.

10 Feb 2015

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").

9 Feb 2015

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.

3 Feb 2015

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.

2 Feb 2015

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.

30 Jan 2015

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).

20 Jan 2015

Using MDRS to accelerate deformulation: a new whitepaper from Malvern Instruments

A new whitepaper from Malvern Panalytical on Oral Solid Dose (OSD) deformulation demonstrates how the analytical technique of Morphologically Directed Raman Spectroscopy (MDRS) can be used to accelerate the development of generic products to a successful conclusion.

From Malvern Panalytical 13 Jan 2015

Soligenix's SGX301 receives FDA 'Fast Track' designation for CTCL treatment

Soligenix, Inc., a late-stage biopharmaceutical company developing products that address unmet medical needs in the areas of inflammation, oncology and biodefense, announced today that its SGX301 (synthetic hypericin) development program for the first-line treatment of cutaneous T-cell lymphoma (CTCL) has received "Fast Track" designation from the US Food and Drug Administration.

7 Jan 2015

LEO Pharma submits NDA for aerosol foam formulation to treat patients with plaque psoriasis

LEO Pharma announces it has submitted a New Drug Application (NDA) for calcipotriene and betamethasone dipropionate aerosol foam, 0.005%/0.064%, to the U.S. Food and Drug Administration (FDA) for the treatment of plaque psoriasis.

6 Jan 2015

FDA receives Actavis' NDA resubmission for cariprazine

Actavis plc (NYSE: ACT) and Gedeon Richter Plc. today announced that the U.S. Food and Drug Administration (FDA) has acknowledged receipt of Actavis' New Drug Application (NDA) resubmission for its atypical antipsychotic cariprazine, a potent dopamine D3/D2 receptor partial agonist with preferential binding to D3 receptors.