New Drug Application News and Research

RSS

Merck’s resubmission of the NDA for suggammadex sodium injection accepted for review by the FDA

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the resubmission of the New Drug Application (NDA) for sugammadex sodium injection has been accepted for review by the U.S. Food and Drug Administration (FDA). Merck expects the FDA’s review to be completed in the first half of 2013.

7 Jan 2013

Paratek receives FDA QIDP designation for omadacycline to treat ABSSSI, CABP

Paratek Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has designated the Company's lead antibiotic candidate, omadacycline (formerly known as PTK 0796), as a Qualified Infectious Disease Product (QIDP) for both intravenous (IV) and oral formulations in the treatment of acute bacterial skin and skin structure infections (ABSSSI) and community-acquired bacterial pneumonia (CABP).

3 Jan 2013

Kareus announces start of KU-046 Phase I study in Alzheimer's

Kareus Therapeutics SA, the private biotechnology company focused on the development of novel therapeutics for the unmet treatment of age-related and chronic diseases, today announces the start of a Phase I clinical study following the Investigational New Drug (IND) approval from the US Food and Drug Administration for the development of KU-046, a first-in-class disease modifying new chemical entity discovered for the treatment of Alzheimer's disease using Kareus' proprietary bioenergetics and KARLECT platforms.

3 Jan 2013

FDA acknowledges resubmission of Merck’s NDA for ezetimibe and atorvastatin tablets

Merck, known as MSD outside the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) has acknowledged the resubmission of a New Drug Application (NDA) for ezetimibe and atorvastatin tablets, an investigational combination medicine.

3 Jan 2013

Salix receives FDA approval for crofelemer to treat HIV-associated diarrhea

On New Year's Eve of 2012, the US Food and Drug Administration (FDA) announced its approval of crofelemer (Fulyzaq, Salix Pharmaceuticals, Ltd., Raleigh, North Carolina) — marking the second time a botanical, and the first time an orally administered botanical, has received drug approval from the Administration.

3 Jan 2013

Soligenix's OrbeShield granted FDA oral BDP orphan drug designation

Soligenix, Inc., a development stage biopharmaceutical company, announced today that the Office of Orphan Products Development of the US Food and Drug Administration (FDA) has granted orphan drug designation to OrbeShield (oral beclomethasone 17,21-dipropionate or oral BDP) for the prevention of death following a potentially lethal dose of total body irradiation during or after a radiation disaster.

2 Jan 2013

Aeterna Zentaris reaches SPA agreement with FDA for AEZS-108 Phase 3 trial in endometrial cancer

Aeterna Zentaris Inc. today announced that it has reached an agreement with the U.S. Food and Drug Administration ("FDA") on a Special Protocol Assessment ("SPA") for an upcoming Phase 3 registration trial in endometrial cancer with its doxorubicin peptide conjugate, AEZS-108. The SPA agreement states that the proposed trial protocol design, clinical endpoints and planned analyses are acceptable to the FDA to support a regulatory submission.

29 Dec 2012

AMAG seeks FDA sNDA approval for Feraheme Injection

AMAG Pharmaceuticals, Inc. today announced that it has submitted a supplemental new drug application (sNDA) to the United States Food and Drug Administration (FDA) for Feraheme (ferumoxytol) Injection for Intravenous (IV) use.

25 Dec 2012

BCPR, Orexigen partner to accelerate patient enrollment for Contrave obesity Light Study

Blue Chip Patient Recruitment, a division of Blue Chip Marketing Worldwide, a full-service integrated marketing agency, has successfully partnered with Orexigen Therapeutics to accelerate patient enrollment of The Light Study, Orexigen's cardiovascular outcomes trial evaluating Contrave (naltrexone sustained release (SR)/bupropion SR).

21 Dec 2012

Cubist seeks FDA sNDA approval for ENTEREG to accelerate GI recovery

Cubist Pharmaceuticals, Inc. (NASDAQ: CBST) today announced that it has submitted a supplemental new drug application (sNDA) to the U.S. Food and Drug Administration (FDA) requesting approval for the use of ENTEREG® (alvimopan) to accelerate GI recovery following any surgery that includes a bowel resection with primary anastomosis; expanded from the current indication in patients requiring surgery for colorectal disease.

21 Dec 2012

Acorda Therapeutics acquires Neuronex

Acorda Therapeutics, Inc. today announced that the Company has completed the acquisition of Neuronex, Inc., a privately held company developing a nasal spray formulation of diazepam. Under the terms of the agreement, Acorda paid $6.8 million to Neuronex to complete the acquisition.

21 Dec 2012

Bayer files radium-223 NDA with FDA for treatment of CRPC patients with bone metastases

Bayer HealthCare today announced that the company has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for radium Ra 223 dichloride (radium-223), an investigational compound for the treatment of castration-resistant prostate cancer (CRPC) patients with bone metastases.

15 Dec 2012

Pfizer, Ligand announce FDA acceptance of bazedoxifene/conjugated estrogens NDA

Pfizer Inc. and Ligand Pharmaceuticals Incorporated today announced that the United States Food and Drug Administration (FDA) accepted for review a New Drug Application (NDA) for bazedoxifene/conjugated estrogens (BZA/CE), a potential new medicine for non-hysterectomized women for the treatment of moderate-to-severe vasomotor symptoms (VMS) and vulvar and vaginal atrophy (VVA) associated with menopause, as well as the prevention of postmenopausal osteoporosis.

14 Dec 2012

Takeda, Lundbeck announce FDA acceptance of vortioxetine NDA submission

Takeda Global Research & Development Center, Inc., (Takeda) and H. Lundbeck A/S (Lundbeck) jointly announced today that the U.S. Food and Drug Administration (FDA) has accepted for filing their submission of a New Drug Application (NDA) for vortioxetine for the treatment of major depressive disorder (MDD) in adult patients.

13 Dec 2012

Top-line results from Durata Therapeutics’ dalbavancin Phase 3 study on ABSSSI

Durata Therapeutics, Inc. today announced preliminary, top-line results for its DISCOVER 1 ("Dalbavancin for Infections of the Skin COmpared to Vancomycin at an Early Response") Phase 3 study of dalbavancin, which is under investigation for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible gram-positive bacteria, including MRSA (methicillin resistant Staphylococcus aureus).

11 Dec 2012

Lotus Pharmaceutical submits generic Xenical ANDA with FDA

Lotus Pharmaceutical Company Inc. has confirmed its submission of Abbreviated New Drug Application for Orlistat capsules, a generic version of Xenical, to the US Food and Drug Administration (FDA).

11 Dec 2012

AMAG presents new data from two ferumoxytol phase III trials on IDA at ASH annual meeting

AMAG Pharmaceuticals, Inc. today announced that new data from two pivotal phase III clinical trials were presented at the American Society of Hematology's (ASH) annual meeting in Atlanta, Georgia.

11 Dec 2012

Ligand commences PG-free melphalan pivotal trial in multiple myeloma

Ligand Pharmaceuticals Incorporated announced today that it has initiated a pivotal trial of Captisol-enabled, propylene glycol-free (PG-free) high-dose melphalan as a conditioning treatment prior to autologous transplant for patients with multiple myeloma.

11 Dec 2012

Janssen receives FDA approval for ZYTIGA to treat metastatic castration-resistant prostate cancer

Janssen announced today that the U.S. Food and Drug Administration (FDA) has approved a broader indication for the oral, once-daily medication ZYTIGA (abiraterone acetate).

10 Dec 2012

ADVENTRX Pharmaceuticals updates corporate website

ADVENTRX Pharmaceuticals, Inc. today announced the launch of its redesigned and updated corporate website,www.adventrx.com. The new website features clinician videos, patient resources, and important news pertaining to sickle cell disease and ADVENTRX's lead product candidate, ANX-188 (purified poloxamer 188).

3 Dec 2012

New Drug Application News and Research

Merck’s resubmission of the NDA for suggammadex sodium injection accepted for review by the FDA

Paratek receives FDA QIDP designation for omadacycline to treat ABSSSI, CABP

Kareus announces start of KU-046 Phase I study in Alzheimer's

FDA acknowledges resubmission of Merck’s NDA for ezetimibe and atorvastatin tablets

Salix receives FDA approval for crofelemer to treat HIV-associated diarrhea

Soligenix's OrbeShield granted FDA oral BDP orphan drug designation

Aeterna Zentaris reaches SPA agreement with FDA for AEZS-108 Phase 3 trial in endometrial cancer

AMAG seeks FDA sNDA approval for Feraheme Injection

BCPR, Orexigen partner to accelerate patient enrollment for Contrave obesity Light Study

Cubist seeks FDA sNDA approval for ENTEREG to accelerate GI recovery

Acorda Therapeutics acquires Neuronex

Bayer files radium-223 NDA with FDA for treatment of CRPC patients with bone metastases

Pfizer, Ligand announce FDA acceptance of bazedoxifene/conjugated estrogens NDA

Takeda, Lundbeck announce FDA acceptance of vortioxetine NDA submission

Top-line results from Durata Therapeutics’ dalbavancin Phase 3 study on ABSSSI

Lotus Pharmaceutical submits generic Xenical ANDA with FDA

AMAG presents new data from two ferumoxytol phase III trials on IDA at ASH annual meeting

Ligand commences PG-free melphalan pivotal trial in multiple myeloma

Janssen receives FDA approval for ZYTIGA to treat metastatic castration-resistant prostate cancer

ADVENTRX Pharmaceuticals updates corporate website

Advancing Intracellular Delivery with LumiPore®

How ELRIG Is Helping Mid-Career Scientists Navigate Leadership, Career Change and Redundancy

The role of UV-Vis in biopharma QC

Latest News