New Drug Application News and Research

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Avedro submits VibeX/KXL System NDA with FDA to treat keratoconus, corneal ectasia

Avedro, Inc. announced today that the Company submitted a New Drug Application (NDA) to the United States Food and Drug Administration (FDA) for its VibeX (riboflavin ophthalmic solution) /KXL System for the treatment of keratoconus and corneal ectasia following refractive surgery.

9 Mar 2012

Unigene fourth quarter net income increases to $4.4 million

Unigene Laboratories, Inc., today announced financial results for the fourth quarter and full-year ended December 31, 2011.

9 Mar 2012

Columbia Labs fourth quarter total net revenues decrease to $6.4M

Columbia Laboratories, Inc. today reported financial results for the three- and twelve-month periods ended December 31, 2011.

8 Mar 2012

FDA issues Complete Response Letter to Eisai for Dacogen sNDA

Astex Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration has issued a Complete Response Letter to partner Eisai for their supplemental New Drug Application (sNDA) for Dacogen (decitabine) for Injection for patients with acute myeloid leukemia (AML) in adults 65 years of age or older who are not considered candidates for induction therapy.

7 Mar 2012

Santarus fourth quarter total revenues increase 65% to $42.6M

Santarus, Inc. (NASDAQ: SNTS) today reported financial and operating results for the three and 12 month periods ended December 31, 2011.

5 Mar 2012

Astex fourth quarter total revenues increase to $21.2 million

Astex Pharmaceuticals, Inc., today reported financial results for the fourth quarter and year ended December 31, 2011.

5 Mar 2012

FDA accepts Eisai's resubmission of perampanel NDA for review

Eisai Inc. announced today that the U.S. Food and Drug Administration (FDA) has accepted for review Eisai's resubmission of the New Drug Application (NDA) for perampanel (E2007), an investigational drug, for the treatment of partial-onset seizures associated with epilepsy.

5 Mar 2012

Repligen seeks EMA marketing approval for SecreFlo for pancreatic imaging

Repligen Corporation announced today that it has submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA) for SecreFlo to improve detection of pancreatic duct abnormalities in patients with pancreatitis.

5 Mar 2012

NEJM publishes results from two Jakafi Phase III studies on MF

The New England Journal of Medicine (NEJM) today published results from two Phase III studies (COMFORT-I and COMFORT-II) of Jakafi (ruxolitinib), a JAK1 and JAK2 inhibitor recently approved by the Food and Drug Administration (FDA) for the treatment of intermediate or high-risk myelofibrosis.

1 Mar 2012

FDA extends action date for Bristol-Myers Squibb, Pfizer's Eliquis NDA

Bristol-Myers Squibb Company and Pfizer announced today that the U.S. Food and Drug Administration (FDA) has extended the action date by three months for the New Drug Application (NDA) for Eliquis (apixaban) for the prevention of stroke and systemic embolism in patients with atrial fibrillation.

1 Mar 2012

EpiCept fourth quarter revenue decreases to $0.2 million

EpiCept Corporation today announced operating and financial results for the fourth quarter and full year ended December 31, 2011, and provided an update on the Company's key business initiatives.

29 Feb 2012

FDA accepts Tau Therapeutics' mibefradil IND for treatment of cancer

Tau Therapeutics LLC, a pharmaceutical company developing T-type calcium channel inhibitors for the treatment of solid tumors, announced today that its investigational new drug application (IND 109196) for its novel drug mibefradil has been accepted by the Food and Drug Administration (FDA).

28 Feb 2012

FDA assigns Priority Review designation to JRD's XARELTO sNDA

Janssen Research & Development, LLC (JRD) announced today that the U.S. Food and Drug Administration (FDA) has assigned a Priority Review designation to the supplemental New Drug Application (sNDA) filed on December 29, 2011 for XARELTO (rivaroxaban), an oral anticoagulant, to reduce the risk of thrombotic cardiovascular events in patients with Acute Coronary Syndrome (ACS).

27 Feb 2012

EMA acceptance of peginesatide MAA triggers $5M milestone payment to Affymax

Affymax, Inc. today announced that it will receive a $5 million development milestone payment from Takeda Pharmaceutical Company as part of the companies' exclusive global agreement to develop and commercialize peginesatide.

27 Feb 2012

FDA issues complete response letter for Watson's progesterone vaginal gel 8% NDA

Watson Pharmaceuticals, Inc. and Columbia Laboratories, Inc. today confirmed that, as expected, Watson has received a complete response letter from the U.S. Food and Drug Administration (FDA) for its New Drug Application (NDA 22-139) for progesterone vaginal gel 8% for use in the reduction of risk of preterm birth in women with a singleton gestation and a short uterine cervical length in the mid-trimester of pregnancy.

27 Feb 2012

Impax announces FDA acceptance of NDA filing for IPX066

Impax Pharmaceuticals, the branded products division of Impax Laboratories, Inc. today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the Company's New Drug Application (NDA) for IPX066 for the treatment of idiopathic Parkinson's disease (PD) submitted to the Agency on December 21, 2011.

23 Feb 2012

Medivir reports net sales of SEK 698.6M for fiscal 2011

Today, Medivir AB, a research-based specialty pharmaceutical company focused on infectious diseases, is publishing its Interim Report for the period 1 January - 31 December and its operational report for the fourth quarter of 2011.

23 Feb 2012

Enrollment complete in Onyx Phase 3 ASPIRE trial for relapsed multiple myeloma

Onyx Pharmaceuticals, Inc. today announced that it has reached the target enrollment in the ASPIRE trial, a Phase 3 international clinical trial evaluating carfilzomib in combination with lenalidomide (Revlimid) and low dose dexamethasone in patients with relapsed multiple myeloma.

23 Feb 2012

Onyx reports total operating revenue of $237.0M for fourth quarter 2011

Onyx Pharmaceuticals, Inc. today reported its financial results for the full year and fourth quarter 2011. Onyx reported non-GAAP net income of $42.0 million, or $0.66 per diluted share, for the full year 2011 compared to non-GAAP net income of $39.2 million, or $0.63 per diluted share, for the same period in 2010.

23 Feb 2012

FDA EMDAC recommends approval of VIVUS' Qnexa for obesity

VIVUS, Inc. today announced that the U.S. Food and Drug Administration Endocrinologic and Metabolic Drugs Advisory Committee recommended Qnexa be granted marketing approval by the FDA for the treatment of obesity in adults.

23 Feb 2012