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Mallinckrodt to present MNK-795 clinical data at PAINWeek 2013

Mallinckrodt announced today that the first clinical data on MNK-795 will be presented at PAINWeek 2013, to be held September 4-7 in Las Vegas. MNK-795 is an extended-release oral formulation of oxycodone and acetaminophen that has been studied in clinical trials for the management of moderate to severe acute pain where the use of an opioid analgesic is appropriate.

29 Aug 2013

FDA approves NDA filing for ibrutinib inhibitor in two B-cell malignancies

Pharmacyclics, Inc. (Nasdaq: PCYC) today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing its New Drug Application (NDA) for the investigational oral Bruton's tyrosine kinase (BTK) inhibitor ibrutinib, for two B-cell malignancy indications: previously treated mantle cell lymphoma (MCL) and previously treated chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL).

29 Aug 2013

FDA grants Priority Review designation to sNDA for Nexavar tablets

Bayer HealthCare and Onyx Pharmaceuticals today announced that the U.S. Food and Drug Administration has granted Priority Review designation to the supplemental New Drug Application for the oral multi-kinase inhibitor Nexavar (sorafenib) tablets under evaluation for the treatment of locally advanced or metastatic radioactive iodine-refractory differentiated thyroid cancer.

27 Aug 2013

Navidea Biopharmaceuticals signs SPA agreements with FDA for NAV5001 Phase 3 program

Navidea Biopharmaceuticals, Inc., a biopharmaceutical company focused on precision diagnostic radiopharmaceuticals, today announced that it has reached agreement with the U.S. Food and Drug Administration for two special protocol assessments for the Company's pivotal Phase 3 program with NAV5001 as an aid in the differential diagnosis of Parkinsonian Syndromes from non-Parkinsonian tremor.

23 Aug 2013

Nuvo: FDA accepts to review New Drug Application for PENNSAID 2%

Nuvo Research Inc., a specialty pharmaceutical company dedicated to building a portfolio of products for the topical treatment of pain and the development of its immune modulating drug candidate WF10 today announced that its U.S. licensee for PENNSAID (diclofenac sodium topical solution) 1.5% w/w and PENNSAID 2% (diclofenac sodium topical solution) 2% w/w, Mallinckrodt has advised that the U.S. Food and Drug Administration has accepted for filing and review the New Drug Application for PENNSAID 2% submitted by Mallinckrodt on August 7, 2013.

22 Aug 2013

Oramed starts patient recruitment in Israel for ORMD-0801 clinical trial for patients with T1DM

Oramed Pharmaceuticals Inc., a developer of oral drug delivery systems, announced today that it has initiated patient recruitment for a new clinical trial of its orally ingestible insulin capsule, ORMD-0801 for patients with type 1 diabetes mellitus in Israel.

22 Aug 2013

FDA grants Orphan Drug Designation to Alnylam ALN-AT3 for treatment of hemophilia B

Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), a leading RNAi therapeutics company, announced today that the U.S. Food & Drug Administration (FDA) has granted an Orphan Drug Designation to ALN-AT3 as a therapeutic for the treatment of hemophilia B.

17 Aug 2013

Omeros announces financial results for second quarter of 2013

Omeros Corporation, a clinical-stage biopharmaceutical company committed to discovering, developing and commercializing products targeting inflammation, coagulopathies and disorders of the central nervous system, today announced its financial results for the second quarter of 2013.

12 Aug 2013

Eteplirsen offers great hope to patients with Duchenne muscular dystrophy

Results from a clinical trial of eteplirsen, a drug designed to treat Duchenne muscular dystrophy, suggest that the therapy allows participants to walk farther than people treated with placebo and dramatically increases production of a protein vital to muscle growth and health.

8 Aug 2013

Study offers new hope for treatment of diffuse large B-cell lymphoma

Researchers have discovered how an experimental drug is capable of completely eradicating human lymphoma in mice after just five doses. The study, led by researchers at Weill Cornell Medical College, sets the stage for testing the drug in clinical trials of diffuse large B-cell lymphoma, the most common subtype of non-Hodgkin lymphoma, itself the seventh most frequently diagnosed cancer in the U.S.

2 Aug 2013

Omeros submits OMS302 NDA to FDA for patients undergoing ILR surgery

Omeros Corporation announced that the company recently submitted a New Drug Application to the U.S. Food and Drug Administration for approval of OMS302 for use in patients undergoing intraocular lens replacement surgery.

1 Aug 2013

FDA accepts NDA for MNK-795 oral formulation

Depomed, Inc. (NASDAQ: DEPO) announced today that the U. S. Food and Drug Administration (FDA) has accepted for filing a New Drug Application (NDA) from Mallinckrodt (NYSE: MNK) for MNK-795.

30 Jul 2013

Anacor Pharmaceuticals submits tavaborole NDA to FDA for treatment of onychomycosis

Anacor Pharmaceuticals announced today that on July 26, 2013 it submitted its New Drug Application to the U.S. Food and Drug Administration for tavaborole, its drug candidate for the topical treatment of onychomycosis. Onychomycosis is a fungal infection of the nail and nail bed that affects approximately 35 million people in the United States.

30 Jul 2013

FDA acknowledges receipt of NDA resubmission of dapagliflozin drug for treatment of type 2 diabetes

AstraZeneca (NYSE: AZN) and Bristol-Myers Squibb Company (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has acknowledged receipt of the New Drug Application (NDA) resubmission for investigational drug dapagliflozin for the treatment of adults with type 2 diabetes.

26 Jul 2013

Mylan, Orion sign settlement, license agreement for generic version of STALEVO

Mylan Inc. today confirmed that Mylan Pharmaceuticals Inc. and Orion Corporation have entered into a settlement and license agreement settling the parties litigation in connection with Mylan's filing of an Abbreviated New Drug Application with the U.S. Food and Drug Administration for Carbidopa/Levodopa/Entacapone Tablets, 12.5 mg/50 mg/200 mg, 18.75 mg/75 mg/200 mg, 25 mg/100 mg/200 mg, 31.25 mg/125 mg/200 mg, 37.5 mg/150 mg/200 mg, and 50 mg/200 mg/200 mg.

25 Jul 2013

Prana Biotechnology completes PBT2 phase 2 trial in patients with Huntington's disease

Prana Biotechnology today announced the successful completion of Reach2HD, a phase 2 clinical trial in patients with early to mid-stage Huntington disease. The Company expects to announce the results arising from the trial in October.

23 Jul 2013

GW Pharmaceuticals to expand marketing authorization for Sativex to France

GW Pharmaceuticals plc, a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform, announced that it has submitted an application under the European Mutual Recognition Procedure seeking to expand the marketing authorization for Sativex into France for the treatment of spasticity due to Multiple Sclerosis.

22 Jul 2013

FDA gives tentative approval to Perrigo's ANDA for generic version of Prandin Tablets

Perrigo Company today announced that it has received tentative approval from the U.S. Food & Drug Administration for its abbreviated new drug application for repaglinide tablets, the generic equivalent to Prandin Tablets (repaglinide tablets).

20 Jul 2013

Anacor presents Phase 3 safety and efficacy results of Tavaborole for treatment of onychomycosis

Anacor Pharmaceuticals (NASDAQ:ANAC) announced today that its abstract "Pivotal Phase 3 Safety and Efficacy Results of Tavaborole (Formerly AN2690), a Novel Boron-Based Molecule for the Topical Treatment of Toenail Onychomycosis" was accepted for oral presentation at the 2013 APMA Annual Scientific Meeting (The National) to be held in Las Vegas, Nevada.

19 Jul 2013

Par Pharmaceutical receives final ANDA approval for generic version of Trilipix

Par Pharmaceutical Companies, Inc. today announced that it has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for fenofibric acid EQ 45 mg and EQ 135 mg delayed-release capsules.