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FDA approves NDA for Edgemont's Fluoxetine 60 mg tablet

Edgemont Pharmaceuticals, LLC, a neuroscience focused company, today announced that the U.S. Food and Drug Administration (FDA) has approved its New Drug Application (NDA) for Fluoxetine Tablets 60 mg.

12 Oct 2011

DMC completes review of BioSante's LibiGel Phase III cardiovascular and breast cancer study

BioSante Pharmaceuticals, Inc., announced today that the independent Data Monitoring Committee (DMC) has completed the seventh unblinded review of the LibiGel Phase III cardiovascular and breast cancer safety study, which has completed enrollment of subjects.

11 Oct 2011

Takeda, Affymax announce data from multiple studies of peginesatide on anemia

Affymax, Inc. and Takeda Pharmaceuticals Global Research & Development Center, Inc., U.S., today announced data from multiple studies of peginesatide have been accepted for presentation at the American Society of Nephrology (ASN) Kidney Week 2011 taking place November 8-13, 2011 in Philadelphia, Pa.

11 Oct 2011

FDA to review Banner's Bexarotene ANDA for CTCL skin cancer treatment

Banner Pharmacaps Inc. has confirmed that its Abbreviated New Drug Application for Bexarotene 75 mg soft gelatin capsules, a generic version of Targretin, has been accepted for review by the US Food and Drug Administration.

11 Oct 2011

Targacept commences AZD3480 Phase 2b study in Alzheimer’s disease

Targacept, Inc., a clinical-stage biopharmaceutical company developing novel NNR Therapeutics™, today announced the initiation of a potential registration study of AZD3480 in mild to moderate Alzheimer's disease. The study is the subject of a Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration.

10 Oct 2011

Creabilis receives $20 million in Series B funding

Creabilis SA, a clinical stage European biotechnology company addressing unmet medical needs in dermatology, inflammation and pain, has raised €15 million ($20 million) in a Series B funding round led by Abbott Biotech Ventures.

4 Oct 2011

Circadian subsidiary submits IND application to FDA to initiate VGX-100 study against cancer

Circadian Technologies Limited is extremely proud to announce that its 100% owned subsidiary, Vegenics Pty Ltd, has submitted an investigational new drug application to the U.S. Food and Drug Administration to initiate clinical studies of VGX-100.

1 Oct 2011

ADVENTRX holds Type A meeting with FDA to discuss Exelbine NDA

ADVENTRX Pharmaceuticals, Inc. announced today that it held a Type A meeting with the U.S. Food and Drug Administration (FDA) to discuss the complete response letter (CRL) it received in August from the FDA regarding the Company's New Drug Application (NDA) for Exelbine (vinorelbine injectable emulsion) for the treatment of non-small cell lung cancer.

1 Oct 2011

AstraZeneca settles SEROQUEL XR patent infringement litigation

AstraZeneca today announced it has entered into a settlement agreement in its U.S. SEROQUEL XR patent infringement litigation against Handa Pharmaceuticals, LLC regarding Handa's proposed generic version of AstraZeneca's SEROQUEL XR extended-release tablets.

30 Sep 2011

Circadian files IND with FDA for VGX-100 for the treatment of cancer patients with solid tumors

Circadian Technologies Limited (ASX: CIR, OTCQX:CKDXY) is extremely proud to announce that its 100% owned subsidiary, Vegenics Pty Ltd, has submitted an investigational new drug (IND) application to the U.S. Food and Drug Administration (FDA) to initiate clinical studies of VGX-100. The first trial (Phase I) will involve the treatment of a variety of different cancer types in patients with late stage cancer.

29 Sep 2011

Almirall submits linaclotide MAA to EMA for treatment of IBS-C

Ironwood Pharmaceuticals, Inc. today announced that its European partner Almirall, S.A. submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for linaclotide, a guanylate cyclase type-C (GC-C) agonist, for the treatment of irritable bowel syndrome with constipation.

29 Sep 2011

Transcept announces resubmission of NDA for Intermezzo to FDA

Transcept Pharmaceuticals, Inc., a specialty pharmaceutical company focused on the development and commercialization of proprietary products that address important therapeutic needs in the field of neuroscience, today announced that the company has resubmitted the New Drug Application for Intermezzo (zolpidem tartrate sublingual tablet) to the U.S. Food and Drug Administration.

28 Sep 2011

22nd Century completes enrollment in X-22 Phase II-B smoking cessation study

22nd Century Group, Inc., a company focused on smoking cessation and tobacco harm reduction products, announced today that enrollment of its X-22 Phase II-B clinical trial has been successfully completed; 234 smokers have been randomized in the double-blind, active-controlled, multi-center smoking cessation study.

27 Sep 2011

Arena, Eisai announce new data from lorcaserin Phase 3 clinical trial program

Arena Pharmaceuticals, Inc. and Eisai Inc. announced today that new data analyses from the lorcaserin Phase 3 clinical trial program will be presented in poster sessions at Obesity 2011, the 29th Annual Scientific Meeting of The Obesity Society in Orlando, Florida.

27 Sep 2011

Alnylam commences ALN-PCS Phase I trial in severe hypercholesterolemia

Alnylam Pharmaceuticals, Inc., a leading RNAi therapeutics company, announced today that it has initiated dosing in its Phase I clinical trial with ALN-PCS, an RNAi therapeutic targeting proprotein convertase subtilisin/kexin type 9, or PCSK9, for the treatment of severe hypercholesterolemia.

27 Sep 2011

Pacira announces data from EXPAREL clinical study presented at ASPS 2011 meeting

Pacira Pharmaceuticals, Inc. today announced that the company's lead investigational product for postsurgical pain management, EXPAREL, was highlighted in the "Hot Topics in Plastic Surgery" panel at the annual scientific assembly of the American Society of Plastic Surgeons (ASPS) in Denver, Colo.

26 Sep 2011

Positive results from Clermont's non-preserved latanoprost phase III trial on glaucoma

Clermont Pharmaceuticals, Inc., a privately held ophthalmic-focused biopharmaceutical company, announced today positive results from a phase III trial of non-preserved latanoprost. In the study, non-preserved latanoprost was compared to Xalatan (latanoprost ophthalmic solution) 0.005%, in subjects diagnosed with open-angle glaucoma.

26 Sep 2011

Enrollment complete in Spectrum Pharmaceuticals' belinostat pivotal trial for PTCL

Spectrum Pharmaceuticals, a biotechnology company with fully integrated commercial and drug development operations with a primary focus in hematology and oncology, today announced that it has achieved the target enrollment of the minimum of 100 evaluable relapsed or refractory peripheral T-cell lymphoma (PTCL) patients in the BELIEF registration trial.

26 Sep 2011

FDA denies FOIA regarding Gilead Sciences' Truvada correspondence, AHF sues

AIDS Healthcare Foundation (AHF) today filed a lawsuit against the Food and Drug Administration (FDA) over its denial of AHF's Freedom of Information Act (FOIA) requests regarding correspondence between the FDA and Gilead Sciences regarding its potential application to the FDA to expand the use of its AIDS drug, Truvada, for use as an HIV prevention pill for pre-exposure prophylaxis (PrEP) in uninfected individuals.

23 Sep 2011

Helsinn commences Netupitant/Palonosetron Phase III combination study in CINV

Helsinn Group and Eisai Inc. announced today that Helsinn has commenced a multi-centered Phase III clinical study program investigating the Netupitant/Palonosetron (300mg/0.50mg) oral fixed-dose combination for the prevention of chemotherapy-induced nausea and vomiting.

23 Sep 2011