Zingo (lidocaine hydrochloride monohydrate) powder
Company: Anesiva, Inc.
Received FDA Approval of Supplemental New Drug Application to Expand Zingo Indication, January 9, 2009
Company Comments: Anesiva is seeking to license Zingo, as well as the underlying drug delivery technology and intellectual property.
EGP-437 (dexamethasone phosphate)
Company: EyeGate Pharma
Receives Orphan Drug Designation from FDA, January 9, 2009
Company Comments: EyeGate is enrolling two Phase 2 clinical studies utilizing EGP-437 in uveitis and dry eye patients.
QPI-1002 (DGFi)
Company: Quark Pharmaceuticals, Inc.
Announced Dosing of the First Patient in Phase 1/2 Clinical Trial, January 8, 2009
Company Comments: The multi-center, two-part Phase 1/2 clinical trial in DGF is expected to enroll up to 204 adult kidney transplant recipients. The first part of the study is a dose-escalation design to evaluate the safety and tolerability of a single intravenous injection of QPI-1002 in renal transplant patients at high risk to develop DGF. The second part of the study will evaluate safety and potential clinical activity of a selected dose of QPI-1002 in the same patient population.
Naprelan (naproxen sodium) Controlled-Release Tablets
Company: Victory Pharma, Inc.
Launched Additional Naprelan Prescription Products, January 8, 2009
Company Comments: Victory plans to commence promotion on 500 milligram and 750 milligram Naprelan dose strengths.
olanzapine LAI
Company: Eli Lilly and Company
FDA Issued a Complete Response Letter for Lilly’s Olanzapine LAI for Treatment of Schizophrenia in Adults, January 7, 2009
Company Comments: The FDA does not require any additional clinical trials for the continued review of the NDA. Per the agency’s request, Lilly is preparing a proposed Risk Evaluation and Mitigation Strategy (REMS), which will be submitted in the near future.
IQP-0410 (pyrimidinedione HIV inhibitor)
Company: ImQuest Life Sciences
Announced the successful submission of an IND application to the Food and Drug Administration to initiate human clinical trials for IQP-0410, January 7, 2009
Company Comments: IQP-0410 is a novel small molecule inhibitor of HIV which primarily acts as a nonnucleoside reverse transcriptase inhibitor (NNRTI). Phase 1 studies will begin in the first quarter of 2009.
Moxatag (amoxicillin extended-release) Tablets, 775mg
Company: MiddleBrook Pharmaceuticals, Inc.
Announced that the professional launch of Moxatag will be March 16, 2009, January 7, 2009
Company Comments: Moxatag is approved for the treatment of adults and pediatric patients 12 years and older with tonsillitis and/or pharyngitis.
ToleroMune
Company: Circassia Ltd
Completes Patient Recruitment for Phase 2 Clinical Trial in Cat Allergy, January 7, 2009
Company Comments: The study, which is underway in Canada, has recruited 120 patients with confirmed cat allergies, and all the participants have completed screening and initial dosing with none experiencing any significant adverse events or safety issues.
Epiduo Gel (adapalene and benzoyl peroxide)
Company: Galderma
Announces Availability of Epiduo Gel, January 6, 2009
Company Comments: The new prescription acne treatment received approval from the U.S. Food and Drug Administration in December, and will be on pharmacy shelves nationwide in the first quarter of 2009.
CMX001
Company: Chimerix, Inc.
Initiated a Phase 2 Multi-dose Clinical Trial, January 6, 2009
Company Comments: The first Phase 2 trial will study the effects of multiple doses of CMX001 given to stem cell and kidney transplant recipients with BK viruria, a condition which may eventually lead to loss of the kidney graft, or to uncontrolled bleeding in the bladder.
DOR201 (oral beclomethasone dipropionate)
Company: DOR BioPharma, Inc.
Obtains Fast Track Designation from the FDA for DOR201 in the Prevention of Acute Radiation Enteritis, January 6, 2009
Company Comments: Fast track designation is designed to facilitate the development and expedite the review of new drugs. For instance, should events warrant, DOR will be eligible to submit a new drug application (NDA) for DOR201 on a rolling basis, permitting the FDA to review sections of the NDA prior to receiving the complete submission.
EXPAREL (DepoBupivacaine)
Company: Pacira Pharmaceuticals, Inc.
Announced enrollment has been completed in two pivotal Phase 3 SIMPLE trials, January 6, 2009
Company Comments: Pacira Pharmaceuticals, Inc. announced today that enrollment has been completed in two pivotal Phase 3 SIMPLE trials to evaluate the safety and efficacy of a single intraoperative administration of EXPAREL (DepoBupivacaine) for prolonged postoperative analgesia.
NEXTERONE (amiodarone HCl) Injection
Company: Prism Pharmaceuticals
Received FDA Approval of NEXTERONE for Life-Threatening Ventricular Fibrillation and Ventricular Tachycardia, January 5, 2009
Company Comments: Prism intends to submit a supplemental NDA for the premixed configurations which will form the focus of the commercial launch of NEXTERONE as a complete product line.
tesetaxel
Company: Genta Incorporated
Receives Orphan Drug Designation, January 5, 2009
Company Comments: Orphan drug status provides for a period of marketing exclusivity, certain tax benefits, and an exemption from certain fees upon submission of a New Drug Application.
CX-4945
Company: Cylene Pharmaceuticals
Initiates Phase 1 Trial in patients with advanced solid tumors, Castleman’s disease, or multiple myeloma, January 5, 2009
Company Comments: The primary endpoints of the oral dose escalating trial are determination of safety, tolerance, and PK properties of CX-4945 and to select the appropriate dose for Phase 2 trials.
orBec
Company: DOR BioPharma, Inc.
Received SPA Clearance From the FDA to Begin Confirmatory Phase 3 Clinical Trial of orBec in GI GVHD, January 5, 2009
Company Comments: Based on data from the prior Phase 3 study of orBec, the upcoming confirmatory Phase 3 protocol will be a highly-powered, double-blind, randomized, placebo-controlled, multi-center trial and will seek to enroll an estimated 166 patients.
nimotuzumab (EGFR targeting drug)
Company: YM BioSciences Inc.
Initiated multinational Phase 3 trial, January 5, 2009
Company Comments: The NCCS is the lead cancer center coordinating this clinical trial, which will involve approximately 22 institutions from 12 countries worldwide.
CV9103 (a RNActive-derived mRNA vaccine)
Company: CureVac GmbH
Received IND Approval from the FDA to start its Phase 1/2a mRNA Vaccine Clinical Trial in Prostate Cancer, January 5, 2009
Company Comments: The Phase 1/2a trial is designed to assess the safety, tolerability, and biological activity of the vaccine.
Filed Under: Drug Discovery
