New Drug Application News and Research

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AFREZZA non-inferior to standard therapy insulin lispro in reducing HbA1c levels of Type 1 diabetics

MannKind Corporation today announced that results of a new 16-week trial show that the investigational ultra rapid acting mealtime insulin, AFREZZA™ (insulin human [rDNA origin]) Inhalation Powder, combined with basal insulin, is clearly non-inferior to standard therapy insulin lispro, a rapid acting insulin, also combined with basal insulin, in reducing HbA1c levels in subjects with inadequately controlled Type 1 diabetes.

11 Jun 2010

FDA advisory committee recommends approval of Novartis' FTY720 for relapsing MS

Today, an advisory committee of the US Food and Drug Administration (FDA) recommended approval of FTY720 (fingolimod) for the treatment of patients with relapsing multiple sclerosis, the most common form of the disease. The FDA has the option of seeking the advice of one of its advisory committees as it reviews and decides whether to approve a new treatment. The committee voted unanimously that FTY720 demonstrated substantial efficacy in treating relapsing remitting MS and that safety of the proposed 0.5 mg dose justified approval.

11 Jun 2010

Gilead Sciences receives Paragraph IV Certification Notice Letter regarding Lupin's generic Ranexa ANDA

Gilead Sciences, Inc. today announced receipt of a Paragraph IV Certification Notice Letter advising that Lupin Limited submitted an Abbreviated New Drug Application (ANDA) to the U.S. Food and Drug Administration (FDA) requesting permission to manufacture and market a generic version of Ranexa® (ranolazine extended-release tablets).

11 Jun 2010

FDA approves Roxane Laboratories' Valacyclovir Hydrochloride Tablets ANDA

Roxane Laboratories, Inc. announced today the Abbreviated New Drug Application (ANDA) approval of Valacyclovir Hydrochloride Tablets 500mg and

10 Jun 2010

Positive initial results from Nektar Therapeutics' NKTR-102 Phase 2 study for metastatic breast cancer

Nektar Therapeutics today announced positive preliminary initial results from a two-stage Phase 2 clinical study evaluating single-agent NKTR-102 in women with advanced/metastatic breast cancer patients who have received a prior taxane. The increased use of taxanes in breast cancer often renders tumors resistant to these drugs by the time the disease recurs, thereby underscoring the urgent need for new treatment options with novel mechanisms of action for metastatic disease.

10 Jun 2010

NIH awards Aestus $2M SBIR grant for clinical trials of treatment for chronic neuropathic pain

Aestus Therapeutics, Inc. announced that it has been awarded a $2 million Small Business Innovative Research (SBIR) grant from the National Institutes of Health (NIH). The grant, from the NIH's National Institute of Neurological Disorders and Stroke (NINDS), will fund clinical trials of Aestus's novel, first-in-class treatment for chronic neuropathic pain.

9 Jun 2010

Helsinn Healthcare S.A., Eisai announce signing of licensing agreement

Helsinn Healthcare S.A. and Eisai Inc. today announce the signing of a licensing agreement granting Eisai Inc. commercialization rights for a new product for potential use in the prevention of chemotherapy-induced nausea and vomiting in the United States.

9 Jun 2010

Repligen's fiscal 2010 total revenue decreases to $20,971,000

Repligen Corporation today reported results for the fourth quarter and fiscal year 2010, ended March 31, 2010. Total revenue for the year was $20,971,000 compared to total revenue of $29,362,000 for fiscal year 2009 ended March 31, 2009.

9 Jun 2010

$Phase 2 Study: NKTR-102 holds great therapeutic potential for women with platinum-resistant/refractory ovarian cancer$

Phase 2 Study: NKTR-102 holds great therapeutic potential for women with platinum-resistant/refractory ovarian cancer

Nektar Therapeutics today announced positive results from a Phase 2 clinical study evaluating single-agent NKTR-102 in women with platinum-resistant/refractory ovarian cancer. A total of 68 patients were enrolled with platinum-resistant disease, half of whom were platinum refractory. All 68 patients were evaluable for the primary endpoint of objective response rate using Gynecologic Cancer InterGroup criteria, which is a combination of response by tumor imaging (RECIST) and/or ovarian cancer biomarker (CA-125) criteria.

8 Jun 2010

Findings from Abraxis BioScience's phase 3 ABRAXANE trial in patients with NSCLC presented at ASCO

Abraxis BioScience, Inc. announced today that findings from their phase 3 randomized trial of nanoparticle albumin bound driven chemotherapy, nab-paclitaxel (ABRAXANE for Injectable Suspension; paclitaxel albumin protein-bound particles for injectable suspension) plus carboplatin, showed a statistically significant 31 percent improvement in overall response rate when compared with Taxol (paclitaxel) injection plus carboplatin in the first-line treatment of patients with non-small cell lung cancer.

8 Jun 2010

ZIOPHARM presents positive data from PICASSO Phase II trial for soft tissue sarcoma at 46th ASCO

ZIOPHARM Oncology, Inc. announced today that Dr. Claire Verschraegen of the University of New Mexico, Albuquerque and first author of the abstract, "A phase II randomized controlled trial of palifosfamide plus doxorubicin vs. doxorubicin in patients with soft tissue sarcoma (PICASSO)," (Abstract #10004) presented in an oral session today updated positive data from PICASSO.

8 Jun 2010

Can-Fite BioPharma opens CF101 IND for psoriasis with US FDA

Can-Fite BioPharma Ltd, a biotechnology company traded on the Tel Aviv Stock Exchange, announced today that it has opened Investigational New Drug application (IND) with the United States Food and Drug Administration (US FDA). The IND is for Can-Fite's lead compound, CF101, for the treatment of patients with psoriasis. This is the third US IND for CF101, and the fourth for Can-Fite.

8 Jun 2010

Acella Pharmaceuticals signs license agreement for marketing rights to generic broad-spectrum antibiotic

Acella Pharmaceuticals has signed a licensing agreement for the U.S. marketing rights to a generic version of an intravenous administered broad-spectrum antibiotic.

8 Jun 2010

FDA accepts Depomed's DM-1796 NDA for pain after shingles

Depomed, Inc. today announced that the New Drug Application (NDA) for DM-1796 was accepted by the U.S. Food and Drug Administration (FDA) for the management of postherpetic neuralgia (PHN), or pain after shingles. DM-1796 is an investigational, extended release, once-daily tablet formulation of gabapentin designed to reduce dosing frequency and have a low incidence of side effects.

8 Jun 2010

Hana Biosciences signs Investment Agreement with Warburg Pincus and Deerfield Management

Hana Biosciences Inc., a biopharmaceutical company focused on strengthening the foundation of cancer care, today announced that it has entered into an Investment Agreement with Warburg Pincus and Deerfield Management for the sale of up to $100 million in preferred stock. Warburg Pincus, the lead investor in the financing, is a new investor in Hana, and Deerfield is the company's largest existing shareholder prior to this financing.

7 Jun 2010

Onyx reports encouraging ORR from ongoing Carfilzomib Phase 2 study for multiple myeloma

Onyx Pharmaceuticals, Inc. today announced interim results from an ongoing Phase 2 study, known as the 004 study. Carfilzomib, a selective, next-generation proteasome inhibitor, demonstrated encouraging overall response rates (ORR), tolerability and durable disease control when administered as a single-agent in patients with relapsed and/or refractory multiple myeloma.

7 Jun 2010

Phase III trial comparing PHP with melphalan to BAC for hepatic metastases highlighted at ASCO 2010

Delcath Systems, Inc. a development stage, specialty pharmaceutical and medical device company focused on oncology, highlighted the Phase III trial data presented on June 5 at the American Society of Clinical Oncology's 2010 Annual Meeting, comparing percutaneous hepatic perfusion with melphalan to the best alternative care for patients with hepatic metastases from ocular or cutaneous melanoma.

7 Jun 2010

ChemGenex reports positive safety findings from two OMAPRO clinical trials at ASCO 2010

ChemGenex Pharmaceuticals Limited announced that positive safety findings from a combined analysis of two clinical trials for its lead product candidate, OMAPRO™ (omacetaxine mepesuccinate), were presented today during a poster discussion session at the 2010 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, Illinois.

7 Jun 2010

Onyx presents interim results of Phase 1b dose-escalation carfilzomib combination trial for multiple myeloma

Onyx Pharmaceuticals, Inc. today announced updated interim results of the Phase 1b dose-escalation trial, known as the 006 study, evaluating carfilzomib in combination with lenalidomide (Revlimid®) and low dose dexamethasone in patients with relapsed and/or refractory myeloma. These data are being presented today at the 46th American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago.

5 Jun 2010

Mylan subsidiary receives FDA approval for generic version of Neurontin Tablets

Mylan Inc. today announced that its subsidiary Matrix Laboratories Limited has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for Gabapentin Tablets USP, 600 mg and 800 mg, the generic version of Pfizer's Neurontin Tablets for the treatment of postherpetic neuralgia, a complication of shingles.

5 Jun 2010

New Drug Application News and Research

AFREZZA non-inferior to standard therapy insulin lispro in reducing HbA1c levels of Type 1 diabetics

FDA advisory committee recommends approval of Novartis' FTY720 for relapsing MS

Gilead Sciences receives Paragraph IV Certification Notice Letter regarding Lupin's generic Ranexa ANDA

FDA approves Roxane Laboratories' Valacyclovir Hydrochloride Tablets ANDA

Positive initial results from Nektar Therapeutics' NKTR-102 Phase 2 study for metastatic breast cancer

NIH awards Aestus $2M SBIR grant for clinical trials of treatment for chronic neuropathic pain

Helsinn Healthcare S.A., Eisai announce signing of licensing agreement

Repligen's fiscal 2010 total revenue decreases to $20,971,000

Phase 2 Study: NKTR-102 holds great therapeutic potential for women with platinum-resistant/refractory ovarian cancer

Findings from Abraxis BioScience's phase 3 ABRAXANE trial in patients with NSCLC presented at ASCO

ZIOPHARM presents positive data from PICASSO Phase II trial for soft tissue sarcoma at 46th ASCO

Can-Fite BioPharma opens CF101 IND for psoriasis with US FDA

Acella Pharmaceuticals signs license agreement for marketing rights to generic broad-spectrum antibiotic

FDA accepts Depomed's DM-1796 NDA for pain after shingles

Hana Biosciences signs Investment Agreement with Warburg Pincus and Deerfield Management

Onyx reports encouraging ORR from ongoing Carfilzomib Phase 2 study for multiple myeloma

Phase III trial comparing PHP with melphalan to BAC for hepatic metastases highlighted at ASCO 2010

ChemGenex reports positive safety findings from two OMAPRO clinical trials at ASCO 2010

Onyx presents interim results of Phase 1b dose-escalation carfilzomib combination trial for multiple myeloma

Mylan subsidiary receives FDA approval for generic version of Neurontin Tablets

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