Drug Delivery News and Research

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Drug delivery is a term that refers to the delivery of a pharmaceutical compound into the body. Most common methods of delivery include the preferred non-invasive oral (through the mouth), nasal, pneumonial (inhalation), and rectal routes. Much research is now focussing on nanotechnology as a drug delivery method.

PARI Pharma commences enrollment in L-CsA Phase 2b efficacy study

PARI Pharma has enrolled the first patient in its Phase 2b clinical trial studying inhaled liposomal cyclosporine A (L-CsA) delivered via a customized Investigational eFlow Nebulizer System. The multinational study is investigating the safety and efficacy of PARI's L-CsA formulation. In previous clinical trials, reactions from physicians and lung transplant recipients to PARI's drug-device combination were encouraging.

11 Feb 2010

Cambrex announces fourth-quarter financial results ended December 31, 2009

Cambrex Corporation reports fourth quarter results for the period ended December 31, 2009.

10 Feb 2010

Trimel BioPharma Holdings updates business developments

Trimel BioPharma Holdings Inc. is today providing an update on a number of operational items that have contributed significantly to advancing the Company and achieving its initial objectives.

10 Feb 2010

DMC recommends Celsion to continue its Phase III ThermoDox clinical trial for primary liver cancer

Celsion Corporation announced today that after reviewing safety data from 120 patients enrolled in the pivotal Phase III ThermoDox® clinical trial ("HEAT" trial) for primary liver cancer, the Data Monitoring Committee (DMC) has recommended that Celsion continue to enroll patients in the trial.

10 Feb 2010

Alexza Pharmaceuticals announces development and commercialization collaboration with Biovail Laboratories International

Alexza Pharmaceuticals, Inc. announced today that it has established a collaboration with Biovail Laboratories International SRL, a subsidiary of Biovail Corporation, to develop and commercialize AZ-004 (Staccato® loxapine) in the U.S. and Canada. AZ-004 is Alexza's lead program, based on the company's proprietary technology, the Staccato system. Alexza submitted its New Drug Application (NDA) for Staccato loxapine in December 2009. Alexza is seeking regulatory approval to market AZ-004, an inhalation product candidate developed for the rapid treatment of agitation in patients with schizophrenia or bipolar disorder.

10 Feb 2010

Biovail and Alexza Pharmaceuticals sign collaboration and license agreement for anti-agitation drug

Biovail Corporation today announced that its subsidiary, Biovail Laboratories International SRL (BLS), has entered into a collaboration and license agreement with Alexza Pharmaceuticals, Inc.

10 Feb 2010

TI commences Phase IIa clinical trial for its lead molecule in CDH

Trigemina, Inc. (TI), a Mountain View based startup, has begun a Phase IIa clinical trial for its lead molecule in Chronic Daily Headache (CDH) in collaboration with Dr. Egilius Spierings at MedVadis Research Corporation located outside of Boston.

10 Feb 2010

Chi-Fu Trading to market and sell Delcath PHP Systems in Taiwan

Delcath Systems, Inc. (DCTH), a medical technology company testing its proprietary treatment system for primary and metastatic cancers to the liver, announced today the signing of its first research, distribution, sales and marketing agreement for its Percutaneous Hepatic Perfusion (PHP) System (the Delcath PHP System™). The agreement grants Chi-Fu Trading Co., Ltd. the exclusive right to market and sell the Delcath PHP System in Taiwan for hepatic malignancies and infectious disease upon Taiwan Food and Drug Administration (TFDA) approval, and any other approved use, with a conditional option for Singapore.

9 Feb 2010

Debiopharm Group signs exclusive licence agreement with Novartis for alisporivir

Debiopharm Group, a Swiss-based global biopharmaceutical group of companies with a focus on the development of prescription drugs that target unmet medical needs, today announced the signature of an exclusive licence agreement with Novartis for the development, manufacture and commercialisation of Debio 025 (alisporivir), a selective, first-in-class cyclophilin (Cyp) inhibitor with a potent anti-hepatitis C virus (HCV) effect. The product is currently in phase 2b clinical development for the treatment of hepatitis C. Debiopharm granted Novartis worldwide commercialisation rights to Debio 025 except for Japan.

9 Feb 2010

NexMed raises $2.3M through private placement

NexMed, Inc., a specialty CRO with a pipeline of products based on the NexACT® technology , announced today that it has raised $2.3 million in a private placement of promissory notes from two accredited U.S. investors. The promissory notes, due on or before August 4, 2010, are repayable at NexMed’s option in either cash or shares of unregistered common stock at prices ranging from $0.36 to $0.40 per share.

9 Feb 2010

FDA approves Lupin Pharmaceuticals' Amlodipine/Benazepril capsules

Lupin Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (U.S. FDA) has granted final approval for its Amlodipine/Benazepril 2.5mg/10mg, 5mg/10mg, 5mg/20mg and 10mg/20mg capsules. Commercial shipments of the product have already commenced.

9 Feb 2010

BD recalls certain lots of BD Q-Syte Luer Access Devices and BD Nexiva Closed IV Catheter Systems

BD (Becton, Dickinson and Company) has voluntarily executed a product recall of certain lots of BD Q-Syte™ Luer Access Devices and BD Nexiva™ Closed IV Catheter Systems. Use of the affected devices may cause an air embolism or leakage of blood and/or therapy, which may result in serious injury or death. This field corrective action included notification to customers worldwide by letter. Neither the costs anticipated with the recall, nor the impact on BD's business, are expected to be material.

From BD (Becton, Dickinson and Company) 9 Feb 2010

Strativa Pharmaceuticals' Zuplenz NDA: FDA issues complete response letter

Strativa Pharmaceuticals announced today that the U.S. Food and Drug Administration (FDA) issued a complete response letter regarding the new drug application (NDA) for Zuplenz® (ondansetron) oral soluble film for the prevention of nausea and vomiting associated with highly- and moderately-emetogenic chemotherapy, radiotherapy and surgery.

6 Feb 2010

Pharma IQ to organize 4th Improving Solubility conference at The Park Hyatt in Philadelphia

Organized by Pharma IQ, a division of IQPC, the 4th Improving Solubility conference will be held March 29-31, 2010 at The Park Hyatt in Philadelphia, PA. This forum brings together pharmaceutical researchers and scientists to uncover advances in enhancing solubility, amorphous forms, bioavailability & lipid-based formulation of drugs.

From IQPC Ltd 5 Feb 2010

Intrathecal drug delivery cost effective for chronic pain treatments

Estimates of pain care treatment costs exceed $1 billion annually in the United States. Today at the American Academy of Pain Medicine's 26th Annual Meeting two abstracts looked at the issue. One evaluated intrathecal drug delivery (a targeted medicine delivery system) that could save costs over time. The other analyzed the differences between the costs of treatment for chronic pain treatments.

5 Feb 2010

Access Pharmaceuticals initiates Cobalamin technology program for targeted delivery of siRNA therapies

ACCESS PHARMACEUTICALS, INC. announced today that it initiated an internal pre-licensing program to confirm the utility of its proprietary Cobalamin (vitamin B12) platform technology for targeted delivery of siRNA therapies. The program is considered important because, despite the widely publicized potential of RNA therapy, researchers up to now have been stymied in their efforts to design a pharmaceutical product that efficiently transports siRNA therapeutics into the cells they are designed to inhibit or kill.

5 Feb 2010

Data analysis of Delcath Systems' Phase III trial of melphalan to be commenced

Delcath Systems, Inc., a medical technology company testing its proprietary treatment system for metastatic cancers to the liver, announced today that sufficient events have been reached to allow data analysis to begin on its Phase III trial. The trial uses the drug melphalan to treat patients with metastatic melanoma in the liver.

4 Feb 2010

Ipsen launches Decapeptyl LP 22.5 mg in France

Ipsen, an innovation-driven global specialty pharmaceutical group and Debiopharm Group (Debiopharm), a Swiss-based global biopharmaceutical group of companies with a focus on the development of prescription drugs that target unmet medical needs, announce the launch by Ipsen in France of Decapeptyl(R) LP 22.5 mg 6-month sustained-release formulation for the treatment of locally advanced or metastatic hormone-dependent prostate cancer.

4 Feb 2010

HealthSport's bi-layer edible film strip technology related patent application receives Mexican approval

HealthSport, Inc., the preeminent formulator and developer of edible, multi-layer film strips that deliver drug and dietary supplement actives through buccal and sublingual absorption as well as oral ingestion, announced today that the Mexican Institute of Industrial Property has approved HealthSport's patent application relating to its bi-layer edible film strip technology.

4 Feb 2010

BD Diagnostics launches Be a Flu Fighter initiative to increase awareness and prevent influenza

BD Diagnostics, a segment of BD (Becton, Dickinson and Company) (NYSE: BDX), today announced the launch of the Be a Flu Fighter initiative, aimed at increasing awareness and prevention of influenza.

From BD (Becton, Dickinson and Company) 3 Feb 2010

Drug Delivery News and Research

Further Reading

PARI Pharma commences enrollment in L-CsA Phase 2b efficacy study

Cambrex announces fourth-quarter financial results ended December 31, 2009

Trimel BioPharma Holdings updates business developments

DMC recommends Celsion to continue its Phase III ThermoDox clinical trial for primary liver cancer

Alexza Pharmaceuticals announces development and commercialization collaboration with Biovail Laboratories International

Biovail and Alexza Pharmaceuticals sign collaboration and license agreement for anti-agitation drug

TI commences Phase IIa clinical trial for its lead molecule in CDH

Chi-Fu Trading to market and sell Delcath PHP Systems in Taiwan

Debiopharm Group signs exclusive licence agreement with Novartis for alisporivir

NexMed raises $2.3M through private placement

FDA approves Lupin Pharmaceuticals' Amlodipine/Benazepril capsules

BD recalls certain lots of BD Q-Syte Luer Access Devices and BD Nexiva Closed IV Catheter Systems

Strativa Pharmaceuticals' Zuplenz NDA: FDA issues complete response letter

Pharma IQ to organize 4th Improving Solubility conference at The Park Hyatt in Philadelphia

Intrathecal drug delivery cost effective for chronic pain treatments

Access Pharmaceuticals initiates Cobalamin technology program for targeted delivery of siRNA therapies

Data analysis of Delcath Systems' Phase III trial of melphalan to be commenced

Ipsen launches Decapeptyl LP 22.5 mg in France

HealthSport's bi-layer edible film strip technology related patent application receives Mexican approval

BD Diagnostics launches Be a Flu Fighter initiative to increase awareness and prevent influenza

Drug Discovery - Second Edition eBook

Achieving and maintaining ISO/IEC 27001 and BS 10012 certifications

Expanding research and clinical options for children with cancer

Examining how pain could play a direct protective role in the gut

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