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.

FDA grants tentative approval for Impax Laboratories' generic Opana ER

Impax Laboratories, Inc. today confirmed that the U.S. Food and Drug Administration (FDA) has granted tentative approval of the Company's Abbreviated New Drug Application (ANDA) for generic version of Opana® ER (oxymorphone hydrochloride) 5, 7.5, 10, 15, 20, 30 and 40 mg tablets.

14 May 2010

Phase 2a study results of Aerosurf for prevention of RDS in premature infants published

Discovery Laboratories, Inc., announces the publication of results from its previously-conducted Phase 2a feasibility study of Aerosurf, the Company's aerosolized KL4 surfactant, for the prevention of respiratory distress syndrome in premature infants, in the May 2010 issue of the Journal of Aerosol Medicine and Pulmonary Drug Delivery in the study titled "An Open Label, Pilot Study of Aerosurf Combined with nCPAP to Prevent RDS in Preterm Neonates".

14 May 2010

DMC recommends Celsion to continue enrollment in ThermoDox clinical study for primary liver cancer

Celsion Corporation announced today that after reviewing data from 294 patients including data from 12 Japanese patients enrolled in the pivotal Phase III ThermoDox® clinical study (HEAT Study) for primary liver cancer, the Data Monitoring Committee (DMC) has recommended that Celsion continue to enroll patients in the trial.

14 May 2010

Merit Medical Systems to acquire BioSphere Medical

Merit Medical Systems, Inc. today announced that it has signed a definitive merger agreement to acquire BioSphere Medical, Inc. in an all cash transaction valued at approximately $96 million, inclusive of all common equity and Series A Preferred preferences.

14 May 2010

Aradigm reports total revenue of $4.0M for first-quarter 2010

Aradigm Corporation today announced financial results for the first quarter and three months ended March 31, 2010.

13 May 2010

AlphaRx continues to develop Indaflex for the Chinese market

AlphaRx, Inc., has been advised by Cypress Biosciences, its development partner for Indaflex, that Cypress is not funding development of Indaflex. Notwithstanding to the termination of all Indaflex activity in the U.S.A., AlphaRx continues to develop Indaflex for the Chinese market.

13 May 2010

pSivida reports consolidated net loss of $2.7 million for third-quarter 2010

pSivida Corp., a drug delivery company with two of the only three ophthalmic sustained release delivery products approved by the FDA for treatment of back-of-the-eye diseases, today announced financial results for its third quarter and nine months ended March 31, 2010.

13 May 2010

NIH awards PLx Pharma multiple grants for development of GI safer NSAIDs

PLx Pharma, a pharmaceutical company developing safer formulations of proven non-steroidal anti-inflammatory drugs (NSAIDs), today announced that it has been awarded multiple grants from the National Institutes of Health (NIH) totaling approximately $2,000,000. This funding has been awarded to support further advancement of a range of products currently under development by PLx.

12 May 2010

Patient enrollment completed in Phase 2 clinical trial of orBec for prevention of acute GVHD

Soligenix, Inc., a late-stage biopharmaceutical company, announced today that patient enrollment has been completed in a randomized, double-blind, placebo-controlled Phase 2 clinical trial of orBec for the prevention of acute Graft-versus-Host disease after allogeneic hematopoietic cell transplantation with myeloablative conditioning regimens.

12 May 2010

Researchers develop anti-angiogenic molecule SR16388 for treatment of MM

SRI International, an independent nonprofit research and development organization, announced today that researchers have developed an anti-angiogenic molecule SR16388 that has demonstrated preclinical antitumor activity against multiple myeloma.

12 May 2010

Vetter signs preferred partnership agreement with Sentry BioPharma Services

Vetter, a leading provider of aseptic pre-filled drug-delivery systems, and Sentry BioPharma Services, a provider of supply chain management and clinical packaging services, today announced that they have signed a preferred partnership agreement.

12 May 2010

CEA-Leti launches TARGET-PDT project to increase effectiveness of PDT for treating cancer

CEA-Leti today announced the launch of the TARGET-PDT project designed to increase the effectiveness of photodynamic therapy for treating cancer by developing a novel nano carrier-based approach.

12 May 2010

FDA approves delivery of Cefepime in B. Braun's DUPLEX System

The U.S. Food and Drug Administration recently approved an application that permits B. Braun Medical Inc. (B. Braun) to deliver FDA-approved 1g and 2g Cefepime for Injection USP and Dextrose Injection USP in B. Braun's DUPLEX® Drug Delivery System.

From B. Braun Melsungen AG 12 May 2010

Alexza Pharmaceuticals first-quarter net loss increases to $13.4 million

Alexza Pharmaceuticals, Inc. today reported financial results for the first quarter ended March 31, 2010 and provided a business update.

11 May 2010

Generex Biotechnology enrolls over 400 subjects in global Phase III study of Generex Oral-lyn

Generex Biotechnology Corporation, the leader in drug delivery for metabolic diseases through the inner lining of the mouth, today announced that it has achieved enrolled of over 400 subjects in its pivotal global Phase III study of its flagship product, Generex Oral-lyn™, a proprietary buccal insulin spray product designed to replace prandial injections of insulin.

10 May 2010

Health Canada approves BDSI's NDS for ONSOLIS

BioDelivery Sciences International, Inc. today announced the approval of a New Drug Submission (NDS) by Health Canada, the regulatory authority in Canada, for ONSOLIS (fentanyl buccal soluble film) in the management of breakthrough pain in opioid-tolerant adult patients with cancer. ONSOLIS is the first product approved in Canada for this indication.

10 May 2010

European patent strengthens Soligenix' topically active steroid intellectual property portfolio

Soligenix, Inc., a late-stage biotechnology company, announced today that the European Patent Office granted patent EP 1392321 "Method of Treating Inflammatory Disorders of the Gastrointestinal Tract using Topically Active Corticosteroids." The new patent's main claims cover the use of topically active corticosteroids in orally administered dosage forms that act concurrently in the upper and lower gastrointestinal tract.

10 May 2010

FDA approves Cipher's CIP-TRAMADOL ER for chronic pain

Cipher Pharmaceuticals Inc. today announced the U.S. Food and Drug Administration has approved CIP-TRAMADOL ER, the Company's extended-release tramadol product, for the treatment of moderate to moderately severe chronic pain in adults.

10 May 2010

BD Biosciences introduces new Influx Cell Sorting System

BD Biosciences, a segment of BD (Becton, Dickinson and Company), announced today the launch of the new BD Influx™ Cell Sorting System that researchers can configure with up to seven lasers to support two-way, four-way and six-way sorting, giving them flexibility to meet specific application or environmental requirements.

From BD (Becton, Dickinson and Company) 10 May 2010

Halozyme Therapeutics first-quarter net loss decreases to $11.8 million

Halozyme Therapeutics, Inc., a biopharmaceutical company developing and commercializing products targeting the extracellular matrix for the endocrinology, oncology, dermatology and drug delivery markets, today reported financial results for the first quarter ended March 31, 2010.

7 May 2010