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.

Depomed licensee submits DM-1796 NDA for management of PHN

Depomed, Inc. today announced that its licensee has submitted a New Drug Application (NDA) for DM-1796 to 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.

31 Mar 2010

Access Pharmaceuticals, bioRASI sign collaborative agreement to develop Cobalamin oral insulin product

ACCESS PHARMACEUTICALS, INC. signed a collaborative development agreement with bioRASI, LLC, a full-service global CRO specializing in the accelerated development of novel therapeutics, to facilitate clinical development for its Cobalamin™-based oral insulin and other Cobalamin-based products.

31 Mar 2010

Titan Pharmaceuticals commences Phase 3 study of Probuphine for opioid addiction

Titan Pharmaceuticals, Inc. today announced the initiation of a randomized, placebo and active controlled, multi-center Phase 3 clinical study of Probuphine in the treatment of opioid addiction. This confirmatory Phase 3 study will be conducted at approximately 23 sites in the United States and randomize approximately 250 patients into three arms: Probuphine (100 patients), Suboxone® (100 patients) and placebo (50 patients).

31 Mar 2010

Insight into scorpion venom may help understand diseases like pancreatitis

A Brazilian scorpion has provided researchers at North Carolina State University and East Carolina University insight into venom's effects on the ability of certain cells to release critical components. The findings may prove useful in understanding diseases like pancreatitis or in targeted drug delivery.

30 Mar 2010

Dicerna Pharmaceuticals, Ipsen announce collaboration in DsiRNA research and peptide engineering

Dicerna Pharmaceuticals, Inc., (Dicerna) a second generation RNA interference (RNAi) company, and Ipsen, a global biotechnology specialty care group, announced today that the two companies have entered into an exclusive research collaboration agreement to leverage their expertise in Dicer Substrate siRNA (DsiRNA) research and peptide engineering. The companies will develop novel conjugates of Dicerna's DsiRNA molecules and Ipsen's peptide targeting vectors in the therapeutic areas of oncology and endocrinology.

30 Mar 2010

NexMed files IND with FDA for Phase II trial of PrevOnco for HCC

NexMed, Inc, a specialty CRO with a pipeline of products based on the NexACT® technology, today announced that the Company has filed an Investigational New Drug (IND) application with the U.S. Food & Drug Administration (FDA) for a Phase II trial of its recently acquired cancer drug candidate PrevOnco™, in combination with doxorubicin in patients with advanced, unresectable hepatocellular carcinoma (HCC). The FDA has 30 days to comment on the IND before NexMed can proceed with human testing.

29 Mar 2010

Generex Biotechnology announces FDA Expanded Access Treatment IND Program for 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 expanded its plans for its United States Food and Drug Administration (FDA) Expanded Access Treatment IND Program for its flagship product, Generex Oral-lyn™, to include licensed and qualified Nurse Practitioners in the United States.

29 Mar 2010

AlphaRx plans listing of subsidiary on Canadian exchange

AlphaRx, Inc. today announced that the Company plans to list its' Canadian subsidiary, which has been focused on China and emerging markets, on a Canadian exchange in a transaction that will result in two independent and highly focused public companies - one dedicated to the Far East and one to developed markets.

29 Mar 2010

Positive results from Pearl Therapeutics' Phase 1 study of inhaled combination bronchodilator for COPD

Pearl Therapeutics Inc., a company developing clinically differentiated combination therapies for the treatment of highly prevalent chronic respiratory diseases, today announced positive results from a Phase 1 safety and pharmacokinetics study of PT003, its lead combination therapeutic for the treatment of chronic obstructive pulmonary disease (COPD). Based on these results, and previously announced positive results from Phase 2a studies of PT003's individual components, the company has advanced PT003 into a Phase 2b trial.

29 Mar 2010

Health Canada accepts Cipher Pharmaceuticals' NDS for CIP-TRAMADOL ER

Cipher Pharmaceuticals Inc. today announced that its New Drug Submission (NDS) to Health Canada for CIP-TRAMADOL ER, its extended-release formulation of tramadol, has been accepted for review. The Company expects the review to be completed by early 2011.

26 Mar 2010

Global home health management market expanding at CAGR of 10% through 2012

Remote health management is the fastest growing segment of a burgeoning home health management market. However, RHM’s full potential will materialize only if health insurers adopt reimbursement practices that encourage greater physician adoption, concludes Scientia Advisors, a global strategy consulting firm, in its review of the worldwide home health management market released today.

26 Mar 2010

JCOM receives approval from KFDA to commercialize MuGard in Korea

ACCESS PHARMACEUTICALS, INC. announced that JCOM Co., Ltd., its Korean licensee for both MuGard™ and ProLindac™, has received approval from the Korean Food and Drug Administration of its Registration Dossier for MuGard, an oncology supportive-care treatment for the management of oral mucositis.

26 Mar 2010

BioScrip acquires Critical Homecare Solutions Holdings

BioScrip, Inc. today announced that it has completed its acquisition of Critical Homecare Solutions Holdings, Inc. (“CHS”), a leading provider of home infusion and home nursing products and services to patients suffering from chronic and acute medical conditions.

26 Mar 2010

Altuglas International launches new acrylic resins for medical devices applications

Altuglas International, a world leader in acrylic plastics, has expanded its family of Medical grade acrylic resins, with Altuglas® CR30 and Altuglas® CR50 impactmodified grades. These resins, feature exceptional alcohols and lipids resistance that reduces environmental stress cracking due to attack of aggressive drugs and disinfectants. These novel acrylic resins are designed for easy injection molding of complex multi-cavity parts.

25 Mar 2010

SCOLR Pharma's total revenue dips 2% in 2009, but significant improvements in operating expenses

SCOLR Pharma, Inc. today reported financial results for the twelve months ended December 31, 2009. The Company will host a live conference call on March 31, 2010, at 11:30 a.m. (Eastern Standard Time).

25 Mar 2010

FDA grants Orphan Drug Designation for anti-diabetic drug

The FDA has granted Orphan Drug Designation of Diamyd Medical´s lead drug candidate Diamyd®. Orphan drugs qualify for seven years of market exclusivity from the date of US marketing approval, tax credits for clinical research and a waiver for FDA user fees.

24 Mar 2010

LPI's ANDA for Eszopiclone tablets receives tentative approval from USFDA

Lupin Pharmaceuticals, Inc. announced today that it has received tentative approval for the Company's Abbreviated New Drug Application for Eszopiclone tablets, 1 mg, 2 mg and 3 mg from the U.S. Food and Drug Administration.

23 Mar 2010

DSM Biomedical expands resources and operations in the U.S. and Europe

DSM Biomedical, a global leader in biomedical materials science, today announced the expansion of its resources and operations in the United States and Europe to support the growing demand for the company’s portfolio of innovative polyurethanes for chronically implanted medical devices in the regions.

23 Mar 2010

BEMA Granisetron development program: BDSI announces positive meeting with FDA

BioDelivery Sciences International, Inc. announced the positive outcome of a meeting with the FDA on the development program for BEMA Granisetron, the company’s potential treatment for the prevention of nausea and vomiting associated with cancer therapy. FDA concurred with BDSI’s plans to pursue a development program based on clinical pharmacokinetic data for a 505(b)(2) New Drug Application.

22 Mar 2010

StockPreacher.com releases investment report on A.P. Pharma

StockPreacher.com announces an investment report featuring A.P. Pharma Inc. (Nasdaq:APPA). The report includes financial, comparative and investment analyses, and industry information you need to know to make an educated investment decision.

22 Mar 2010