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FDA approves the NDA of Roxane Laboratories' Morphine Sulfate Oral Solution CII

Roxane Laboratories, Inc. announced today the New Drug Application (NDA) approval of Morphine Sulfate Oral Solution CII, 100mg/5mL (20mg/mL) 30mL and 120mL bottles as of January 25th, 2010 by the Food and Drug Administration.

27 Jan 2010

Sumavel DosePro and Levadex to earn up to $400M by 2018

Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that Zogenix/Astellas Pharma/Desitin Pharmaceuticals' needle-free Sumavel DosePro, which launched earlier this month in the United States, and MAP Pharmaceuticals' orally-inhaled Levadex will earn approximately $400 million in combined sales by 2018 in the migraine drug market.

27 Jan 2010

Book highlights causes and remedies for bad breath

So, you've bought the candy, the diamond necklace, made the reservations at her favorite restaurant and had your suit cleaned and pressed. Still, even if you earn that special Valentine's Day kiss, it won't make a difference if your breath is so bad that it could motivate the dog to leave the room.

27 Jan 2010

FDA approves oral pain relief solution for opioid-tolerant patients

The U.S. Food and Drug Administration today approved Morphine Sulfate Oral Solution for the relief of moderate to severe, acute and chronic pain in opioid-tolerant patients. This medicine will be available in 100 milligrams per 5 mL or 20 milligrams per 1 mL.

27 Jan 2010

ZIOPHARM receives Notice of Allowance for palifosfamide from U.S. patent office

ZIOPHARM Oncology, Inc. announced today that it has received a Notice of Allowance from the U.S. Patent and Trademark Office for Application Serial No. 11/257,766 entitled “Salts of Isophosphoramide mustard and analogs thereof as anti-tumor agents” with claims directed to compounds, pharmaceutical compositions, and lyophilisates. These claims cover the Company’s proprietary palifosfamide composition (ZIO-201 or ZymafosTM). The Company has recently reported positive randomized Phase II sarcoma interim data for intravenous palifosfamide at the Annual Meeting of the Connective Tissue Oncology Society (CTOS) on November 6, 2009 and expects, following U.S. Food and Drug Administration (FDA) review, to initiate a registration trial the first half of 2010.

27 Jan 2010

IntelGenx and LTS announce strategic alliance

IntelGenx Corp. ("IntelGenx") today announced a strategic alliance with LTS Lohmann Therapie-Systeme AG ("LTS") for the exclusive manufacturing of products developed by IntelGenx using its VersaFilm drug delivery technology.

25 Jan 2010

BioScrip signs definitive agreement to acquire Critical Homecare Solutions

BioScrip, Inc. today announced it has signed a definitive agreement to acquire Critical Homecare Solutions (“CHS”), a leading provider of home infusion and home health agency services to patients suffering from chronic and acute medical conditions.

25 Jan 2010

Institute of Medicine urges healthcare providers to take steps to battle hepatitis B and C

The Institute of Medicine, a branch of the US National Academy of Sciences, is urging healthcare providers to take steps to battle liver-damaging hepatitis B and C, which are often overlooked viruses.

25 Jan 2010

New online resource to help people with Oral Mucositis launched

From today, a new resource is available to help people with Oral Mucositis: http://www.mouthsmadegood.com. Oral Mucositis (OM) is a side effect of cancer therapy and is characterised by a red, swollen and ulcerated mouth and tongue.

25 Jan 2010

Dermatological nuisance caused by toilet seats making a comeback in pediatricians' offices

Considered a dermatological nuisance that was long gone, skin irritations caused by toilet seats appear to be making a comeback in pediatricians' offices, according to research led by Johns Hopkins Children's Center investigator Bernard Cohen, M.D.

25 Jan 2010

FDA's Ampyra approval wonderful news for people with MS experiencing walking problems

The U.S. Food and Drug Administration has approved the marketing of Ampyra™ (dalfampridine, formerly known as fampridine SR, from Acorda Therapeutics) for its ability to improve walking speed in people with any type of multiple sclerosis.

23 Jan 2010

Data from GenVec's trial in esophageal cancer showcased at 2010 Gastrointestinal Cancer Symposium

GenVec, Inc. announced today that data from the Company's trial in esophageal cancer were presented at the American Society of Clinical Oncology's 2010 Gastrointestinal Cancer Symposium in Orlando, Florida on January 22, 2010.

22 Jan 2010

Acorda Therapeutics receives marketing approval from FDA for AMPYRA

Acorda Therapeutics, Inc. today announced that it has received marketing approval from the U.S. Food and Drug Administration (FDA) for AMPYRA™ (dalfampridine), an oral treatment to improve walking in patients with multiple sclerosis (MS).

22 Jan 2010

CMO to manufacture Gaia BioPharma's GAI-122 Mitochondria-targeted neuroprotective agent

AlphaRx Inc. announced today that its licensee, Gaia BioPharma Limited, has signed an agreement with a contract manufacturing organization (CMO), to manufacture GAI-122 for use in the planned Phase I and II clinical trials of that product candidate. GAI-122 is being developed as I.V. administered formulation of an intracellular neuroprotectant that employs AlphaRx's proprietary nano-emulsion formulation technology.

22 Jan 2010

AKD Global announces new class of cancer treatments in development

AKD Global announced today the discovery of a new class of cancer treatments in development, providing hope for millions of sufferers. The spectacular results demonstrate a highly potent effect on cancer cells with no toxicity to healthy tissue. AKD is raising funds to continue development.

22 Jan 2010

Panel discussion on benefits of oral chemotherapy in cancer care

US Oncology, Inc. partnered with the Association of Community Cancer Centers, Association of Oncology Social Work, American Society for Clinical Oncology, Community Oncology Alliance, Oncology Nursing Society and the National Patient Advocate Foundation in hosting a panel discussion on Capitol Hill today to examine the benefits of oral chemotherapy in cancer care, as well as challenges in its prescribing, accessibility and adherence in the current health care system.

22 Jan 2010

Watson Pharmaceuticals provides detailed overview of its global operations at Investor Day meeting in NY

Watson Pharmaceuticals, Inc. today provided a detailed overview of its expanded global operations, enhanced supply chain capabilities and commercial and pipeline developments in its Brand and Generics businesses during an Investor Day meeting held in New York, NY.

22 Jan 2010

FDA accepts ACT Biotech's ACTB1003 IND

ACT Biotech Inc., a privately held biotechnology company developing a portfolio of oral kinase inhibitors as anti-cancer drugs, today announced the acceptance of the Investigational New Drug (IND) application for ACTB1003 by the US Food and Drug Administration (FDA). The company has now assembled a complete preclinical package, including manufacturing and toxicology studies, allowing ACTB1003 to enter a clinical trial.

22 Jan 2010

Depomed receives second $500,000 milestone payment from Covidien

Depomed, Inc. announced today that it has received a second $500,000 milestone payment under its worldwide license agreement with Covidien focusing on the exclusive development of four acetaminophen/opioid analgesic combination products utilizing Depomed’s Acuform® gastric retentive drug delivery technology. The most recent payment from Covidien, which was received in December 2009, relates to the development of a formulation for the second product candidate under the collaboration.

21 Jan 2010

MDRNA to receive European patent for its intranasal insulin formulation

MDRNA, Inc., a leading RNAi-based drug discovery and development company, today announced that the European Patent Office intends to grant a patent for application EP06826368 covering formulations for the intranasal delivery of rapid acting insulin, and its use for the treatment of diabetes.

21 Jan 2010