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FDA accepts MannKind's resubmission of AFREZZA NDA, sets PDUFA action date

MannKind Corporation today announced that it has submitted, and the U.S. Food and Drug Administration has accepted, MannKind's resubmission of its New Drug Application for AFREZZA™ (insulin human [rDNA origin]) and classified it as a Class 2 resubmission. With the Class 2 designation, the FDA set a corresponding Prescription Drug User Fee Act action date of December 29, 2010.

21 Jul 2010

Ingestion of probiotic supplements prevents eczema: Study

Mothers who drank milk with a probiotic supplement during and after pregnancy were able to cut the incidence of eczema in their children by almost half,a new study published in the British Journal of Dermatology has shown.

21 Jul 2010

Active play is important for children’s physical activity

Active play makes a significant contribution to children’s physical activity and could play an important part in the health of future generations, a new study has found.

20 Jul 2010

World-first dialysis study set to reduce health costs

The results of a world-first controlled trial of dialysis start-time in patients with Stage V chronic kidney disease is set to have major impact on the cost and infrastructure of chronic kidney disease (CKD) treatment and dialysis services.

20 Jul 2010

Prostate cancer: To screen or not to screen

Men with a family history of prostate cancer who are confused about whether to undergo controversial screening could soon have access to an online resource to have their questions answered.

20 Jul 2010

New & improved rotavirus vaccine to be trialed in Melbourne

Now a vaccine is being developed against rotavirus in Melbourne. At present Australian children were given rotavirus vaccine at the age of six to eight weeks since 2007. This new vaccine will be applicable to infants from birth.

20 Jul 2010

New development in flu prevention & treatment

In a groundbreaking development, scientists at the Australian National University in Canberra have found the key to the mutation of the flu virus. This may allow the manufacturing of a life-long vaccine stopping the need for repeated vaccinations. The scientists reveal that they have found a protein in the virus that changes or mutates in order to develop resistance in the virus.

20 Jul 2010

HIV – Rising menace

Nevirapine is considered to be an effective drug that can prevent HIV infection in babies born to mothers with HIV. However a new study shows that only about half of babies born to mothers with HIV receive the drug. The study appeared in the July 21 HIV/AIDS themed issue of the Journal of the American Medical Association.

20 Jul 2010

Forest Laboratories reports first-quarter diluted EPS of $0.39

Forest Laboratories, Inc., an international pharmaceutical manufacturer and marketer, announced that diluted earnings per share equaled $0.39 in the first quarter of fiscal 2011. Excluding the charge related to the United States Department of Justice investigations described below, and a charge of $50.0 million, or $0.17 per share net of tax, for a new product licensing fee, non-GAAP earnings per share for the first fiscal quarter were $0.95 per share.

20 Jul 2010

ARUP announces new version of Septin 9 methylated DNA test

ARUP Laboratories, a leading national clinical and anatomic pathology reference laboratory and a leader in innovative laboratory research and development, today announced it is offering the Septin 9 methylated DNA test, a new blood-based colorectal cancer screening method. While ARUP is not the first laboratory to offer this test, this new version, developed and validated independently by ARUP, is clinically proven to detect a higher proportion of colorectal cancers than Septin 9 tests developed by other companies.

20 Jul 2010

Arcion reports top-line results from ARC-4558 Phase 2b clinical trial for painful diabetic neuropathy

Arcion Therapeutics, a venture backed clinical stage biotechnology company developing topical therapies for chronic pain, today announced top-line results from a successful Phase 2b double-blind, randomized, placebo-controlled clinical trial of its lead topical pain candidate, ARC-4558, in adult patients with painful diabetic neuropathy (PDN). Arcion recently held an End of Phase 2 meeting with the United States Food and Drug Administration (FDA) and the ARC-4558 program is now poised to enter Phase 3 studies.

20 Jul 2010

International Stem Cell, IBVI sign letter of intent concerning funding, establishment of ISCO India

International Stem Cell Corporation, www.internationalstemcell.com, and Insight Bioventures India Private Limited, announced today that they have signed a letter of intent concerning funding and establishment of an Indian affiliate of ISCO. The goal is to establish world-class development and manufacturing operations for ISCO's research and pharmaceutical products in India, including its Lifeline Cell Technology research products and human corneal tissue, CytoCor, for treatment of corneal vision impairment and testing of chemicals.

20 Jul 2010

Affymax completes sale of all auction rate securities held by UBS

Affymax, Inc. today announced the completion of the sale at par value of all auction rate securities held by UBS AG and its affiliates in a transaction which generated net proceeds of $5.0 million to Affymax, after payment of $5.4 million from the proceeds to retire a loan due to UBS. From April 1, 2010 through June 30, 2010, $3.7 million of the UBS ARS were settled at par value resulting in a corresponding reduction in the balance of UBS ARS and related loan since the first quarter 2010. The company now has no debt liability on its balance sheet.

20 Jul 2010

Access selects BioScrip as exclusive distribution and service partner for MuGard

ACCESS PHARMACEUTICALS, INC., a biopharmaceutical company specializing in products for cancer and supportive care, announced today it has signed an exclusive specialty distribution agreement with BioScrip for its lead product, MuGard -- an FDA-approved, ready-to-use mucoadhesive oral wound rinse for the management of oral mucositis, a debilitating side effect of radiotherapy and/or chemotherapy.

20 Jul 2010

SDIX announces multi-year collaboration with Banyan Biomarkers

SDIX, today announced a multi-year collaboration with Banyan Biomarkers, Inc. to provide products and services for Banyan's biomarker discovery work in the detection of traumatic brain injury.

20 Jul 2010

StemCell Holding leads CHF 20 million investment in Pantec Biosolutions

Pantec Biosolutions AG, a privately-owned company developing innovative technologies for transdermal drug delivery, today announced the closing of a CHF 20 million investment achieved by two financing rounds. The StemCell Holding AG, an Austrian investment company in the life sciences sector, acted as lead investor.

20 Jul 2010

TCG releases Will-Call Rx system for accurate prescription pick up, inventory management

TCGRx announces the release of Will-Call Rx, a computerized system for hanging and retrieving will call prescriptions. Will-Call Rx uses energy efficient LED lights to identify prescription locations and barcode scanning ensures prescription verification, accurate prescription pick up and inventory management.

20 Jul 2010

Neogen fiscal 2010 net income increases 26% to $17.5M

Neogen Corporation announced today that its net income for its 2010 fiscal year, which ended May 31, increased 26% from the previous year to $17,521,000. Net income in the fiscal year increased to $0.76 per share, compared to the prior year's $0.61, adjusted for a 3-for-2 stock split that was effective Dec. 15, 2009.

20 Jul 2010

Winston Laboratories receives NOC for CIVANEX

Winston Laboratories, Inc., a wholly-owned subsidiary of Winston Pharmaceuticals, Inc., a pharmaceutical company focused on developing and commercializing novel pain management therapies, announced that it has received Notice of Compliance from the Therapeutics Drug Directorate, Health Canada for its New Drug Submission for CIVANEX (zucapsaicin cream 0.075%) for the treatment of the signs and symptoms of osteoarthritis.

20 Jul 2010

Archer Biosciences initiates third drug-escalation cohort in TPI-287 trial for metastatic melanoma

Archer Biosciences, Inc. announced that the trial of its novel, proprietary drug TPI-287 (an abeotaxane) for the treatment of metastatic melanoma has initiated a third drug-escalation cohort. The primary objective of this study is to determine the safety, tolerability and maximum tolerated dose (MTD) of TPI-287 in combination with temozolomide (TMZ) in adult patients with metastatic melanoma.

20 Jul 2010