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FDA grants tentative approval for Teva Pharmaceutical Industries' generic Argatroban ANDA

Teva Pharmaceutical Industries Ltd. announced today that the U.S. Food and Drug Administration (FDA) has granted tentative approval for the Company's Abbreviated New Drug Application (ANDA) to market a generic version of the anticoagulant, Argatroban® injection, 100mg/mL.

26 Mar 2010

FDA approves Mirapex ER tablets for signs and symptoms of idiopathic PD

Boehringer Ingelheim Pharmaceuticals, Inc., today announced that the U.S. Food and Drug Administration has approved once-daily Mirapex ER® (pramipexole dihydrochloride) extended-release tablets for the signs and symptoms of idiopathic Parkinson's disease, which includes early and advanced PD. PD is the second most common chronic neurological disorder in older adults after Alzheimer's. Parkinson's disease has no cure.

26 Mar 2010

Dyax to use proceeds of public offering for commercialization and distribution activities of KALBITOR

Dyax Corp. today announced the pricing of an underwritten public offering of 17,000,000 shares of its common stock at a price to the public of $3.25 per share. The gross proceeds from the sale of shares, after underwriting discounts and commissions and estimated offering expenses, are expected to be approximately $51.8 million. The offering is expected to close on or about March 30, 2010, subject to customary closing conditions.

26 Mar 2010

New research may help advance treatment strategies for common liver disease

A research article published in the journal PloS Pathogens could lead to improvements in the production of vaccines for hepatitis A, the most widespread viral disease in the world.

26 Mar 2010

Standard HCV therapy less effective in urban minority patients: Study

A recent study confirms that the standard hepatitis C therapy, pegylated interferon and ribavirin, is significantly less effective in urban minority patients treated in an ordinary clinical practice setting compared with results produced during clinical trials.

26 Mar 2010

AVASTIN receives Health Canada approval for patients with GBM

Roche Canada announced today that Health Canada has approved AVASTIN(R) (bevacizumab), as a single agent, for the treatment of patients with glioblastoma multiforme, the most aggressive primary malignant brain tumour, after relapse or disease progression, following prior therapy.

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

New initiative to reduce prescription drug abuse

With overdoses and deaths involving the use of prescription drugs skyrocketing in the United States, the Department of Justice (DOJ) has selected the Heller School for Social Policy and Management at Brandeis University to host a new initiative to reduce diversion and abuse of these drugs: the PMP Center of Excellence.

26 Mar 2010

Children with severe food allergic reactions need two doses of epinephrine

In a large six-year review of emergency department (ED) data, researchers at Children's Hospital Boston, in collaboration with Massachusetts General Hospital, found that many children with severe food-related allergic reactions need a second dose of epinephrine, suggesting that patients carrying EpiPens should carry two doses instead of one.

25 Mar 2010

Techulon, UC sign worldwide exclusive license agreements to market Glycofect-Transfection Reagent

Techulon Inc., a life sciences company, has signed worldwide exclusive license agreements with the University of Cincinnati to manufacture and sell novel transfection reagents used for research and therapeutic delivery of nucleic acids.

25 Mar 2010

Public and private sectors fund bioprocessing research for drug development

The search for new medicines will receive a £10M boost this week as the public and private sectors unite to fund bioprocessing research. The money is now available for scientists to apply for from the Bioprocessing Research Industry Club (BRIC) which aims to bring academics and industry together to find ways of delivering new medicines from biological materials more quickly and effectively.

25 Mar 2010

Glaxosmithkline, Pfizer will supply 60M doses of reduced-price pneumococcal vaccines to developing countries over 10 years, GAVI says

The GAVI Alliance on Tuesday formally announced that drugmakers GlaxoSmithKline and Pfizer had signed off on a "10-year deal … to supply 60 million doses a year of cut-price pneumococcal vaccines to developing nations," Reuters reports.

25 Mar 2010

EMA accepts MAA filing of ViroPharma's Cinryze for HAE

ViroPharma Incorporated today announced that the European Medicines Agency (EMA) has accepted the filing of its Marketing Authorization Application for Cinryze for acute treatment and prophylaxis against hereditary angioedema, which was submitted through the centralized procedure in March 2010. ViroPharma is seeking European approval for both prevention and treatment of acute attacks of hereditary angioedema.

25 Mar 2010

Clinic sites seek gay men to participate in HIV vaccine study

Clinic sites in 13 cities across the U.S. are looking for a total of 1,350 HIV-negative gay men to participate in the latest HIV vaccine study from the HIV Vaccine Trials Network (HVTN). And they're using social media to help reach these individuals where they are, which, these days, is increasingly online.

25 Mar 2010

Research could pave way for new generation of painkillers

An international group of scientists led by Dr Nikita Gamper of the University's Faculty of Biological Sciences has discovered how two proteins play a key role in the way we feel pain, offering new targets on which drug development can be focused.

25 Mar 2010

Hepatic encephalopathy drug XIFAXAN 550 mg tablets receives FDA marketing approval

Salix Pharmaceuticals, Ltd. today announced the U.S. Food and Drug Administration has granted marketing approval for XIFAXAN 550 mg tablets for reduction in risk of overt hepatic encephalopathy recurrence in patients 18 years of age or older. HE is a serious disorder caused by chronic liver failure, resulting in cognitive, psychiatric and motor impairments. This approval was supported by findings from the largest randomized trial of maintenance therapy in HE conducted to date, which assessed the efficacy and safety of XIFAXAN 550 mg tablets and demonstrated a statistically significant and clinically meaningful reduction in the risk of overt HE recurrence.

25 Mar 2010

Clinical data of dendritic cell based vaccine to be presented at Cancer Stem Cells Conference

ImmunoCellular Therapeutics announced today that Manish Singh, Ph.D., President and CEO, will be presenting at the Cancer Stem Cells Conference, a leading industry event, on Wednesday, March 24th at 2:00 p.m. eastern time.

25 Mar 2010

Experimental vaccine can help delay IBD and colon cancer

An experimental vaccine against an abnormal protein found in some tumors has the potential to delay the onset of inflammatory bowel disease (IBD) and in turn prevent progression to colon cancer, according to researchers at the University of Pittsburgh School of Medicine.

25 Mar 2010

China set to dominate prescription drug markets

New reports indicate that prescription drug sales in emerging markets will grow quickly, especially in the hugely influential market of China. In fact, China's pharmaceutical market continues to expand its dominance and clout at an astonishing rate.

25 Mar 2010

Pernix Therapeutics Holdings acquires oral third-generation cephalosporin, CEDAX

Pernix Therapeutics Holdings, Inc. today announced the acquisition of the antibiotic CEDAX® (ceftibuten) from Shionogi Pharma, Inc.

25 Mar 2010

Pharmaceutical News

FDA grants tentative approval for Teva Pharmaceutical Industries' generic Argatroban ANDA

FDA approves Mirapex ER tablets for signs and symptoms of idiopathic PD

Dyax to use proceeds of public offering for commercialization and distribution activities of KALBITOR

New research may help advance treatment strategies for common liver disease

Standard HCV therapy less effective in urban minority patients: Study

AVASTIN receives Health Canada approval for patients with GBM

JCOM receives approval from KFDA to commercialize MuGard in Korea

New initiative to reduce prescription drug abuse

Children with severe food allergic reactions need two doses of epinephrine

Techulon, UC sign worldwide exclusive license agreements to market Glycofect-Transfection Reagent

Public and private sectors fund bioprocessing research for drug development

Glaxosmithkline, Pfizer will supply 60M doses of reduced-price pneumococcal vaccines to developing countries over 10 years, GAVI says

EMA accepts MAA filing of ViroPharma's Cinryze for HAE

Clinic sites seek gay men to participate in HIV vaccine study

Research could pave way for new generation of painkillers

Hepatic encephalopathy drug XIFAXAN 550 mg tablets receives FDA marketing approval

Clinical data of dendritic cell based vaccine to be presented at Cancer Stem Cells Conference

Experimental vaccine can help delay IBD and colon cancer

China set to dominate prescription drug markets

Pernix Therapeutics Holdings acquires oral third-generation cephalosporin, CEDAX

PhD researcher at LifeArc

Unveiling Hidden Potential: Organoids for Disease Modeling in Neuroscience Research

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