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FDA accepts Protalix's taliglucerase alfa NDA, assigns PDUFA action date

Protalix BioTherapeutics, Inc., announced today that the Company's New Drug Application (NDA) for taliglucerase alfa has been accepted for review by the U.S. Food and Drug Administration (FDA). The FDA granted taliglucerase alfa a standard review time of ten months, assigning a Prescription Drug User Fee Act (PDUFA) action date of February 25, 2011.

12 Jul 2010

Lectures on DermaVir to be presented at International Conference on Nanosciences & Nanotechnologies

Julianna Lisziewicz, PhD, President of Genetic Immunity, a biopharmaceutical company developing nanomedicine-based immunotherapies, is an invited speaker at this week's 7th International Conference on Nanosciences & Nanotechnologies in Ouranoupolis Halkidiki, Greece. The conference gathers front-line researchers, scientists and industry experts specialized in nanotechnology applications. Leading experts such as Dr. Lisziewicz are invited to present lectures covering the latest research in this rapidly progressing field.

12 Jul 2010

Vaccine manufacturers may be able to produce lower-cost HPV vaccines, say researchers

Vaccine manufacturers in India and other developing countries may be able to produce a lower-cost HPV vaccine in spite of the complicated array of patent protections on the technology, say researchers at the Duke Institute for Genome Sciences & Policy. At a cost of at least $300 for the three-dose regimen, the blockbuster HPV vaccines, including Gardasil- from Merck and Cervarix- from GlaxoSmithKline, are some of the most expensive ever introduced.

12 Jul 2010

Discovery of antibodies that kill more than 90% of HIV viruses gives new hope for vaccine

"An effective vaccine against the AIDS virus may have moved one step closer to reality, researchers said Thursday," the Los Angeles Times reports. "Federal researchers have identified a pair of naturally occurring antibodies that are able to kill more than 90% of all strains of the AIDS virus, a finding they say could lead to the development of new treatments for HIV infections and to the production of the first successful vaccine against the virus" (Maugh, 7/9).

12 Jul 2010

FDA accepts to review sNDA for SPRYCEL for treating adult patients with CML

Bristol-Myers Squibb Company and Otsuka Pharmaceutical Co., Ltd. today announced that the U.S. Food and Drug Administration has accepted for filing and review the supplemental New Drug Application for SPRYCEL (dasatinib) for the treatment of adult patients with newly diagnosed chronic myeloid leukemia in chronic phase.

12 Jul 2010

CPhA welcomes announcement of agreement to lower generic drug prices

The Canadian Pharmacists Association today welcomed the announcement of an agreement reached between the Government of British Columbia, the British Columbia Pharmacy Association, and the Canadian Association of Chain Drug Stores to lower generic drug prices and invest in expanded pharmacy services.

12 Jul 2010

Glaxo’s diabetes pill Avandia under FDA scrutiny again

GlaxoSmithKline (GSK) is under Food and Drug Administration (FDA) scrutiny again. This is for its diabetes pill Avandia which is under review for the second time in three years.

11 Jul 2010

UM researcher uses computer algorithms to develop vaccines for new strains of influenza viruses

Defeating the flu is challenging because the virus responsible for the disease undergoes frequent changes of its genetic code, making it difficult for scientists to manufacture effective vaccines for the seasonal flu in a timely manner. Now, a University of Miami computer scientist, Dimitris Papamichail, and a team of researchers from Stony Brook University have developed a rapid and effective approach to produce vaccines for new strains of influenza viruses.

9 Jul 2010

HHS to give states $25 million for HIV drugs; Researchers identify antibodies that may help in AIDS vaccine research

Health and Human Services Secretary Kathleen Sebelius said Thursday "that she would provide $25 million more to help states buy life-saving medications for people with H.I.V. or AIDS. Advocates for patients said the money was not nearly enough to eliminate waiting lists, which have surged to record levels as people have lost health insurance, along with their jobs, and states have cut their budgets. Ms. Sebelius said she was 'reallocating and transferring $25 million in existing resources' to provide medicines for people on waiting lists.

9 Jul 2010

Natrol offers two new beauty nutraceuticals that provide anti-aging skin and hair support for women

Most dermatologists would agree that premature skin aging can result from sun over-exposure, poor antioxidant intake, and excess free-radical production. Additionally, regarding hair health, about 20 million U.S. women experience premature hair-loss and hair-thinning. Natrol, Inc., a premier marketer, manufacturer, and distributor of nationally branded nutritional products, now offers two new beauty nutraceuticals that help provide anti-aging skin and hair support for women -- one dietary supplement helps optimize skin radiance via antioxidant protection for the skin, and another helps maximize follicular growth for hair.

9 Jul 2010

Merck to lay off 15 percent of workers, close plants, research facilities

Drugmaker Merck announced it is closing eight research centers and eight manufacturing plants and laying off 15,000 people from its worldwide operations during the next two years because of its merger with Schering-Plough. "The restructuring is expected to save $2.7 billion to $3.1 billion in 2012, the company said. Meanwhile, the pretax cost of the initial phase of the cost-cutting program is expected to range from $3.5 billion to $4.3 billion, much of it in severance packages for employees."

9 Jul 2010

Data shows potential health benefits of S-equol in relieving menopausal symptoms

The findings of a scientific conference examining the growing body of research and potential health benefits of S-equol were published this month in the Journal of Nutrition. Manuscripts based on presentations made at the conference, which was organized by the Life Sciences Research Office, reveal data that S-equol is a safe, natural and effective solution to providing relief of menopausal symptoms such as hot flashes and muscle discomfort.

9 Jul 2010

EPO grants Brookhaven patent for use of vigabatrin in prevention of addiction to opioids

Catalyst Pharmaceutical Partners, Inc. today announced that the European Patent Office (EPO) granted to Brookhaven Science Associates/Brookhaven National Laboratory (Brookhaven) a European patent for the use of vigabatrin for the prevention of addiction to opioids (e.g., oxycodone, hydrocodone) used in pain management.

9 Jul 2010

Pfizer to present results of hemophilia studies at WFH 2010 Congress

Pfizer Inc, the world's leading biopharmaceutical company, today announced that the results of a number of hemophilia studies will be presented at the World Federation of Hemophilia 2010 Congress taking place July 10-14, 2010, in Buenos Aires, Argentina. Key research includes a pre-clinical evaluation of recombinant factor Xa as a potential new approach to restoring hemostasis, as well as a study assessing the potential for an engineered recombinant factor VIIa molecule to improve therapeutic outcomes in mouse models of hemophilia.

9 Jul 2010

Semuloparin reduces incidence of VTE in orthopedic surgery patients, study finds

An ultra-low-molecular-weight heparin called semuloparin has been found to reduce the incidence of venous thromboembolism in orthopedic surgery patients in a large clinical program being lead by a steering committee chaired by McMaster University professor Dr. Alexander Turpie.

9 Jul 2010

Derma Sciences submits 510(k) application to FDA for MEDIHONEY Gel Wound & Burn Dressing

Derma Sciences, Inc., a medical device and pharmaceutical company focused on advanced wound care, announces the achievement of regulatory and commercial milestones.

9 Jul 2010

Allergan receives UK MHRA authorisation of BOTOX for prophylaxis of headache in chronic migraine

Allergan is pleased to announce that BOTOX® (botulinum toxin type A) has been licensed by the MHRA in the UK for the prophylaxis of headaches in adults who have chronic migraine (headaches on at least 15 days per month of which at least 8 days are with migraine). This is the first licence worldwide of BOTOX® for this indication, and is also the first prophylactic (preventative) treatment to receive a specific licence for patients with chronic migraine.

9 Jul 2010

Patients with advanced Parkinson's disease prefer dopamine agonists, shows review

Of the three main types of oral drugs commonly added to levodopa therapy for patients with advanced Parkinson's disease, one might be the most effective, according to a new review.

9 Jul 2010

Hormonal contraceptives are less effective for birth control in overweight or obese women: Study

As obesity continues to be a worldwide health risk, one of its "side effects" could include less effective birth control for overweight and obese women who use hormonal contraceptives.

9 Jul 2010

Accudial's weight-based rotating labels prevent underdosing and overdosing in children's OTC medications

There is plenty to worry about when it comes to the job of parenting. However, wondering if a child is receiving the correct amount of over-the-counter (OTC) medication can now be a concern of the past, thanks to Children's AccuDial(R), a patented new line of children's medication available across Canada, with a dosing system based on body weight, not age.

9 Jul 2010

Pharmaceutical News

FDA accepts Protalix's taliglucerase alfa NDA, assigns PDUFA action date

Lectures on DermaVir to be presented at International Conference on Nanosciences & Nanotechnologies

Vaccine manufacturers may be able to produce lower-cost HPV vaccines, say researchers

Discovery of antibodies that kill more than 90% of HIV viruses gives new hope for vaccine

FDA accepts to review sNDA for SPRYCEL for treating adult patients with CML

CPhA welcomes announcement of agreement to lower generic drug prices

Glaxo’s diabetes pill Avandia under FDA scrutiny again

UM researcher uses computer algorithms to develop vaccines for new strains of influenza viruses

HHS to give states $25 million for HIV drugs; Researchers identify antibodies that may help in AIDS vaccine research

Natrol offers two new beauty nutraceuticals that provide anti-aging skin and hair support for women

Merck to lay off 15 percent of workers, close plants, research facilities

Data shows potential health benefits of S-equol in relieving menopausal symptoms

EPO grants Brookhaven patent for use of vigabatrin in prevention of addiction to opioids

Pfizer to present results of hemophilia studies at WFH 2010 Congress

Semuloparin reduces incidence of VTE in orthopedic surgery patients, study finds

Derma Sciences submits 510(k) application to FDA for MEDIHONEY Gel Wound & Burn Dressing

Allergan receives UK MHRA authorisation of BOTOX for prophylaxis of headache in chronic migraine

Patients with advanced Parkinson's disease prefer dopamine agonists, shows review

Hormonal contraceptives are less effective for birth control in overweight or obese women: Study

Accudial's weight-based rotating labels prevent underdosing and overdosing in children's OTC medications

Advancing brain microphysiological systems (bMPS)

PhD researcher at LifeArc

Unveiling Hidden Potential: Organoids for Disease Modeling in Neuroscience Research

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