News Update
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7/28/2010
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UCB announces clinically significant benefit for Neupro®
Brussels, Belgium — UCB has announced the results of its clinical study of Neupro, a rotigotine transdermal system (2mg and 3mg per 24 hours). The study showed sustained, clinically relevant improvements in symptoms of Restless Legs Syndrome (RLS) as well as high rates of complete remission. The most adverse events were mild to moderate in intensity, the most common of which being application site-reactions (27% rotigotine versus 5% placebo), nausea (18.1% rotigotine versus 10% placebo), and headache (11.6% rotigotine versus 8% placebo).
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7/27/2010
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Antares Pharma announces positive results from Phase 3 study of Anturol™ Gel
Ewing, New Jersey, USA — Antares Pharma, Inc has announced positive results from a Phase 3 study of its Anturol Gel, which uses its proprietary ATD Gel technology, in patients with overactive bladder (OAB). The study showed a statistically significant reduction in episodes of urinary incontinence for both doses studied. By the fourth quarter of 2010, the company will complete an open-label extension study, evaluating long-term safety. Additionally, subjects tolerated the drug well. No serious adverse events related to treatment took place. Anticholinergic side effects such as dry mouth and constipation were low, and compared to placebo, no CNS (Central Nervous System) side effects occurred.
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7/26/2010
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Zyleris PharmaTech announces high-throughput, formulation-screening service
Lake Bluff, Illinois, USA — Zyleris PharmaTech has announced its new high-throughput, formulation-screening service for topical and transdermal drug development. The technology uses the Franz Cell principle in a high-throughput fashion, which is at least 20 times faster than the present industrial standard and lowers costs up to 90% per formulation. The service also provides higher detection sensitivity than Franz Cell technology. Zyleris' technology offers compact design, a flexible diffusion area suitable for percutaneous absorption and permeation studies, glass-and-Teflon construction, and an easy mechanism for sample collection.
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7/22/2010
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Arcion Therapeutics' topical gel demonstrates significant pain reduction
Baltimore, Maryland, USA — Arcion Therapeutics has announced results from a successful Phase 2b clinical trial of its lead topical pain candidate, ARC-4558, in adult patients with painful diabetic neuropathy (PDN). ARC-4558 is a 0.1% gel formulation of clonidine hydrochloride for topical administration. The ARC-4558 program will begin Phase 3 studies now. ARC-4558 was most effective in reducing pain in subjects with evidence of preserved nociceptors, nerve fibers responsible for pain signaling, in the skin. Subjects in the ARC-4558 group with at least minimal nociceptor function had significantly more reduction of pain than subjects in the placebo group (p<0.05). The significance of the response increased with higher levels of nociceptors in the subject's skin (p<0.005). ARC-4558 did not demonstrate efficacy in subjects without evidence of preserved nociceptor function.
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7/21/2010
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Nanoparticles in ivy may hold key to making sunscreen safer
Knoxville, Tennessee, USA — Researchers in biomedical engineering at the University of Tennessee, Knoxville have found that ivy nanoparticles may protect skin from UV radiation at least four times better than the metal-based sunblocks. The scientists placed the yellowish material that ivy secretes for surface climbing on a silicon wafer and examined it under an atomic-force microscope. They found many nanoparticles, which provide the leaves of the vine with the ability to hold almost two-million times its weight. In addition, they found that ivy nanoparticles are more uniform than metal-based nanoparticles and have unique material properties that may help to enhance the absorption and scattering of light, therefore serving as a better sunblocker.
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7/20/2010
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Pantec Biosolutions closes financing for P.L.E.A.S.E.® IVF
Ruggell, Liechtenstein — Pantec Biosolutions AG has announced the closing of a CHF 20-million investment in two financing installments, with the StemCell Holding AG as lead investor. StemCell is an Austrian investment company. Pantec will use the funds from the first round to drive development of the company's two proprietary, transdermal candidates that work in combination with its P.L.E.A.S.E. (Painless Laser Epidermal System). The products are hormone patches for In-Vitro Fertilization (IVF) therapy. The monies will support development up to market approval and also will fund the market launch of Pantec's new P.L.E.A.S.E.® Professional product line for dermatological applications.
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7/20/2010
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Shire issues nonsafety voluntary recall for Daytrana ® patches
Dublin, Ireland — Shire voluntarily has recalled one lot of its Daytrana [Attention-Deficit Hyperactivity Disorder (ADHD)] patch and has conducted a voluntary market withdrawal of ten lots. These actions occurred because some Daytrana patches do not meet, or in the future, may not meet liner-removal specifications, and as a result, patients and caregivers could have difficulty removing the liners. These actions do not relate to the safety of the patches.
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7/19/2010
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FDA approves Mylan's generic patch
Pittsburgh, Pennsylvania, USA — The US FDA has approved Mylan Inc's ANDA for a generic version of its patch, a Clonidine transdermal system for treatment of high blood pressure. Boehringer Ingelheim makes the brand-name version of the drug. The product is available for immediate shipment.
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7/15/2010
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Merck completes acquisition of Millipore
Billerica, MA/Darmstadt, Germany — Merck KGaA has announced completion of its acquisition of Millipore Corporation, stating an aggregate purchase price including debt and cash of approximately $7.0 billion. Millipore's shareholders approved the transaction at a special meeting held on June 3, 2010. EMD Millipore, or Merck Millipore outside USA and Canada, employs 10,000 people in 64 countries and had revenues of $2.9 billion in fiscal year 2009. Headquartered in Billerica, Massachusetts, the new division will offer a range of products, technologies, and services that help pharma and biotech companies, as well as scientists in academia, to improve productivity in the laboratory and to develop and optimize manufacturing processes.
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7/14/2010
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Millipore Corporation and BioOutsource Ltd collaborate
Billerica, Massachusetts, USA — Millipore Corporation has announced that the company has formed a strategic alliance with BioOutsource Ltd. This collaboration will enable Millipore — with its state-of-the-art cGMP facility in Leiden, the Netherlands — and BioOutsource — with its custom-built cGMP facility in Glasgow, UK — to bring a full range of biosafety services to industrial clients.
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7/13/2010
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BioSante Pharmaceuticals announces LibiGel® study
Lincolnshire, Illinois, USA — BioSante Pharmaceuticals, Inc has announced the start of a clinical trial to evaluate the effect of LibiGel (testosterone gel) on cognitive function in menopausal women. The trial will compare LibiGel to placebo treatment on a variety of learning and memory tasks.
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7/12/2010
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World Health Organization (WHO) uses Bioject's intradermal system
Tualatin, Oregon, USA — Bioject Medical Technologies Inc has announced that the WHO's clinical trial has demonstrated that intradermal administration of fractional doses of inactivated poliovirus vaccine is safe and effective for infants, using seroconversion as an indication of effectiveness. They indicate that both healthcare administrators and parents prefer it over the typical full-dose needle and syringe. The study also demonstrated a significant savings in use of the system as compared to use of an auto-disable needle and syringe. The study used Bioject's Biojector®2000 (B2000) needle-free-injection delivery device to administer the intradermal fractional-dose.
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7/10/2010
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Drug delivery system uses nanoparticles triggered by electromagnetic field
Kingston, Rhode Island, USA — Chemical engineers at the University of Rhode Island have developed a new system for the controlled delivery of pharmaceutical drugs using nanoparticles embedded in a liposome that can be triggered by noninvasive electromagnetic fields. When the researchers mix lipids and nanoparticles in a solvent, add water, and evaporate off the solvent, the materials automatically assemble themselves into liposomes. This process joins the hydrophobic nanoparticles and lipids to form the shell of the liposome and captures the hydrophilic drug molecules inside the spherical shell. The researchers embed superparamagnetic, iron-oxide nanoparticles in the shell of the liposome, which makes the shell leaky. The system releases the drug by heat-activating the shell in an alternating-current, electromagnetic field operating at radio frequencies.
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7/7/2010
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Nexmed meets requirements for NASDAQ listing
San Diego, California, USA — NexMed, Inc has announced that the company has met the applicable requirements for listing on the NASDAQ stock market. The company had received a letter, dated July 6, 2010, from the NASDAQ Hearings Panel, stating that it has regained its listing. On January 26, 2010, the NASDAQ Listing Qualifications staff notified NexMed that the company no longer satisfied the minimum requirement for bid price.
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