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FDA grants orphan drug designation for Synageva BioPharma's SBC-102

Synageva BioPharma Corp., a privately held biopharmaceutical company, announced that the U.S. Food and Drug Administration has granted orphan drug designation for SBC-102, the Company's enzyme replacement therapy in development to treat Lysosomal Acid Lipase Deficiency, also known as Wolman Disease and Cholesteryl Ester Storage Disease, a condition for which there is currently no approved treatment.

7 Jul 2010

Neoprobe initiates third multi-center Phase 3 clinical study of Lymphoseek

Neoprobe Corporation, a diversified developer of innovative oncology surgical and diagnostic products, today announced that a third multi-center Phase 3 clinical study of Lymphoseek (NEO3-09) has received investigational review board approval and begun enrollment of subjects diagnosed with breast cancer or melanoma.

7 Jul 2010

SDI Pharmaceutical Company Image 2010 study: Novo Nordisk ranked top among endocrinologists

According to SDI's Pharmaceutical Company Image 2010 study, Novo Nordisk was ranked by endocrinologists as the top company overall. The company was mentioned by 62% of the endocrinologists who participated in the annual study - a substantial increase from last year, when it was mentioned by 52% of participants and ranked second.

7 Jul 2010

Investment report on Hemispherx BioPharma

MicroStockProfit.com announces an investment report featuring Hemispherx BioPharma Inc.. The report includes financial, comparative and investment analyses, and recent company news that you need to know to make an educated investment decision.

7 Jul 2010

Cipher Pharmaceuticals reaches cumulative sales milestone for Lipofen

Cipher Pharmaceuticals Inc. today announced that it reached a cumulative sales milestone for Lipofen, the Company's fenofibrate product. Achieving this target triggers a US$1.0 million milestone payment from Kowa Pharmaceuticals America Inc., Cipher's U.S. marketing and distribution partner, which will be reflected in Cipher's revenue for the second quarter of fiscal 2010.

7 Jul 2010

Alnylam Pharmaceuticals initiates dosing in Phase I human clinical study with ALN-TTR01

Alnylam Pharmaceuticals, Inc., a leading RNAi therapeutics company, announced today it has initiated dosing in a Phase I human clinical study with ALN-TTR01. The study is aimed at evaluating the safety and tolerability of ALN-TTR01 in patients with transthyretin -mediated amyloidosis, and is also designed to provide preliminary data on human proof of concept based on measurements of TTR serum levels.

7 Jul 2010

Nile completes dosing in CD-NP Phase II study for acute decompensated heart failure

Nile Therapeutics, Inc., a biopharmaceutical company focused on the development of novel therapeutics for cardiovascular disease, today announced that it has completed the dosing of the last patient in NIL-CDNP-CT005, an open-label, single-blind, placebo-controlled Phase II study of CD-NP in patients with acute decompensated heart failure, or ADHF. The study was designed to provide additional information on the safety and tolerability of CD-NP when infused for up to 72 hours in patients with ADHF and mild to moderate renal insufficiency.

7 Jul 2010

Drug use debilitates sexual response: Study

Sharing a bottle of red wine may seem like the best recipe for a romantic interlude. However, the evening may not turn out as planned according to a Concordia University study, which evaluated the effect of a wide range of drugs, including alcohol, on sexual behaviour. The findings, published in the journal Hormones and Behavior, definitively show that despite our preconceived notions, use of many recreational drugs can cause a loss in that lovin' feeling.

7 Jul 2010

Epeius Biotechnologies receives notice of allowance from USPTO for gene delivery platform

Epeius Biotechnologies Corporation, an emerging leader in the field of targeted genetic medicine, received a notice of allowance from the USPTO for another crucial patent covering its leading tumor-targeted gene delivery platform. The issuance of this high-value patent protection for targeting metastatic disease follows on the heels of two major patent issuances covering tumor-targeted gene delivery and precision-targeted cancer immunotherapy, respectively.

7 Jul 2010

Research could lead to remote stimulation of cells to treat cancer or diabetes

Clusters of heated, magnetic nanoparticles targeted to cell membranes can remotely control ion channels, neurons and even animal behavior, according to a paper published by University at Buffalo physicists in Nature Nanotechnology.

7 Jul 2010

Stand-By Systems now eligible to sell products to federal government

Emerging Healthcare Solutions, Inc. disclosed today that Stand-By Systems has favorably completed their US Government Central Contractor Registration and is now eligible to sell their breakthrough products to the federal government. EHSI has verified the federal eligibility as part of their due diligence related to an option with Stand-By Systems (SBS), owner of the FDA approved SBS 1615 catalytic oxygen generator and associated systems. The option agreement allows EHSI management to perform due diligence prior to finalizing a definitive agreement.

7 Jul 2010

Combination of Biothera's Imprime PGG and Erbitux doubles response rate in colorectal cancer patients

The combination of Biothera's experimental drug Imprime PGG® and Erbitux® (cetuximab) doubled the historical overall response rate and the time to progression of second- and third-line metastatic colorectal cancer patients treated with Erbitux monotherapy. The data was released last weekend at the 13th World Congress on Gastrointestinal Cancer at the European Society for Medical Oncology (ESMO).

7 Jul 2010

Aquapharm Biodiscovery signs research agreement with AMRI

Aquapharm Biodiscovery, a leading marine biotechnology company, announced today it has signed a research agreement with Albany Molecular Research to identify novel drug-like compounds and scaffolds with anti-microbial and anti-inflammatory activity from Aquapharm's marine natural products library derived from its extensive collection of marine micro-organisms.

7 Jul 2010

Apicore files DMF for Fondaparinux Sodium API with U.S. FDA

Apicore LLC announced today that they filed a drug master file (DMF) for Fondaparinux Sodium active pharmaceutical ingredient (API) with the U.S. Food and Drug Administration (FDA) on June 28, 2010.

7 Jul 2010

FDA grants Fougera first generic approval for Adapalene Cream 0.1%

E. Fougera & Co., a leading specialty pharmaceutical manufacturer, announced it has received first generic approval from the FDA for Adapalene Cream 0.1% (Rx). Fougera's Adapalene Cream 0.1% is rated AB, generically equivalent to Differin® by Galderma Pharmaceuticals. According to industry data, U.S. sales of the brand named product in 2009 exceeded $55 million. This approval also marks the fourth product approval that the FDA has granted to Fougera this year.

7 Jul 2010

WHO H1N1 response probe's second meeting highlights divergent views

The independent team of health experts responsible for reviewing the WHO's response to H1N1 (swine flu) wrapped up a second round of public hearings on Friday, "during which members heard testimony from widely divergent groups, from health officials to some of its most public critics," CIDRAP News reports.

7 Jul 2010

Caraco Pharmaceutical Laboratories commences shipping azelastine ophthalmic solution

Caraco Pharmaceutical Laboratories, Ltd. has started shipping azelastine ophthalmic solution, 0.05%. This product was recently approved by the US Food and Drug Administration (FDA) for Sun Pharma's Abbreviated New Drug Application (ANDA).

7 Jul 2010

Shire receives FDA approval of Daytrana for ADHD in adolescents

Shire plc, the global specialty biopharmaceutical company, announced the US Food and Drug Administration (FDA) approval of Daytrana® (methylphenidate transdermal system) for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adolescents aged 13 to 17 years. Daytrana, the first and only transdermal ADHD patch, is already an FDA-approved ADHD treatment for children 6 to 12 years. Daytrana is indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, and social).

7 Jul 2010

Phase Ia clinical trial of SYL040012 for treating elevated intraocular pressure, glaucoma completed

Sylentis, a biopharmaceutical subsidiary of Grupo Zeltia and a pioneer in the research and development of new drugs based on gene silencing (interference RNA, RNAi), has completed Phase Ia of its first clinical trial with SYL040012 in the form of ophthalmic drops to treat elevated intraocular pressure and glaucoma.

7 Jul 2010

Pfizer's new chewable Lipitor for children receives European Commission approval

Pfizer Inc. announced it has received European Commission approval of a new chewable form of Lipitor (atorvastatin calcium) suitable for use in children aged 10 or older with high levels of LDL ("bad") cholesterol and high triglycerides due to the inherited disorder familial hypercholesterolemia and other primary causes, which can increase the risk of heart disease and premature death. This pediatric indication has also been approved for the currently available tablet form of Lipitor.

7 Jul 2010

Pharmaceuticals News and Research

FDA grants orphan drug designation for Synageva BioPharma's SBC-102

Neoprobe initiates third multi-center Phase 3 clinical study of Lymphoseek

SDI Pharmaceutical Company Image 2010 study: Novo Nordisk ranked top among endocrinologists

Investment report on Hemispherx BioPharma

Cipher Pharmaceuticals reaches cumulative sales milestone for Lipofen

Alnylam Pharmaceuticals initiates dosing in Phase I human clinical study with ALN-TTR01

Nile completes dosing in CD-NP Phase II study for acute decompensated heart failure

Drug use debilitates sexual response: Study

Epeius Biotechnologies receives notice of allowance from USPTO for gene delivery platform

Research could lead to remote stimulation of cells to treat cancer or diabetes

Stand-By Systems now eligible to sell products to federal government

Combination of Biothera's Imprime PGG and Erbitux doubles response rate in colorectal cancer patients

Aquapharm Biodiscovery signs research agreement with AMRI

Apicore files DMF for Fondaparinux Sodium API with U.S. FDA

FDA grants Fougera first generic approval for Adapalene Cream 0.1%

WHO H1N1 response probe's second meeting highlights divergent views

Caraco Pharmaceutical Laboratories commences shipping azelastine ophthalmic solution

Shire receives FDA approval of Daytrana for ADHD in adolescents

Phase Ia clinical trial of SYL040012 for treating elevated intraocular pressure, glaucoma completed

Pfizer's new chewable Lipitor for children receives European Commission approval

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