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Scientific/technical review for XIAFLEX' European MAA commences

BioSpecifics Technologies Corp., a biopharmaceutical company developing first in class collagenase-based products, today announced that its partner Auxilium Pharmaceuticals, Inc. announced that Pfizer Inc. received notification from the European Medicines Agency that the Marketing and Authorization Application (MAA) for XIAFLEX™ for the treatment of Dupuytren's disease (a debilitating disorder resulting from excessive collagen deposition that causes contractures of the fingers) has completed the validation phase successfully and that the scientific/technical review procedure commenced today.

21 Jan 2010

Teva Pharmaceutical Industries receives FDA tentative approval for generic Femara Tablets

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 its generic version of Novartis’ breast cancer treatment Femara® (letrozole) Tablets, 2.5 mg. Final approval of Teva’s Letrozole Tablets is expected upon expiry of patent protection for the brand product in June 2011.

21 Jan 2010

US FDA grants tentative approval for LPI's Memantine HCl tablets

Lupin Pharmaceuticals, Inc. (LPI) announced today that it has received tentative approval from the US Food and Drug Administration (US FDA) for its Memantine Hydrochloride tablets, 5mg and 10mg.

21 Jan 2010

Depomed receives second $500,000 milestone payment from Covidien

Depomed, Inc. announced today that it has received a second $500,000 milestone payment under its worldwide license agreement with Covidien focusing on the exclusive development of four acetaminophen/opioid analgesic combination products utilizing Depomed’s Acuform® gastric retentive drug delivery technology. The most recent payment from Covidien, which was received in December 2009, relates to the development of a formulation for the second product candidate under the collaboration.

21 Jan 2010

MDRNA to receive European patent for its intranasal insulin formulation

MDRNA, Inc., a leading RNAi-based drug discovery and development company, today announced that the European Patent Office intends to grant a patent for application EP06826368 covering formulations for the intranasal delivery of rapid acting insulin, and its use for the treatment of diabetes.

21 Jan 2010

Phase Forward releases Empirica Signal version 7.2 signal detection and management software

Phase Forward, a leading provider of data solutions for clinical trials and drug safety, today announced the availability of version 7.2 of its Empirica™ Signal product, a significant new release of the company’s flagship signal detection and management software. The Empirica Signal solution is a state-of-the-art data mining and knowledge management tool and a cornerstone component of Phase Forward’s Empirica Suite of pharmacovigilance and risk management products.

21 Jan 2010

Symbollon Pharmaceuticals to launch IoGen women's breast health dietary supplement in February

Symbollon Pharmaceuticals, Inc. has announced today that the retail launch of IoGen™, its dietary supplement for women's breast health, will commence in February. IoGen™ is the first dietary supplement formulated to promote breast health for women. Initially, the Company plans to market IoGen™ through its own retail web site, which is currently being developed by Atech Solutions.

21 Jan 2010

Health care companies assess where they stand on health reform after election

The Wall Street Journal reports that several firms reiterated support for a health care reform bill Wednesday, a day after the overhaul's viability was called into question by the victory of Republican Sen.-elect Scott Brown in Massachusetts. "PhRMA, the drug industry association, as well as companies including Pfizer Inc., Johnson & Johnson, WellPoint Inc. and Humana Inc., voiced support for an overhaul of some kind, despite objections among insurers about the efforts to date."

21 Jan 2010

Pfizer and Auxilium Pharmaceuticals announce completion of European MAA validation phase for XIAFLEX

Pfizer Inc. and Auxilium Pharmaceuticals, Inc. today announced that Pfizer received notification from the European Medicines Agency that the Marketing Authorization Application (MAA) for XIAFLEX™ (collagenase clostridium histolyticum), a novel, first-in-class, biologic for the treatment of Dupuytren’s contracture (a condition resulting in the contracture of the fingers into the palm), has completed the validation phase successfully. As a result, the scientific/technical review procedure commenced on 21 January 2010.

21 Jan 2010

Illicit drug consumption in Europe

Europeans belong to the largest consumers of illicit drugs, absorbing about one fifth of the global heroin, cocaine and cannabis supply, as well as one third of ecstasy production (UNODC World Drug report, 2008). However, the vast majority of Europeans have never tried any illicit substance. In popular perception, illicit drugs still represent alien cultures challenging traditional European patterns, including consumption of our favourite drugs - alcoholic beverages.

21 Jan 2010

Moxifloxacin more favorable than amoxicillin/clavulanate for COPD exacerbations

Chronic obstructive pulmonary disease (COPD) affects a large number of subjects worldwide and is characterised by a progressively rising epidemiological, clinical and socio-economic impact. The objectives of treatment are to decrease the burden of the disease through relief of symptoms, improvement of exercise tolerance, and prevention and treatment of exacerbations.

21 Jan 2010

Tufts CSDD: Orphan product designations increased up to 425 in 2006-08

The number of orphan product designations in the U.S. more than doubled during the last decade, reflecting growing interest by pharmaceutical and biotech companies in developing products to treat orphan diseases, according to a study recently completed by the Tufts Center for the Study of Drug Development.

21 Jan 2010

Men who buy fake internet drugs for ED problems face significant health risks

Men who buy fake internet drugs for erection problems can face significant risks from potentially hazardous contents and bypassing healthcare systems could leave associated problems like diabetes and high blood pressure undiagnosed.

21 Jan 2010

Global health community to be engaged in using resources of GSK and Alnylam IP Pool

BIO Ventures for Global Health, GlaxoSmithKline (GSK), and Alnylam announced today that the organizations are partnering to engage the global health community in using the powerful resources of the GSK and Alnylam Intellectual Property (IP) Pool.

21 Jan 2010

ABC publishes Pycnogenol monograph

The nonprofit American Botanical Council (ABC) has just published a monograph summarizing selected scientific and clinical studies of Pycnogenol®, a patented dietary ingredient from French maritime pine bark.

21 Jan 2010

Getting vaccinated within five days after exposing to chickenpox prevents chickenpox

For people who haven't had chickenpox and are exposed to an ill family member, getting vaccinated within five days can reduce the risk of developing chickenpox—or at least reduce the severity of disease, reports a study in the January issue of The Pediatric Infectious Disease Journal.

21 Jan 2010

Lupin's Mandideep facility receives FDA clearance

Pharma major, Lupin Ltd announced today that it has received official communication from the US FDA on the satisfactory resolution of the Warning Letter issued earlier to its Mandideep site. The company had received a Warning letter for its Mandideep site in May 2009. In the ensuing seven months, the company made significant enhancements and took appropriate corrective actions.

21 Jan 2010

Ipsen enters into partnership agreement with Inspiration Biopharmaceuticals

Ipsen and Inspiration Biopharmaceuticals, Inc. (Inspiration) today announced that they have entered into a partnership to create a world leading hemophilia franchise. The partnership is designed to leverage combined expertise and resources to advance a broad portfolio of recombinant proteins, which address all major hemophilia disorders in a unique way by focusing on two significant unmet needs: wider access to treatment with coagulation factors and treatment for inhibitor complications.

21 Jan 2010

Acyclovir does not reduce risk of HIV transmission for people infected with both HIV and HSV-2

A five-year international multi-center clinical trial has found that acyclovir, a drug widely used as a safe and effective treatment taken twice daily to suppress herpes simplex virus-2 (HSV-2), which is the most common cause of genital herpes, does not reduce the risk of HIV transmission when taken by people infected with both HIV and HSV-2.

21 Jan 2010

Aetna and Walgreens collaborate to educate people on taking adequate levels of Vitamin D

Aetna (NYSE: AET) and Walgreens announced today that they have joined forces to educate people about the need to take in adequate levels of Vitamin D. The two organizations are working with United Way of the Midlands on a Vitamin D giveaway program being piloted in Richland and Lexington counties in South Carolina.

21 Jan 2010

Pharmaceutical News

Scientific/technical review for XIAFLEX' European MAA commences

Teva Pharmaceutical Industries receives FDA tentative approval for generic Femara Tablets

US FDA grants tentative approval for LPI's Memantine HCl tablets

Depomed receives second $500,000 milestone payment from Covidien

MDRNA to receive European patent for its intranasal insulin formulation

Phase Forward releases Empirica Signal version 7.2 signal detection and management software

Symbollon Pharmaceuticals to launch IoGen women's breast health dietary supplement in February

Health care companies assess where they stand on health reform after election

Pfizer and Auxilium Pharmaceuticals announce completion of European MAA validation phase for XIAFLEX

Illicit drug consumption in Europe

Moxifloxacin more favorable than amoxicillin/clavulanate for COPD exacerbations

Tufts CSDD: Orphan product designations increased up to 425 in 2006-08

Men who buy fake internet drugs for ED problems face significant health risks

Global health community to be engaged in using resources of GSK and Alnylam IP Pool

ABC publishes Pycnogenol monograph

Getting vaccinated within five days after exposing to chickenpox prevents chickenpox

Lupin's Mandideep facility receives FDA clearance

Ipsen enters into partnership agreement with Inspiration Biopharmaceuticals

Acyclovir does not reduce risk of HIV transmission for people infected with both HIV and HSV-2

Aetna and Walgreens collaborate to educate people on taking adequate levels of Vitamin D

Advancing brain microphysiological systems (bMPS)

PhD researcher at LifeArc

Unveiling Hidden Potential: Organoids for Disease Modeling in Neuroscience Research

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