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CytRx announces its plans to advance multiple oncology development programs in 2010

CytRx Corporation, a biopharmaceutical company specializing in oncology, today announced its plans for 2010 aimed at advancing the clinical development of its high-value drug development pipeline and enhancing shareholder value.

22 Jan 2010

NicOx receives EMEA approval for naproxcinod MAA

NicOx S.A. today announced that the European Medicines Agency (EMEA) has validated the Marketing Authorization Application (MAA) for naproxcinod, which was submitted through the centralized procedure in December 2009. NicOx is seeking approval for an indication for the relief of the signs and symptoms of primary osteoarthritis. This follows the acceptance for filing of a New Drug Application (NDA) by the US Food and Drug Administration (FDA) in November 2009.

22 Jan 2010

Envision Pharmaceutical Services receives high customer satisfaction rating for second consecutive year

The Pharmacy Benefit Management Institute (PBMI) recently released the results of its 2009 Pharmacy Benefit Management Customer Satisfaction Report and Envision Pharmaceutical Services, Inc. received the highest overall customer scores for the second straight year.

22 Jan 2010

Controversy around Merck's pricing for its AIDS drug Isentress

The controversy around Merck and Co. Pharmaceuticals’ pricing for its key AIDS drug Isentress — at nearly $13,000 per patient yearly, the most expensive first line AIDS therapy on the US market today — continued this week following Merck’s reaction to recent public criticism of its AIDS drug pricing. Merck ramped up its damage control PR efforts, issuing a press release that sought to rewrite the history of Isentress and deflect attention by claiming AIDS Healthcare Foundation has been unfairly attacking them.

22 Jan 2010

Heilongjiang Tianlong Pharmaceutical changes R&D focus to antibiotics and cardiac drugs

China Sky One Medical, Inc., a leading fully integrated pharmaceutical company developing and producing over-the-counter drugs in the People's Republic of China ("PRC"), today announced that Heilongjiang Tianlong Pharmaceutical Company ("Tianlong"), the Company's wholly owned subsidiary, will change its R&D focus from external use medicines to antibiotics and cardiac drugs.

22 Jan 2010

Update on the status of Somaxon Pharmaceuticals' NDA for Silenor provided

Somaxon Pharmaceuticals, Inc., a specialty pharmaceutical company focused on the in-licensing, development and commercialization of proprietary branded pharmaceutical products and late-stage product candidates for the treatment of diseases and disorders in the central nervous system therapeutic area, today provided an update on the status of its New Drug Application (NDA) for Silenor® (doxepin) for the treatment of insomnia.

22 Jan 2010

FDA accepts ACT Biotech's ACTB1003 IND

ACT Biotech Inc., a privately held biotechnology company developing a portfolio of oral kinase inhibitors as anti-cancer drugs, today announced the acceptance of the Investigational New Drug (IND) application for ACTB1003 by the US Food and Drug Administration (FDA). The company has now assembled a complete preclinical package, including manufacturing and toxicology studies, allowing ACTB1003 to enter a clinical trial.

22 Jan 2010

Genzyme receives PDUFA date from FDA for its Biologics License Application for Lumizyme

Genzyme Corporation announced today that it has received a June 17, 2010 PDUFA date from the FDA for its Biologics License Application for Lumizyme™ (alglucosidase alfa) seeking approval for the therapy produced at the 4000 L scale.

21 Jan 2010

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

Pharmaceutical News

CytRx announces its plans to advance multiple oncology development programs in 2010

NicOx receives EMEA approval for naproxcinod MAA

Envision Pharmaceutical Services receives high customer satisfaction rating for second consecutive year

Controversy around Merck's pricing for its AIDS drug Isentress

Heilongjiang Tianlong Pharmaceutical changes R&D focus to antibiotics and cardiac drugs

Update on the status of Somaxon Pharmaceuticals' NDA for Silenor provided

FDA accepts ACT Biotech's ACTB1003 IND

Genzyme receives PDUFA date from FDA for its Biologics License Application for Lumizyme

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

Achieving and maintaining ISO/IEC 27001 and BS 10012 certifications

Expanding research and clinical options for children with cancer

Examining how pain could play a direct protective role in the gut

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