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FDA's Ampyra approval wonderful news for people with MS experiencing walking problems

The U.S. Food and Drug Administration has approved the marketing of Ampyra™ (dalfampridine, formerly known as fampridine SR, from Acorda Therapeutics) for its ability to improve walking speed in people with any type of multiple sclerosis.

23 Jan 2010

FDA approves fampridine-SR drug for treatment of multiple sclerosis

The Food and Drug Administration has approved the drug fampridine-SR for the treatment of multiple sclerosis. Researchers at the University of Rochester Medical Center (URMC) have been evaluating the effects of the drug in MS for more than 10 years- it is the first medication shown to enhance some neurological functions in people with the disease - and their efforts helped pave the way for today's action by the FDA.

23 Jan 2010

Ampyra receives FDA approval for improving walking in MS patients

The U.S. Food and Drug Administration today approved Ampyra (dalfampridine) extended release tablets to improve walking in patients with multiple sclerosis (MS). In clinical trials, patients treated with Ampyra had faster walking speeds than those treated with an inactive pill (placebo). This is the first drug approved for this use.

23 Jan 2010

Study shows certain heart medications may decrease risk of Parkinson's disease

UCLA researchers have discovered that a specific type of medication used to treat cardiovascular conditions such as hypertension, angina and abnormal heart rhythms may also decrease the risk of developing Parkinson's disease.

22 Jan 2010

BioSyent Pharma receives exclusive rights to manufacture and market Virsani sanitizer in Canada and U.S.

BioSyent Inc. ("BioSyent") announces that its subsidiary BioSyent Pharma Inc. has signed a license and distribution agreement with Notlers for VirsaniTM personal sanitizer.

22 Jan 2010

Acorda Therapeutics receives marketing approval from FDA for AMPYRA

Acorda Therapeutics, Inc. today announced that it has received marketing approval from the U.S. Food and Drug Administration (FDA) for AMPYRA™ (dalfampridine), an oral treatment to improve walking in patients with multiple sclerosis (MS).

22 Jan 2010

DIA Annual EuroMeeting programme in Monaco

The Drug Information Association (DIA) in Europe will host its 22nd Annual EuroMeeting from 8-10 March 2010 in Monaco. The DIA Annual EuroMeeting features more than 110 hot-topic sessions across 13 themes and attracts more than 3,000 professionals from the biopharmaceutical industry, contract service organisations, regulatory agencies, health ministries and academia, as well as patients and students worldwide.

22 Jan 2010

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