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Acorda reports net income of $12.4 million for third quarter 2010

Acorda Therapeutics, Inc. today announced its financial results for the third quarter of 2010.

1 Nov 2010

Cell Therapeutics announces submission of MAA to European Medicines Agency for Pixuvri

Cell Therapeutics, Inc. announced today that it has submitted a Marketing Authorization Application to the European Medicines Agency for Pixuvri (pixantrone dimaleate) as monotherapy for the treatment of adult patients with multiply relapsed or refractory aggressive non-Hodgkin's lymphoma.

1 Nov 2010

FDA approves Afinitor drug for tuberous sclerosis complex

The Tuberous Sclerosis Alliance (TS Alliance) today announced the first drug approved for a tuberous sclerosis complex (TSC) indication by the Federal Drug Administration (FDA). This drug, manufactured by Novartis Oncology, is called Afinitor and will be used to treat subependymal giant cell astrocytomas (SEGAs) in individuals with TSC.

1 Nov 2010

FDA new approvals, antibiotic and neurological drugs

Two new drugs have gained approval from the US Food and Drug Administration (FDA) – one is an antibiotic from Forest Labs and the other a first-time treatment for a neurological disorder developed by Avanir Pharmaceuticals. Another waiting for approval is Biodel's fast-acting insulin Linjeta. On the other hand seven new drugs got rejected including a diabetes drug from Amylin Pharmaceuticals and weight-loss drugs from Arena Pharmaceuticals and Vivus, respectively.

31 Oct 2010

Health Canada approves PRADAX for preventing stroke in AF patients

Health Canada, the Canadian health authority, has approved PRADAX™ (dabigatran etexilate), Boehringer Ingelheim's novel, oral direct thrombin inhibitor for the prevention of stroke and systemic embolism in patients with atrial fibrillation (AF) in whom anticoagulation is appropriate, marking the second approval of this new oral anticoagulant following the recent marketing authorisation by the US Food and Drug Administration (FDA).

30 Oct 2010

Rite Aid to host flu shot clinics at nationwide pharmacies

With the holidays getting closer, Rite Aid is reminding people to get a flu shot so that the only thing they are spreading this season is good cheer. According to The Centers for Disease Control and Prevention (CDC), it can take up to two weeks for flu shots to be effective and protect against the flu; those who get their flu shot now can help protect themselves by the time they sit down for Thanksgiving dinner.

30 Oct 2010

EcoNugenics introduces new nutraceutical compound for breast health

EcoNugenics® is proud to introduce BreastDefend™, a new nutraceutical compound formulated specifically to promote and maintain breast health. Physician-formulated BreastDefend is crafted from eight exclusive, clinically tested compounds, including scientifically supported nutrients, herbs, and medicinal mushrooms.

30 Oct 2010

FDA approves Teflaro for treatment of community-acquired bacterial pneumonia

Forest Laboratories, Inc. announced today that Teflaro(ceftaroline fosamil), a broad-spectrum bactericidal cephalosporin with activity against both gram-positive and gram-negative microorganisms, was approved by the U.S. Food and Drug Administration (FDA) for the treatment of community-acquired bacterial pneumonia (CABP), including cases caused by Streptococcus pneumoniae bacteremia, and acute bacterial skin and skin structure infection (ABSSSI), including cases caused by methicillin-resistant Staphylococcus aureus (MRSA).

30 Oct 2010

Inter Press Service reports on counterfeit medicine challenges in central, Eastern Europe

Central and Eastern Europe is facing 'significant challenges' in combating a multi-billion euro, and often lethal, trade in fake medicines, security and pharmaceutical groups have warned, Inter Press Service reports in an article that examines the scope of the problem in a region now identified as a key smuggling route in an illicit trade which is growing every year.

30 Oct 2010

APP receives FDA marketing approval for Metoprolol Tartrate Injection

APP Pharmaceuticals, Inc., a wholly owned subsidiary of Fresenius Kabi Pharmaceuticals Holding, Inc., announced today that it has received approval from the U.S. Food and Drug Administration (FDA) to market Metoprolol Tartrate Injection, USP, and expects to launch the medication soon.

30 Oct 2010

FDA approves NUEDEXTA capsules for pseudobulbar affect

AVANIR Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved NUEDEXTA (dextromethorphan hydrobromide and quinidine sulfate) capsules, as the first treatment for pseudobulbar affect.

30 Oct 2010

Teflaro receives FDA approval for treatment of bacterial infections

The U.S. Food and Drug Administration today approved Teflaro (ceftaroline fosamil), an injectable antibiotic to treat adults with community acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI), including methicillin-resistant Staphylococcus aureus (MRSA).

30 Oct 2010

Drug and device makers face new taxes, fees

A Fox Business report shows the health overhaul is cutting deeper into drug and device makers' profits than many expected. Research & development programs are already being drastically scaled back.

30 Oct 2010

Pneumonia vaccination increases among older Americans, but still falls short of Healthy People 2010 goal

Between 2000 and 2007, the proportion of Americans age 65 and older who were vaccinated against pneumonia increased from 53 percent to 58 percent, but the rate fell far short of the Healthy People 2010 goal of 90 percent for pneumonia vaccinations in that age group, according to the latest News and Numbers from the Agency for Healthcare Research and Quality.

29 Oct 2010

SPRYCEL receives FDA approval for treating adult patients with Ph+ CML in chronic phase

After receiving a priority review, Bristol-Myers Squibb Company and Otsuka Pharmaceutical Co., Ltd. today announced that the U.S. Food and Drug Administration (FDA) has approved SPRYCEL (dasatinib) 100 mg once daily for the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase.

29 Oct 2010

DiaGenic third quarter income increases from NOK -9.3 million to NOK -9.6 million

DiaGenic: The interim report for the third quarter 2010 was approved by the Board of Directors on 28 October 2010.

29 Oct 2010

ACADIA and BLS enter agreement to conclude pimavanserin collaboration

ACADIA Pharmaceuticals Inc. today announced that it has entered into an agreement with Biovail Laboratories International SRL ("BLS"), a wholly owned subsidiary of Valeant Pharmaceuticals International, Inc., pursuant to which ACADIA and BLS have agreed to conclude their previously established collaboration to develop and commercialize pimavanserin in the United States and Canada.

29 Oct 2010

PHARMABIZ.com examines India’s push for clearer definition of counterfeit, substandard medicines

India has taken the lead to get together a number of generic drug-producing nations to call for better definitions to ensure quality, strengthening of regulatory authorities in the respective countries, and bringing focus of the world to public health instead of intellectual property, PHARMABIZ.com writes in an article that examines the recent meeting of leaders from Brazil, India and South Africa on issues regarding counterfeit medicines.

29 Oct 2010

VIVUS receives FDA CRL for QNEXA NDA

VIVUS, Inc. announced today that it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for the investigational new drug QNEXA® (phentermine/topiramate) Controlled-Release Capsules. The FDA issued the CRL to communicate its decision that the NDA cannot be approved in its present form.

29 Oct 2010

Nursing homes struggle to allow seniors use of medical marijuana

The New York Times: As states begin embracing medical marijuana they are also grappling with how they allow or don't allow seniors in nursing homes to use it. "The prospect has just begun to raise difficult questions for administrators and state regulators.

29 Oct 2010