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U.S. FDA approves 2011-2012 influenza vaccine formulation

The U.S. Food and Drug Administration announced today that it has approved the influenza vaccine formulation for the 2011-2012 vaccine that will be used by the six manufacturers licensed to produce and distribute influenza vaccine for the United States.

19 Jul 2011

FDA approves Lannett's Diethylproprion HCl Tablets ANDA for anti-obesity treatment

Lannett Company, Inc. today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) of Diethylproprion HCl Tablets, 25 mg. Diethylproprion HCl Tablets, 25 mg, is therapeutically equivalent to the reference listed drug, Tenuate Tablets, 25 mg, of Watson Pharmaceuticals.

19 Jul 2011

Flu vaccine for 2011-12 season approved and ready

According to an announcement from the Food and Drug Administration (FDA) on Monday, it has approved the new flu vaccine for the season beginning this year. Each year the FDA works with other federal agencies and global health experts to design a vaccine to protect against the three viral strains most likely to cause the flu.

19 Jul 2011

Graceway receives FDA approval for Zyclara Cream to treat actinic keratoses

Graceway Pharmaceuticals, LLC announced today that the Food and Drug Administration (FDA) has approved Zyclara Cream, 2.5% for the treatment of actinic keratoses, determining it to be safe and effective for the treatment of clinically typical, visible or palpable actinic keratoses.

19 Jul 2011

Shionogi to acquire Victory Pharma's products to treat pain and infectious diseases

Shionogi Inc., the U.S.-based group company of Shionogi & Co., Ltd., today announced that it has entered into an agreement to acquire all currently marketed products from Victory Pharma, Inc., including seven treatments for pain and two for infectious diseases. The products, which are all approved by the Food and Drug Administration (FDA), will be marketed by Shionogi's existing sales force.

18 Jul 2011

CSL Behring supports World Federation of Hemophilia with 1 million IUs of von Willebrand factor/Factor VIII

CSL Behring has donated more than 1 million international units (IU) of von Willebrand factor (VWF)/Factor VIII (FVIII) replacement medication to patients through the World Federation of Hemophilia (WFH). The donation supports WFH's progress in improving the diagnosis and treatment of bleeding disorders in developing countries through its Global Alliance for Progress (GAP) program.

18 Jul 2011

FDA files MedImmune's sBLA for quadrivalent intranasal nasal influenza vaccine, FluMist

MedImmune has received confirmation from the U.S. Food & Drug Administration (FDA) that the Agency has filed the Company's supplemental Biologics License Application (sBLA) for a quadrivalent (four-strain) version of FluMist® (Influenza Vaccine Live, Intranasal). The company submitted the sBLA early in the second quarter of this year.

18 Jul 2011

FDA approves Shire's Lialda for maintenance of remission of ulcerative colitis

Shire plc, the global specialty biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) approved Lialda® (mesalamine) Delayed Release Tablets for the maintenance of remission in patients with ulcerative colitis.

18 Jul 2011

HER2-positive metastatic breast cancer women benefit from trastuzumab and chemotherapy

The use of trastuzumab, chemotherapy and surgery among women with HER2-positive metastatic breast cancer significantly improved survival from the time central nervous system metastases were diagnosed.

18 Jul 2011

Researchers discover unexpected mode of action for vaccine adjuvant alum

The teams of Doctor Christophe Desmet and Professor Fabrice Bureau, of the Laboratory of Cellular and Molecular Physiology within the University of Liège's GIGA-Research centre, and of Professor Ken Ishii at the University of Osaka in Japan have just discovered an unexpected mode of action for the vaccine adjuvant alum.

18 Jul 2011

QRxPharma seeks NDA approval for MoxDuo IR

QRxPharma Limited announced today initiation of the New Drug Application (NDA) approval process for MoxDuo IR with the United States Food and Drug Administration (FDA). This NDA submission sets the stage for the regulatory approval process for MoxDuo IR for the treatment of moderate to severe acute pain, a $2.5 billion segment of the $8 billion spent annually on prescription opioids in the US.

18 Jul 2011

Transcept decreases workforce following FDA news on Intermezzo NDA

Transcept Pharmaceuticals, Inc. announced today plans to reduce operating expenses by eliminating approximately 45% of its workforce following notification from the U.S. Food and Drug Administration (FDA) that the resubmitted New Drug Application (NDA) for Intermezzo, the company's lead product candidate, cannot be approved in its present form.

16 Jul 2011

Shah congratulates researchers on PrEP findings

In statement released Thursday, USAID Administrator Rajiv Shah said, "I congratulate the Partners PrEP and CDC TDF2 teams on their study findings demonstrating that PrEP (pre-exposure prophylaxis) - and HIV medication when taken orally, once a day - is highly effective in preventing HIV in heterosexual men and women.

16 Jul 2011

New antidepressant prescription linked to increased risk of falls in nursing home residents

Nursing home residents taking certain antidepressant medications are at an increased risk of falling in the days following the start of a new prescription or a dose increase of their current drug, according to a new study by the Institute for Aging Research of Hebrew SeniorLife, an affiliate of Harvard Medical School.

16 Jul 2011

Propranolol can block brain from retrieving cocaine-associated memories

New discoveries by researchers at the University of Wisconsin-Milwaukee (UWM) offer potential for development of a first-ever pharmacological treatment for cocaine addiction.

16 Jul 2011

Successful strategies for launching fixed dose combination products to market

The pharmaceutical industry is under constant pressure to produce new products and fixed dose combination therapies are one of the industry's strategies to offset lackluster pipelines and patent loss.

16 Jul 2011

Teva, Amgen settle G-CSF patent litigation

Amgen announced today that the United States (U.S.) District Court in Pennsylvania has entered final judgment and a permanent injunction against Teva Pharmaceutical Industries Ltd. and Teva Pharmaceuticals USA prohibiting them from infringing Amgen's patents relating to human G-CSF and methods for its use.

16 Jul 2011

Zocor, Crestor drugs may cause serious muscle and kidney problems

Crestor and Zocor are widely-used prescription strength drugs designed to lower "bad cholesterol". Both drugs are classified as "statins", medicine which lowers blood cholesterol levels by inhibiting HMG-CoA reductase.

16 Jul 2011

FDA ODAC recommends approval of Seattle Genetics' ADCETRIS for Hodgkin lymphoma after ASCT

Seattle Genetics, Inc. today announced that the Oncologic Drugs Advisory Committee (ODAC) to the U.S. Food and Drug Administration (FDA) voted 10-0 to recommend that the FDA grant accelerated approval of ADCETRIS™ (brentuximab vedotin) for the treatment of patients with Hodgkin lymphoma who relapse after autologous stem cell transplant (ASCT).

15 Jul 2011

EC grants marketing authorization for Amgen's XGEVA to prevent skeletal-related events

Amgen today announced that the European Commission (EC) has granted marketing authorization for XGEVA (denosumab) for the prevention of skeletal-related events (SREs) in adults with bone metastases from solid tumors.

15 Jul 2011

Pharmaceutical News

U.S. FDA approves 2011-2012 influenza vaccine formulation

FDA approves Lannett's Diethylproprion HCl Tablets ANDA for anti-obesity treatment

Flu vaccine for 2011-12 season approved and ready

Graceway receives FDA approval for Zyclara Cream to treat actinic keratoses

Shionogi to acquire Victory Pharma's products to treat pain and infectious diseases

CSL Behring supports World Federation of Hemophilia with 1 million IUs of von Willebrand factor/Factor VIII

FDA files MedImmune's sBLA for quadrivalent intranasal nasal influenza vaccine, FluMist

FDA approves Shire's Lialda for maintenance of remission of ulcerative colitis

HER2-positive metastatic breast cancer women benefit from trastuzumab and chemotherapy

Researchers discover unexpected mode of action for vaccine adjuvant alum

QRxPharma seeks NDA approval for MoxDuo IR

Transcept decreases workforce following FDA news on Intermezzo NDA

Shah congratulates researchers on PrEP findings

New antidepressant prescription linked to increased risk of falls in nursing home residents

Propranolol can block brain from retrieving cocaine-associated memories

Successful strategies for launching fixed dose combination products to market

Teva, Amgen settle G-CSF patent litigation

Zocor, Crestor drugs may cause serious muscle and kidney problems

FDA ODAC recommends approval of Seattle Genetics' ADCETRIS for Hodgkin lymphoma after ASCT

EC grants marketing authorization for Amgen's XGEVA to prevent skeletal-related events

Advancing brain microphysiological systems (bMPS)

PhD researcher at LifeArc

Unveiling Hidden Potential: Organoids for Disease Modeling in Neuroscience Research

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