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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

FDA asks Guided Therapeutics to provide additional information on LuViva PMA

Guided Therapeutics, Inc., developer of a rapid and painless biophotonic testing platform for the early detection of cancer, today announced that, after a series of meetings with the U.S. Food and Drug Administration (FDA), and after reviewing draft responses, the FDA has asked the company to provide additional information in the company's response to one remaining question.

15 Jul 2011

Women with current major depression more likely to use crack

Women who are clinically depressed at the time they enter drug court have a substantially higher risk of using crack cocaine within four months, according to a new study.

15 Jul 2011

Neuralstem receives U.S. patent allowance for three new neurogenic compounds

Neuralstem, Inc. announced that it has received notice of allowance for U.S. Patent Applications 12/939,897 and 12/939,914 entitled: "Compositions to Effect Neuronal Growth."

15 Jul 2011

Transcept receives FDA Complete Response Letter for Intermezzo NDA

Transcept Pharmaceuticals, Inc. announced today that it has received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) regarding the resubmitted New Drug Application (NDA) for Intermezzo.

15 Jul 2011

Teva commends U.S. Senators for introducing Affordable Medicines Utilization Act of 2011

Teva commends Senators Scott Brown, Ron Wyden and John McCain for introducing the Affordable Medicines Utilization Act of 2011.

15 Jul 2011

Oxytocin does not boost prospects for normal births

A new Cochrane review says that oxytocin, a medication often used to quicken slow-paced labor in its early stages, doesn't boost the prospects for normal births. Riskier births that required cesarean section or the use of forceps didn't become less common.

15 Jul 2011