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Takeda receives FDA approval for EDARBYCLOR to treat hypertension

Takeda Pharmaceutical Company Limited and its wholly-owned subsidiary, Takeda Pharmaceuticals North America, Inc., announced that the U.S. Food and Drug Administration (FDA) approved EDARBYCLOR (azilsartan medoxomil and chlorthalidone) for the treatment of hypertension to lower blood pressure in adults.

21 Dec 2011

FDA approves modernized labeling for ViroPharma's Vancocin Capsules

ViroPharma Incorporated today announced the modernization of labeling for Vancocin (vancomycin hydrochloride, USP) Capsules made effective through the U.S. Food and Drug Administration's (FDA) approval of a supplemental new drug application.

15 Dec 2011

Celgene reports final results from REVLIMID plus VIDAZA phase II study on higher-risk MDS

Celgene International Sàrl, a subsidiary of Celgene Corporation, today reported final results from the phase II portion of a multi-center phase I/II study evaluating combination therapy with REVLIMID (lenalidomide) and VIDAZA (azacitidine) in patients with higher-risk myelodysplastic syndromes (MDS) not previously treated with either drug.

13 Dec 2011

Novartis to showcase 160 presentations on breast cancer, hematological disease drugs at SABCS and ASH

Novartis Pharmaceuticals Corporation will showcase more than one hundred and sixty presentations on data from its robust oncology portfolio at two key medical congresses this month, demonstrating significant advances for patients with cancers and hematological diseases.

3 Dec 2011

Takeda receives FDA approval for VELCADE sNDA to treat MM

Millennium: The Takeda Oncology Company with its parent company Takeda Pharmaceutical Company Limited today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for VELCADE (bortezomib) for Injection, which updates the label to include additional long-term overall survival (OS) data from the VISTA trial.

2 Nov 2011

Boehringer Ingelheim receives FDA approval for COMBIVENT RESPIMAT to treat COPD

Boehringer Ingelheim Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved COMBIVENT RESPIMAT, a new, propellant-free inhaler product that uses a slow-moving mist to deliver the same active ingredients of COMBIVENT Inhalation Aerosol in a metered dose inhaler.

10 Oct 2011

New clinical data on Bristol-Myers Squibb's NULOJIX to be presented at ESOT 2011 congress

Bristol-Myers Squibb Company today announced that new data on NULOJIX (belatacept) will be presented at the European Society for Organ Transplantation (ESOT) Congress on September 4 -7, 2011 in Glasgow, Scotland, United Kingdom.

2 Sep 2011

Antidepressant alert – Citalopram associated to heart rhythm disturbances

Antidepressant citalopram (Celexa, Forest Laboratories) should not be used in doses higher than 40 mg per day because of concerns that it can cause potentially fatal changes in heart rhythm, the US Food and Drug Administration (FDA) warns.

25 Aug 2011

Health Canada approves Tasigna for newly diagnosed Philadelphia chromosome-positive CML

Over a decade ago, Canadian patients diagnosed with chronic myeloid leukemia (CML), celebrated when PrGleevec (imatinib mesylate) was approved in Canada.

27 Jun 2011

FDA approves NULOJIX

Bristol-Myers Squibb Company announced that the U.S. Food and Drug Administration (FDA) approved NULOJIX, the first selective T-cell costimulation blocker indicated for the prophylaxis of organ rejection in adult patients receiving a kidney transplant, in combination with basiliximab induction, mycophenolate mofetil (MMF), and corticosteroids.

18 Jun 2011

Alnylam's ALN-VSP Phase I trial data on liver cancer presented at ASCO 2011

Alnylam Pharmaceuticals, Inc., a leading RNAi therapeutics company, announced today the results from its Phase I clinical trial with ALN-VSP, a systemically delivered RNAi therapeutic for the treatment of advanced solid tumors with liver involvement.

6 Jun 2011

Results from HSPPC-96 Phase 2 study against recurrent gliobastoma presented at ASCO 2011

In data presented at The American Society of Clinical Oncology (ASCO) Annual Meeting, cancer researchers found that the brain tumor vaccine HSPPC-96 for treating recurrent gliobastoma (GBM) has a favorable safety profile and extends survival by two to three times more than the current median survival rate.

4 Jun 2011

ZYTIGA clinical study data on prostate cancer to be presented at ASCO 2011

Data related to ZYTIGA (abiraterone acetate) will be presented at the 2011 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago.

3 Jun 2011

NEJM publishes ZYTIGA plus prednisone Phase 3 trial data in metastatic castration-resistant prostate cancer

A study titled "Abiraterone and Increased Survival in Metastatic Prostate Cancer," published in the May 26 issue of NEJM, found that patients with metastatic castration-resistant prostate cancer who have received prior chemotherapy containing docetaxel showed a significant improvement in overall survival when treated with ZYTIGA plus prednisone compared to patients treated with prednisone plus placebo.

26 May 2011

SYMBICORT long-term comparative study data in African American asthma patients presented at ATS 2011

AstraZeneca today announced results from a long-term study comparing SYMBICORT Inhalation Aerosol 160/4.5 mcg with budesonide pressurized metered-dose inhaler 160 mcg in self-reported African American patients with moderate to severe persistent asthma.

17 May 2011

Lead investigator to discuss growing impact of AFib on US health care costs and resources

Two studies to be presented this week address the often-overlooked costs associated with atrial fibrillation, the most common form of cardiac arrhythmia.

5 May 2011

AstraZeneca announces U.S. availability of vandetanib for rare medullary thyroid cancer

AstraZeneca today announced that the orphan drug vandetanib is now available to U.S. patients for the treatment of medullary thyroid cancer that cannot be removed by surgery or that has spread to other parts of the body.

25 Apr 2011

AstraZeneca's vandetanib receives FDA approval in medullary thyroid cancer

AstraZeneca today announced that the U.S. Food and Drug Administration approved the orphan drug vandetanib for the treatment of medullary thyroid cancer that cannot be removed by surgery or that has spread to other parts of the body.

7 Apr 2011

Triad alcohol prep pads with ARIXTRA Starter Kits not to be used

GlaxoSmithKline (GSK) has become aware of a United States market recall of all lots of alcohol prep pads, swabs and swabsticks manufactured by the Triad Group and marketed under various brand names. The Triad Group recall has been initiated due to concerns about potential microbial contamination of the alcohol products with Bacillus cereus that could potentially lead to life-threatening infections.

25 Jan 2011

FDA approves Novartis' Amturnide for treatment of high blood pressure

Today Novartis announced that the US Food and Drug Administration (FDA) approved Amturnide (aliskiren, amlodipine and hydrochlorothiazide) tablets for the treatment of high blood pressure. Amturnide combines the only approved direct renin inhibitor worldwide, Tekturna (aliskiren), with the widely used calcium channel blocker amlodipine and the diuretic hydrochlorothiazide (HCTZ).

23 Dec 2010