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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

Patients with chronic constipation prefer Kristalose oral solution

Cumberland Pharmaceuticals Inc. today announced the publication of a patient preference study evaluating Kristalose (lactulose) for Oral Solution, a prescription laxative packaged as a crystalline powder, compared to liquid lactulose products.

2 Dec 2010

SYMBICORT improves lung function in African American asthma patients compared to budesonide alone

AstraZeneca announced today that results from TITAN, a 12-week study of SYMBICORT® (budesonide/formoterol fumarate dihydrate) Inhalation Aerosol in African American patients with moderate to severe persistent asthma, showed significant improvement in lung function for patients taking SYMBICORT compared with those using budesonide alone.

3 Nov 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

Strativa enters amended agreement with Sobi for Nascobal Vitamin B12 Nasal Spray

Strativa Pharmaceuticals today announced that it has entered into an amended and restated license and supply agreement with Swedish Orphan Biovitrum (Sobi) covering the European development and commercialization rights of Strativa's Nascobal (cyanocobalamin) Vitamin B12 Nasal Spray. Strativa acquired the worldwide rights to Nascobal from QOL Medical, LLC in March 2009, which included a pre-existing agreement with Sobi.

26 Oct 2010

COU-AA-301 Phase 3 study demonstrates improvement in CRPC survival rate

Results from a pre-specified interim analysis of a randomized, placebo-controlled Phase 3 study, COU-AA-301, demonstrate that patients treated with the investigational agent abiraterone acetate plus low-dose prednisone/prednisolone showed a significant improvement in overall survival compared to patients treated with prednisone/prednisolone plus placebo.

11 Oct 2010

Amneal Pharmaceuticals receives FDA approval for Spironolactone HCl tablets

Amneal Pharmaceuticals, LLC is pleased to announce that it has received U.S. FDA approval to manufacture Spironolactone HCl tablets in 25 mg, 50 mg and 100 mg strengths effective July 2, 2010.

26 Aug 2010

Tasigna receives approval for chronic myeloid leukemia in Canada

Tasigna (nilotinib) capsules have been approved with conditions in Canada as a new therapy for patients with CML, in the chronic phase (first phase) of the disease. Patients must be resistant to or intolerant of at least one prior therapy, including (Pr)Gleevec (imatinib mesylate), an established standard of care.

20 Aug 2010