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Health Canada approves Afinitor for treatment of brain tumours caused by TSC in children

Families with children suffering from brain tumours caused by an uncommon genetic disorder known as Tuberous Sclerosis Complex (TSC) have new hope with Health Canada's recent conditional approval of a new therapeutic use for the drug Afinitor (everolimus). Afinitor is the first drug therapy approved in Canada for the treatment of brain tumours caused by TSC in patients three years of age and older.

14 Sep 2011

Kremers Urban reaches settlement agreement with ALZA over Concerta patent litigation

Kremers Urban Pharmaceuticals Inc. is pleased to announce that it has reached a settlement dismissing all pending litigation arising from its Abbreviated New Drug Application (ANDA) to market an extended release methylphenidate hydrochloride product, for which Concerta is the reference listed drug product. The ANDA is currently under review with FDA.

14 Sep 2011

FDA’s response to Tobacco company’s allegations on graphic cigarette labels

The Food and Drug Administration (FDA) has replied to the claims from cigarette makers that new graphic-warning labels due to take effect next year violate tobacco companies’ free speech rights.

13 Sep 2011

Older drugs may be better than newly approved ones

It is a common belief that drugs given the okay by the Food and Drug Administration (FDA) are safer and more effective than they have to be to win approval, according to a new study. Especially in the first few years after a drug becomes available, researchers note, there are still questions about how well it will work and whether it will have any serious side effects warn experts. For example FDA-approved painkiller Vioxx was pulled off the market in 2004 after longer-term evidence showed that it may increase the risk of heart attack and stroke.

13 Sep 2011

FDA announces organizational changes within CDER's Office of Oncology Drug Products

Today, the U.S. Food and Drug Administration announced organizational changes within the office responsible for reviewing all drug and biologic applications for cancer therapies.

13 Sep 2011

New drug combination may treat two aggressive cancers

Researchers at Brigham and Women's Hospital (BWH) have identified a new combination of targeted therapies that, together, may treat two aggressive tumor types that until now have not had effective treatments. These findings are published in Cancer Cell on September 13, 2011.

13 Sep 2011

Researchers identify new type of potential anticancer drug

Researchers at Emory University School of Medicine have identified a new type of potential anticancer drug. The compound, named FOBISIN, targets 14-3-3 proteins, important for the runaway growth of cancer cells.

13 Sep 2011

Cardiotrophin 1 has marked effect on fat and glucose metabolism

Scientists from the Center for Applied Medical Research (CIMA) of the University of Navarra (Spain) have discovered that cardiotrophin 1, a protein synthesized by muscle cells and adipose tissue, has a marked effect on fat and glucose metabolism.

13 Sep 2011

Hawthorn, CoPlex Therapeutics sign licensing deal to develop and commercialize hawAD14 for Alzheimer's

Hawthorn Pharmaceuticals, Inc. announced today an exclusive global licensing deal with CoPlex Therapeutics on hawAD14, a preclinical oral small molecule candidate for the treatment of Alzheimer's and other neurodegenerative diseases.

13 Sep 2011

Impax confirms JALYN patent challenge

Impax Laboratories, Inc. today confirms that it has initiated a challenge of the patents listed in connection with JALYN capsules.

13 Sep 2011

Micronutrient powder helps prevent malnutrition in children up to two years old, study review shows

In a systematic review published by the Cochrane Collaboration last week, researchers found that the micronutrient powder used in recent years to combat malnutrition, anemia and iron deficiency in children was very helpful in preventing malnutrition in children six to 24 months old, VOA News reports.

12 Sep 2011

Lantus initiation may help limit weight gain in type 2 diabetes patients

Sanofi announced today data that demonstrates that initiating Lantus® (insulin glargine [rDNA origin] injection) in type 2 diabetes patients leads to better glycemic control and comparable and modest weight gain versus a comparator group consisting of other insulins, oral antidiabetics and dietary changes.

12 Sep 2011

Low-dose aspirin increases risk for GI bleeding

The risk of gastrointestinal (GI) bleeding needs to be considered when determining the potential preventive benefits associated with low-dose aspirin for cardiovascular disease and cancer.

12 Sep 2011

Health Canada approves Merus Labs' advanced wound care product, Collexa

Merus Labs International Inc. is pleased to announce that Health Canada has approved its advanced wound care product Collexa. Collexa is exclusively licensed to Merus Labs by Innocoll for sales and distribution in Canada.

12 Sep 2011

Genentech submits NDA to FDA for vismodegib to treat advanced basal cell carcinoma

Curis, Inc., a drug development company seeking to develop next generation targeted small molecule drug candidates for cancer treatment, today announced that its collaborator Genentech, a member of the Roche Group, has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking sales and marketing approval for vismodegib to treat people with advanced basal cell carcinoma (BCC), which includes metastatic and locally advanced BCC for whom surgery is inappropriate.

12 Sep 2011

InterMune to launch Esbriet for German patients with IPF

InterMune, Inc. today announced that Esbriet will be offered to patients in Germany beginning September 15, 2011. This will mark the first time Esbriet will be commercially available in Europe since it was approved by the European Commission in adults for the treatment of mild to moderate idiopathic pulmonary fibrosis (IPF), a devastating and fatal lung disease.

12 Sep 2011

Genentech submits vismodegib NDA to FDA for treatment of advanced basal cell carcinoma

Genentech, a member of the Roche Group, today announced that the company has submitted a New Drug Application for vismodegib to the U.S. Food and Drug Administration (FDA) for the treatment of people with advanced basal cell carcinoma (BCC) for whom surgery is considered inappropriate.

12 Sep 2011

Spinifex announces new data from EMA401 pre-clinical study on diabetic neuropathy

Spinifex Pharmaceuticals, an Australian pain drug development company, today announces the presentation of new data from a study of EMA401 in a model of diabetic neuropathy.

12 Sep 2011

EpiCept announces FDA's feedback on Ceplene clinical development for AML

EpiCept Corporation today announced that at a recent meeting with the U.S. Food and Drug Administration (FDA) the Company was provided more definitive guidance regarding the clinical development of Ceplene, the Company's lead product administered with interleukin-2 (IL-2) for the remission maintenance and prevention of relapse of patients with acute myeloid leukemia (AML) in first complete remission.

12 Sep 2011

FDA advisory panel suggests warning for bisphosphonates but does not specify wording

Two independent advisory panels to the Food and Drug Administration (FDA) on Friday recommended increasing the cautionary language on the product labels of bone-building drugs taken by more than five million women in the United States. They did not however mention the exact words of the safety warnings and did not recommend limiting use of the drugs to a proposed five years. About 11 percent of women 55 and older take the drugs to prevent bone fractures.

12 Sep 2011

Pharmaceutical News

Health Canada approves Afinitor for treatment of brain tumours caused by TSC in children

Kremers Urban reaches settlement agreement with ALZA over Concerta patent litigation

FDA’s response to Tobacco company’s allegations on graphic cigarette labels

Older drugs may be better than newly approved ones

FDA announces organizational changes within CDER's Office of Oncology Drug Products

New drug combination may treat two aggressive cancers

Researchers identify new type of potential anticancer drug

Cardiotrophin 1 has marked effect on fat and glucose metabolism

Hawthorn, CoPlex Therapeutics sign licensing deal to develop and commercialize hawAD14 for Alzheimer's

Impax confirms JALYN patent challenge

Micronutrient powder helps prevent malnutrition in children up to two years old, study review shows

Lantus initiation may help limit weight gain in type 2 diabetes patients

Low-dose aspirin increases risk for GI bleeding

Health Canada approves Merus Labs' advanced wound care product, Collexa

Genentech submits NDA to FDA for vismodegib to treat advanced basal cell carcinoma

InterMune to launch Esbriet for German patients with IPF

Genentech submits vismodegib NDA to FDA for treatment of advanced basal cell carcinoma

Spinifex announces new data from EMA401 pre-clinical study on diabetic neuropathy

EpiCept announces FDA's feedback on Ceplene clinical development for AML

FDA advisory panel suggests warning for bisphosphonates but does not specify wording

Advancing brain microphysiological systems (bMPS)

PhD researcher at LifeArc

Unveiling Hidden Potential: Organoids for Disease Modeling in Neuroscience Research

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