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Genentech granted FDA hearing on Avastin for metastatic breast cancer

Genentech, a member of the Roche Group, today announced the U.S. Food and Drug Administration (FDA) has granted a hearing to allow the company the opportunity to present its views on why Avastin® (bevacizumab) should remain FDA-approved for metastatic breast cancer (mBC). The FDA has scheduled the hearing for June 28 to 29, 2011.

25 Feb 2011

New 'closed-loop' system can provide tightly controlled anesthesia in patients undergoing surgery

A new 'closed-loop' system can precisely adjust levels of anesthetics and analgesic drugs in patients undergoing surgery, reports a study in the March issue of Anesthesia & Analgesia, official journal of the International Anesthesia Research Society.

25 Feb 2011

Celgene, Elan enter settlement and license agreement for ABRAXANE

Elan Corporation plc and Celgene Corporation, today announced that Elan subsidiary Elan PharmaInternational Limited has entered into a settlement and license agreement with Celgene Corporation resolving the patent infringement litigation involving ABRAXANE.

24 Feb 2011

FDA approves sBLA for CSL's Hizentra to treat PI

CSL Behring announced today that the U.S. Food and Drug Administration has approved a supplemental Biologics License Application to extend the shelf life of Hizentra, Immune Globulin Subcutaneous, 20% Liquid, from 24 months to 30 months.

24 Feb 2011

Supreme Court raises the bar for suits against vaccine producers

The decision, announced Tuesday, will make it harder for parents who maintain that their children were injured by vaccines to file lawsuits against drug makers. Public health advocates say the ruling will help maintain the nation's vaccine supply levels.

24 Feb 2011

Steroid administration may impact immune system in children with asthma

Children experiencing an asthma attack who are treated with a short burst of oral steroids may have a transient depression of immune response according to a new study led by Universit- de Montr-al.

24 Feb 2011

Study examines several homicides involving anesthetic drugs, outlines anesthesiologists' experiences

A study published in March's issue of Anesthesiology examines several homicides involving anesthetic drugs and calls on anesthesiologists to assist in the investigation and prosecution of criminals who divert and kill with these drugs.

24 Feb 2011

Stamford Hospital to participate in US FDA Expanded Access Treatment IND program for Generex Oral-lyn

Generex Biotechnology Corporation announced today that Stamford Hospital has agreed to participate in the United States Food and Drug Administration Expanded Access Treatment Investigational New Drug Program for Generex Oral-lyn, the Company's proprietary buccal insulin spray product for the treatment of patients with diabetes.

24 Feb 2011

Takeda submits NDA to FDA for fixed-dose combination of azilsartan medoxomil plus CLD to treat hypertension

Takeda Pharmaceutical Company Limited announced today that Takeda Global Research & Development Center, Inc. U.S., submitted a New Drug Application to the U.S. Food and Drug Administration for an investigational fixed-dose combination of azilsartan medoxomil plus chlorthalidone for the treatment of hypertension, or high blood pressure.

24 Feb 2011

G-CSF treatment improves inadequate endometrium during IVF cycles

During in vitro fertilization cycles, treatment with a medication called granulocyte-colony stimulating factor significantly improves inadequate endometrium, according to a report published electronically on February 15 in Fertility and Sterility - the official journal of the American Society for Reproductive Medicine.

24 Feb 2011

New strategies to improve developing countries' access to low-cost generic drugs needed, experts say

New strategies that ensure developing countries have access to low-cost generic medicines and encourage innovation are needed, according to experts who attended a recent meeting sponsored by the WHO, World Intellectual Property Organization, and World Trade Organization (WTO) that addressed growing concern that strict intellectual property protections are limiting access to low-cost generic medicines, BMJ News reports.

24 Feb 2011

UBC study shows Canadians and Americans receive different drug information online

Americans and Canadians are getting vastly different search results when they look up prescription drug information online, says a study by researchers at the University of British Columbia.

24 Feb 2011

Scientists find bovine colostrum can massively reduce leaky gut syndrome

Scientists investigating natural ways to enhance athletic performance have found that bovine colostrum can massively reduce gut permeability - otherwise known as 'leaky gut syndrome.'

24 Feb 2011

Aminothiazoles as therapeutic leads for prion diseases

Scientists who examined more than 10,000 chemical compounds during the last year in search of potential new drugs for a group of untreatable brain diseases, are reporting that one substance shows unusual promise.

24 Feb 2011

New vaccine offers hope against Hepatitis C

Immunology: Three percent of the world's population is currently infected by hepatitis C. The virus hides in the liver and can cause cirrhosis and liver cancer, and it's the most frequent cause of liver transplants in Denmark.

24 Feb 2011

FDA approves ONGLYZA to treat type 2 diabetes patients with renal impairment

Bristol-Myers Squibb Company and AstraZeneca today announced that the U.S. Food and Drug Administration has approved the inclusion of data from two clinical studies in an update to the ONGLYZA U.S. Prescribing Information for adult type 2 diabetes patients.

24 Feb 2011

CST, Astellas Pharma enter commercialization partnership for cancer diagnostic, therapeutic products

Cell Signaling Technology, Inc. of Danvers, MA announced today a joint commercialization partnership with Astellas Pharma, Inc. of Tokyo, Japan focused on the delivery of personalized cancer therapeutics and diagnostics.

From Cell Signaling Technology 24 Feb 2011

Polio: Myanmar plans vaccination campaign after confirming first new case in three years; India fights disease in rural areas

UNICEF said that Myanmar is planning a mass polio vaccination campaign of children under age five after the country confirmed its first case of the disease in three years, Agence France-Presse reports.

24 Feb 2011

Novo Nordisk submits rFXIII BLA to FDA for treatment of inherited bleeding disorder

Novo Nordisk announced today that a Biologic License Application has been submitted to the U.S. Food and Drug Administration requesting the approval of a recombinant factor XIII compound for the vast majority of patients with congenital factor XIII deficiency, an inherited bleeding disorder.

From Novo Nordisk 23 Feb 2011

Researchers identify low-dose, two-drug cocktail that reduces noise-induced hearing loss in mice

Whether on a battlefield, in a factory or at a rock concert, noise-induced hearing loss is one of the most common hazards people face. Researchers at Washington University School of Medicine in St. Louis have identified a low-dose, two-drug cocktail that reduces hearing loss in mice when given before they are exposed to loud noise. The drugs, already FDA-approved for other conditions, also treat hearing loss after noise exposure.

23 Feb 2011

Pharmaceutical News

Genentech granted FDA hearing on Avastin for metastatic breast cancer

New 'closed-loop' system can provide tightly controlled anesthesia in patients undergoing surgery

Celgene, Elan enter settlement and license agreement for ABRAXANE

FDA approves sBLA for CSL's Hizentra to treat PI

Supreme Court raises the bar for suits against vaccine producers

Steroid administration may impact immune system in children with asthma

Study examines several homicides involving anesthetic drugs, outlines anesthesiologists' experiences

Stamford Hospital to participate in US FDA Expanded Access Treatment IND program for Generex Oral-lyn

Takeda submits NDA to FDA for fixed-dose combination of azilsartan medoxomil plus CLD to treat hypertension

G-CSF treatment improves inadequate endometrium during IVF cycles

New strategies to improve developing countries' access to low-cost generic drugs needed, experts say

UBC study shows Canadians and Americans receive different drug information online

Scientists find bovine colostrum can massively reduce leaky gut syndrome

Aminothiazoles as therapeutic leads for prion diseases

New vaccine offers hope against Hepatitis C

FDA approves ONGLYZA to treat type 2 diabetes patients with renal impairment

CST, Astellas Pharma enter commercialization partnership for cancer diagnostic, therapeutic products

Polio: Myanmar plans vaccination campaign after confirming first new case in three years; India fights disease in rural areas

Novo Nordisk submits rFXIII BLA to FDA for treatment of inherited bleeding disorder

Researchers identify low-dose, two-drug cocktail that reduces noise-induced hearing loss in mice

Advancing brain microphysiological systems (bMPS)

PhD researcher at LifeArc

Unveiling Hidden Potential: Organoids for Disease Modeling in Neuroscience Research

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