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FDA grants Priority Review status to Takeda's investigational drug vedolizumab for ulcerative colitis

Takeda Pharmaceutical Company Limited and its wholly-owned subsidiary, Takeda Pharmaceuticals U.S.A., Inc., today announced that the United States Food and Drug Administration has granted Priority Review status for the Biologics License Application for its new investigational drug vedolizumab for the treatment of adults with moderately to severely active ulcerative colitis.

5 Sep 2013

People with CVD more likely to take preventive medicines when combined in one pill

People are much more likely to take preventive medicines if they're combined in one pill, an international study has found. The findings are published today in the Journal of the American Medical Association.

5 Sep 2013

Neurodyn acquires all assets related to new drug candidate Memogain from Galantos Pharma

Neurodyn Inc. announced today that it has acquired from Galantos Pharma GmbH, Mainz, Germany all assets related to their Alzheimer's prescription drug candidate - Memogain. Memogain has completed an extensive preclinical development program and is ready to proceed into Phase 1 clinical trials in late 2013. The terms of the acquisition were not disclosed.

5 Sep 2013

Sanofi, POZEN ink license agreement to commercialize PA8140 and PA32540 tablets in US

Sanofi US and POZEN Inc. announced the signing of an exclusive license agreement for the commercialization of POZEN's proprietary, investigational, coordinated-delivery tablets combining immediate-release omeprazole, a proton pump inhibitor, and enteric-coated aspirin in a single tablet ("PA"), PA8140 and PA32540.

5 Sep 2013

Myriad, Astrazeneca Expand Collaboration On Olaparib

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4 Sep 2013

Dakota Laboratories banned from manufacturing and distributing drugs

Dakota Laboratories LLC and its president, Charles L. Voellinger, Sr., are prohibited from manufacturing and distributing drugs until they correct their ongoing violations of the drug manufacturing laws.

4 Sep 2013

New Ebook lists the top 5 influencers in pharma compliance

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4 Sep 2013

Aliskiren does not slow progression of coronary atherosclerosis in prehypertension patients

Among patients with prehypertension and coronary artery disease, use of the renin (an enzyme secreted by the kidneys) inhibitor aliskiren, compared with placebo, did not result in improvement or slowing in the progression of coronary atherosclerosis, according to a study published by JAMA. The study is being released early online to coincide with its presentation at the European Society of Cardiology Congress 2013.

4 Sep 2013

Study: Fixed-dose combination medication helps CVD patients

In a randomized trial that included about 2,000 patients with or at high risk of cardiovascular disease (CVD), use of a fixed-dose combination medication for blood pressure, cholesterol, and platelet control compared to usual care resulted in significantly improved medication adherence after 15 months and small improvements in systolic blood pressure and low-density lipoprotein cholesterol, according to a study in the September 4 issue of JAMA.

4 Sep 2013

Microencapsulated brain cancer drug may simplify treatment and provide tightly controlled therapy

Consistently uniform, easily manufactured microcapsules containing a brain cancer drug may simplify treatment and provide more tightly controlled therapy, according to Penn State researchers.

4 Sep 2013

Researchers identify mechanisms necessary to live without insulin

Several millions of people around the world suffer from insulin deficiencies. Insulin is a hormone, secreted by the beta cells in the pancreas, which plays a major role in the regulation of energy substrates such as glucose.

4 Sep 2013

Taiwan's HBV immunization program for newborns lowers chronic HBV carriers, incidence of HCC

"Hepatitis B virus infection causes infant fulminant hepatitis, and chronic HBV infection may progress to chronic liver disease and hepatocellular carcinoma. Taiwan launched a nationwide HBV immunization program for newborns in July 1984, which has successfully lowered the prevalence of chronic HBV carriers, incidence of HCC, and mortality of IFH in vaccinated birth cohorts. The mortality of CLD before and after HBV immunization has never been examined," write Chun-Ju Chiang, Ph.D., of National Taiwan University, Taipei, and colleagues.

4 Sep 2013

New vaccine to protect against four strains of flu virus

For the first time, there will be a vaccine which protects against four strains of the flu virus. Until now, flu vaccines have only protected against three forms of the virus.

4 Sep 2013

AQUARIUS trial data shows Aliskiren reduced incidents of death, stroke, heart attack

Patients with clogged and hardened arteries who already have their blood pressure under control may benefit from an additional blood pressure-lowering medication, according to research from the Cleveland Clinic Coordinating Center for Clinical Research (C5Research).

4 Sep 2013

Avanir Pharmaceuticals enters into patent settlement agreement with Actavis

Avanir Pharmaceuticals, Inc. today announced that it has entered into a settlement agreement with Actavis South Atlantic LLC and Actavis, Inc. (collectively, "Actavis") to resolve pending patent litigation in response to Actavis' abbreviated new drug application seeking approval to market generic versions of Avanir's NUEDEXTA (dextromethorphan hydrobromide/quinidine sulfate) capsules.

4 Sep 2013

Renin inhibitor aliskiren not effective in slowing progression of coronary atherosclerosis

3 Sep 2013

NPS MedicineWise reiterates safety messages around newer oral anticoagulants

NPS MedicineWise is reiterating safety messages around the newer anticoagulants dabigatran (Pradaxa) and apixaban (Eliquis) following their PBS listing for preventing stroke on 1 September 2013 – and again for rivaxabaran (Xarelto) which was PBS listed in August for the same purpose.

2 Sep 2013

Roche's Herceptin formulation wins EU approval for treatment of HER2-positive breast cancer

Halozyme Therapeutics, Inc. announced today that the European Commission has granted Roche European Union marketing authorization for the use of a time-saving subcutaneous formulation of Herceptin (trastuzumab) for the treatment of HER2-positive breast cancer.

2 Sep 2013

Common blood pressure drug reduces fatal cardiac problem in patients with Marfan syndrome

A common drug that is used to treat high blood pressure in the general population has been found to significantly reduce a dangerous and frequently fatal cardiac problem in patients with Marfan syndrome.

2 Sep 2013

Use of anticoagulant does not reduce ischemic events among patients undergoing PCI

Use of the novel anticoagulant otamixaban did not reduce ischemic events compared with unfractionated heparin plus eptifibatide but increased bleeding among patients with non-ST-segment elevation acute coronary syndromes undergoing a percutaneous coronary intervention (PCI; procedures such as balloon angioplasty or stent placement used to open narrowed coronary arteries), according to a study published by JAMA.

2 Sep 2013

Pharmaceutical News

FDA grants Priority Review status to Takeda's investigational drug vedolizumab for ulcerative colitis

People with CVD more likely to take preventive medicines when combined in one pill

Neurodyn acquires all assets related to new drug candidate Memogain from Galantos Pharma

Sanofi, POZEN ink license agreement to commercialize PA8140 and PA32540 tablets in US

Myriad, Astrazeneca Expand Collaboration On Olaparib

Dakota Laboratories banned from manufacturing and distributing drugs

New Ebook lists the top 5 influencers in pharma compliance

Aliskiren does not slow progression of coronary atherosclerosis in prehypertension patients

Study: Fixed-dose combination medication helps CVD patients

Microencapsulated brain cancer drug may simplify treatment and provide tightly controlled therapy

Researchers identify mechanisms necessary to live without insulin

Taiwan's HBV immunization program for newborns lowers chronic HBV carriers, incidence of HCC

New vaccine to protect against four strains of flu virus

AQUARIUS trial data shows Aliskiren reduced incidents of death, stroke, heart attack

Avanir Pharmaceuticals enters into patent settlement agreement with Actavis

Renin inhibitor aliskiren not effective in slowing progression of coronary atherosclerosis

NPS MedicineWise reiterates safety messages around newer oral anticoagulants

Roche's Herceptin formulation wins EU approval for treatment of HER2-positive breast cancer

Common blood pressure drug reduces fatal cardiac problem in patients with Marfan syndrome

Use of anticoagulant does not reduce ischemic events among patients undergoing PCI

Advancing brain microphysiological systems (bMPS)

PhD researcher at LifeArc

Unveiling Hidden Potential: Organoids for Disease Modeling in Neuroscience Research

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