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Ranbaxy obtains FDA approval to manufacture, market Fenofibrate Capsules USP, 43 mg and 130 mg

Ranbaxy Laboratories Limited announced today that the Company has received approval from the U.S. Food and Drug Administration to manufacture and market Fenofibrate Capsules USP, 43 mg and 130 mg. The Office of Generic Drugs, U.S. Food and Drug Administration, has determined the Ranbaxy formulations to be bioequivalent and have the same therapeutic effect as that of the reference listed drug Antara Capsules, 43 and 130 mg, respectively, of Lupin Atlantis.

5 Nov 2014

Non-injectable vaccine may provide long-term protection against deadly Ebola virus

A potentially breathable, respiratory vaccine in development has been shown to provide long-term protection for non-human primates against the deadly Ebola virus, as reported this week in the online edition of the journal Molecular Pharmaceutics.

5 Nov 2014

BioElectronics to present innovative chronic pain therapy at OTC Pharma Asia Conference

BioElectronics Corporation, the maker of advanced consumer and healthcare medical devices announced today that its Executive Vice President, Dr. Deepak Kotak has been invited to present BioElectronics' innovative chronic pain therapy at the OTC Pharma Asia Conference, on Tuesday, March 3, 2015 in Singapore.

5 Nov 2014

Mylan announces U.S. launch of generic Loestrin 24 Fe

Mylan Inc. today announced the U.S. launch of its Norethindrone Acetate and Ethinyl Estradiol Tablets USP, 1 mg/0.02 mg and Ferrous Fumarate, which is the generic version of Warner Chilcott's Loestrin 24 Fe.

5 Nov 2014

Even brief workouts can reduce risk of relapse during meth withdrawal

Scientists at The Scripps Research Institute (TSRI) have found that even brief workouts can reduce the risk of relapse in rats withdrawing from methamphetamine. In addition, the team found that exercise affected the neurons in a brain region that had never before been associated with meth withdrawal, suggesting a new direction for drug development.

5 Nov 2014

Glenmark gets final approval from FDA for Omeprazole DR Capsules ANDA

Glenmark Generics Inc. USA, the subsidiary of Glenmark Generics Limited, has been granted final approval for its abbreviated new drug application (ANDA) from the United States Food and Drug Administration for Omeprazole Delayed Release Capsules, their generic version of Prilosec by AstraZeneca.

5 Nov 2014

Researchers develop new test to identify drugs that could work against Lyme disease

Researchers from the Johns Hopkins Bloomberg School of Public Health have developed a test they say will allow them to test thousands of FDA-approved drugs to see if they will work against the bacteria that causes tick-borne Lyme disease.

4 Nov 2014

Hemp Health launches CBD wellness supplements

Hemp Health Inc., a pioneer in hemp cannabidiol (CBD) products, today launched their line of CBD wellness supplements. Available in oil, spray and capsule form, Hemp Health's products offer a compelling alternative to medical marijuana. The CBD supplements provide consumers with the therapeutic ingredient in hemp while allowing them to avoid the negative mental and physical effects of marijuana.

4 Nov 2014

NSAIDs protect against colorectal cancer by inducing cell suicide pathways in intestinal stem cells

Aspirin and other nonsteroidal anti-inflammatory drugs (NSAIDs) protect against the development of colorectal cancer by inducing cell suicide pathways in intestinal stem cells that carry a certain mutated and dysfunctional gene, according to a new study led by researchers at the University of Pittsburgh Cancer Institute and the School of Medicine.

4 Nov 2014

Anesthetics can cause long-term memory loss, reveal University of Toronto researchers

Researchers at the University of Toronto's Faculty of Medicine have shown why anesthetics can cause long-term memory loss, a discovery that can have serious implications for post-operative patients.

4 Nov 2014

Nasal vaccine shows promise against Ebola virus

A nasal vaccine in development by researchers at The University of Texas at Austin has been shown to provide long-term protection for non-human primates against the deadly Ebola virus. Results from a small pre-clinical study represent the only proof to date that a single dose of a non-injectable vaccine platform for Ebola is long-lasting, which could have significant global implications in controlling future outbreaks.

4 Nov 2014

FDA approves Fluzone High-Dose vaccine sBLA to include efficacy data in Prescribing Information

Sanofi Pasteur, the vaccines division of Sanofi, today announced that the U.S. Food and Drug Administration has approved the supplemental biologics license application (sBLA) for Fluzone High-Dose (Influenza Vaccine) to include efficacy data in the Prescribing Information.

3 Nov 2014

Astellas' isavuconazole gets FDA orphan drug designation for treatment of invasive candidiasis

Astellas announced today that the U.S. Food and Drug Administration has granted orphan drug designation to isavuconazole for the treatment of invasive candidiasis.

3 Nov 2014

Epicure project: an interview with Frédéric Cren

Epicure is a project led by Inventiva and Institut Curie that aims to deliver pre-clinical candidates on two novel epigenetic targets that have been selected due to their potential to activate immune responses against cancer cells. In addition one of these two targets has potential in respiratory indications such as asthma or COPD.

3 Nov 2014

Gates Foundation awards US$156 million to support PATH Malaria Vaccine Initiative

In support of a bold quest to rid the world entirely of malaria, the Bill & Melinda Gates Foundation today announced an award of US$156 million to PATH to support the PATH Malaria Vaccine Initiative (MVI) in building new vaccines that will interrupt the cycle of malaria parasite transmission and help realize the "accelerating to zero" agenda. Such vaccines would ensure that parasite reintroduction is prevented by providing what could be called an "immunological bed net."

3 Nov 2014

Diabetes treatment with low-cost generic drug can have positive implications for patient's quality of life

New research from CVS Health finds starting a new diabetes patient on metformin, a generic oral diabetes medicine that helps control blood sugar levels, reduced the need to add on additional treatments to control the condition over time. Although there are many classes of oral diabetes medications, there has historically been little evidence available on the comparative effectiveness of treatments to help patients and providers select an initial diabetes therapy.

31 Oct 2014

Profectus BioSciences gets funding to develop VesiculoVax Zaire-Ebola virus vaccine

Profectus BioSciences, Inc., a clinical-stage vaccine company developing novel vaccines for the treatment and prevention of infectious diseases, announced today that the Department of Defense through the Medical Countermeasure Systems-Joint Vaccine Acquisition Program, a subordinate command of the Joint Program Executive Office for Chemical and Biological Defense, Edgewood, MD, has contracted the manufacture and IND-enabling preclinical testing of the Profectus trivalent Ebola/Marburg vaccine.

31 Oct 2014

New consensus guidelines for toxicity testing of oligonucleotide-based therapeutics

Oligonucleotide-based therapeutics present unique challenges when it comes to testing their potential to cause reproductive and developmental harm. New consensus guidelines for toxicity testing that take into consideration the combined chemical and biological characteristics of these novel biopharmaceuticals are presented in Nucleic Acid Therapeutics, a peer-reviewed journal from Mary Ann Liebert, Inc. publishers.

31 Oct 2014

Veloxis receives tentative FDA approval for Envarsus XR

Veloxis Pharmaceuticals A/S announced today that the U.S. Food and Drug Administration has informed Veloxis of the tentative approval of Envarsus XR. FDA stated that the final approval of Envarsus XR will be delayed until expiration of the exclusivity period for Astellas' Astagraf XL.

31 Oct 2014

Dosing of antiretroviral medication to prevent HIV infection differs by sex

A mathematical model developed by NIH grantees predicts that women must take the antiretroviral medication Truvada daily to prevent HIV infection via vaginal sex, whereas just two doses per week can protect men from HIV infection via anal sex.

31 Oct 2014

Pharmaceutical News

Ranbaxy obtains FDA approval to manufacture, market Fenofibrate Capsules USP, 43 mg and 130 mg

Non-injectable vaccine may provide long-term protection against deadly Ebola virus

BioElectronics to present innovative chronic pain therapy at OTC Pharma Asia Conference

Mylan announces U.S. launch of generic Loestrin 24 Fe

Even brief workouts can reduce risk of relapse during meth withdrawal

Glenmark gets final approval from FDA for Omeprazole DR Capsules ANDA

Researchers develop new test to identify drugs that could work against Lyme disease

Hemp Health launches CBD wellness supplements

NSAIDs protect against colorectal cancer by inducing cell suicide pathways in intestinal stem cells

Anesthetics can cause long-term memory loss, reveal University of Toronto researchers

Nasal vaccine shows promise against Ebola virus

FDA approves Fluzone High-Dose vaccine sBLA to include efficacy data in Prescribing Information

Astellas' isavuconazole gets FDA orphan drug designation for treatment of invasive candidiasis

Epicure project: an interview with Frédéric Cren

Gates Foundation awards US$156 million to support PATH Malaria Vaccine Initiative

Diabetes treatment with low-cost generic drug can have positive implications for patient's quality of life

Profectus BioSciences gets funding to develop VesiculoVax Zaire-Ebola virus vaccine

New consensus guidelines for toxicity testing of oligonucleotide-based therapeutics

Veloxis receives tentative FDA approval for Envarsus XR

Dosing of antiretroviral medication to prevent HIV infection differs by sex

Real-time Raman monitoring for pharmaceutical hot melt extrusion

Synthetic Psychedelics: A Growing Public Health Concern

How the Vutara VXL simplifies single-molecule imaging

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