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C3BS plans to open new U.S.-based facility to manufacture C-Cure for use in Phase III trial

Cardio3 BioSciences, a leader in the discovery and development of engineered cell therapies, today confirmed plans to open a new U.S.-based manufacturing facility in Rochester, Minnesota. The facility will support the Company’s current and anticipated manufacturing needs in the United States for both the Phase III clinical trial evaluating lead cardiovascular product candidate C-Cure (CHART-2), and its recently acquired CAR T-cell therapies’ portfolio.

26 Mar 2015

BeyondSpring files two patent applications to expand therapeutic scope of Plinabulin

BeyondSpring Pharmaceuticals, Inc., a clinical stage biopharmaceutical company focused on the development of innovative cancer therapies, today announced that it has filed two new method of treatment patent applications with the United States Patent and Trademark Office to cover methods of treating brain tumors as well as cancers expressing a mutant form of RAS protein through administration of the Company’s lead compound, Plinabulin.

26 Mar 2015

Novasep, Celladon sign agreement to develop and supply MYDICAR drug substance

Novasep, a leading supplier of services and technologies for the life sciences and chemical industries, and Celladon Corporation, a clinical-stage cardiovascular gene therapy company, today announce that they have signed a Development, Manufacturing and Supply Agreement pursuant to which, if supported by upcoming MYDICAR clinical data, Novasep would manufacture MYDICAR drug substance through 2018 with extension options through 2020.

26 Mar 2015

Theravectys gets authorization to produce lentiviral vectors for clinical use and CAR-T cell-based immunotherapy

THERAVECTYS, a clinical development biotechnology company that focuses on the development of therapeutic vaccines and immunotherapies, proudly announces that its manufacturing plant has obtained the status of a pharmaceutical manufacturing establishment, granted by the French National Agency for Medicines and Health Products Safety.

26 Mar 2015

Regulus' RG-012 receives orphan medicinal product designation in EU for treatment of Alport syndrome

Regulus Therapeutics Inc., a biopharmaceutical company leading the discovery and development of innovative medicines targeting microRNAs, announced today that the European Commission has granted orphan medicinal product designation for RG-012, a single stranded, chemically modified oligonucleotide that binds to and inhibits the function of microRNA-21 ("miR-21") for the treatment of Alport syndrome, a life-threatening genetic kidney disease with no approved therapy.

25 Mar 2015

Accelovance named finalist for Best Contract Research Organization at ViE Awards

Accelovance, a therapeutically focused contract research organization (CRO), has been named a finalist for "Best Contract Research Organization" at the upcoming Vaccine Industry Excellence (ViE) Awards hosted by the World Vaccine Congress.

25 Mar 2015

FDA approves Quadracel vaccine to protect young children from life-threatening diseases

Sanofi Pasteur, the vaccines division of Sanofi, announced today that the U.S. Food and Drug Administration has approved use of Quadracel (Diphtheria and Tetanus Toxoids and Acellular Pertussis Absorbed and Inactivated Poliovirus; DTaP-IPV) vaccine for active immunization against diphtheria, tetanus, pertussis and poliomyelitis in children 4 through 6 years of age.

25 Mar 2015

Marken secures Best Life Science Logistics Provider award

Marken announced today that they won the pharmaceutical clinical research industry award of Best Life Science Logistics Provider at the 5th Annual BioPharma Asia Industry Awards. The award was announced at a dinner and ceremony held in conjunction with the BioPharma Asia conference in Singapore, drawing an annual attendance of 1600.

25 Mar 2015

Many teens still ignorant of significant physical danger posed by legal drugs

Legal drugs such as OxyContin now kill more people than heroin and cocaine combined. While awareness of the dangers of illegal drugs has increased, many teens are still ignorant of the significant physical danger posed by legally prescribed drugs, according to a new study in Journal of Public Policy & Marketing.

25 Mar 2015

Only few studies demonstrate the effectiveness of marijuana

While many states have pushed for new laws to legalize the use of marijuana for medical reasons, there are few well-controlled studies that demonstrate its effectiveness.

25 Mar 2015

Oncolytics' REOLYSIN granted EMA Orphan Drug Designation for treatment of gynecological cancers

Oncolytics Biotech Inc., a clinical-stage biotechnology company focused on the development of oncolytic viruses as potential cancer therapeutics, today announced that the European Medicines Agency has granted Orphan Drug Designation for its lead product candidate, REOLYSIN, for the treatment of ovarian, fallopian tube and primary peritoneal cancers.

25 Mar 2015

Egalet announces plans to commercialize SPRIX Nasal Spray and OXAYDO tablets

Egalet Corporation, a fully integrated specialty pharmaceutical company focused on developing, manufacturing and marketing innovative pain treatments, today announced its plans for the commercialization of SPRIX (ketorolac tromethamine) Nasal Spray and OXAYDO (oxycodone HCI, USP) tablets for oral use only –CII.

25 Mar 2015

Study: Early improvements not sustained in patients treated with PRP injection for facet joint arthropathy

Early gains in pain relief, behavioral markers and function were not sustained in patients treated with platelet-rich plasma (PRP) injection for facet joint arthropathy, new research shows. Results were available at the 31st Annual Meeting of the American Academy of Pain Medicine.

25 Mar 2015

CMV-based vaccine provides long-lasting protective immunity against Ebola virus

A cytomegalovirus (CMV)-based vaccine provides long-lasting protective immunity against Ebola virus, and has potential for development as a disseminating vaccine strategy to prevent ebolavirus infection of wild African ape populations.

25 Mar 2015

Experimental drug that attacks brain tumor cells passes early tests

An experimental drug that attacks brain tumor tissue by crippling the cells' energy source called the mitochondria has passed early tests in animal models and human tissue cultures, say Houston Methodist scientists.

25 Mar 2015

TPU's submission of Docetaxel Injection Concentrate, Non-Alcohol Formula NDA acknowledged by FDA

Teikoku Pharma USA announced today that it has submitted a 505(b)(2) New Drug Application (NDA) to the U.S. Food and Drug Administration for Docetaxel Injection Concentrate, Non-Alcohol Formula on February 26, 2015 and received an acknowledgment of the receipt from FDA.

25 Mar 2015

Confluence pharmaceuticals signs co-development and marketing agreement with AOP orphan for fragile X syndrome drug

Confluence is a biopharmaceutical company focused on developing therapeutic treatments for Fragile X Syndrome and Autism Spectrum Disorders. AOP is an Austrian based company specializing in the development and marketing of medicines for rare and complex diseases.

24 Mar 2015

Study explains why COPD patients develop tolerance to roflumilast drug

Roflumilast, a drug recently approved in the United States to treat severe chronic obstructive pulmonary disease (COPD), increases the production of a protein that causes inflammation, which possibly results in patients developing a tolerance to the drug after repeated use and makes the drug less effective, according to researchers at Georgia State University, Kumamoto University and the University of Rochester Medical Center.

24 Mar 2015

Discontinuation of statin therapy may benefit patients with terminal illness

Discontinuing statin use in patients with late-stage cancer and other terminal illnesses may help improve patients' quality of life without causing other adverse health effects, according to a new study by led by researchers at the University of Colorado Anschutz Medical Campus and Duke University and funded by the National Institute of Nursing Research (NINR).

24 Mar 2015

Vitamin D3 and metformin show promising results in preventing colorectal cancer

The concept was simple: If two compounds each individually show promise in preventing colon cancer, surely it's worth trying the two together to see if even greater impact is possible.

24 Mar 2015

Pharmaceutical News

C3BS plans to open new U.S.-based facility to manufacture C-Cure for use in Phase III trial

BeyondSpring files two patent applications to expand therapeutic scope of Plinabulin

Novasep, Celladon sign agreement to develop and supply MYDICAR drug substance

Theravectys gets authorization to produce lentiviral vectors for clinical use and CAR-T cell-based immunotherapy

Regulus' RG-012 receives orphan medicinal product designation in EU for treatment of Alport syndrome

Accelovance named finalist for Best Contract Research Organization at ViE Awards

FDA approves Quadracel vaccine to protect young children from life-threatening diseases

Marken secures Best Life Science Logistics Provider award

Many teens still ignorant of significant physical danger posed by legal drugs

Only few studies demonstrate the effectiveness of marijuana

Oncolytics' REOLYSIN granted EMA Orphan Drug Designation for treatment of gynecological cancers

Egalet announces plans to commercialize SPRIX Nasal Spray and OXAYDO tablets

Study: Early improvements not sustained in patients treated with PRP injection for facet joint arthropathy

CMV-based vaccine provides long-lasting protective immunity against Ebola virus

Experimental drug that attacks brain tumor cells passes early tests

TPU's submission of Docetaxel Injection Concentrate, Non-Alcohol Formula NDA acknowledged by FDA

Confluence pharmaceuticals signs co-development and marketing agreement with AOP orphan for fragile X syndrome drug

Study explains why COPD patients develop tolerance to roflumilast drug

Discontinuation of statin therapy may benefit patients with terminal illness

Vitamin D3 and metformin show promising results in preventing colorectal cancer

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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