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Mylan launches Tolterodine Tartrate ER Capsules, 2 mg and 4 mg

Mylan Inc. today announced that its U.S.-based subsidiary Mylan Pharmaceuticals Inc. has launched Tolterodine Tartrate Extended-release Capsules, 2 mg and 4 mg. Tolterodine Tartrate ER Capsules are the generic version of Pfizer's Detrol LA, and are indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and frequency. Mylan received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for this product.

7 Jan 2014

Navidea Biopharmaceuticals, GMST sign distribution agreement for Lymphoseek Injection in Taiwan

Navidea Biopharmaceuticals, Inc., a biopharmaceutical company focused on precision diagnostic radiopharmaceuticals, announced today it has entered into a distribution agreement for Lymphoseek (technetium Tc 99m tilmanocept) Injection in Taiwan with Global Medical Solutions Taiwan, Ltd., a leading in-country distributor of nuclear medicine and diagnostic imaging products.

7 Jan 2014

FDA OOPD grants orphan drug designation to Alitair's Erdosteine for treatment of bronchiectasis

Alitair Pharmaceuticals, Inc., today announced that the Office of Orphan Products Development of the Food and Drug Administration has granted orphan drug designation for its drug candidate, Erdosteine, for the treatment of bronchiectasis. Erdosteine is a mucolytic with antibacterial, anti-inflammatory, and antioxidant properties.

7 Jan 2014

EC grants approval for ABRAXANE in combination with gemcitabine for metastatic pancreatic cancer

Celgene International Sàrl, a wholly-owned subsidiary of Celgene Corporation, today announced that the European Commission has granted approval for ABRAXANE (paclitaxel formulated as albumin bound nanoparticles, or nab-paclitaxel) in combination with gemcitabine for first-line treatment of adult patients with metastatic adenocarcinoma of the pancreas, or metastatic pancreatic cancer.

7 Jan 2014

Epizyme achieves POC milestone in EPZ-5676 DOT1L inhibitor clinical program

Epizyme, Inc., a clinical stage biopharmaceutical company creating innovative personalized therapeutics for patients with genetically defined cancers, today announced the achievement of the proof of concept milestone in the EPZ-5676 DOT1L inhibitor clinical program, earning a $25 million payment under the company's collaboration with Celgene Corporation.

7 Jan 2014

Cancer cells less likely to develop resistance when multiple drugs delivered simultaneously

Researchers have developed a technique for creating nanoparticles that carry two different cancer-killing drugs into the body and deliver those drugs to separate parts of the cancer cell where they will be most effective. The technique was developed by researchers at North Carolina State University and the University of North Carolina at Chapel Hill.

7 Jan 2014

Antidepressant medications do not increase suicide risk in children

A Vanderbilt University Medical Center study released today shows there is no evidence that the risk of suicide differs with two commonly prescribed antidepressants prescribed to children and adolescents.

7 Jan 2014

Aeterna Zentaris announces FDA acceptance for filing of macimorelin acetate NDA for AGHD

Aeterna Zentaris Inc. today announced that the U.S. Food and Drug Administration has accepted for filing the Company's New Drug Application for its ghrelin agonist, macimorelin acetate, in Adult Growth Hormone Deficiency. The acceptance for filing of the NDA indicates the FDA has determined that the application is sufficiently complete to permit a substantive review.

7 Jan 2014

Population Council gets USAID cooperative agreement to develop non-ARV microbicides that block HIV, STI

The Population Council today announced it was awarded a cooperative agreement from the US Agency for International Development's (USAID) Office of HIV and AIDS: "Non-ARV Based Combination Microbicide that Blocks HIV and Other STIs."

6 Jan 2014

Influenza and pneumococcal vaccines together appear to increase risk of fever in children

Giving young children the influenza and pneumococcal vaccines together appears to increase their risk of fever, according to a study led by researchers from Columbia University Medical Center (CUMC) and the Centers for Disease Control and Prevention (CDC). However, the fever was brief, and medical care was sought for few children, supporting the routine immunization schedule for these vaccines, including the recommendation to administer them simultaneously.

6 Jan 2014

UVA team works with local rescue squads to diagnose stroke patients before they reach hospital

A University of Virginia Health System team is working with local rescue squads to diagnose stroke patients before they reach the hospital, enabling more patients to receive lifesaving treatment and have a full recovery.

6 Jan 2014

Amneal launches generic Esomeprazole strontium delayed-release capsules 49.3 mg

Amneal Pharmaceuticals LLC today announced the launch of generic Esomeprazole strontium delayed-release capsules 49.3 mg. This new esomeprazole therapy is the generic equivalent of the recently launched brand Esomeprazole strontium. It contains the same active moiety (esomeprazole) in a different salt form as found in the leading PPI brand Nexium (esomeprazole magnesium) and presents a potentially more affordable treatment option for GERD in adult patients.

6 Jan 2014

FDA grants orphan drug designation for DiaVacs' type 1 diabetes mellitus therapy

DiaVacs, Inc. announced today that the Office of Orphan Products Development of the Food and Drug Administration has granted orphan drug designation for the company's type 1 diabetes mellitus (T1DM) therapy.

6 Jan 2014

Adherence to nutrition recommendations is weak among people with metabolic syndrome

Adherence to dietary recommendations is weak among people suffering from metabolic syndrome or having increased risk for metabolic syndrome, according to the Nordic SYSDIET study led by the University of Eastern Finland.

6 Jan 2014

Jones Engineering Group to focus on pharmaceutical industries in Saudi Arabia

Jones Engineering Group is continuing to develop its presence in Saudi Arabia with a strategic focus on the food and beverage, pharmaceutical and health care industries. The leading international engineering contracting group has recently signed a deal with a major multinational FMCG client worth an estimated €20 million. Work on the project will commence immediately.

6 Jan 2014

RegeneRx's Tβ4 gets FDA Orphan Drug designation for treatment of Neurotrophic Keratopathy

RegeneRx Biopharmaceuticals, Inc. announced that it has received Orphan Drug designation from U.S. FDA's Office of Orphan Products Development for its drug candidate, Thymosin beta 4 (Tβ4), for the treatment of Neurotrophic Keratopathy, a serious degenerative disease of the corneal epithelium (the outside layer of the eye).

5 Jan 2014

NPS Pharmaceuticals' Natpara gets orphan drug designation for treatment of hypoparathyroidism

NPS Pharmaceuticals, Inc., a global biopharmaceutical company pioneering and delivering therapies that transform the lives of patients with rare diseases, today announced that the European Commission has granted orphan drug designation to Natpara (recombinant human parathyroid hormone (rhPTH[1-84]) for the treatment of hypoparathyroidism.

3 Jan 2014

Marina Biotech, Mirna modify license agreement regarding development of microRNA-based therapeutics

Marina Biotech, Inc., a leading oligonucleotide-based drug discovery and development company, and Mirna Therapeutics, Inc., a privately-held biotechnology company pioneering microRNA replacement therapy for cancer, announced today that they have amended their license agreement regarding the development and commercialization of microRNA-based therapeutics utilizing Mirna's proprietary microRNAs and Marina Biotech's novel SMARTICLES liposomal delivery technology.

3 Jan 2014

AstraZeneca to take over Probiodrug's CDK9 inhibitor program

Probiodrug AG announced today the transfer of its experimental cyclin-dependent kinase 9 inhibitor program to AstraZeneca. The transaction includes the sale to AstraZeneca of a lead molecule and back-up compounds with the associated intellectual property. CDK9, which has been implicated in the transcriptional regulation of genes involved in proliferation and inflammation, is a promising target for the treatment of both cancer and inflammatory diseases.

3 Jan 2014

Chinese herbal medicine effective at alleviating acute inflammatory and nerve pain

A compound derived from a traditional Chinese herbal medicine has been found effective at alleviating pain, pointing the way to a new nonaddictive analgesic for acute inflammatory and nerve pain, according to UC Irvine pharmacology researchers.

3 Jan 2014

Pharmaceutical News

Mylan launches Tolterodine Tartrate ER Capsules, 2 mg and 4 mg

Navidea Biopharmaceuticals, GMST sign distribution agreement for Lymphoseek Injection in Taiwan

FDA OOPD grants orphan drug designation to Alitair's Erdosteine for treatment of bronchiectasis

EC grants approval for ABRAXANE in combination with gemcitabine for metastatic pancreatic cancer

Epizyme achieves POC milestone in EPZ-5676 DOT1L inhibitor clinical program

Cancer cells less likely to develop resistance when multiple drugs delivered simultaneously

Antidepressant medications do not increase suicide risk in children

Aeterna Zentaris announces FDA acceptance for filing of macimorelin acetate NDA for AGHD

Population Council gets USAID cooperative agreement to develop non-ARV microbicides that block HIV, STI

Influenza and pneumococcal vaccines together appear to increase risk of fever in children

UVA team works with local rescue squads to diagnose stroke patients before they reach hospital

Amneal launches generic Esomeprazole strontium delayed-release capsules 49.3 mg

FDA grants orphan drug designation for DiaVacs' type 1 diabetes mellitus therapy

Adherence to nutrition recommendations is weak among people with metabolic syndrome

Jones Engineering Group to focus on pharmaceutical industries in Saudi Arabia

RegeneRx's Tβ4 gets FDA Orphan Drug designation for treatment of Neurotrophic Keratopathy

NPS Pharmaceuticals' Natpara gets orphan drug designation for treatment of hypoparathyroidism

Marina Biotech, Mirna modify license agreement regarding development of microRNA-based therapeutics

AstraZeneca to take over Probiodrug's CDK9 inhibitor program

Chinese herbal medicine effective at alleviating acute inflammatory and nerve pain

Advancing brain microphysiological systems (bMPS)

PhD researcher at LifeArc

Unveiling Hidden Potential: Organoids for Disease Modeling in Neuroscience Research

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