Pharma News

REGENXBIO Inc.  a leading biotechnology company focused on the development, commercialization and licensing of recombinant adeno-associated virus (AAV) gene therapy,  announced that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease Designation to RGX-111, the Company’s investigational gene therapy product candidate for the treatment of mucopolysaccharidosis Type I (MPS I).

Amarantus Bioscience Holding Inc. , a biotechnology company focused on developing products for Regenerative Medicine, Neurology and Orphan Diseases, announced that it has requested Rare Pediatric Disease Designation (RPDD) and Orphan Drug Designation (ODD) from the US Food and Drug Administration (FDA) to treat GCMN with Engineered Skin Substitute (ESS). It is estimated that the incidence of GCMN, a rare dermatological condition present at birth, is between 8 and 80 births annually in the United States.

Daiichi Sankyo Company, Limited announced that its wholly owned subsidiary, Daiichi Sankyo Korea Co., Ltd. (hereafter “DSKR;” headquarters: Jongno-gu, Seoul, South Korea), and Daewoong Pharmaceutical Co., Ltd. (hereafter “Daewoong Pharmaceutical;” headquarter: Gangnam-gu, Seoul, South Korea) have signed an agreement for the co-promotion of the oral, once-daily anti-coagulant, LIXIANA® (generic name: edoxaban).

Drug major Lupin has received US health regulator's approval to market Fyavolv tablets, used to treat postmenopausal osteoporosis, in the American market. The company has received received the final approval from the United States Food and Drug Administration (FDA) to market Fyavolv tablets, Lupin today said in a statement.

A new oral drug whose efficacy in combating breast cancer has been demonstrated alone and in combination with endocrine therapy, also has potential to combat other types of cancer, new research has found.

The World Health Organisation on Tuesday declared the end of the Ebola outbreak in the West African nation of Guinea, two years after the beginning of the epidemic.

A newly created antibody could treat the decline in muscle mass and power associated with ageing, show results of a phase-two trial by an international research team.

The delay of patients in recognising heart-attack symptoms and seeking the treatment later may increase the damage to heart, warns a new study. The researchers in this study compared the impact of the time from heart attack symptom onset-to-balloon and door-to-balloon on heart muscle function.

Despite legislation and public education, China has not been able to curb tobacco use which remains the same as it was five years ago, a recent national survey found.

Use of ultrasound in detecting breast cancer has been shown to be comparable in its sensitivity to that of mammography and should be considered when testing for the disease, according to a new study.