The FDA announcement was announced in April 10th. FDA requires a lengthening of the review time to fully assess the effect of the drug on the liver function of patients in the elagolix application data for the treatment of endometriosis related pain new drugs. The PDUFA will be delayed for… Continue Reading FDA extended the review time for 3 months, AbbVie heavy endometriosis new drug elagolix postponed.
Since the first scientific breakthrough of the migraine drug, Schuma Cootassages, the first scientific breakthrough in the early 90s, startan drugs have led and driven the growth of the global market for anti migraine drugs. In 2005, the global anti migraine drug market reached US $3 billion 500 million. In… Continue Reading Detailed guidelines for the development of FDA’s latest acute migraine drug development guidelines
GPCR (G Protein-Coupled Receptor), the largest membrane protein family in the mammalian genome, is widely distributed in the central nervous system, the immune system, the cardiovascular, retina and other organs and tissues, and is involved in the development of the body and the functioning of normal functions. If the regulation… Continue Reading Research and development of antibody drugs for GPCR family
In April 23rd, the listing application of Heng Rui PD-1 monoclonal antibody Camrelizumab injection (SHR-1210) (CXSS1800009) was accepted by CDE. So far, 5 companies have applied for PD-1 mAb in China, and BMS’s Opdivo has been the first to receive priority assessment. The indications of the 5 companies were different.… Continue Reading HengRui pharmaceutical PD-1 mAb SHR-1210 is listed on the market
In the decades since Genentech’s birth, the biomedical industry has seen countless new technologies, countless new companies. Many of these technologies have been touted as a revolutionary new breakthrough in recombinant DNA, such as gene sequencing, gene editing and RNA interference. But today, no single technology can revolutionize the pharmaceutical… Continue Reading Conceit, determination and frustration: the unveiling of the biggest unicorn, Moderna
On April 6, Incyte announced a key phase III ECHO – 301 (KEYNOTE – 252) the results of clinical research, according to data epacadostat inhibitor (IDO) joint Keytruda inhibitors (PD – 1) treatment is surgical resection or metastatic melanoma than used alone Keytruda failed to significantly improve progression-free surial (PFS).… Continue Reading After the defeat of IDO, what new progress has been made in the field of small molecule tumor immunotherapy?
On April 17, takeda announced “Ixazomib citrate capsules obtains the national food and drug supervision and administration bureau (CFDA, now the SDA) issued by the drug import registration certificate, allowed to joint drug lenalidomide and dexamethasone for the treatment of always get at least one line treatment of multiple myeloma… Continue Reading Ixazomib was approved by the CFDA for approval, and the import of new drugs was accelerated in China.
In 1970, the zambian nun Mary Jucunda wrote a letter to Ernst Stuhlinger, who worked for NASA. “There are still so many children on the planet who don’t have enough to eat,” said sister Mary Jucunda. “why is NASA investing billions of dollars in space programs?” . Mary Jucunda didn’t… Continue Reading Age of natural antibody: new drug dreams of LiaoHuaXin and ZhengWeihong
On April 18, the FDA approved a listing application for the monoclonal antibody drug Burosumab (Crysvita) for the treatment of x-linked low phosphate-linked rickets (XLH) for children aged 1 and above and adults. Prior to that, Burosumab had received conditional approval from the European Union in February. It is understood… Continue Reading Burosumab approved by FDA for the treatment of rare rickets
Throughout the development of new drugs in the field of Alzheimer’s disease (AD), the high failure rate in clinical trials is prohibitive. There are many reasons for this. The core problem is not enough awareness of AD itself. Therefore, we need to adjust the cognition of AD from all angles.… Continue Reading Detailed description of FDA’s latest development guidelines for Alzheimer’s disease