Recently, Sage Therapeutics issued a statement saying that the FDA has extended the PDUFA date for priority review of new drug applications for its new drug Zulress (brexanolone) for the treatment of postpartum depression. This means that the previously disclosed PDUFA on December 19, 2018 will be extended by… Continue Reading FDA delays approval of new postpartum depression drug brexanolone, requiring risk assessment and mitigation strategies

  On November 21, Taiwan’s OBI Pharma announced that the FDA has granted OBI-888 the right to treat orphan drugs for pancreatic cancer. OBI-888 is a first-in-class passive immunotherapy treatment of monoclonal antibody against Globo H, a tumor cell surface antigen, whose mechanism of action is antibody-dependent cytotoxicity, antibody-dependent macrophage… Continue Reading Taiwan’s Hao Ding Harvest FDA’s third orphan drug qualification: OBI-888 for the treatment of pancreatic cancer

  The FDA issued a warning message on August 29, 2018: Cases of rare, severe genital and genital area infections of sodium-glucose cotransporter 2 (SGLT2) inhibitors have been received. This rare and serious infection is called perineal necrotizing fasciitis, also known as Funeral gangrene. The FDA believes that new warnings… Continue Reading Warning: This type of hypoglycemic agent can cause serious reproductive area infection

  On October 5, the FDA approved a supplemental application for Merck’s Gardasil 9 (9-valent recombinant human papillomavirus vaccine, HPV vaccine) for vaccination for women aged 27-45 and male adults. Prior to this, Gardasil 9 was intended for women aged 9-26 or male adolescents and adults, and the FDA did… Continue Reading FDA approves cervical cancer vaccine Gardasil 9 expanded for use: available to women and men aged 27-45

On July 17, US time, FDA Administrator Scott Gottlieb publicly criticized biotech pharmaceutical companies for using unpleasant strategies to keep low-cost competitors out of the market. The Brookings Institution, the US think-tank, also said in a recent speech that it is developing a Biosimilars Action Plan that includes improving the… Continue Reading FDA Director calls for increased overseas drug imports

Recently, Dr. Scott Gottlieb, the US FDA’s director, issued a statement announcing that the FDA will continue to vigorously promote the development of gene therapy and released six new guidelines. Gene therapy was once a theory and has now become a therapeutic reality for patients. Gene therapy has the potential… Continue Reading Fully promote gene therapy, FDA released 6 new guidelines

In the first half of 2018, the FDA approved 20 new molecular entities and new biological products, including 15 new molecular entities and 5 new biological products. 1. Lutathera (lutetium Lu 177 dotatate) On January 26th, the FDA approved Nutra Subsidiary France Advanced Accelerator Applications (Advanced Accelerator Application) Lutathera for… Continue Reading FDA approved new drugs in the first half of 2018

On June 16th, Novartis announced the 14-month follow-up data of Kymriah (tisagenlecleucel) in the critical Phase II JULIET study of adult relapsed or refractory diffuse large B-cell lymphoma (DLBCL) at the EHA 2018 conference. The data shows that in 93 evaluable patients, the ORR at the 14th month was 52%,… Continue Reading The latest 14-month follow-up data of Kymriah treatment DLBCL: Complete remission rate 40%

Amgen announced on June 11 that the FDA had approved its supplementary application and was approved to write positive survival data in the ASPIRE Phase III study into the drug label of Kyprolis, namely: Kyprolis plus lenalidomide plus dexamethasone. Treatment of patients with relapsed and refractory multiple myeloma who had… Continue Reading FDA Approves Kyprolis to Update Drug Labels: Death Risk Decreases by 21%, OS Extends 7.9 Months

On June 4, the FDA approved the marketing of Mylan Fulphila (pegfilgrastim-jmdb) to reduce the risk of neutropenia infection and fever. Fulphila is the 10th biosimilar approved by the FDA and the first biosimilar of Amgen Neulasta (pegfilgrastim).   Amgen launched the world’s first recombinant human granulocyte colony-stimulating factor, Neupogen… Continue Reading The first bioanalogue of Amgen’s $4.5 billion product