Recently, the US FDA approved Novartis’s spinal muscular atrophy (SMA) gene therapy Zolgensma, which brought dawn to SMA patients and their families, but it has once again refreshed the drug price record with a price of 2.1 million US dollars, making it the most expensive medicine in history. The… Continue Reading World Health Assembly passed the “Transparent Drug Market” resolution: will affect future drug pricing

  On February 6, the FDA approved the introduction of Cablivi (caplacizumab-yhdp) injection developed by Sanofi’s subsidiary Ablynx for plasma exchange and immunosuppressive therapy for adult acquired thrombotic thrombocytopenic purpura (aTTP). On September 3, 2018, the European Union has approved the application for the listing of Cablivi for this indication.… Continue Reading FDA approves first Nanobody to treat acquired thrombotic thrombocytopenic purpura

  In recent years, the number of new drugs approved by the FDA has reached record highs. With this situation, the pricing of specialty drugs is getting higher and higher, and the prices of some new technology therapies that have not yet been approved are even more jaw-dropping. According to… Continue Reading The 20 most expensive drugs in the US pharmacy retail price in 2018

  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