Johnson & Johnson’s Invokana has become the only drug in the SGLT2 inhibitor class to be approved by the FDA for treating diabetic kidney disease (DKD) and to reduce the risk of hospitalisation for heart failure in patients with type 2 diabetes and DKD. Based on results of the CREDENCE trial, J&J’s drug reduced the
In the 1980s, only 4% of new drugs approved by the FDA were cancer treatments. But since 2010, cancer drugs have claimed 27% of new approvals—a share that doubled over the previous decade—according to a new report from the Tufts Center for the Study of Drug Development. It is believed that this is due to
Johnson & Johnson’s Ethicon unit has received a 510(k) clearance from the FDA for its Vistaseal applicators, which spray a biological sealant to stem moderate bleeding during open or laparoscopic surgical procedures. The airless spray products are the first fruit of a broad partnership between the device maker. and plasma-derived medicine manufacturer Grifols, which developed the human fibrin sealant for
Eli Lilly has picked up yet another FDA approval for CDK4/6 inhibitor Verzenio – its third in five months – as it tries to chase down Pfizer’s category-leading Ibrance. The US regulator has given the nod to Verzenio for use in combination with an aromatase inhibitor as initial endocrine-based therapy for women with breast cancer
Swedish Biopharmaceutical company, Swedish Orphan Biovitrum AB has announced that the FDA has issued a “study may proceed” letter for the first study in humans, thereby accepting the investigational new drug (IND) application for the drug candidate SOBI003 for the treatment of mucopolysaccharidosis type IIIA. In addition, SOBI003 was granted Fast Track status by the
Novartis’ CDK4/6 inhibitor Kisqali has acquired Breakthrough status in the US as an initial endocrine-based treatment in certain patients with breast cancer. The FDA awarded the designation for of pre- or perimenopausal women with hormone-receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer in combination with tamoxifen or an aromatase
Novo Nordisk has acquired its first global approval for its once-weekly diabetes therapy Ozempic in the US. The FDA has approved the drug’s use alongside diet and exercise to improve glycaemic control in adults with type II diabetes. Ozempic is a glucagon-like peptide 1 (GLP-1) receptor agonist that induced clinically meaningful and statistically significant reductions
Alexion has finally claimed FDA approval for its complement inhibitor Soliris in Myasthenia Gravis (MG), which could potentially add $1bn-plus in peak sales for the product. The US regulator has approved Soliris (Eculizumab) to treat adults with refractory generalised MG who are anti-acetylcholine receptor (AchR) antibody-positive, a patient group that “continues to suffer from significant
The FDA, in partnership with international regulatory and law enforcement agencies, recently acted against over 500 websites that illegally sell potentially dangerous, unapproved versions of prescription medicines. Medicines which included opioids, antibiotics and injectable epinephrine products to American consumers. These actions were part of a major global operation that the FDA participated in to target
Doctors at Children’s Hospital Colorado are hoping to launch as many as 25 new clinical trials in the next six months following a recently signed federal law opened the floodgates to test experimental cancer drugs for children. “The paediatric oncology community is really excited,” said Dr. Lia Gore, the director of Children’s Center for Cancer
