Regulatory approval of Incyte’s cancer immunotherapy, Zynyz, comes two years after the FDA rejected an application seeking approval in a rare type of anal cancer. The decision makes the new Incyte drug the third approved treatment for metastatic Merkel cell carcinoma.
Atopic dermatitis patients now have a new therapeutic option that comes as a topical cream. The FDA approved Incyte’s drug, Opzelura, as a treatment for the inflammatory skin condition, but the regulatory nod comes with a black box warning on the label that broadly covers the entire class of JAK inhibitors.
The European Commission has approved a BioMarin Pharmaceutical drug that treats achondroplasia, a rare genetic disorder that slows bone growth and is the most common cause of dwarfism. The commission also granted conditional approval to a cancer drug from partners Incyte and MorphoSys.
An Incyte drug developed as a treatment for a rare type of anal cancer has fallen short of FDA approval. The regulator said it needs to see more clinical data that demonstrate clinical benefit for the antibody drug.
The FDA approved Monjuvi for second-line diffuse large B-cell lymphoma. Though the drug has the same antigen target as approved CAR-T cell therapies, it is designed for patients unable to tolerate such intensive treatments.
While focus of potential Covid-19 treatment drugs has fallen on antivirals such as Gilead's remdesivir, there are anti-inflammatory drugs being tested to mitigate the huge overreaction of the immune system often seen in patients.
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
The company said it is working with the FDA to start a Phase III study of Jakafi in Covid-19-associated cytokine storm, which may be behind severe disease in some patients and for which JAK inhibitors have been suggested as a possible therapeutic option.
The deal, worth up to $2B in milestones and other other payments, involves the monoclonal antibody tafasitamab, for which MorphoSys recently submitted an FDA approval application.
Keep the champagne on ice. In an unexpected twist, the FDA has requested more dosage and safety data for Eli Lilly's baricitinib (Olumiant) — a delay that could cost millions.
A European Union regulatory committee’s recommendation to approve a drug developed by Incyte (NASDAQ:INCY) to treat the bone marrow disease myelofibrosis has triggered a $40 million milestone payment from Novartis (NYSE:NVS). The recommendation was made for Jakavi (ruxolitinib) by the European Medicines Agency’ Committee for Medicinal Products for Human Use. The EU regulatory body usually […]
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
