Gilead Sciences drug Trodelvy is now approved for treating patients whose breast cancer is classified as HR positive and HER2 negative, expanding use of the drug to a much wider group of patients. In other regulatory approval news, use of a Takeda Pharmaceutical rare disease drug has expanded to younger children.
Gilead Sciences is building up its autoimmune disease drug pipeline by turning to EVOQ Therapeutics, a startup with technology that takes a novel approach to restoring immune tolerance. For EVOQ, the Gilead deal is its second with a big pharma company.
In partnering with clinical-stage Arcellx, Gilead Sciences gains the opportunity to develop a cell therapy for multiple myeloma that could offer advantages over currently available therapies for the blood cancer. The deal announced Friday came as Arcellx reported additional data during the annual meeting of the American Society of Hematology that showed continued durability of the cell therapy.
Gilead Sciences is betting that a MacroGenics antibody drug for blood cancers can offer a safety edge over others that address the same target. It’s the second partnership between the two companies; an alliance that began in 2013 expired without Gilead licensing any molecules from the deal.
European marketing authorization of the Gilead Sciences drug, Sunlenca, provides a twice-yearly treatment option for HIV patients whose virus has become resistant to multiple therapies. An FDA decision for drug is expected in December.
Gilead Sciences said it has statistically significant and clinically meaningful data from a pivotal test of its cancer drug, Trodelvy, in the most common type of breast cancer. While detailed data remain undisclosed, the company said it has filed a submission with the FDA seeking to expand the drug’s approval to include this larger group of breast cancer 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.
An FDA safety review has cleared Gilead Sciences to resume five clinical trials that were placed under a partial hold in January. The experimental Gilead drug, magrolimab, is part of a class of cancer immunotherapies that address a hot target for the field.
Gilead Sciences did not disclose details about the safety concern that led to an FDA partial clinical hold on five studies evaluating its cancer drug, magrolimab. But this experimental cancer immunotherapy introduces a safety risk that's a known problem for all drugs in this class.
Mirum Pharmaceuticals drug Livmarli is now approved to treat pruritus caused by Alagille syndrome, a rare liver disease that can worsen to the point of requiring a transplant. Mirum licensed the drug from Shire in 2018.
In the eight months since the Gilead Sciences antiviral drug remdesivir became the first FDA-approved treatment for Covid-19, the company has been collecting real-world data about drug’s effect. The data continue to show that the drug reduces the risk of death and helps patients get discharged from the hospital sooner.
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.
Clinical tests of drugs from Gilead Sciences and Novo Nordisk have yielded encouraging results in nonalcoholic steatohepatitis (NASH), and the partners now want to see if the drug combinations help patients in a larger mid-stage study. The planned Phase 2b study expands on a 2019 R&D alliance.
FDA approval for Yescarta in follicular lymphoma makes it the first approved CAR-T treatment for this type of cancer. It also marks Gilead Sciences' third approved indication for a CAR-T cell therapy.
The decision to discontinue all clinical trials for ziritaxestat is the latest setback in a broad alliance between Gilead Sciences and Galapagos. Last year, the FDA rejected a rheumatoid arthritis drug covered under the partnership.
The therapeutic vaccine will be based on Gritstone Oncology’s technology and will use antigens from Gilead Sciences. It’s the latest in a string of partnerships Gilead has signed in its search for an HIV cure.
The company said it was meeting real-time supply demands for Veklury (remdesivir) in the U.S. and anticipated meeting global demands for the drug worldwide. AmerisourceBergen will continue acting as sole U.S. distributor.
