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.
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.
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 company is developing a PRMT5 inhibitor, currently in a Phase I study for lymphomas, myeloid malignancies and solid tumors.
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.
A spokesperson said the data stolen would not have included patient information. A cybersecurity expert said organizations that aggregate data, like CROs, are often a target for criminals as well as foreign espionage groups, especially from China.
A team at Nemours Alfred I. duPont Hospital for Children developed a cerebral palsy patient registry. At the HIMSS Pop Health Forum in Chicago, the hospital explained the challenges it encountered along the way.
Amalgam Rx, founded by WellDoc co-founder and former chief medical officer Dr. Suzanne Clough and Ryan Sysko, who served as CEO at the diabetes management business, secured FDA clearance for its first app — iSage Rx.
Burlington, North Carolina-based LabCorp is rumored to be negotiating an $8 billion acquisition of Pharmaceutical Product Development (PPD), a global contract research organization operating in over 50 countries.
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.
Social media has become an important tool for pharmaceutical companies to raise brand awareness and assess the public’s appetite for its products. Some groups are also studying the effect of financial and charitable incentives to influence behavior. Now AstraZeneca (NYSE: AZN) has combined these in one website promoting national breast cancer awareness month. AstraZeneca division […]
Angel investment networks tend to stick to metropolitan cities on the East Coast and West Coast. Why? Most angels see themselves as philanthropic investors and want to invest locally. Startups tend to sprout in places that encourage entrepreneurship and reward it. Traditionally, that has been in cities on the coasts but that is beginning to […]
In AstraZeneca’s (NYSE: AZN) statement outlining additional changes the drug maker will make to its global business to achieve scientific leadership this week, it underscored the magnitude with a few words. “Focus” was mentioned 11 times — a few times in bold. “Accelerate” was used eight times and “transform” got a few mentions too. But […]
AstraZeneca (NYSE:AZN) is revamping its research and development divisions to improve drug development by cutting 1,600 from its global operations and focusing R&D staff in three sites including Gaithersburg, Maryland. It plans to ditch its London headquarters in favor of a new $500 million center in Cambridge in the UK by 2016. By focusing on […]
Biotechnology company iBio (NYSE MKT: IBIO) with a plant-based platform to develop vaccines and therapeutics has formalized a collaboration agreement with a Texas-based life science company. A previous iteration of that company used iBio’s plant technology for a DARPA-backed large-scale production facility to develop vaccines and therapeutics using tobacco plants as part of “the GreenVax” […]
