A federal judge disagreed with AstraZeneca’s claims that the Inflation Reduction Act causes harm by disincentivizing innovation and violates its constitutional rights to due process. Blockbuster AstraZeneca drug Farxiga is one of 10 medications selected for the Medicare drug price negotiation program created by the law.
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.
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.
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.
At the Abarca Forward conference earlier this year, George Van Antwerp, managing director at Deloitte, discussed how social determinants of health and a personalized member experience can improve medication adherence and health outcomes.
While many sellers were found to express altruistic motives, the researchers wrote that improperly stored insulin creates risks of lost potency and contamination. The findings highlight the need for substantive policy reform, according to the study's lead author.
The company is developing a PRMT5 inhibitor, currently in a Phase I study for lymphomas, myeloid malignancies and solid tumors.
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.
Hartford, Connecticut-based Aetna has bid adieu to the Affordable Care Act exchanges. On Wednesday the insurer revealed plans to withdraw from the Nebraska and Delaware markets.
We will highlight Build My Health's revenue practice management tools, which could help physician practices add up to $250,000 to their practices.
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.
Through a new partnership with the maker of GORE-TEX, San Diego's ViaCyte is looking to finetune its PEC-Encap combination device that could one day offer a functional cure for type 1 diabetes.
Most of the contents of a $140 million lawsuit Walgreens filed against Theranos last week have been unsealed. And the charges — at least the parts that haven't been redacted — paint a picture of incompetency and deception.
In the wake of the Supreme Court's decision to uphold federal subsidies for health insurance under the Affordable Care Act, Pennsylvania no longer will be establishing its own, state-run exchange, Gov. Tom Wolf said Thursday.
Leading Edge Ventures, a $10 million venture investment fund in Delaware is relatively new on the venture scene since its launch last year. Among its targets are early stage and seed stage medical device and IT companies. In a recent interview with Keystone Edge e-newsletter, General Partner Doug Petillo talked about his background as a […]