Before healthcare providers onboard workers sourced from staffing agencies, they should make sure these laborers are hired as W-2 employees rather than 1099 independent contractors, one lawyer recently warned. The Department of Labor is increasing its efforts to ensure healthcare facilities are complying with the law as it pertains to contract labor and overtime pay.
CommonSpirit Health is facing a proposed class-action lawsuit over a ransomware attack it suffered last fall that exposed 623,774 patients' personal data. However, hospitals' data breach lawsuits usually never make it court, a legal expert said.
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.
In response to emailed questions, Alicia Jackson talked about her healthcare background and how the healthcare startup is responding to a shifting legal landscape for women's health following the overturning of Roe v. Wade by the U.S. Supreme Court.
The FDA issued a warning letter about nicotine gummies—the first ever notification sent for such a product. The agency’s concern is that the flavored gummies resemble candy and pose a toxicity risk to children.
FDA approval of Bluebird Bio’s Zynteglo makes it the first gene therapy in the U.S. for the rare blood disorder beta thalassemia. The biotech company set a $2.8 million price for the one-time treatment, but it also came up with a reimbursement strategy designed to ease the financial risk to payers.
Enhertu, a breast cancer drug from AstraZeneca and Daiichi Sankyo, is now FDA approved for treating patients whose tumors express low levels of the protein HER2. The decision makes the infused therapy the first targeted treatment for this new category of breast cancer patients.
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.
The FDA has granted the Pfizer and BioNTech Covid-19 full approval for use in adolescents. In other Covid-19 news, pharmacists were granted additional prescribing powers for an antiviral and Novavax’s European marketing authorization has been expanded to an additional age group.
Messenger RNA vaccine biotech CureVac is suing BioNTech, alleging that its rival’s Covid-19 vaccine infringes on intellectual property built on more than two decades of research. BioNTech responded that its work is original and the company will defend against the infringement allegations.
The FDA placed a partial clinical hold on late-stage tests of Sanofi multiple sclerosis drug tolebrutinib after some patients developed drug-induced liver injury. While U.S. tests are paused, Sanofi said clinical testing in other countries is continuing with additional safety monitoring.
The new FDA approval for Breyanzi moves the Bristol Myers Squibb cancer cell therapy into an earlier line of treatment for an aggressive type of blood cancer. The decision also gives the pharmaceutical giant access to an additional pool of patients untapped by a rival cell therapy from Gilead Sciences.
We will highlight Build My Health's revenue practice management tools, which could help physician practices add up to $250,000 to their practices.
Drug prices are on the minds of patients and politicians. The November election is expected to tip the balance of power in Congress and a panel held during the Biotechnology Innovation Organization’s annual meeting discussed what that change could mean for drug price legislation.
The FDA approved Pluvicto, a Novartis radiopharmaceutical, as a new treatment option for advanced prostate cancer. Novartis added the therapy via its $2.1 billion acquisition of Endocyte four years ago.
Alnylam Pharmaceuticals has proprietary lipid nanoparticle technology used in its FDA-approved RNA therapies. The biotech company claims that the messenger RNA Covid-19 vaccines from Moderna and Pfizer infringe on a patent covering this LNP technology.
Research of Johnson & Johnson’s baby powder included a prison study in which inmates, mostly Black men, were injected with asbestos. The study was intended to assess how asbestos’s effects on the skin compare to talc, the key component of baby powder.
The FDA told Reata that the clinical data do not show that the drug, bardoxolone, slows the progression of the loss of kidney function in patients who have the rare disease Alport syndrome. The regulatory decision follows an FDA advisory committee vote recommending against approval of the small molecule drug.