The PTC Therapeutics drug Translarna failed its confirmatory study in Duchenne muscular dystrophy. Analysts say the European Commission’s decision to not adopt the Committee on Medicinal Products for Human Use’s negative opinion on the drug is unusual, if not unprecedented.
Labcorp’s $239 million offer was selected as the winning bid for the assets of genetic testing company Invitae, which filed for bankruptcy protection earlier this year. The acquisition deal, Labcorp's second in the past month, will enable it to expand in oncology and rare diseases.
This eBook, in collaboration with Care Logistics, details how hospitals and health systems can facilitate more effective decision-making by operationalizing elevated awareness.
More than 33,000 Providence employees filed a class-action complaint against the health system in 2021, alleging that it had been withholding their wages by denying them breaks and rounding down their working hours. Last week, Providence was ordered to pay more than $200 million in damages — a decision that “sends a message to healthcare corporations,” according to an attorney representing the workers.
AliveCor CEO Priya Abani argues that Apple has made a habit of taking intellectual property from smaller medical device firms in order to improve the functionalities its Apple Watch. She also believes that Apple has been able to avoid taking accountability for this by “bombarding” smaller companies with litigation it knows they won’t be able to afford — a claim that medical IP lawyers have backed up.
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.
Fruit Street Health's complaint alleged that Sharecare violated the terms of their shared business agreement by rolling out its own version of Fruit Street’s diabetes prevention program, which had been previously offered to Sharecare members. Sharecare said that the lawsuit is baseless.
Canada has a proud history of achievement in the areas of science and technology, and the field of biomanufacturing and life sciences is no exception.
Novartis became the seventh drugmaker to legally challenge the White House’s Medicare drug pricing negotiation program. The company filed its lawsuit three days after HHS announced the first 10 drugs that were selected for the program — its heart failure medication Entresto was one on the list. HHS can expect to face more lawsuits from the manufacturers of the 10 drugs it named last week, experts have warned.
The Labor Department recently sued UnitedHealth Group subsidiary UMR, alleging that it wrongfully denied claims for emergency room services and urinary drug screenings since 2015. UMR did not determine the medical necessity of the claims, denying them “based solely on diagnosis codes and not applying a prudent layperson standard," according to the complaint.
Digital health startup Dorsata filed a lawsuit against EHR provider athenahealth and women’s health company Unified Women's Healthcare. The startup alleged that athenahealth stole trade secrets, used deceptive business practices and breached its contract — and that Unified aided and abetted these purported practices.
CMS recently proposed a $9 billion lump sum payment to remedy illegal payment cuts for 340B drugs from 2018 to 2022. In general, hospital groups have reacted positively to the fact that 340B providers will receive lump sum payments but have expressed concern about CMS’ methods for maintaining budget neutrality with this plan.
The TSX Venture Exchange has a strong history of helping early-stage health and life sciences companies raise patient capital for research and development.
LGBTQ advocacy groups and clinicians argue that healthcare providers have a responsibility to treat the recent wave of laws banning gender-affirming care for minors like the public health crisis that it is. To do this, providers must educate themselves about the laws in their state and nearby states, fight misinformation and collaborate with nonprofits to deliver care to kids in states where their access is under attack.
Lawsuits filed in opposition to the White House's drug pricing negotiation program are beginning to mount, but legal experts agree that the plaintiffs’ arguments probably won’t hold up during a court battle. However, these lawsuits still could delay when the government's ability to negotiate price goes into effect.
Healthcare dealmakers must prepare for a new law and a recently-introduced bill in the California Senate, both of which aim to increase oversight in the healthcare M&A space. This is a legislative trend other states are beginning to participate in too — such as New York, Massachusetts and Connecticut.
Merck recently became the first drugmaker to sue the federal government over its Medicare drug price negotiation program. The company's lawsuit argues that the program violates the Constitution’s First and Fifth Amendments, but healthcare law expert Robin Feldman said the defense doesn't have any legs.
A federal jury found three former Outcome Health executives guilty of 47 counts of fraud. The convictions come after a 10-week trial that investigated the former leaders’ role in a billion-dollar scheme in which the company lied to its customers about how many physicians' offices their advertisements would appear in.