The bizarre saga of biotech executive Frank Reynolds took another turn today when federal authorities arrested the PixarBio (OTC:PXRB) CEO and two associates on securities fraud charges, claiming they misled investors about its opioid substitute and falsely claimed a $1 billion valuation. PixarBio is purportedly developing a drug to replace morphine and other opiates, but prosecutors alleged […]
Legal News
Companies push back against allegations of FCA violations over excess at-home blood testing
A 70-year-old former Marine is taking a group of companies to court over their at-home blood testing services, arguing that the industry players broke the law by requiring patients to conduct weekly tests. The companies then submit these bills to Medicare for reimbursement, even asking to be repaid for services that weren’t rendered, according to […]
Report: Pharma companies ask Supremes to take eye-dropper case
A group of pharmaceutical companies, including Allergan (NYSE:AGN) and Merck (NYSE:MRK), have asked the Supreme Court to review a case between the industry players and patients regarding the design of the companies’ eye-droppers, according to a report from the AP. In the on-going legal debate, patient groups have claimed that the companies’ devices dispense large drops of medication […]
Alere forks over $33m to settle DOJ inquiry
The U.S. Dept. of Justice said today that Abbott‘s (NYSE:ABT) Alere (NYSE:ALR) agreed to pay $33.2 million to resolve allegations that it knowingly sold unreliable point-of-care diagnostic devices, causing hospitals to submit false claim to Medicare, Medicaid and other federal healthcare programs. The U.S. alleged that Alere sold materially unreliable Triage devices, which are designed to diagnose […]
House passes “right to try” bill allowing use of experimental drugs for terminally ill patients
The US House of Representatives yesterday passed a bill aiming to expand the “right to try” experimental drugs, sending the bill, which is backed by President Trump, to the Senate. The bill would allow terminally ill patients access to investigational drugs drugs that haven’t been approved by the FDA, according to a report from The […]
Tribe looks to stop patent board’s review of Restasis IP
Allergan (NYSE:AGN) and the St. Regis Mohawk Tribe asked the Federal Circuit last week to stop the U.S. Patent Trial and Appeal Board from reviewing the IP for Allergan’s blockbuster eye drug, Restasis. The move comes in response to the board’s February decision that sovereign immunity does not shield tribes from patent challenges. The board’s ruling […]
Mass. Supremes: Pharma Cos. liable for generic labeling issues
Merck (NYSE:MRK) and other large brand-name pharmaceutical manufacturers could be legally liable for injuries resulting not from the use of their brand name products, but from generic versions of those drugs made by other companies, according to a new ruling from the Massachusetts Supreme Judicial Court. The court ruling could set the precedent that such brand-name […]
SEC charges Theranos, CEO Holmes with ‘Massive Fraud’
The US Securities and Exchange Commission today charged controversial blood-testing developer Theranos, founder & CEO Elizabeth Holmes and former prez Ramesh Balwani with “massive fraud” – charges which Theranos and Holmes have agreed to resolve, according to the SEC. Charges include claims that the company raised more than $700 million from investors in “an elaborate, […]
Controversial “right to try” bill fails in the House
A controversial bill that would grant terminal patients access to experimental therapies failed yesterday in the House. Although the “right to try” effort didn’t muster up enough votes to send it to the Senate, majority leader Rep. Kevin McCarthy (R-CA) said in a statement that the fight wasn’t over. “We will try again, pass legislation, […]
Judge rips into Abbott’s diabetes test strip supplier over discovery fraud
A supplier that sells an international version of Abbott‘s (NYSE:ABT) FreeStyle Diabetes test strips committed discovery fraud when it forked over only a select group of relevant documents last year, according to a U.S. magistrate judge. Lois Bloom ruled that the supplier, H&H, lost the right to invoke attorney-client privilege when it is deposed about […]
