At least four drugmakers and two drug distributors are under investigation by federal prosecutors for possible violation of the Controlled Substances Act on allegations they helped fuel the opioid crisis through their management of opioids. Amneal Pharmaceuticals, Johnson & Johnson, Mallinckrodt and Teva, and drug distributors McKesson and AmerisourceBergen have already received subpoenas, and more companies are expected to receive subpoenas in the coming months, a source says.
MiMedx, together with former CEO Parker Petit, former COO William Taylor and former CFO Michael Senken, agreed to pay $1.5 million to settle allegations that the company misstated the firm's revenues and misled investors. The complaint involves what investigators say were undisclosed side arrangements with five distributors.
Some members of the Democratic Party are shifting away from the push for Medicare for All particularly in states where it could hurt them politically. Sens. Bernie Sanders, I-Vt. and Elizabeth Warren, D-Mass., continue to tout the plan but other Democrats are not in favor of it and say it may be a political liability.
A federal jury hit Roche with a $137.3 million verdict for infringing three laboratory system patents covering electrochemiluminescence technology. "There is no impact on our ability to offer and distribute our Cobas e/Elecsys products to customers, neither in the US nor in ex-US markets," Roche said, noting it was disappointed by the outcome.
MedTech Europe said that the European government authorities lack preparation for the upcoming Medical Device Regulation ruling. "As we have maintained throughout the regulations' transition periods to-date, this incomplete implementation by the EU member states and European Commission threatens the continuity of patient access and care, both in Europe and in the more than 100 countries around the world that rely on the EU CE marking of medical technologies," according to the medtech trade association.
The European Union has proposed to include all class I devices on the four-year extension in the EU market before they must be fully compliant with the Medical Device Regulation. Member states are being given eight days to consider whether their class I-classified devices under the MDR are eligible for the upgrade.
The ACS X12 standards body was urged by some organizations to include medical device identifiers on insurance claims forms. "X12's proposal to add device identifiers to claims is a critical next step to using real world evidence to assess the safety and performance of artificial joints, cardiac devices, and other medical implants," says Ben Moscovitch of The Pew Charitable Trusts.
The New York City Council passed an ordinance banning all flavored e-cigarette and vaping product flavors except tobacco in a 42-2 vote Tuesday. "With this vote, the City Council is moving to ban the fruity, minty, candy-like flavors of e-cigarettes, which were clearly designed to appeal to young people in the first place," City Council Health Committee Chair Mark Levine said.
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