Thomas Kendris appointed Chief Legal Officer ad interim
Basel, March 5, 2021 Novartis announced today that Shannon Thyme Klinger, Chief Legal Officer, has decided to resign from Novartis and return to the US to take an executive role at a biotechnology company. Ms. Klinger will step down from the Executive Committee of Novartis (ECN), effective March 15, 2021.
Thomas N. Kendris, currently Global Head Litigation and US Country President, will be appointed Chief Legal Officer ad interim and attendee to the ECN in this capacity. Novartis has started an executive search process to evaluate internal and external candidates for the role of its Chief Legal Officer.
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Notable CIAs and Trends
Amendments. Like the number of CIAs, the number of CIA amendments also increased in 2020. Although the HHS-OIG typically enters into one or two amendments per year, 2020 saw seven such agreements. One amendment postponed the CIA’s effective date to account for the demands of the pandemic and another added a party to account for corporate restructuring. One aa highlighted the HHS-OIG’s close review of compliance programs, adding additional compliance obligations to address concerns regarding patient safety issues and CIA adherence. The majority of amendments (four) required revisions to IRO review provisions and altered stipulated penalties for claims reviews. In particular, the HHS-OIG replaced an IRO review with a skilled nursing facility claims review and required stipulated penalties of $2,500 for each day the companies fail to submit claims review reports or to repay any overpayment identified by the IRO.
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Some product liability suits are dead on arrival. At least, that is the position the Fifth Circuit took late last week in affirming the dismissal of a pro se plaintiff’s suit against a collection of generic and brand-name drug manufacturers.
The case in question is
Johnson v. Novartis Pharmaceuticals Corporation, et al., and concerns Mr. Johnson’s purported struggles with Peyronie’s Disease (PD), a connective tissue disorder that causes painful, bent erections, after he had ingested generic forms of the prescription drugs Minocin (an antibiotic) and Tegretol (an anticonvulsant).
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A test that monitors blood levels of DNA fragments released by dying tumor cells may serve as an accurate early indicator of treatment success in people in late stages of one of the most aggressive forms of skin cancer, a new study finds.
Led by NYU Grossman School of Medicine and Perlmutter Cancer Center researchers, the investigation looked at adults with undetectable levels of freely circulating tumor DNA (ctDNA) four weeks into drug treatment for metastatic melanoma tumors that cannot be removed surgically (unresectable). The study showed that these patients, all of whom had common genetic changes (BRAFV600 mutations) linked to cancer, were living nearly twice as long without cancer growth as those who continued to have detectable levels.