FDA on Novartis data manipulation controversy: ‘We happened to be lucky’

Since the Food and Drug Administration blasted Novartis (NVS) earlier this month over data manipulation, one of the major questions looming over the matter has been why the agency came down so publicly on the drug maker. The answer, according to a top FDA official, is because the stakes were too high to do otherwise.

Dr. Peter Marks, who wrote the statement that created a storm of controversy around Novartis and data used to support approval of the drug

, said in an interview that any case in which data are mishandled and patients are harmed could set the whole field of gene therapy back, just as the death of a patient, Jesse Gelsinger, froze research two decades ago. read more »

Deutsche Bank to pay $16m to settle US ‘princelings’ case

Regulator had said it corruptly hired unqualified relatives of foreign officials to win business

Deutsche Bank has agreed to pay a $16m fine to US authorities overallegations that it hired unqualified relatives of powerful Russian and Chinese government officials to win business.

The Securities and Exchange Commission alleged that Germany’s largest lender had used false books to record the hirings, which meant the relatives – known in China as “princelings” – did not have to go through rigorous interview processes.

The SEC alleged that the hiring of poorly qualified relatives was in violation of the Foreign Corrupt Practices Act. read more »

Wells Fargo pays $6.5 million to Navajo Nation over 'predatory' practices

Wells Fargo & Co will pay the Navajo Nation $6.5 million to settle a lawsuit over “predatory and unlawful practices” by the bank, the Native American tribe said on Thursday.

The Navajo Nation sued Wells Fargo in federal and tribal courts in 2017, alleging the San Francisco-based bank had opened unauthorized accounts for vulnerable tribe members as part of the potentially millions of fake accounts opened by bank employees nationwide. read more »

Judge dismisses turnaround guru's racketeering case vs McKinsey

A federal judge dismissed claims on Monday by turnaround pioneer Jay Alix that McKinsey & Co violated racketeering laws when the consulting firm expanded into advising bankrupt U.S. companies.

Alix said that McKinsey’s bankruptcy work was a “criminal enterprise” that generated an unlawful profit of at least $101 million, at the expense of AlixPartners, the firm Alix founded.

The judge asked for further briefing on three other claims brought under state law, including allegations that McKinsey failed to exit the restructuring business as promised by the head of the firm in a private meeting with Alix. read more »