The voluntary recall was motivated by the presence of high levels of nitrosamine, which may increase the risk of cancer. Separately, a study showed that a drug Mirati Therapeutics that blocks the cancer protein KRAS shrunk tumors in 22% of patients with advanced colon cancer.
USA Today: Chantix recall: Pfizer recalls smoking cessation drug for cancer risk
Pfizer is voluntarily recalling all lots of its popular anti-smoking drug Chantix for high levels of nitrosamine, which may increase cancer risk. According to the notice posted on the Food and Drug Administration website, the recall involves all batches of 0.5 mg and 1 mg varenicline tablets. The recall notice says long-term ingestion may lead to “an increased risk of cancer in humans, but there is no immediate risk to patients taking this drug.” (Tyko, 9/17)
Stat: New Colon Cancer Study Suggests Mirati Has Best KRAS Blocker Drug
A drug from Mirati Therapeutics designed to block the cancer protein called KRAS shrunk tumors in 22% of patients with advanced colon cancer, according to the results of a clinical trial presented on Sunday. When the drug Mirati, a pill called adagrasib, was combined with another targeted drug, the response to colon cancer increased to 43%. The results of the adagrasib study are the strongest reported to date for a new class of cancer drugs that work by blocking the effects of a specific type of KRAS damage called G12C. The drug Mirati is potentially superior to a competitor drug from Amgen which gained US approval in May to treat patients with lung cancer targeted by KRAS. (Feuerstein, 19/9)
In the legal news –
AP: Official Approval of Use of Benefits of OxyContin to Combat Opioids
A judge officially approved a plan on Friday to turn OxyContin maker Purdue Pharma into a new company no longer owned by members of the Sackler family and whose profits will be used to fight the opioid epidemic. U.S. bankruptcy judge Robert Drain officially confirmed the reorganization on Friday, more than two weeks after announcing he would do so pending two largely technical changes to the plan presented by the company and in discussions with attorneys representing the people with claims against the company. (Mulvihill, 9/17)
Stat: Former Mylan CIO Pleads Guilty to Insider Trading
A former Mylan IT executive pleaded guilty to an insider trading scheme in which he acted on the advice of another executive before public announcements regarding profits, drug approvals and a merger ongoing with a Pfizer division (PFE). In court documents, the United States Securities and Exchange Commission alleged that Dayakar Mallu, 51, was briefed by an anonymous senior executive at Mylan and acted on the information on four occasions between September 2017 and July 2019. In exchange for the inside information, the former Mylan executive shared a portion of the profits with the manager through cash transactions in India. (Silverman, 9/19)
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