LyrArc Article Gist
Stricter warnings on Amgen's Epogen and Aranesp, and J&J's Procrit, Anemia drugs.

LyrArc Article Gist
Efforts by banks to bring their operations in line with regulator requirements. The Citigroup bank much smaller than at the time of the financial crisis, with its "living will" approved by the U.S. Federal Reserve in April 2016.

LyrArc Article Gist
Two of Amgen's drugs that treat anemia in cancer and kidney-failure patients have questions raised about their safety and marketing. The two anemia drugs Epogen and Aranesp generate about half of Amgen's sales. THey now have ablack box warning placed on them by FDA requirements.

LyrArc Article Gist
American Airlines share price ended at $1.98, down 33%, on Oct. 3, 2011. AMR averted bankruptcy protection in 2003. This is the lowest level for the share price since 2003. AMR suffers from higher labor costs than other large airlines that went through bankruptcy and realigned costs. AMR says its labor costs are $800 millon higher than its competitors. AMR says it has $4.2 billion in unrestricted cash as of Sept 30, 2011, a decline from the $5.1 billion on June 30, 2011. Debt obligations due for AMR are $2.5 billion for 2011, $1.8 for 2012 and $1 billion in 2013. AMR raised $726 million in aircraft- backed bonds to refinance part of $1.3 billion in debt obligations due in second half of 2011. AMR has ordered 460 new fuel efficient aircraft in a lease financing deal offered by Boeing that does not stress AMR's balance sheet. Fears that AMR is burning cash with its expected operating loss caused Moddy's to change its outlook for AMR to negative from stable. AMR had $17.1 billion in total debt on June 30, 2011....

LyrArc Article Gist
Questions raised about Dr Pazdur's decisions at FDA for anemia drugs made by Amgen and Johnson and Johnson. Dr Pazdur is head of the FDA office that regulates oncology drugs, all cancer drugs. Dr Pazdur's review process and decision shows how reviewers are human and their own experience helps determine what they see prominently. His experience with his father who suffered severely from the side effects of steroid drugs would make him aware of the the other effects of drugs. He is an oncologist, his wife is an oncology nurse, and some relatives have died of cancer, so he has lived with cancer patients. It appears from close associates that he like open communication and hears all sides but makes the final decision himself. He had an experience with a drug for lung cancer Iressa made by Astra -Zeneca, which the FDA approved based on testimonials, but not enough statistical evidence, which later failed and approval had to be withdrawn. This may have made him more inclined to look for strong results and statistical evidence before concluding on the safety and effectivenes of a drug. An approach evident with Amgen's anemia drug. It also appears that the FDA is not clear on whether the drug's effectiveness is to be judged by what result, is it whether it prolongs life only that counts, or whether the effectiveness in relieving significantly the symptoms of a patient even if life is not prolonged. There is the controversy surrounding the FDA's rejection of a drug by Genta Inc Genasense that relieved patient symptoms for leukemia but did not prolong their life. These and other questions continue to give sleepless nights to people at the FDA and outside as the drug review process faces difficult balancing act between what to give importance and what direction to take with a drug in patient's interests. In Dr Pazdur's case this is made more difficult as he thinks every day of his father who died in 1979 and suffered from the side effects of steroid drugs, went blind when Dr Pazdur was only a teen, and had pulmonary fibrosis and diabetes. He is described by doctors who trained under him as gentle but did meet a patient's eyes and tell him that he had to come to terms with his disease. ...

LyrArc Article Gist
U.S. District Judge Jed Rakoff was critical of the S.E.C.'s practice of entering into consent judgements which allowed defendents to not admit to wrongdoing. In his order Judge Rakoff rejected a $285 million settlement with Citigroup for a mortgage-bond deal. In his order he said such settlements are viewed by the business community as "a cost of doing business." He found it hard to discern what the S.E.C. would be getting out of such a settlement "except a quick headline." Rakoff summarized the problem with such settlements and the S.E.C.'s practices when it comes to the public's interest: "In any case like this that touches on the transparency of financial markets whose gyrations have so depressed our economy and debilitated our lives, there is an overriding public interest in knowing the truth. In much of the world, propaganda reigns, and truth is confined to secretive, fearful whispers. Even in our nation, apologists for suppressing or obscuring the truth can always be found. But the S.E.C., of all agencies, has a duty, inherent in its statutory mission, to see that the truth emerges; and if it fails to do so, this Court must not, in the name of deference or convenience, grant judicial enforcement to the agency's contrivances."...

LyrArc Article Gist
Gretchen Morgenson provides an account of the history of activities under Countrywide Financial management and board of directors. Mozilo was CEO of the company before its activities led to the mortgage financial crisis of 2008. The subsequent wave of foreclosures had a devastating effect on the middle class and the U.S. economy.

LyrArc Article Gist
Countrywide and Mozilo, Raj Rajaratnam and Galleon hedge fund, and the Madoff prosecutions. Nocera says the Galleon hedge fund prosecutions do not extend to others who benefitted or had knowledge of what was happening, as has happened in the Madoff case. In the case of Mozilo and Countrywide little has happened to deter future behaviour.