LyrArc Article Gist
Sanofi-Aventis and liver risks of its drug Ketek. And the questionable practices of Sanofi in the study assessing the liver risk that the FDA draws attention to in its letter to Sanofi-Aventis.

LyrArc Article Gist
Chinese plant not inspected by the FDA made an active ingredient in a blood thinner for Baxter International. The blood thinner led to 4 deaths. Baxter has temporarily stopped production of its version of Heparin. China has 14% of the $31 billion market for active drug ingredients according to a 2007 report from Credit Suisse. Only 7% of foreign drug making facitlites are inspected each year by the FDA, so its way behind in inspection, and at this rate it would take 13 years to cover all the foreign plants.

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Only after the FDA made it apparent that it would take atougher stand against taranabant did Merck decide on scrapping this obesity drug which has psychiatric side effects.

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The FDA has found deficiencies and violations of safe manufacturing practices at 2 Ranbaxy plants in India. The FDA issued a ban on imports of 30 generic drugs from Ranbaxy in India.

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New ways to price drugs based on how well they work for patients.

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Sue Desmond-Hellmann, CEO of the Bill and Melinda Gates Foundation, describes her growing up experiences in Reno, Nevada, seeing her father help people struggling with some problem as he ran a drug store in the town. This has influenced her own style of managing people, showing care in teaching people so that they can operate in their sweet spot without fear of being overwhelmed by too big a challenge. The ability to bring out the best in a person who is struggling, is one of the things she looks for in people she hires. Innovation, failure, resilience, and the humility that brings care and respect for others, are other things she looks for.

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The campaign rhetoric for renegotiating NAFTA and building a wall at the border has had a sharply negative effect on growth in Mexico. Growth slowed in 2016 and is expected to be close to zero in 2017 with declining foreign investment in the economy. The uncertainty is leading to sharp decline in foreign direct investment of 24% in the first 9 months of 2016, according to the Bank of Mexico. Further declines can be expected in 2017. The decline in the value of the peso of 16% since May 2016 has led to 6 interest rate increases in the past year. Inflation on annual basis was at 4.72% in Jan. 2017 and is rising. As Mexico depends on exports for one third of its output growth, and 80% is sent to the U.S., there is a need to diversify with trade agreements made with the European Union and other countries. Mexicans now question the value of NAFTA trade agreement as average growth of 2.6 since NAFTA was signed is below the 4.6% in the 2 decades prior to that. And poverty level is the same with about 60% of people in the underground economy. In addition crime, drug trade, a weak education system, weak rule of law, political corruption, show that Mexico has not made the progress since NAFTA that it should have made. ...

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J&J, Novartis and Wyeth plan to stop selling cough and cold medicines to infants under the age of 2, just as the FDA is reviewing cases of deaths in the use of these medications by infants.