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The McNeil unit of J&J has made serious errors in its response to FDA's warning letter of of consumer complaints about its Tylenol arthritis caplets. Reminscent of the recent problems at Toyota which like J&J had been a leader in product safety and quality, J&J has mismanaged the FDA complaint. In January the FDA sent a warning leter to McNeil that it had failed to investigate properly consumer complaints made since 2008 of a musty odor from the bottles of Tylenol Arthritis caplets. The source of the problem lies in failure of quality control in its manufacturing facilities. McNeil is now conducting a comprehensive review of its quality management systems. McNeil has identified the cause of the smell as the breakdown of a preservative, used to treat wooden transport pallets, that had leached into the products at a company plant in Las Piedra, Puerto Rico.
The McNeil unit of J&J has made serious errors in its response to FDA's warning letter of of consumer complaints about its Tylenol arthritis caplets. Reminscent of the recent problems at Toyota which like J&J had been a leader in product safety and quality, J&J has mismanaged the FDA complaint. In January the FDA sent a warning leter to McNeil that it had failed to investigate properly consumer complaints made since 2008 of a musty odor from the bottles of Tylenol Arthritis caplets. The source of the problem lies in failure of quality control in its manufacturing facilities. McNeil is now conducting a comprehensive review of its quality management systems. McNeil has identified the cause of the smell as the breakdown of a preservative, used to treat wooden transport pallets, that had leached into the products at a company plant in Las Piedra, Puerto Rico.
LyrArc Article Gist
McNeil unit of J&J fails to provide information on the actual number of bottles involved in the recall of its products. Different practice of P&G is cited for a recall of its Scope product- the size of the recall being 35,000 bottles.
McNeil unit of J&J fails to provide information on the actual number of bottles involved in the recall of its products. Different practice of P&G is cited for a recall of its Scope product- the size of the recall being 35,000 bottles.
LyrArc Article Gist
Criticism of the FDA's inability to exert pre-market quality control. Questions raised by a Professor of Pharmaceutical Sciences, about the FDA's inability to detect quality issues in manufacturing. After the J&J recalls for childrens Tylenol and other medicines, the FDA sent a warning letter to Perrigo, a company based in Michigan, that ships these children's medicines, about manufacturing violations. This includes ibuprofen tablets with metal shavings.
Criticism of the FDA's inability to exert pre-market quality control. Questions raised by a Professor of Pharmaceutical Sciences, about the FDA's inability to detect quality issues in manufacturing. After the J&J recalls for childrens Tylenol and other medicines, the FDA sent a warning letter to Perrigo, a company based in Michigan, that ships these children's medicines, about manufacturing violations. This includes ibuprofen tablets with metal shavings.
LyrArc Article Gist
The apparent call by the US Chamber of Commerce for a Scopes type monkey trial cited in a Los Angeles times article -like that of the 1920' for evolutionists and creationists- to test the science of climate change, has led to vigorous protest from Exelon, autility company that manages most of the nuclear plants in the country. PG&M and PNM are other companies that vigorously protested these theatrics as they call it. The US Chamber of Commerce has opposed environmental legislation and is vocally opposing the EPA's use of an existing law, the Clean Air Act, to set limits on greenhouse gases. Exelon, PG&E, and PNM have withdrawn from the US Chamber of Commerce to protest. Other companies opposing the chamber's statements on climate change are Nike, J&J, Duke Energy.
The apparent call by the US Chamber of Commerce for a Scopes type monkey trial cited in a Los Angeles times article -like that of the 1920' for evolutionists and creationists- to test the science of climate change, has led to vigorous protest from Exelon, autility company that manages most of the nuclear plants in the country. PG&M and PNM are other companies that vigorously protested these theatrics as they call it. The US Chamber of Commerce has opposed environmental legislation and is vocally opposing the EPA's use of an existing law, the Clean Air Act, to set limits on greenhouse gases. Exelon, PG&E, and PNM have withdrawn from the US Chamber of Commerce to protest. Other companies opposing the chamber's statements on climate change are Nike, J&J, Duke Energy.
LyrArc Article Gist
The S&P 500 has changed since 1998 for top 10 companies. Phillip Morris and Coca Cola are gone from the top 10. Apple at 256th is now the biggest by far exceeding Exxon by $200 billion in market value. J&J, Chevron are in, General Electric and Microsoft stay in. Added are Google and Wal-Mart in the top 10. Better management and vision played a role.
The S&P 500 has changed since 1998 for top 10 companies. Phillip Morris and Coca Cola are gone from the top 10. Apple at 256th is now the biggest by far exceeding Exxon by $200 billion in market value. J&J, Chevron are in, General Electric and Microsoft stay in. Added are Google and Wal-Mart in the top 10. Better management and vision played a role.
LyrArc Article Gist
Stricter warnings on Amgen's Epogen and Aranesp, and J&J's Procrit, Anemia drugs.
Stricter warnings on Amgen's Epogen and Aranesp, and J&J's Procrit, Anemia drugs.
LyrArc Article Gist
Johnson & Johnson stock dropped 10% after a Reuter report that company executives knew for decades that its baby powder sometimes showed positive for small amounts of asbestos, according to this report in WSJ. J&J called it an "absurd conspiracy theory."
German company Bayer shares were down about 40% in 2018 due to legal issues related to its Roundup weed killer. Though baby powder represents only 2% of sales and J&J has $16 billion in cash flow the situation is unsettling for investors.
Johnson & Johnson stock dropped 10% after a Reuter report that company executives knew for decades that its baby powder sometimes showed positive for small amounts of asbestos, according to this report in WSJ. J&J called it an "absurd conspiracy theory."
German company Bayer shares were down about 40% in 2018 due to legal issues related to its Roundup weed killer. Though baby powder represents only 2% of sales and J&J has $16 billion in cash flow the situation is unsettling for investors.
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Original article 2 minutes, gist 1 minute
Original article 2 minutes, gist 1 minute
LyrArc Article Gist
When regulators told J&J that tens of millions of doses at a Baltimore plant had to be discarded for contamination, the initial enthusiasm for a one dose vaccine began to fade. Production problems and the pause in the vaccine J&J as problems are sorted out, is making the J&J vaccine less effective in this crisis. Only 11.4 million doses have been adminstered of J&J vaccine says the NYT, making its role less significant.
When regulators told J&J that tens of millions of doses at a Baltimore plant had to be discarded for contamination, the initial enthusiasm for a one dose vaccine began to fade. Production problems and the pause in the vaccine J&J as problems are sorted out, is making the J&J vaccine less effective in this crisis. Only 11.4 million doses have been adminstered of J&J vaccine says the NYT, making its role less significant.
LyrArc Article Gist
In a bold decision that shows courage and foresight president Biden lifts IP protection for Covid 19 vaccine patents of American companies such as Pfizer, Moderna, J&J and Novavax. This has huge implications for vaccination supplies for countries such as India, Indonesia, Brazil, Mexico, that are hard hit by the pandemic as well as the rest of the world. It will open up manufacturing additional vaccine supplies in countries as diverse as France and India, that can ramp up quickly because of already established pharmaceutical bases.
In a bold decision that shows courage and foresight president Biden lifts IP protection for Covid 19 vaccine patents of American companies such as Pfizer, Moderna, J&J and Novavax. This has huge implications for vaccination supplies for countries such as India, Indonesia, Brazil, Mexico, that are hard hit by the pandemic as well as the rest of the world. It will open up manufacturing additional vaccine supplies in countries as diverse as France and India, that can ramp up quickly because of already established pharmaceutical bases.
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Original article 6 minutes, gist 1 minute
Original article 6 minutes, gist 1 minute
LyrArc Article Gist
Unlike other vaccines being developed J&J vaccine entering final stage testing does not need to be frozen, and can be give with one shot dose instead of two shots.
Unlike other vaccines being developed J&J vaccine entering final stage testing does not need to be frozen, and can be give with one shot dose instead of two shots.
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