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There are serious serious flaws with the FDA regulations for weight loss pills and dietary supplements. THe law enacted in 1994 gives the FDA jurisdiction only after the pills go on the market whereas for drugs they get reviewed first. THe re is only aspot checking of manufacturers and distributors once the pills are on the dshelves or on the internet. THe FDA believes there may be hundreds of contaminated weight loss diet supplements. Says Michael Levy director of the FDA's deivision of New Drugs and Labeling Compliance, alarge percentage of these products contain dangerous undeclared ingredients. Even after the products are on the market the FDA does not have thability to remove pills from stores, initially the law allows that its upto the companies to issue arecall. It is only eventually that the FDA can act and it does not have the resources to deal with this problem. This even though these ingredients can cause heart atttacks, seizures, and all kinds of health problems. About $27 billion are spent on dietary supplement, $1.7 billion on weight loss pills, and 15% of the population say they have used weight loss supplements, and most have not told their doctors about it. ...

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Compare the presidential election spending in France and US one sees a huge, really huge difference. In France by law the first round it is limited to 16 million euros and second round to 22 million euros. Companies cannot donate and maximum donation is euros 4600 per year. All candidates must be given equal time by networks after official campaigns start usually March 28. If you get 5% of the presidential vote you get about 48% of the $22 million ceiling and if not only about 5%. Its a fairer system considering about $5 billion will be spent in US presidential election 2024. It keeps out lobbyists and donors looking for silent favors as the pharma industry and the tech industry in the US that has prevented any legislation on fair drug pricing or oversight of the monopolies of Apple, Google, Microsoft, Amazon, Meta and others, taxation of profits of tech and fossil fuel companies, or passage of healthcare for all. Indian elections cost of 1.35 lakh crores or $13 billion in 2024 are also similar to the US with parties spending leading to much corruption in the democratic process and defeating its best character.  ...

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US president Biden signs a broad executive order on July 9, that is directed at promoting competitive behaviour in the American economy, and taking action against companies that have anti competitive behaviours. It also aims to limit corporate dominance that then can lead to anti competitive behaviours. These types of behaviours puts consumers, workers and small compoanies at a disadvantage. The Biden plan stretches from the smaller items such as hearing aids and baggage fees, to the task of putting in place the first antitrust regulation on tech companies Apple, Google, Amazon and others. Industries Biden sees as needing help are agriculture, healthcare, shipping, transportation, technology, and labor practices that limit wages and mobility. In making the executive order the White House says it "will lower prices for families, increase wages for workers and promote innovation and even faster economic growth." As each step is taken by the Biden administration to help workers, families, women and children, the situation is a reminder of the actions taken by Franklin Delano Roosevelt at another period of crisis in the nation's history. The July 9 executive order will create a Competition Council as proposed by Tim Wu, special assistant to the president for technology and competition policy in the White House National Economic Council. The Compeititon Council task will be to get federal agencies to take action to promote competitive behaviours for the first time since the 1980's when Republican presidents Reagan, Bush, and Democratic presidents Clinton, Obama, allowed such behaviours in some industries to get entrenched. In Biden's own words "the rise of monopolies weaken labor." In each industry agencies will now have the task of pushing back against anti-competitive behaviours already put in place by companies. In agriculture it will help small farmers, in pharmaceutical sector it will help the American people deal with a problem that has no end in sight of high drug prices and practices that support this. In all areas of the economy the Biden plan is for a new coordinated effort across all the agencies of the government and under the leadership of the president, to restore the vibrant economy to what it was before the long deterioration through anti-competitive behaviours. ...

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Some key takeaways from the Biden State of the Union- Biden has a vision for the future and the way forward for the US to a new frontier and new progress, where his predecessor really has none or has shown none. On China under his predecessor the US was shown as being behind and the US did little to sending of advanced US technologies to China. Today the US is growing and has the strongest economy of the G-7 and China is falling behind, flow of advanced technologies to China is stopped. On investing in the US. It is there plain for everyone to see. If the US has fair taxes the US can rebuild its infrastructure, modernize, invest in education and the working people of the country, and yet cut the deficit by large amounts. The thousand billionaires in the US pay only 8.2% in taxes. At 25% tax what a firefighter or policeman or teacher pays this would cut the deficit by $500 billion over 10 years. The oil companies and other corporations are similarly only paying less than what ordinary Americans are paying. This at fair tax rate of a minimum of 21% instead of 15% would further cut the deficit by hundreds of billions of dollars after investing in the infrastructure and modernization of the economy that his predecessor has no plans for and instead given a tax cut to the corporations which studies show was really not paid for. Negotiating drug prices for Medicare with drug companies would save the country hundreds of billions of dollars. This could be reinvested in cutting child poverty, in free preschool education, in raising teachers wages. Sitting next to Jill Biden the First Lady was the prime minister of Sweden. What it told the US was that countries like Sweden and Finland in NATO had strengthened the alliance and it was for mere political reasons that Ukraine aid was prevented by his predecessor from being passed in the House after passage in the Senate by 70-30 with bipartisan support that also exists in the House. ...

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Speaking for the Biden administration Anthony Blinken says that "on the current trajectory, if we don't do more, if the entire world doesn't do more, the entire world won't be vaccinated until 2024." What is needed he said is to "speed this up, and get that done, I think, in a much shorter time." Experts say the immediate impact of the Biden decision to give waivers on transfer of patents technologies is to get drug companies to cooperate with each other and for them to voluntarily join in the manufacture of vaccines globally. This would be done through global manufacturing alliances in major pharmaceutical manufacturing nations such as France, India and other countries that can quickly ramp up manufacturing if they have access to the technologies involved and the knowhow itself. The Biden decision is then the first of many decisions that would lead to voluntary action by pharmaceutical companies cooperating say Novartis and Sanofi in France and Switzerland with a Pfizer or Moderna in increasing manufacturing capacity or a Serum Institute or Reddy Labs in India working with Pfizer and Moderna or Novavax. These companies already have the basic structures to ramp up. This would take months yet the process has to start immediately. Today many companies such as Glaxo Smith Kline in UK and US are in a position to get involved in manufacturing but need access to the technologies and knowhow. Leadership by the US plays a huge part in making that happen.  ...

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Both Ranbaxy and Dr.Reddy's, two of India's largest pharmaceutical companies, are bidding for Betapharm, Germany's fourth largest generic drugs maker. Ranbaxy's bid at 500 million euros was 50 million euros higher than Dr. Reddy's. Betapharm based in Augsburg, Germany, has sales of 161 million euros, and a workforce of 350. For Dr. Reddy's this is a way to get a foothold in a branded generic market in a developed country, says Dr. Reddy. This will be the largest foreign acquisition for an Indian pharmaceutical company.

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Coronavirus testing is being ramped up in the U.S. as the Food and Drug Administration new regulations allow commercial labs to manufacture and distribute  coronavirus tests. Now many players can now acquire and conduct tests including state and local governments, hospitals, universities, and private companies. so that tracking nationwide distribution is still difficult. Deborah Brx the response coordinator of the White House task force on coronavirus says U.S. has completed 220,000 tests in last 8 days.  In New York the scaled up efforts in a region with over half the coronavirus cases in the U.S., 13,000 were tested on Monday, March 23. Some hospitals in New York such as Mount Sinai expect to do double or triple the tests a day in a scaling up effort by March 30. In Los Angeles a city councilman negotiated with a South Korean company for delivery of 100,000 tests a week, having already secured 20,000 new tests. Additionally swabs and protective equipment are also needed to conduct tests and labs need to process results with speed. ...

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Kristof of the NYT writes about DJT Action in Venezuela January 3, 2026.  Some of the least understood aspects of the US president's language on Venezuela- The president's reference to oil resources is not for the US to benefit from the oil reserves. It is about oil in the sense that the oil industry in Venezuela is in total disrepair and broken from years and decades of nationalization followed by lack of investment, lack of western technology.  Sanctions put a huge price on the Venezuelan economy with the brunt of it borne by ordinary people- the same people that a socialist like Hugo Chavez thought he could help with his erratic ideology. As China, and now India has learned the only way to get ahead in this world for nations is to invest, invest, invest with larger and larger pools of capital, technologies and labour. By alienating the US or EU there is a loss of technologies and of investment so that one is going to bat with only one strike and you are out, so that from Day 1, China under Mao, India under Nehru had lost the race, so did all the "socialist" regimes in the world. Conversely China under Deng and successors, and India under Modi are breaking development records. How does the US change this? First it removes the sanctions on the Venezuelan economy. Second it gives Chevron the green light for increased production. Oil facilities of the Venezuelan oil company will get foreign investment and US investment from American oil companies with returns for both and the state oil revenues invested under a government that is able to invest it free of corruption or it being funneled out of the country to support other regimes in Latin America. This will rebuild the country's health system, its broken infrastructure, restore its finances, and make it in a decade one of the advanced economies in Latin America. But only if- the gangs and other private militias, the other military elements from the two decades of utter mismanagement and drug trafficking are  removed. A new way will have to be devised that the US as to work out ad hoc meaning in the process of doing, invented that meets the conditions of getting this done and the process of reconstruction of Venezuela under the Monroe doctrine of keeping the entire western hemisphere free of such elements. The US achieved this with the help of Great Britain in 1823 when it was only 50 years since it's founding in 1776. The US has the resources in 2026 to make this happen in the interests of the people of the western hemisphere, in the quality of life of people in the western hemisphere. It does not seek any country's resources, it seeks the development of the countries in the western hemisphere in the great tradition of Jefferson, Monroe, Lincoln, FDR and JFK. ...

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Among the reasons given for Roche's bid are the need to bring the creative energies of Genentech inside Roche's own pharmaceutical division. This at a time when pharmaceutical companies are having a difficult time coming up with new drugs, without as Bill Burns the head of Roche pharmaceutical put it, a "Chinese wall" between Genentech scientists and Roche scientists. Other reasons are the opportunity for the Basel based company to capture all the profits from Genentech and achieve cost savings of $850 million annually by combining the 2 companies' clinical research teams and sales, manufacturing and administrative departments in the USA. Another reason is that the agreement with Genentech for Roche to market its drugs outside the USA expires in 2015. With Genentech's share price at a low Roche's bid at a 9% premium also appears as an attempt to get the remaining 44% of the company that Roche does not own for a low bid. It risks however the 18 year relationship betweeen Roche and Genentech, in which Genentech operated within its own scientific culture in the San Francisco area, almost like a separate company. Roche CEO Schwan, still wants to keep some of this arrangement and have Genentech drug researchers operate as a separate group, but its not clear how the cost savings and the interaction with Roche scientists would occur under the new arrangement. Genentech was founded in 1976 after a meeting between venture capitalist Robert Swan and bichemist Herbert Boyer at a bar near the University of California, San Francisco campus. It has come up with a number of successful cancer drugs such as Avastin, Herceptin, and Tarceva, and total sales are $11.7 billion, a significant part of Roche's overall sales....

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40 people out of 172 in a database surveyed by Dr. Edwards director of WHO drug monitoring center, had Goehring's desease. What does this mean and should it be made public? These are some of the dilemmas facing medicine and drug companies as more and more databases and their resultant statistics become available to researchers. It also poses a new kind of risk for drug companies as they face increased scrutiny.

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How drug companies like Roche are diversifying away from pharmaceuticals because of the weak pricing and poor new drug discovery rates that are in the industry's immediate future. Roche is diversifying into machines that diagnose diseases like breast cancer through acquisitions.

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In a new twist drugmaker AbbieVie will bring out less costly versions of Humira in Europe where its patents have expired and still keep the U.S. market at higher Humira prices using a thicket of patents. Reports show pharmaceutical drug pricing as a major issue in U.S. midterm elections. Biologic drugs are costly. In this case Humira will sell at a 10-20% discount in Europe. Abbie Vie countered by getting hundreds of new patents in the U.S. to continue selling at high prices.

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Drug companies spent $168 million on lobbying in 2007, up 32% from 2006, according to the Center for Public Integrity. The biggest spender is the Pharmaceutical Research and Manufacturer's Association of America which paid $23 million, a 26% rise from ayear earlier. Amgen was first among drug firms at $16.2 million, Pfizer at $13.8 million, Roche at $9 million, Sanofi-Aventis at $8.4 million, GlaxoSmithKline at $8.2 million, and Johnson & Johnson at $7.7 million. In 2006 Democrats received 31% of the industry lobbying funds, now with Democrats controlling Congress the shift is to more money given to Democrats.

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Gilead Sciences contracts with seven Indian generics drug makers to provide Hepatitis drug Sovaldi at $10 a pill for a 24 week course. These Indian companies will pay royalties to Gilead Sciences and supply the market in poor countries. There are about 350,000 deaths from Hepatitis C each year, most of them in middle income or poor countries. Worldwide about 180 million people are infected with Hepatitis C. There is intense criticism for the $1000 a pill charged for Sovaldi in the U.S., with $10 billion in sales for 2014 already set for the new drug's 12 week regimen that costs about $84,000. Gilead spends about 19% of sales on R&D.

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Abbott Labs will split into two publicly traded companies, with a medical products company including products such as Similac, Ensure and stent devices, and a pharmaceutical company that would have its Humira rheumatoid arthritis therapy Humira. Humira generates about $8 billion in sales, but faces patent expiration in 2016 and competition from a new drrug expected from Pfizer, as well as generics. Abbott's CEO sees the opportunities in the two products falling in different areas. The medical products business has greater potential in emerging markets, and will require a different focus from the slower growing pharmaceutical business facing competition and payor cost pressures. The medical product company includes a drug coated stent Xience, with $1.5 billion in sales, which has improved prospects as J&J is leaving the stent business. The medical products business sales are 40% from emerging markets, and 40% of revenue comes from patients not from cost conscious governments or insurers, according to CEO White. Its the emerging markets emphasis that convinced White to go with the split. Richard Gonzalez who runs the pharmaceutical business will head the pharmaceutical company, and CEO Miles White will run the medical products company....

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Large drug companies are raising money in the bond markets to finance their mergers and acquisitions. Will this result in better research and new products/ At the same time as this is happening the capital markets are doing little for biotech startups and biotech startup are running short of cash, most of them having 6 months of cash to support them. See the link to this.

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A new arrangement is being tried by pharmaceutical companies like Merck and Pfizer to develop new drugs. This is to have scientists inside major research universities and company scientists work together in searching for new drugs and working through the drug development process in a longer term collaboration arrangement, with scientists in universities learning how to work in a company environment and scientists in companies learning how to work in a university environment. On April 25, 2008 Pfizer invested $14 million in an alliance with 4 universities to study obesity and diabetes. Merck and Harvard are working on drug discovery for cancer, and just signed an agrement to develop treatments for bone disease osteoporosis. Efforts at collaboration would need to address issues like patent disputes, academic publication rights, cultural adjustment for university scientists who now have to work at getting FDA approval through a rigorous process. Policies are being developed to overcome the patent and publication issues and Harvard has hired 40 scientists from large pharmaceutical companies to coach university scientists on drug development....

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Chinese bio tech hubs around Shanghai started by biotech engineers from China trained in the US returning to China are giving the US competition. These biotech companies in China are coming up with drugs for lung cancer and other fields at a fraction of the cost. This happened in AI with DeepSeek doing what ChatGPT does at 10% of the cost.

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George Bush's administration passed healthcare legislation that allowed private pharmaceutical companies not to have to negotiate with Medicare on cost of drugs. It also passed the so called Medicare Modernization Act that created a huge opportunity for profits through Medicare Advantage Plans. The chart in WSJ shows profits it calls a bonanza. What it means is that instead of reducing the costs of providing medical care to elderly Americans it has increased the cost leaving less and less money for infrastructure for roads and bridges and airports that are dilapidated in the US, and less money for essential services in education and health care, transportation, housing. This has reduced the standard of living and quality of life in America. For healthcare it is providing less for higher cost when compared to China, India, Germany, France and the UK. George W Bush administration put America into 2 wars in Asia and the Arab world which also drained resources contributing to a lack of investment in the country in essential infrastructure and services. ...

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Merck's decision to organize R&D using four innovation hubs in Boston, San Francisco, London and Shanghai. Merck currently lacks a large R&D presence in London and it has commercial operations in Shanghai. Experts say innovation centers enable drug companies to take advantage of academic research at an early stage. Pfizer and other companies are also pursuing a similiar strategy. The new head of R&D at Merck, Dr, Perlmutter plans to shrink staff and focus on promising areas such as immunoterapies for treating cancer and vaccines. Perlmutter comes from Amgen and is bringing people who he worked with at Amgen. The focus is also shifting to tapping the new science behind dieseases.

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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. ...