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In January 2020 employees met at a local Maryland bar to find out how they might salvage their careers in a 33 year old company that had failed to develop an approved vaccine, says this story in WSJ. Only months later following the coronavirus pandemic everything changed as in a miracle for Novavax. The company had to sell manufacturing assets at one point, and had enough cash for another 6 months just months before. By Feb. 2021 shares which had dropped to $4 were up to $229 and valuation which had declined to $127 million went up to 15 billion. Coronavirus has turned things upside down where newcomers are using previously unproven technologies and making them work in this pandemic. The persistence, perseverance and confidence of Novavax even in the most difficult situations shows how the right attitude can lead to remarkable results. Novavax vaccine can be kept in refrigerators for 3 months, and do not require very low freezing temperatures like Moderna and Pfizer vaccines. This is considered a potent weapon in the fight against coronavirus. Novavax says it can produce a couple of billion doses over the next 12 months beginning in April. Novavax has released data showing its vaccine is effective for protection against coronavirus. Results of late stage US trials are expected in March. ...

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Glaxo's 2008 earnings take a hit of $400 million from a settlement of a five year investigation by the US attorney's office in Colorado and the US Attorney's office in Massachusetts. The investigation was about the manner in which Glaxo marketed its antidepressant drug Paxil and the drug Wellbutrin SR. Glaxo is said to have promoted the depressants for off-label uses. This follows settlements of $2.3 billion by Pfizer for off-label promotion of painkiller Bextra. Eli Lilly settled with $1.4 billon for similiar charges on antipsychotic medicine Zyprexa.

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Areas for growth for the Indian drug Industry include the large growing domestic market, the outsourcing by US drug manufacturers, and sales in other developing countries of Asia, Middle East, Latin America and Africa. Analyst estimates are that India will spend $30 billion a year on drugs to improve care for its people in the next 10 years up from $8 billion today. And the distribution network is being developed by drug companies insdie India to reach more people. Also companies like Pfizer plan to double outsourcing of manufacturing drugs from 10% today to 20%.

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This WSJ report looks at the research practices at Theranos. Some researchers say there was a lack of technical rigor in the research and the lack of a patient effort necessary in advancing medical science. Carreyrou cites instances which show the lack of rigorous medical background for management in the company, and premature introduction of products. The blood testing technology Theranos says it is inventing is still at an early and uncertain stage, according to experts. Pfizer says it has done only pilot projects with Theranos at an early exploratory level, and has no projects currently with the company.

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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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So far 17 million people in the UK have received the Astra Zeneca vaccine.  35 cases of blood clots, 15 of pulmonary embolism and 22 of deep vein thrombosis have been reported across the UK and EU. In a normal year more than this number of cases of blood clots are seen say experts. These occur naturally in the population, including elderly population. Astra Zeneca's chief medical officer, Ann Taylor, says the number of blood clots in the 17 million people who have received the vaccine across Europe is actually lower than would be expected in the general population. The EU countries of Germany, France, Netherlands and Italy have temporarily stopped using it after 3 healthcare workers in Norway had blood clots. In Germany 7 out of 1.6 million had a rare condition of cerebral sinus thrombosis. Both EU and medical regulators say that there is no evidence that these blood clots are caused by the vaccine. The number of clots are similar to what was seen in the population before the coronavirus. Also this report in The Times says taken together there is no difference between the number of clots in the population that received the Pfizer vaccine or the Astra Zeneca vaccine.  The Daily Telegraph reports that one in 1000 people have blood clots every year, so that for 17 million people in vaccinated population with the Astra Zeneca vaccine there would be 17000 cases of blood clots over 12 months. During the clinical trials Astra Zeneca reported there were fewer people with blood clots who had been vaccinated than in the people who were not vaccinated. ...

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The Hindu data team looks at the Indian vaccination drive with graphs by state and progress by dates. During the first 10 days of June the vaccination drive has been stepped up. It is now over 3 million a day and at this rate should reach 400 million vaccinated by the end of July, 100 million below target. For the remainder of the year vaccine supplies have to be pushed up so that 8 million doses can be given each day. This would get India to where everyone in the country of 1.2 billion has been vaccinated by Dec 31, 2021. This would make it possible for India to then use its technology and large manufacturing capacity to help other nations in Asia, Africa and Latin America in 2022. This is the first time in history that India has taken on a challenge of this size and complexity. The vaccine strategy has changed to where the federal government is taking over the overall responsibility of coordinating the production of vaccines in the country and providing access to vaccines from other countries. Federal government is also taking on overall responsibility for distribution of vaccines and setting up the logistical effort. Vaccine supply is being opened up by opening India to multiple vaccines including Pfizer, Moderna, and other vaccines. Production of Covaxin is being stepped up. This strategy is designed to get India to somewhere closer to the 8 million doses a day needed and to ensure distribution and logistical efforts are in place. More resources are put into the effort. The speed of economic recovery also depends on the vaccination drive. Lessons were learned during the second wave in May 2021 and the government is better prepared for the hard work ahead. ...

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China faces risk of a surge inthe coronavirus in June 2021. The area in and around Guangzhou appears to be seriously affected. The city tested almost its entire population of 18.7 million between June 6 Sunday and June 8 Tuesday. This report shows pictures of a deserted Beijing airport, strict restrictions on foreign travel. The SinoPharm vaccine effectiveness against the Delta variant in India and UK is unknown. The government is locking down entire neighborhoods rather than entire cities or provinces.  As the risks of the Delta variant and other new variants increases most of the population even in the US and Europe have either no dose or one dose. Researchers at the University of New South Wales in Australia show the Astra Zeneca vaccine effectiveness with one dose at only 30%, only after two weeks following the second dose does the vaccine effectiveness reach about 70%. The population of China and India are so large that much larger parts of the population remain unvaccinated. In China with 1.3 billion people and even if the figure of 800 million doses stated by the government is accepted- it could be an overestimate as the US has only managed 300 million doses with many vaccines- most of the population is unprotected. Vaccine skepticism is high in China making vaccination an uphill task. SinoPharmvaccine is not as effective as Pfizer, Moderna, Astra Zeneca, or Covaxin vaccines, making the task even more of an uphill kind. ...

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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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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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Pfizer and withdrawal of potentially huge heart drug.

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This example of how Forest Laboratories hoped to market an antidepressant Lexapro to doctors through financial incentives to prescribe the drug is detailed in a document that was made public by the Senate's Special Committee on Aging. The document is the "Lexapro Fiscal 2004 Marketing Plan." Forest licensed Celexa from Lundeck of Denmark and brought it to the US market in 1998. Then as the drug's patent life was short it tinkered with it and developed a new version calling it Lexapro and introduced it in the US market in 2002. Withits marketing effort Lexapro had $2.3 billion in sales in 2008, while all the time generic versions of Celexa and other durgs in its class sell for afraction of the Lexapro price. For instance amonth's supply of 5 millgram tablets of Lexapro costs $87.99 at drugstore.com, while a month's supply of generic version of Prozac is $14.99. Forest spends a lot compared to its larger rivals on sending money to doctor's. In the plan $34.7 million was to go to pay 2,000 psychiatrists and primary care doctors to deliver 15,000 marketing lectures to their peers that year. $36 million was to go to providing lunch to doctors in their offices. Asks Senator Herb Kohl, a Democrat from Wisconsin who is chairman of the Committee on Aging- "is the line between medical education and marketing blurred." For these companies there was no line. ...

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Kindler on Pfizer's turnaround in April 2007. H plays jazz piano like his son and likes to spend time with his family where his daughter likes to remind him that he is not CEo around the house. He goes on sales calls with his sales reps to find out what its really like talking to doctors as a sales rep first hand and no one knows who he is. He likes to go out here on the road to talk to people and find out about the business. Kindler's experience is not as a pharmaceutical industry insider. And he has watched Pfizer stock sink by 50% and all sorts of issues come up fromquestions about the integrity of clinical trials to low morale and layoffs, and skeptical public.

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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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Israel vaccination drive has now reached 2 million people for the first dose and 400,000 for the second dose. What do early results show? As the effectiveness is only 52% after the first dose, according to Pfizer for its vaccine, vaccination drive is only one part of the solution. The number of cases in Israel are high at 10,000 a day. There is concern about the ultra-Orthodox community following the protocols and rules for prevention. Ben Gurion International Airport may be restricted to only essential flights. A mutation variant of the coronavirus, a UK detected variant, is seen as making up about 30% of the cases and could make up the bulk of cases in the future. Lessons being learned are that Pfizer vaccine is effective at about 52% for the first dose. Only after the second dose are enough antibodies triggered to resist the virus effectively. This can be as much as 6 to 12 times the increase in antibodies for second dose, compared to what happens after the first dose says the Sheba Medical Centre at Tel Hashomer, Israel.   ...

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Merck's new cholesterol drug Anacetrapib reduced bad cholesterol by 40% and increased good cholesterol by 138% in a recent study. This drug does not increase blood pressure in animals. A drug research effort for torcetrapib was abandoned by Pfizer after the cholesterol drug was found to increase blood pressure.

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In a factory the size of 5 football fields located in Gurnee, Illinois, Abbott Labs makes its BinaxNow Covid-19 home tests. Abbott turned out 1 billion tests in 2021 and at one point had 80% of the market. Along with Pfizer vaccine, BinaxNow Home covid-19 tests are a dominant product during the pandemic. Abbott generated a fifth of its $43 billion in revenue from these home tests. Abbott faced several hurdles along the way. It gained when the US government authorized it to make the test. Yet after vaccination took off by mid 2021 the demand for tests declined and Abbott nearly idled its giant factory in Gurnee. Delta and Omicron variants led to a sudden reversal and surge in demand. Abbott developed its test based on an existing design it used in the US for flu tests, by a company it inherited by acquisition called Binax. To do that test one sends a swab up the nose, add that sample and a liquid mixture to a rectangular paper card, and close the card shut. The liquid then travels up the paper strip, revealing one or two pink lines, one for negative, two for positive. This is done in 15 minutes and the simple design described as a lollipop shape, put Abbott far ahead of competitors. The US FDA authorized Becton Dickinson and Quidel to make the tests before it authorized Abbott, but these rival companies had a poor and complex design. The Trump administration gave Abbott a $760 million contract to buy 150 million tests for distribution to health departments, long termcare facilities, nursing homes, and schools. And by October 2020 Abbott was already making 50 million tests a month. When it comes to distribution Abbott tapped into its pharmacy connections for baby products such as Similac baby formula. This gave it an advantage over Quidel and others who also lacked the manufacturing knowhow for large scale ramp up. The BinaxNow in pharmacies was sold at $24 for a box of two tests, while government paid $5 for one test. Abbott says it makes $ 7 per single consumer test. Yet there was one problem waiting to hit Abbott in 2021- demand dried up as the vaccination campaign took off. In fact the plant manager, Mr. Rodriguez, planned to move to another job inside Abbott as production declined. Then came the Delta variant and he was asked to ramp up production again. With Omicron demand soared. The Biden administration committed $3 billion to help boost test production and asked Kroger and Walmart to sell over the counter tests at cost for 3 months. Abbott had to lure workers from Amazon at $25 an hour for the Gurnee plant expansion. What was learned by the government and Abbott from this experience? The US government now looks for ideas in meeting demand volatility, supply challenges and production needs,. Sustaining production capacity is important for future virus flareups- a new government-industry partnership is required for maintaining test making infrastructure. With government help Abbott plans now to keep the facility at Gurnee operating indefinitely. ...

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Thre drug companies are placing bets on the vaccine business. Johnson and Johnson paid 302 million euros for 18% of Dutch biotech company Crucell NV, to jointly develop vaccines. Abbott Labs says it will acquire a unit of Belgian conglomerate Solvay SA for 4.5 billion euros in adeal that includes a vaccine business. And Merck obtained the marketing rights for a seasonal flu vaccine from Australia's CSL Ltd. This follows Pfizer's Wyeth acquisition. Low prices, high costs and fear of lawsuits made most drug makers to exit the business in the 1980's and 1990's. Now vaccine sales are growing faster than other prescription drugs and are largely protected from generic competition. And government agencies here in the USA and around the world are reliable buyers of vaccines as they seek to stockpile medicines that could be needed in aflu outbreak. Merck never exit the vaccine business and now makes 8 of 10 vaccines recommended for adults. Flu and other vaccines are especially attractive for entering drug markets in Brazil and China and developing countries. Governments lke the idea of lowcost prevention at $10 adose, and with this new relationships are developed in these countries. And even at price of $10 or $20 a dose they provide asteady stream of revenue.Vaccines are estimated to generate $21.5 billion in revenues by 2012 according to Sanofi-Aventis SA, which is a leading vaccine maker....

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Johnson & Johnson begins a 60,000 person clinical trial on 3 continents in the final stage of testing. It could learn vital results in early next year which if positive would lead to government authorization for emergency use soon after. J&J will test whether a single dose of vaccine will work. It is also doing work separately with the UK government for a separate phase three study to test whether a 2 dose vaccine will work.

Other companies in final stage of testing are Moderna and Pfizer with studies results expected in October and Astra Zeneca working with Oxford expecting results by the end of 2020.