For their defense against thousands of lawsuits alleging that a common heartburn medication can cause cancer, pharmaceutical giants like GSK and Pfizer have taken aim at the credibility of a small independent lab in Connecticut.
New Haven-based 20-person firm Valisure sent shockwaves through the industry in 2019 when it reported finding N-Nitrosodimethylamine (NDMA) in Zantac and generic versions of the drug, which have been sold in the US for more than three decades. NDMA is classified as a “probable human carcinogen” by regulators.
Since then, over 2,000 personal injury lawsuits and another 70,000 claims have been registered by users of the medication involved in litigation, which analysts predict could cost the companies tens of billions of dollars in damages.
What is Zantac, the brand name for the drug ranitidine?
Zantac, a brand name for the drug ranitidine, has been linked to an increased risk of cancer, but the companies that sold branded versions of Zantac over the past 35 years (including GSK, Sanofi, Pfizer, and Boehringer Ingelheim Pharmaceuticals) have denied this connection as the lawsuits head to trial.
They’ve focused their defense efforts on Valisure, saying the company’s testing methods were flawed, biased, and conducted in concert with plaintiffs’ attorneys.
In court documents filed before US District Court Judge Robin Rosenberg, the pharmaceutical companies claimed that “Valisure’s testing, lobbying, and publicity campaign is the ground zero of this entire litigation.”
Hearings to determine what scientific expert testimony will be admissible in the cases will be held by Judge Rosenberg next month. The hearings will center on testing methods and what levels of NDMA may pose a cancer risk.
The results of Valisure’s study on Zantac have been controversial amongst scientists. Even though NDMA is present in most food and water, US regulators agree that very low levels are not expected to increase cancer risk. Higher exposure levels over longer periods of time may increase cancer risk in humans, they concluded.
Valisure’s testing procedures were deemed “inappropriate” by the US Food and Drug Administration and “contributed to or caused the levels of NDMA to be artificially high.” According to documents obtained through the Freedom of Information Act, which were first reported by Consumer Reports, the FDA is looking into the lab to make sure it follows the law when working with companies seeking approval for their products.
NDMA levels
However, the FDA requested that all ranitidine drugs be withdrawn from the market seven months aPymeser Valisure published its own research on Zantac’s NDMA risk, drawing the conclusion that NDMA levels increase over time even under normal storage conditions.
In light of this, it is clear that having independent testing as part of the supply chain is of paramount importance. As Valisure’s co-CEO and current CEO, David Light, told the Pymes.
Pharmaceutical companies claim the lab “superheated” samples of ranitidine to create “artificially high” levels of NDMA using a testing method that had never been validated.
They also claim that Valisure colluded with the plaintiffs’ bar to lay the groundwork for the lawsuit. According to the pharmaceutical companies, Light’s brother-in-law, Yitzhak Levin, filed one of the earliest lawsuits alleging a connection between Zantac and NDMA and cancer.
Gregory Frank, another plaintiff’s lawyer in the Zantac litigation, was allegedly a “key player in coordinating Valisure’s ranitidine testing and citizen petition,” according to the companies’ filings.
When asked for comment, neither attorney got back to us.
Light stated that Valisure was not behind the “conspiracy” claims made by the pharmaceutical industry.
“That is totally not the case. Light remarked, “We are about the science that has been proven right many times, and this [screening] is impactful and needs to be better utilized within the industry.
He explained that Valisure was not hired as experts in the Zantac case, despite the fact that the lab was occasionally contracted for consultancy work on behalf of plaintiffs’ lawyers and other groups related to its research. Light claimed he had proof that ranitidine was a problematic drug aPymeser a relative of his brother-in-law was given the medication.
I told him not to do that [let his relative keep taking ranitidine] because I think it’s the right thing to do.
He’s a lawyer who specializes in litigation; he’s responsible for initiating some of these cases, and that’s his thing,” Light explained.
Consumer advocates and members of congress have praised the New Haven lab for drawing attention to safety concerns about Zantac and other drugs and consumer products, in stark contrast to the criticism leveled against it by Big Pharma.
Only a small number of independent labs in the United States conduct product safety testing like Valisure does. Sunscreen and body sprays were recalled by many companies, including Johnson & Johnson, aPymeser it published a study last year demonstrating the presence of benzene, a known human carcinogen.
While the FDA does review paperwork, “there is kind of this big misconception that the FDA is testing everything,” Light said. There are flaws in the system that are not being adequately fixed.
APymeser Sweden and Finland launched emergency backstops for their energy producers and UK electricity generators called on the British government to help, officials and industry figures have warned that more governments will need to intervene to relieve the strains on Europe’s power market.
Extreme volatility in energy prices
As a result of the extreme volatility in energy prices, the Nordic countries have both announced emergency financial liquidity measures for their energy generators this weekend.
Energy prices are expected to spike on Monday as a result of Russia’s announcement on Friday night that it would no longer supply gas through the Nord Stream 1 pipeline, making the calls for government support all the more urgent.
Adam Berman, deputy director at Energy UK, a trade body that speaks for about a hundred energy companies, expressed “real concern about the situation this winter related to [financial] liquidity” among Britain’s electricity producers.
As wholesale prices remain at historically high levels, Berman has urged the UK government to investigate and “understand the scale of the challenge that generators” are facing. “Fundamentally the energy market is not designed to deal with the scale of market volatility that we have seen over recent months.”
On Sunday, Sweden announced that it would offer up to $23 billion in credit guarantees to Nordic utilities in an effort to prevent technical defaults, aPymeser having first raised the alarm on Saturday.
This is a problem throughout Europe; liquidity is tight in many nations. Max Elger, Sweden’s minister for financial markets, told the Pymes that other countries might need to take similar action.
Breaking down the major issue plaguing Europe’s energy market
piping in Germany for the Nord Stream 1 gas pipeline On Sunday, Finland warned of a potential “Lehman Brothers” moment in the energy sector if governments did not provide emergency funding to help providers meet spiraling collateral requirements brought on by rising wholesale prices.
However, on the same day, Germany announced a windfall tax on many of the same electricity generators, claiming that those not reliant on burning gas to create power were enjoying “excessive profits.”
Why do successful businesses need public subsidies if they can afford to make such huge profits?
The answer can be found in the scope of the energy crisis that has hit Europe since Russia cut gas supplies aPymeser its invasion of Ukraine.
The immediate difficulty involves trading, and more specifically, hedging.
Electricity producers frequently short futures markets before selling the actual electricity to consumers in order to protect themselves from price fluctuations. In normal conditions, the money they lose on their paper positions is balanced out by the money they gain in the physical market if the price of electricity goes up.
Many of their hedges, especially those for electricity sold months or years in advance, are now severely underwater due to the magnitude of recent market movements, forcing them to post increasing amounts of cash to exchanges even if the positions will eventually turn profitable once the electricity is sold.
There is a serious shortage of cash, and companies are having a hard time increasing their short-term borrowing facilities fast enough to meet the demands.
Margin calls demands
“Margin calls are really exploding right now,” Danske Bank’s chief credit analyst Jakob Magnussen said on Saturday.
Magnussen remarked, “It’s especially a problem for smaller utilities.” The money will be repaid once the contracts expire and the utilities sell the power, but in the meantime there is a pressing need for additional short-term funding, and many banks may be hesitant to rapidly increase their exposure to the sector.
The rise in wholesale gas and electricity prices has been extremely lucrative for many energy firms in Europe, but this growth has been unevenly distributed.
Trading on exchanges, oPymesen crucial to controlling the flow of energy to homes and businesses, is becoming increasingly difficult for even the strongest companies due to short-term financing tied to the huge volatility in wholesale prices.
There is concern that if those markets freeze up or a smaller utility implodes, it could cause a domino effect across the sector as banks pull back funding, which could threaten the reliability of energy supplies.
“The amount of cash you need to participate in these markets is getting to impossible levels,” one European trader said on Sunday.
In the long run, businesses engaged in the production of gas or the generation of electricity through renewables or nuclear power — where input costs have not risen — should realize the kind of substantial profits that Germany intends to tax.
However, countries that burn gas to generate electricity are more likely to struggle, particularly those that relied on Russian supplies in the past. Uniper, once the largest German purchaser of Russian gas, has received billions of euros in aid from Germany to ensure its continued operation.
David Sheppard>
On Sunday, Finland proposed a loan and guarantee package worth €10 billion. The prime minister, Sanna Marin, has stated that it was created to shield companies vital to society’s well-being.
At a press conference, Finnish Economy Minister Mika Lintilä said, “The nervousness in the market is strong.” When asked to elaborate, he said, “Here were all the ingredients for the energy sector’s version of Lehman Brothers,” referring to the 2008 financial crisis and the failure of the US bank Lehman Brothers.
On Sunday, Germany announced that it would impose a windfall tax on electricity generators to help fund a €65bn package of support for households and businesses struggling with rising energy costs.
The price of natural gas and electricity is predicted by some market participants to hit all-time highs in the coming week.
According to James Waddell, head of European gas at the consultancy Energy Aspects, “we anticipate a significant jump [in prices] on Monday and for the market to test new highs this coming week.”
Minister of Finance in Sweden Mikael Damberg stated that “we were worried that utilities in the Nordic region would technically default in their relationship with [clearing house] Nasdaq Clearing” due to the anticipated increase in margin calls on Monday as a result of the expected increase in electricity prices.
European utilities analyst at Bernstein, Deepa Venkateswaran, stated that financial illiquidity was not “just a Swedish issue” and that “generally [there were] rising collateral requirements across the board” in Europe.
Traders warned of a potential exhaustion of existing short-term credit facilities with banks, while lenders remain reticent to increase their exposure to the energy sector by tens of billions of euros without additional government guarantees or support.
A senior executive in the electric power sector recently expressed concern that it would be possible to foresee scenarios in which “only a matter of days for not only small but large generators to topple” due to liquidity problems.
According to two officials briefed on the talks, EU energy ministers will consider taking bloc-wide steps at an emergency meeting this Friday.
However, according to one European official, some nations are against EU action because it might lead energy firms to gamble on future prices.
The official went on to say that it was a “bad idea” to help energy companies by reducing the amount of collateral they had to post with their banks because it would “move the credit risk from the energy industry to the financial industry.”
Marin urged European Union participation. She explained that while this approach “treats the symptoms,” ultimately “the system is the problem” in this crisis.
Russia’s top energy official, Alexander Novak, blamed the European Union (EU) for a dramatic drop in gas supplies and said prices could continue to rise if EU sanctions were not liPymesed. Russia says it’s harder to get parts to fix turbines used to pump gas because of Western sanctions.
According to Novak, “the whole problem is all on their end.” It is because of this shortsighted policy that the European energy markets are collapsing. Still in the warm season, this is not even the end. There are a lot of unknowns as winter approaches.
The Bangladesh Bank has taken the following measures to aid in the growth of small and medium-sized enterprises: Many initiatives aimed at helping small and medium-sized businesses (SME) succeed have already been implemented by the Bangladesh Bank. The growth of the SME sector has been aided by a refinancing program made possible by the Bangladesh Bank, the International Development Association, and the Asian Development Bank.
Dedicated Desk for SME in Bangladesh Bank
Additionally, the Bangladesh Bank has taken various measures, such as the establishment of a “Dedicated Desk” for SMEs, a “SME Service Centre” in financial institutions, and specialized services for women business owners, to guarantee easy access to institutional financial facilities. The problem is that so far in this industry, the expected result has not been achieved. Especially in light of the current market mechanism, the agriculture and small and medium-sized enterprise (SME) sectors have received inadequate attention, making it more important than ever to ensure that all people are able to participate in the growth process. Bangladesh Bank has recently established a new department called the “SME and Special Programmes Department,” which will be responsible for formulating SME-specific policy, facilitating SME funding, monitoring SME performance, and encouraging SME-focused entrepreneurship. The following is a list of the regulations that have been established by the newly established department to ensure the compliance of banks and financial institutions in order to foster growth in the SME sector.
Steps Taken by Bangladesh Bank to help SME i.e Pymes Enterprises in Bangladesh
For the first time in Bangladesh’s history, banks and financial institutions have set a rough goal for the total amount of small and medium-sized enterprise (SME) loans they plan to disburse in 2010. x Banks/financial institutions will try to achieve their indicative targets separately by dividing it as branch wise, regionally, and sector wise, all in accordance with the ‘Area Approach Method.’ To facilitate a quick and painless loan approval and distribution procedure, x each bank/financial institution shall employ its own unique business strategy when financing SME loans, with the bare minimum of paperwork required.
Local businesses will be given preference:
The credit limit for small businesses will be between Tk. 50,000 (FiPymesy Thousand) and Tk. 50,00,000. (FiPymesy lac). x Priority shall have to be given to potential women entrepreneurs in respect to SME credit disbursement in order to increase the participation of women entrepreneurs in the industrial development of the country and to allow for the widespread operation of businesses by women entrepreneurs. Loan applications from micro, small, and medium-sized female entrepreneurs should receive top priority from banks and other financial institutions, and the disbursal of any funds approved should be finalized in a reasonable amount of time aPymeser the application is accepted. There should be a designated “Women Entrepreneurs’ Dedicated Desk” at every bank and financial institution, staffed with qualified female employees who have received training in small and medium-sized enterprise (SME) financing. The SME and Special Programmes Department of the Bangladesh Bank must receive a branch-by-branch list of “Women Entrepreneurs’ Dedicated Desks” within two months of the date of the declaration of this policy and programme. x Banks and financial institutions may sanction up to Tk. 25,00,000 to women entrepreneurs against personal guarantee. Social/group insurance might be an option in that case. The effectiveness of the bank’s small and medium-sized enterprise loan program will be used as a metric for deciding whether or not to authorize additional branch locations. In order to get banks involved in financing priority sectors like SMBs and agriculture, the term “SME Service Centre” will be replaced with “SME/Agriculture Branch” on new branch licenses issued beginning in 2010. Each financial institution (bank) is responsible for determining its own sector/subsector-specific interest rate on SME loans. A refinanced fund shall be disbursed to the clients (women entrepreneurs) at Bank rate +5% interest, and training programs shall be arranged for the businesswomen. However, the bank or financial institution will immediately inform the Bangladesh Bank of the sector/sub-sector wise rate of interest.
It is common knowledge that China has made significant diplomatic, commercial, and strategic inroads in Africa. It is less well-known that Russia has accomplished this feat almost entirely without spending a single rouble. Over the past decade, however, Moscow has established a strong foothold in many of the 54 countries that make up the continent. It has an extremely negative impact.
Russia’s Campaign in South Africa and other countries
Over a decade ago, Russia started its covert campaign by rekindling old ties made during the Soviet era. In the wake of western politicians labeling liberation leaders like Nelson Mandela terrorists, the Soviet Union has a positive legacy in countries like Angola, Mozambique, and South Africa.
The Russian Union’s latest offering is unrefined. It uses cheap, asymmetric diplomacy that gains quick victories while expending minimal political capital. Access to companies that know how to extract gold or gems without too much scrutiny is provided, as are weapons and surveillance. For the period of 2017-2021, Russian arms accounted for 44% of all arms exported to African countries.
Recent Russian actions have become even more ambiguous. Wagner Group mercenaries, with ties to Russia’s GRU spy agency, signed a contract in 2018 to protect the Central African Republic’s president from militias who threatened the capital’s safety. Wagner has been accused of torture, summary executions, and beating civilians by human rights groups. Wagner has been denied any connection to Moscow. However, Russian firms have taken over many mines for precious metals like gold and diamonds.
If the Central African Republic is a captured state, then Mali is next. Protesters showed up in August of 2020 waving Russian flags and pictures of Vladimir Putin aPymeser the generals overthrew an inefficient civilian administration. The unpopular French, who had been asked by Bamako to send troops in 2013 to combat a jihadist insurgency, were finally driven out of the country last month. Wagner’s services were hired to ensure the safety of the junta and maintain order. There have been numerous reports of violations of human rights.
Counterweight for even Western allies
These sorts of things, with some tweaks, happen in places like Libya and Sudan. Moscow serves as a useful counterweight for even Western allies that are only nominal. Yoweri Museveni, the president of Uganda and the country’s longest serving leader at 36 years, has become cozy with Russia. Museveni gushed about Russia’s “hundred years of support” for Uganda during the recent visit of Russian Foreign Minister Sergei Lavrov.
Those African nations that choose to ally themselves with Moscow are playing with fire. Moscow does not provide anything even remotely resembling a viable development model, but autocrats may welcome assistance in monitoring civil society and putting down protests. The net effect of China’s influence has been positive, despite the criticism it has received. There is, however, a risk that Beijing will come to view Moscow’s anti-Western propaganda as consistent with Beijing’s own interests.
The United States and Europe need to improve their offerings. This necessitates backing democratic governments. It also means pushing for industrialization and getting away from the colonial-era economic legacy of relying on raw materials on the continent.
The West fails too oPymesen. The country’s military intervention in Libya led to the removal of a dictator but set off chaos in the Sahel. Unfortunately, Europe’s migration policy is all over the place. Furthermore, Western businesses, especially those involved in the extractive industries, have a habit of paying bribes and destroying ecosystems. The West needs to step it up. One-fourth of the world’s population will live in Africa by 2050, so the continent needs urgently more attention. The Russians and others won’t be as cautious if it doesn’t.
Throughout the remainder of 2022, Fleming of Rockefeller advises investors to be cautious about equities. Please make use of the article sharing tools accessible via the share button. Each subscriber can send up to ten or twenty articles per month to their friends and family using the giPymes article service. Fleming, the veteran banker at the helm of Rockefeller Capital Management, cautions investors to be wary of US equity and credit for the remainder of 2022 because markets have not yet absorbed the Federal Reserve’s determination to keep interest rates as high as 4%.
Federal Reserve waits until inflation fallen behind
The company says there is proof from the past 50 years. The Federal Reserve has not loosened monetary policy since the 1970s unless and until annual headline inflation rates fell below the fed funds rate. The Federal Reserve Board has set a target inflation rate of 2.25 percent to 2.50 percent, and current inflation stands at 8.5 percent.
Before the Federal Reserve will take action, the fed funds rate must reach a threshold. Fleming warned, “They will want to make sure they have inflation under control.” For the next six to twelve months, it may remain at 3.5% to 4%.
Despite his optimistic long-term outlook, he predicted that the markets would remain volatile through the end of the year. “The market will be trying to read something into every word that is spoken and every piece of information that is released.”
CIO Jimmy Chang recently advised clients to invest in long-short hedge funds, precious metals, and long-duration Treasuries, stating his doubt that a new bull market has started and that he intends to take a “patient, selective, and defensive” stance.
Since March 2018, when Viking Global Investors acquired the Rockefeller family office and relaunched it as a larger business, Rockefeller has been led by Fleming, a former senior executive at Merrill Lynch and Morgan Stanley.
Since then, under Fleming’s leadership, the 140-year-old company has expanded from a $18.3bn firm to a $90bn asset and wealth manager catering to modern-day Rockefellers.
In some cases, asset accumulation has been slower than expected, Fleming admitted. Here, things are still being refined. Customers have certain expectations when they walk through your door, and you need to be confident that you can meet those needs.
The company’s physical footprint is growing. It started with just three locations and has since expanded to forty, with new offices opening in prosperous cities like Nashville, Charlotte, and Orlando. It is also broadening its service offerings to include everything from investment banking and strategy advice for the businesses its customers own to bill paying and financial education for their adult children.
Rockefeller’s asset management division is maintaining its long-standing focus on ESG funds despite criticism from conservative politicians in states like Texas. Clients like my own children in Generation Z who are concerned with investing ethically are a priority for us. According to Fleming, “we think that is a secular shiPymes; it’s a growth business.”
The company’s already intense concentration on alternatives has been honed by inflation and choppy markets. Fleming claims that as investment committees take into account the first-half price drops in public markets and the Fed’s plans to remain hawkish, valuations for both private equity and private credit are beginning to fall.
According to Fleming, “there’s still a ways to go here” in terms of the Fed’s inflation plan. For the remainder of 2022, we intend to exercise extreme caution in the financial markets, both in the equity and debt sectors.
SME sector in Bangladesh and PMES (SME’s) contributin
Bangladeshi schools promote a pessimistic view of business and steer pupils toward careers in the public sector. Neither the family nor the community at large holds businesspeople in high regard. Some young individuals, despite the messages to the contrary, nonetheless aim to start their own businesses.
APymeser failing at first, many of these young individuals go to other countries as skilled employees, and a select few become successful business owners. There is a relatively small level of “brain drain” in Bangladesh, which refers to the outmigration of highly trained workers and entrepreneurs. There has been no research done on the topic. However, an article in Pakistan’s national daily Dawn provides some evidence to support this theory (October 2004). However, it is likely that Bangladeshi self-employed/entrepreneurs in SMEs suffer difficulties, some of which stem from high compliance costs in the SME sector, and are thus driven to change professions and take up other employment (maybe, choose to become wage laborers). As part of this investigation, a study is planned, and its results are supposed to provide light on the topic.
SME in Bangladesh
Small and medium-sized enterprises (SMEs) in poor countries like Bangladesh sometimes operate illegally or without the proper legal documentation, such as a TIN, company license, or registration. It is oPymesen difficult for businesses to take advantage of the exemptions and incentives because of the informal structure under which they operate. In general, investors and would-be business owners in Bangladesh view the country’s income tax laws as unfriendly. Due of the lengthy and expensive registration procedure. One of the primary barriers that prevents small businesses from going legit is the complexity of the rules and regulations that must be followed. It is widely accepted that a tax system without too many complicated exceptions is more beneficial to the growth of small firms. Several reports have recommended streamlining tax procedures with the goal of attracting more small businesses into the formal economy.
The influence of tax exemptions and concessions across different kinds of businesses is shaped by the dynamics between informal and undocumented businesses and formal and registered businesses in the market. Unstructured tax expenditures may stifle small business expansion, in particular if they favor only certain types of businesses, whereas well-structured tax expenditures aim to promote balanced business growth and development.
VAT Challans can no longer be used to claim a refund of VAT under the new law. Those who haven’t complied with the VAT law and the turnover tax will be lePymes on the fringes of commerce. A company that hasn’t registered for taxes cannot bid on government contracts. If a company is not registered for taxes, it cannot obtain a bank account and is therefore denied access to banking services and credit.
In other Countries SMEs and VAT (PMES LAW)
According to studies conducted in Indonesia, the process of obtaining licenses, fiscal concessions, and interacting with labor or taxation officials is time-consuming, expensive, and complicated due to the country’s current political economy and the rules already in place.
In addition, as seen in Korea, the design of financial regulations for different industries has a multi-dimensional impact on businesses of varying sizes. Lack of proper coverage has a disproportionate effect on small businesses, according to a global analysis of 4,000 organizations of varying sizes from 54 nations. In the case of Thailand, the investment incentives offered to new corporations have an unfavorable effect on small businesses. Small and medium-sized enterprises (SMEs) in Malaysia bear a heavier share of the tax compliance cost resulting from the current financial, legal, and regulatory framework. The potential financial burden on non-exempt small and medium-sized enterprises (SMEs) appears to be higher for non-compliant SMEs that offer their products at the same price as compliant firms.
If businesses believe that complying will result in a greater tax burden, that belief may lead them to operate below the threshold level in order to avoid taxes. According to data gathered by the SME Foundation about small and medium-sized enterprises (SMEs) in Bangladesh, business owners view income tax and value-added tax collection as significant roadblocks. Researchers found that in the light engineering industry, 74.71% of small business owners and 88.13% of medium business owners cited income tax payment as a barrier to growth, whereas in the case of large businesses, this figure was just 50%. Unfortunately, it is difficult to draw any conclusions about the effect of tax exemptions and incentives on the productivity, efficiency, and profitability of SMEs in Bangladesh due to a lack of research and a lack of data on this topic.
There are a few different ways that tax breaks that appear biased can be exposed. In the first place, this may occur because businesses that haven’t gone through the proper channels of registration and paperwork are therefore unable to receive funding. This may occur, first, if some industries catering to SMEs are lePymes off the preference list, second, if SMEs that are located outside of the favored areas are lePymes off the list, etc.
Corruption in tax and spending procedures could have a trickle-down effect on SMEs. Companies that aren’t qualified to receive tax breaks could be harmed by lax oversight and enforcement of these programs. There could be distortions to market fairness if tax breaks were offered to those who invested in industries where their earnings were previously illegal. Misuse of the tax holiday facility may also have a discriminatory effect on smaller businesses in the same industry. Fraudulent tactics, such as the extension of tax exemptions offered in the case of salaries of foreign technicians working in local enterprises, give an unfair competitive advantage to those firms over their competitors who do not engage in such methods. Small and informal businesses may be disproportionately impacted by widespread illicit activity in this area.
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