Latest news with #MaggieFick
Yahoo
15-05-2025
- Business
- Yahoo
FDA upheaval pushes some biotech firms to plan early trials out of US
By Maggie Fick LONDON (Reuters) -Some U.S. biotech companies are considering moving early-stage trials of new medicines outside the United States as worry grows that layoffs and policy changes at the drugs watchdog under the Trump administration may delay regulatory reviews, executives, investors, and consultants told Reuters. The U.S. Food and Drug Administration is seen as the global gold standard for drug regulation and companies typically seek American approval first because it provides access to the world's most lucrative drug market. But mass layoffs, leadership exits and the restructuring of the FDA under President Donald Trump are prompting some smaller biotechs to rethink traditional pathways for bringing new medicines to market. Reuters spoke to seven biotech executives, investors, and consultants who said that the staff departures and policy changes at the FDA had prompted some firms to consider launching trials in other international markets - such as the European Union and Australia - and engaging with regulators in those regions earlier in the drug development process. "We know that across our companies, the discussions include whether to go ex-U.S. because of recent FDA uncertainty," said Peter Kolchinsky, managing partner at RA Capital, a major investor in early-stage biotech firms and publicly traded companies with approximately $9 billion in assets under management. The FDA did not respond to a request for comment. U.S. Health Secretary Robert F. Kennedy Jr. has said that the agency's restructuring aims to streamline functions such as IT and communications, and reduce conflicts of interest among its staff and advisors. Consultant Matthew Weinberg of ProPharma Group said his firm is fielding more inquiries from biotech companies about preparing filings with the European Medicines Agency and setting up clinical trials - a shift he attributes to growing concerns about FDA stability. "Historically, companies went to the U.S. first. That may be changing," he said. It is unclear if biotech companies' increasing engagement with the EMA marks a real shift or a tactic to pressure the FDA, given the importance of the U.S. market, a source with knowledge of the matter told Reuters. An EMA spokesperson said it has not seen an increase in scientific advice requests or clinical trial applications, noting it would be early for any such shifts to be reflected in submissions. NEW APPROACHES A loss of confidence in the FDA could reshape drug development, reduce U.S. leadership in innovation, and increase costs for the struggling biotech sector, five of those interviewed said. "What's happening has forced all of us to discuss other approaches," said Sabrina Martucci Johnson, CEO of Dare Bioscience, a San Diego-based women's health biotech worth $25 million that received FDA approval in 2021 for its first product. "We are definitely looking at Europe first for certain products where the need is great and the U.S. regulatory path has become more uncertain or slower." Trump on Monday signed an executive order directing drugmakers to lower the prices of their medicines in line with other countries. Commenting on the executive order, Swiss drugmaker Roche on Tuesday said it is concerned that the order "will undermine the U.S.' position as the world's leading pharmaceutical and healthcare ecosystem." Some biotech executives spoke about early-stage testing on condition of anonymity to avoid drawing attention to their companies or risking retribution for criticising the Trump administration. One biotech CEO said their company plans to seek approval from the EMA to run early-stage clinical trials of its oncology treatment in three European countries - in addition to the trial of the same treatment it launched in the U.S. last October. The expanded European strategy will cost about $1 million in additional filings, consultants, and contract research organisation support - plus several million more to run the trials. "We cannot just hope that things will turn around and that the cuts at the FDA will not have any impact on our business," the executive said. "The irony of this is it goes against the grain of 'America First', because we are offshoring away from the U.S. over to Europe." SLOWER BUT STABLE Another U.S. biotech told Reuters it opted to run two early-stage trials in Australia this month rather than in the U.S. Although some small biotechs had already started to conduct their first in-human trials outside the U.S., particularly in Australia where it is 30% to 40% cheaper, the biotech CEO said that in their firm's case, the decision was driven by FDA staffing cuts and uncertainty. A third biotech CEO said at least two members of the eight-person FDA team reviewing its early-stage trial for an mRNA rare disease therapy have left. They worry this turnover could delay FDA review of trial data. When asked about the impact of shifts at the FDA during earnings calls this month, executives from several big pharma companies including GSK, Merck & Co and Sanofi said they had so far not experienced any changes in their interactions with the regulator. Companies typically file for regulatory approval in the U.S. first to gain access to a market worth approximately $635 billion annually. Even a month or two delay in a regulatory step with the FDA could be existential, said the biotech CEO with the mRNA rare disease therapy. Executives stressed they still intend to run late-stage trials in the U.S. to launch products there. "Europe has been perceived as a little slower, but it has benefited -- and is benefiting now -- from being stable," said Owen Smith, a partner at 4BIO Capital, a London-based venture capital firm that invests in early-stage biotech companies. Error while retrieving data Sign in to access your portfolio Error while retrieving data Error while retrieving data Error while retrieving data Error while retrieving data
Gulf Today
14-05-2025
- Health
- Gulf Today
EU scramble to interpret Trump's new drug pricing order
Maggie Fick, Reuters European governments are examining whether US President Donald Trump can force them to pay more for prescription medicines, after he issued an executive order to lower US drug prices, roiling the global pharmaceutical industry. On Monday, Trump took aim at governments paying a fraction of what Americans have to shell out for their medicines, and directed the use of trade policy to force other nations to pay more for prescription drugs. The Trump administration wants to reduce the gap between US drug prices and those in other developed countries such as many in Europe, where prescription drugs cost, on average, one-third what they do in the United States. Denmark's industry and business minister Morten Bodskov plans to meet with drugmakers based in his country to discuss the order. He did not give details about the meeting. 'The uncertainty (caused) by the US is bad for the world,' he told Reuters. 'Danish pharmaceutical companies are among the best in the world and are of great importance to Denmark. The message from Trump does not change that.' The country of six million has benefited from the expansion of Novo Nordisk and the outsize demand for its diabetes drug Ozempic and for Wegovy, one of the powerful new weight-loss drugs singled out by Trump in his push to lower prices. Novo, Europe's third-largest listed company worth 265 billion euros ($295.74 billion), said it looked forward to the meeting. In the US, drug prices are shaped by complex negotiations involving pharmacy benefit managers that act as middlemen between drugmakers and employer clients and health insurers and have been criticised for inflating costs. In Europe, countries generally have public health systems that negotiate directly with manufacturers and keep costs down. The European Commission, the EU executive, will assess the impact of Trump's order on European companies, a spokesperson told reporters on Tuesday. 'We know the pharmaceutical industry faces challenges both in the US and the EU,' the spokesperson said, noting Commission President Ursula von der Leyen had met with executives last month to address concerns about the threat of US tariffs on medicines. Trump's effort during his first term through a more limited executive order focused on certain drugs covered by the government's Medicare program — was blocked by a court. Trump said if drugmakers do not cut prices they could be hit with tariffs. His administration launched a probe last month into pharmaceutical imports as a potential precursor to placing levies on medicines on national security grounds. 'The United States will no longer subsidize the healthcare of foreign countries, which is what we were doing,' Trump said on Monday. 'I'm not knocking the drug companies. I'm really more knocking the countries than the drug companies.' Although Americans pay significantly more for medicines, they have access to a greater number of treatments. Some 55% more cancer drugs were launched in the U.S. than in the UK over the past three decades, according to a 2024 study in the British Medical Journal. An AstraZeneca spokesperson said the company supports fairer global sharing of pharmaceutical costs, but that changes must avoid 'disrupting patient care, undermining U.S. biotech leadership, or stifling innovation.' Seven drug pricing experts and lawyers told Reuters it is unclear how the administration could legally demand confidential contract details between drugmakers and governments. That information would be needed as Trump's order calls for giving drugmakers price targets within a month. Strict cost containment measures and reimbursement policies prevent drugmakers from charging Britain's financially strapped state-funded National Health Service more for new drugs, said Daniel Howdon, a health economist at the University of Leeds. 'Unless there is some sort of overhaul of UK law or policy, Trump's order will not be able to achieve higher prices,' he said. A spokesperson for Germany's health ministry told Reuters it was not possible to predict how the U.S. order may be implemented. Germany has a 'clearly defined framework for price negotiations on medicines between statutory health insurance and the pharmaceutical industry,' the spokesperson said. The call for developed countries to pay more for drugs so the U.S. can pay less comes as worries grow that uncertainty caused by Trump's whiplash trade war will dampen the 27-nation bloc's already-weak economy. Even with the threat of tariffs, governments may be unable and unwilling to spend more on medicines, particularly as populations age and healthcare budgets tighten, UBS analyst Trung Huynh said. The UK government does not publish the prices it pays for NHS drugs, but a source at the UK's Department of Health and Social Care said prices for some treatments are about a quarter of those paid by the U.S. The DHSC did not respond to a request for comment. Still, a source at a European drugmaker told Reuters the Trump administration could still exert pressure to try to force governments to alter their longstanding pricing practices embedded in national health systems. 'I read this as him showing pharma all of the negotiating tools he has at his disposal,' said Anna Kaltenboeck, a health economist at Verdant Research, 'and giving them some credible threat based on his willingness to impose tariffs so far.'
Yahoo
14-05-2025
- Health
- Yahoo
European governments scramble to interpret Trump's new drug pricing order
By Maggie Fick LONDON (Reuters) -European governments are examining whether U.S. President Donald Trump can force them to pay more for prescription medicines, after he issued an executive order to lower U.S. drug prices, roiling the global pharmaceutical industry. On Monday, Trump took aim at governments paying a fraction of what Americans have to shell out for their medicines, and directed the use of trade policy to force other nations to pay more for prescription drugs. The Trump administration wants to reduce the gap between U.S. drug prices and those in other developed countries such as many in Europe, where prescription drugs cost, on average, one-third what they do in the United States. Denmark's industry and business minister Morten Bodskov plans to meet with drugmakers based in his country to discuss the order. He did not give details about the meeting. "The uncertainty (caused) by the U.S. is bad for the world," he told Reuters. "Danish pharmaceutical companies are among the best in the world and are of great importance to Denmark. The message from Trump does not change that." The country of six million has benefited from the expansion of Novo Nordisk and the outsize demand for its diabetes drug Ozempic and for Wegovy, one of the powerful new weight-loss drugs singled out by Trump in his push to lower prices. Novo, Europe's third-largest listed company worth 265 billion euros ($295.74 billion), said it looked forward to the meeting. In the U.S., drug prices are shaped by complex negotiations involving pharmacy benefit managers that act as middlemen between drugmakers and employer clients and health insurers and have been criticised for inflating costs. In Europe, countries generally have public health systems that negotiate directly with manufacturers and keep costs down. The European Commission, the EU executive, will assess the impact of Trump's order on European companies, a spokesperson told reporters on Tuesday. "We know the pharmaceutical industry faces challenges both in the U.S. and the EU," the spokesperson said, noting Commission President Ursula von der Leyen had met with executives last month to address concerns about the threat of U.S. tariffs on medicines. Trump's effort during his first term -- through a more limited executive order focused on certain drugs covered by the government's Medicare program -- was blocked by a court. Trump said if drugmakers do not cut prices they could be hit with tariffs. His administration launched a probe last month into pharmaceutical imports as a potential precursor to placing levies on medicines on national security grounds. "The United States will no longer subsidize the healthcare of foreign countries, which is what we were doing," Trump said on Monday. "I'm not knocking the drug companies. I'm really more knocking the countries than the drug companies." Although Americans pay significantly more for medicines, they have access to a greater number of treatments. Some 55% more cancer drugs were launched in the U.S. than in the UK over the past three decades, according to a 2024 study in the British Medical Journal. An AstraZeneca spokesperson said the company supports fairer global sharing of pharmaceutical costs, but that changes must avoid "disrupting patient care, undermining U.S. biotech leadership, or stifling innovation." CONFIDENTIAL PRICES Seven drug pricing experts and lawyers told Reuters it is unclear how the administration could legally demand confidential contract details between drugmakers and governments. That information would be needed as Trump's order calls for giving drugmakers price targets within a month. Strict cost containment measures and reimbursement policies prevent drugmakers from charging Britain's financially strapped state-funded National Health Service more for new drugs, said Daniel Howdon, a health economist at the University of Leeds. "Unless there is some sort of overhaul of UK law or policy, Trump's order will not be able to achieve higher prices," he said. A spokesperson for Germany's health ministry told Reuters it was not possible to predict how the U.S. order may be implemented. Germany has a "clearly defined framework for price negotiations on medicines between statutory health insurance and the pharmaceutical industry," the spokesperson said. The call for developed countries to pay more for drugs so the U.S. can pay less comes as worries grow that uncertainty caused by Trump's whiplash trade war will dampen the 27-nation bloc's already-weak economy. Even with the threat of tariffs, governments may be unable and unwilling to spend more on medicines, particularly as populations age and healthcare budgets tighten, UBS analyst Trung Huynh said. The UK government does not publish the prices it pays for NHS drugs, but a source at the UK's Department of Health and Social Care said prices for some treatments are about a quarter of those paid by the U.S. The DHSC did not respond to a request for comment. Still, a source at a European drugmaker told Reuters the Trump administration could still exert pressure to try to force governments to alter their longstanding pricing practices embedded in national health systems. "I read this as him showing pharma all of the negotiating tools he has at his disposal," said Anna Kaltenboeck, a health economist at Verdant Research, "and giving them some credible threat based on his willingness to impose tariffs so far." ($1 = 0.8961 euros)
Yahoo
14-05-2025
- Health
- Yahoo
European governments scramble to interpret Trump's new drug pricing order
By Maggie Fick LONDON (Reuters) -European governments are examining whether U.S. President Donald Trump can force them to pay more for prescription medicines, after he issued an executive order to lower U.S. drug prices, roiling the global pharmaceutical industry. On Monday, Trump took aim at governments paying a fraction of what Americans have to shell out for their medicines, and directed the use of trade policy to force other nations to pay more for prescription drugs. The Trump administration wants to reduce the gap between U.S. drug prices and those in other developed countries such as many in Europe, where prescription drugs cost, on average, one-third what they do in the United States. Denmark's industry and business minister Morten Bodskov plans to meet with drugmakers based in his country to discuss the order. He did not give details about the meeting. "The uncertainty (caused) by the U.S. is bad for the world," he told Reuters. "Danish pharmaceutical companies are among the best in the world and are of great importance to Denmark. The message from Trump does not change that." The country of six million has benefited from the expansion of Novo Nordisk and the outsize demand for its diabetes drug Ozempic and for Wegovy, one of the powerful new weight-loss drugs singled out by Trump in his push to lower prices. Novo, Europe's third-largest listed company worth 265 billion euros ($295.74 billion), said it looked forward to the meeting. In the U.S., drug prices are shaped by complex negotiations involving pharmacy benefit managers that act as middlemen between drugmakers and employer clients and health insurers and have been criticised for inflating costs. In Europe, countries generally have public health systems that negotiate directly with manufacturers and keep costs down. The European Commission, the EU executive, will assess the impact of Trump's order on European companies, a spokesperson told reporters on Tuesday. "We know the pharmaceutical industry faces challenges both in the U.S. and the EU," the spokesperson said, noting Commission President Ursula von der Leyen had met with executives last month to address concerns about the threat of U.S. tariffs on medicines. Trump's effort during his first term -- through a more limited executive order focused on certain drugs covered by the government's Medicare program -- was blocked by a court. Trump said if drugmakers do not cut prices they could be hit with tariffs. His administration launched a probe last month into pharmaceutical imports as a potential precursor to placing levies on medicines on national security grounds. "The United States will no longer subsidize the healthcare of foreign countries, which is what we were doing," Trump said on Monday. "I'm not knocking the drug companies. I'm really more knocking the countries than the drug companies." Although Americans pay significantly more for medicines, they have access to a greater number of treatments. Some 55% more cancer drugs were launched in the U.S. than in the UK over the past three decades, according to a 2024 study in the British Medical Journal. An AstraZeneca spokesperson said the company supports fairer global sharing of pharmaceutical costs, but that changes must avoid "disrupting patient care, undermining U.S. biotech leadership, or stifling innovation." CONFIDENTIAL PRICES Seven drug pricing experts and lawyers told Reuters it is unclear how the administration could legally demand confidential contract details between drugmakers and governments. That information would be needed as Trump's order calls for giving drugmakers price targets within a month. Strict cost containment measures and reimbursement policies prevent drugmakers from charging Britain's financially strapped state-funded National Health Service more for new drugs, said Daniel Howdon, a health economist at the University of Leeds. "Unless there is some sort of overhaul of UK law or policy, Trump's order will not be able to achieve higher prices," he said. A spokesperson for Germany's health ministry told Reuters it was not possible to predict how the U.S. order may be implemented. Germany has a "clearly defined framework for price negotiations on medicines between statutory health insurance and the pharmaceutical industry," the spokesperson said. The call for developed countries to pay more for drugs so the U.S. can pay less comes as worries grow that uncertainty caused by Trump's whiplash trade war will dampen the 27-nation bloc's already-weak economy. Even with the threat of tariffs, governments may be unable and unwilling to spend more on medicines, particularly as populations age and healthcare budgets tighten, UBS analyst Trung Huynh said. The UK government does not publish the prices it pays for NHS drugs, but a source at the UK's Department of Health and Social Care said prices for some treatments are about a quarter of those paid by the U.S. The DHSC did not respond to a request for comment. Still, a source at a European drugmaker told Reuters the Trump administration could still exert pressure to try to force governments to alter their longstanding pricing practices embedded in national health systems. "I read this as him showing pharma all of the negotiating tools he has at his disposal," said Anna Kaltenboeck, a health economist at Verdant Research, "and giving them some credible threat based on his willingness to impose tariffs so far." ($1 = 0.8961 euros) Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
12-05-2025
- Health
- Yahoo
Explainer-What has Trump said about cutting drug prices?
By Maggie Fick (Reuters) -U.S. President Donald Trump signed a broad executive order on Monday directing drugmakers to lower the prices of their prescription drugs to align with what other countries pay. White House officials said the government will give drugmakers price targets in the next month, and will take further action within six months if the companies do not make "significant progress" toward the goal of lower prices. Here is what you need to know: WHAT IS TRUMP'S STANCE ON PRESCRIPTION DRUG PRICES? Trump has sharply criticised the pharmaceutical industry for years over the price of medicines in the United States. He has also chided other wealthy nations for "freeloading" on U.S. pharmaceutical innovation. During his first term, in 2017, he accused the industry of "getting away with murder" in the prices they charge the government for prescription drugs. Trump's proposed international reference pricing program was blocked by a court in 2020. During his 2024 presidential campaign, Trump said Americans were being overcharged for medicines compared to other nations and pledged to take action. On Monday, he said he wants to "equalize" prices with other countries by implementing tariffs. ARE U.S. DRUG PRICES MORE EXPENSIVE? Yes. The U.S. pays the most for prescription medicines in the world, often nearly three times that of other developed nations. Top-selling blood thinner Eliquis from Bristol Myers Squibb and Pfizer carries a U.S. list price of $606 for a month's supply. The previous administration of Democratic President Joe Biden negotiated that down to $295 for Medicare, which goes into effect in 2026, but the drug costs $114 in Sweden and just $20 in Japan. WHAT IS TRUMP GOING TO DO ABOUT IT? Since taking office in January, Trump has reiterated that he wants to end this inequity. On Sunday, he announced on Truth Social that he would sign an executive order to pursue "most favoured nation" pricing. Also known as international reference pricing, it seeks to narrow the gap between the U.S. and foreign drug prices. Reuters reported in April such a policy was under consideration. The executive order on Monday differed from what drugmakers had been expecting. Lobbyist sources had told Reuters ahead of the order's signing on Monday that they expected the "most favored nation" pricing to apply to drugs for Medicare patients. But the order appeared to apply to all medicines. Separately, Trump has also pushed for drugmakers to boost U.S. manufacturing. His administration is conducting an investigation into imports of pharmaceuticals in a bid to levy tariffs on grounds that reliance on foreign production of medicine threatens national security. HOW DOES THIS DIFFER FROM PREVIOUS PRICE REDUCTION EFFORTS? Biden's Inflation Reduction Act allows the government to negotiate the price of its most expensive drugs within Medicare. The prices for the first 10 prescription drugs it negotiated were still on average more than double, and in some cases five times, what drugmakers had agreed to in four other high-income countries, Reuters previously reported. WHAT IS THE PHARMA INDUSTRY'S RESPONSE? The industry is strongly opposed to the prospect of dramatically lower drug prices in the United States, the world's largest pharmaceuticals market. Two industry sources told Reuters last month that any such policy was more concerning to the industry than other potential government moves such as tariffs on imported medicines. The main U.S. lobby group for drugmakers, the Pharmaceutical Research and Manufacturers of America, known as PhRMA, said, "to lower costs for Americans, we need to address the real reasons U.S. prices are higher: foreign countries not paying their fair share and middlemen driving up prices for U.S. patients." "Most favored nation is a deeply flawed proposal that would devastate our nation's small- and mid-size biotech companies," said John Crowley, CEO of BIO, the main U.S. trade group for biotechnology companies, in a statement. WHAT ARE THE CHALLENGES IN CARRYING OUT THE ORDER? Experts warn that referencing prices from other countries is complex, as many drugs sold in the U.S. are not available abroad, and some nations do not publish what they pay for drugs or take years to negotiate prices. The U.S. does not buy drugs directly for a national health system, as countries such as England and Germany do, instead relying on the private sector to manage drug price negotiations for both government and private health plans. Analysts said implementing the broad order would be difficult. The executive order is also likely to face legal challenges, particularly for exceeding limits set by U.S. law, including on imports of drugs from abroad, legal experts said.
