Latest news with #pharmaceuticalindustry
Telegraph
8 hours ago
- Business
- Telegraph
NHS drug charges row hits deadlock
Ministers have failed to agree a crucial deal on NHS drug charges that was meant to be at the centre of a plan to boost growth. Talks on Friday between the Government and pharmaceutical industry bosses ended without an agreement on how much the NHS is able to claw back in rebates on drugs. Ministers had been hoping to be able to address industry complaints of unfairness prior to the publication a strategy for the sector, expected next week. One senior pharmaceutical executive said: 'If a [NHS clawback] deal is not secured, it's a missed opportunity for the life sciences sector plan and one which blocks the UK's ambition to be a life sciences superpower.' Another said that the UK needed to show it wanted to make the scheme competitive again, adding: 'Without that, all the high statements of ambition or new strategies in the world are not going to make the UK a leading life sciences centre.' The Department of Health launched a review of NHS rebates earlier this year under pressure from Donald Trump and the pharmaceutical industry. Ministers said they would take into account the 'concerns of the US president' that countries are unfairly keeping prices low relative to the high drug costs in the American health system. Under the trade agreement signed between the two nations earlier this year, the Government agreed to 'endeavour to improve the overall environment for pharmaceutical companies operating in the UK'. The failure to secure a deal ahead of the publication of the sector strategy follows months of wrangling. Under the current rebate scheme, known as VPAG, pharmaceutical companies have to hand at least 23pc of their revenue from sales of branded medicines back to the NHS. The scheme cut the drug bill by £3bn last year. However, pharmaceutical bosses have warned the scheme is preventing the launch of cutting-edge medicines in the UK. They have pressed for the UK to cut the rate of rebates into single digits, a level seen elsewhere in Europe. The life sciences strategy is one of several sector plans announced as part of Labour's industrial strategy. Others were published this week. A spokesman for the Government said: 'Economic growth is our number one priority and we're taking decisive action to unlock innovation and drive investment in the UK's world-class pharmaceutical sector. As part of this, we continue to work closely with industry on a rapid review of our voluntary scheme for medicines pricing. 'With our work and investment, we will make sure the next game changers in medicine are developed here in Britain, for the benefit of our health at home and abroad.'
Washington Post
17-06-2025
- Health
- Washington Post
FDA to offer faster drug reviews to companies promoting 'national priorities'
WASHINGTON — U.S. regulators will begin offering faster reviews to new medicines that administration officials deem as promoting 'the health interests of Americans,' under a new initiative announced Tuesday. Food and Drug Administration Commissioner Marty Makary said the agency will aim to review select drugs in one to two months. FDA's long-standing accelerated approval program generally issues decisions in six months for drugs that treat life-threatening diseases . Regular drug reviews take about 10 months. Since arriving at the FDA in April, Makary has repeatedly told FDA staff they need to 'challenge assumptions' and rethink procedures. In a medical journal commentary published last week, Makary suggested the agency could conduct 'rapid or instant reviews,' pointing to the truncated process used to authorize the first COVID-19 vaccines under Operation Warp Speed. For the new program, the FDA will issue a limited number of 'national priority vouchers' to companies 'aligned with U.S. national priorities,' the agency said in a statement. The special designation will give the selected companies access to extra FDA communications, streamlined staff reviews and the ability to submit much of their product information in advance. Speeding up drug approvals has long been a priority of the pharmaceutical industry, which has successfully lobbied Congress to create a variety of special programs and pathways for faster reviews. Many aspects of the plan announced Tuesday overlap with older programs. But the broad criteria for receiving a voucher will give FDA officials unprecedented discretion in deciding which companies can benefit from the fastest reviews. 'The ultimate goal is to bring more cures and meaningful treatments to the American public,' Makary said in a statement. Makary previously said the FDA should be willing to ease its scientific requirements for certain drugs, for instance, by not always requiring randomized studies in which patients are tracked over time to track safety and effectiveness. Such trials are generally considered the gold standard of medical research, though the FDA has increasingly been willing to accept smaller, less-definitive studies for rare or life-threatening diseases . In several recent cases , the FDA has faced criticism for approving drugs based on preliminary data that didn't ultimately show benefits for patients. The push to rapidly accelerated drug approvals is the opposite approach that Makary and his boss, Health Secretary Robert F. Kennedy Jr. , have taken on vaccines. Promising a 'return to gold-standard science,' Kennedy previously announced that all new vaccines would have to be compared to placebo, or a dummy shot, to win approval. Kennedy and Makary also have announced a stricter policy on seasonal updates to COVID-19 shots, saying they will have to undergo new testing before they can be approved for use in healthy children and most adults. ___ The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute's Science and Educational Media Group and the Robert Wood Johnson Foundation. The AP is solely responsible for all content.
The Independent
17-06-2025
- Health
- The Independent
FDA to offer faster drug reviews to companies promoting 'national priorities'
U.S. regulators will begin offering faster reviews to new medicines that administration officials deem as promoting 'the health interests of Americans,' under a new initiative announced Tuesday. Food and Drug Administration Commissioner Marty Makary said the agency will aim to review select drugs in one to two months. FDA 's long-standing accelerated approval program generally issues decisions in six months for drugs that treat life-threatening diseases. Regular drug reviews take about 10 months. Since arriving at the FDA in April, Makary has repeatedly told FDA staff they need to 'challenge assumptions' and rethink procedures. In a medical journal commentary published last week, Makary suggested the agency could conduct 'rapid or instant reviews," pointing to the truncated process used to authorize the first COVID-19 vaccines under Operation Warp Speed. For the new program, the FDA will issue a limited number of 'national priority vouchers' to companies 'aligned with U.S. national priorities,' the agency said in a statement. The special designation will give the selected companies access to extra FDA communications, streamlined staff reviews and the ability to submit much of their product information in advance. Speeding up drug approvals has long been a priority of the pharmaceutical industry, which has successfully lobbied Congress to create a variety of special programs and pathways for faster reviews. Many aspects of the plan announced Tuesday overlap with older programs. But the broad criteria for receiving a voucher will give FDA officials unprecedented discretion in deciding which companies can benefit from the fastest reviews. "The ultimate goal is to bring more cures and meaningful treatments to the American public,' Makary said in a statement. Makary previously said the FDA should be willing to ease its scientific requirements for certain drugs, for instance, by not always requiring randomized studies in which patients are tracked over time to track safety and effectiveness. Such trials are generally considered the gold standard of medical research, though the FDA has increasingly been willing to accept smaller, less-definitive studies for rare or life-threatening diseases. In several recent cases, the FDA has faced criticism for approving drugs based on preliminary data that didn't ultimately show benefits for patients. The push to rapidly accelerated drug approvals is the opposite approach that Makary and his boss, Health Secretary Robert F. Kennedy Jr., have taken on vaccines. Promising a 'return to gold-standard science,' Kennedy previously announced that all new vaccines would have to be compared to placebo, or a dummy shot, to win approval. Kennedy and Makary also have announced a stricter policy on seasonal updates to COVID-19 shots, saying they will have to undergo new testing before they can be approved for use in healthy children and most adults. ___ The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute's Science and Educational Media Group and the Robert Wood Johnson Foundation. The AP is solely responsible for all content.
Associated Press
17-06-2025
- Health
- Associated Press
FDA to offer faster drug reviews to companies promoting 'national priorities'
WASHINGTON (AP) — U.S. regulators will begin offering faster reviews to new medicines that administration officials deem as promoting 'the health interests of Americans,' under a new initiative announced Tuesday. Food and Drug Administration Commissioner Marty Makary said the agency will aim to review select drugs in one to two months. FDA's long-standing accelerated approval program generally issues decisions in six months for drugs that treat life-threatening diseases. Regular drug reviews take about 10 months. Since arriving at the FDA in April, Makary has repeatedly told FDA staff they need to 'challenge assumptions' and rethink procedures. In a medical journal commentary published last week, Makary suggested the agency could conduct 'rapid or instant reviews,' pointing to the truncated process used to authorize the first COVID-19 vaccines under Operation Warp Speed. For the new program, the FDA will issue a limited number of 'national priority vouchers' to companies 'aligned with U.S. national priorities,' the agency said in a statement. The special designation will give the selected companies access to extra FDA communications, streamlined staff reviews and the ability to submit much of their product information in advance. Speeding up drug approvals has long been a priority of the pharmaceutical industry, which has successfully lobbied Congress to create a variety of special programs and pathways for faster reviews. Many aspects of the plan announced Tuesday overlap with older programs. But the broad criteria for receiving a voucher will give FDA officials unprecedented discretion in deciding which companies can benefit from the fastest reviews. 'The ultimate goal is to bring more cures and meaningful treatments to the American public,' Makary said in a statement. Makary previously said the FDA should be willing to ease its scientific requirements for certain drugs, for instance, by not always requiring randomized studies in which patients are tracked over time to track safety and effectiveness. Such trials are generally considered the gold standard of medical research, though the FDA has increasingly been willing to accept smaller, less-definitive studies for rare or life-threatening diseases. In several recent cases, the FDA has faced criticism for approving drugs based on preliminary data that didn't ultimately show benefits for patients. The push to rapidly accelerated drug approvals is the opposite approach that Makary and his boss, Health Secretary Robert F. Kennedy Jr., have taken on vaccines. Promising a 'return to gold-standard science,' Kennedy previously announced that all new vaccines would have to be compared to placebo, or a dummy shot, to win approval. Kennedy and Makary also have announced a stricter policy on seasonal updates to COVID-19 shots, saying they will have to undergo new testing before they can be approved for use in healthy children and most adults. ___ The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute's Science and Educational Media Group and the Robert Wood Johnson Foundation. The AP is solely responsible for all content.
Associated Press
11-06-2025
- Business
- Associated Press
Biologic Therapeutic Drugs Technology Analysis and Global Market Forecast Report 2024-2025 & 2029 Featuring Key Players - Merck, F. Hoffmann-La Roche, Johnson & Johnson, Pfizer, & Bristol-Myers Squibb
DUBLIN--(BUSINESS WIRE)--Jun 11, 2025-- The 'Biologic Therapeutic Drugs: Technologies and Global Markets' report has been added to offering. The global market for biologic therapeutic drugs is estimated to increase from $499.2 billion in 2024 to reach $794.5 billion by 2029, at a compound annual growth rate (CAGR) of 9.7% from 2024 through 2029. This report provides an overview of the global biologic therapeutic drug market and analyzes market trends. It includes global revenue ($U.S. millions) for base year data for 2023 and estimated data for 2024. The forecast period is 2024 through 2029. The pharmaceutical industry is undergoing tremendous transformations by focusing more on targeted and personalized therapies. The industry is witnessing a shift from traditional synthetic drugs to biologic therapeutic drugs, which are more efficacious, have better patient outcomes and improve quality of life. Biologic drugs are primarily classified into monoclonal antibodies; vaccines; peptide hormones; cell and gene therapies; and others, which include protein therapeutics (e.g., cytokines, enzymes, blood factors, fusion proteins) and other drugs (e.g., RNA-based therapies). The biopharmaceutical industry has recently been witnessing tremendous growth due to the increasing demand for innovative therapies, such as monoclonal antibodies, cell and gene therapies and vaccines. The demand for these therapies is primarily driven by such factors as the increasing prevalence of chronic diseases, rising healthcare expenditures, increasing awareness, novel product launches and strong pipelines. The biologic approvals by the U.S. Food and Drug Administration (FDA) are increasing year on year, and 2023 was marked by the approval of two breakthrough therapies: the gene editing therapy Casgevy from Vertex Pharmaceutical and Leqembi (lecanemab) from Eisai Inc. The entry of biosimilars into the market is expected to erode the revenues of the current branded products upon patent expiry. The complex manufacturing process, a lack of skilled workforce and high development costs translate to a high cost of therapy, which acts as a major barrier to the market. The report focuses on the significant driving trends and challenges that affect the market and vendor landscape. It analyzes corporate environmental, social and governance (ESG) developments and discusses emerging technologies related to the market. The report concludes with an analysis of the competitive landscape, which provides the ranking and share of key players in the global biologic therapeutic drug market. It also has a section dedicated to company profiles that covers such details as overview, key financials, product portfolio and recent developments of key market players. The report includes: Company Profiles Key Attributes: Key Topics Covered: Chapter 1 Executive Summary Chapter 2 Market Overview Chapter 3 Market Dynamics Chapter 4 Regulatory Landscape Chapter 5 Emerging Technologies and Developments Chapter 6 Market Segmentation Analysis Chapter 7 Competitive Intelligence Chapter 8 Sustainability in Biologics Therapeutic Drug Market: An ESG Perspective Chapter 9 Appendix For more information about this report visit About is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends. View source version on CONTACT: Laura Wood, Senior Press Manager [email protected] For E.S.T Office Hours Call 1-917-300-0470 For U.S./ CAN Toll Free Call 1-800-526-8630 For GMT Office Hours Call +353-1-416-8900 KEYWORD: INDUSTRY KEYWORD: BIOTECHNOLOGY HEALTH TECHNOLOGY PHARMACEUTICAL HEALTH SOURCE: Research and Markets Copyright Business Wire 2025. PUB: 06/11/2025 08:33 AM/DISC: 06/11/2025 08:32 AM
