Trump Administration
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Pharmaceutical
US President Donald Trump issued an executive order on April 15 listing several potential policy changes aimed at lowering US drug prices.
Responding to the announcement, Morningstar’s healthcare equity research director Karen Andersen gave her views on why this matters. 18 April 2025
Pharmaceutical
US President Donald Trump has passed an executive order that answers the pharmaceutical industry’s calls for the scrapping of the Inflation Reduction Act’s (IRA) ‘pill penalty’. 16 April 2025
Pharmaceutical
New research from consultancy Vital Transformation has shown the effects of US policy the Inflation Reduction Act’s (IRA) drug pricing provisions on biopharmaceutical investment, research and development (R&D). 15 April 2025
Biotechnology
US sequencing firm PacBio is cutting jobs and reducing spending across its business as it braces for the financial impact of new global tariffs and growing uncertainty around federal research funding. 14 April 2025
Biotechnology
Shares in US biotech Novavax fell more than 20% before the weekend, following remarks from health and human services secretary Robert F Kennedy Jr, who questioned the scientific basis of the company’s COVID-19 vaccine in a televised interview. 14 April 2025
Pharmaceutical
Speculation about the US Administration’s views on the Pharmaceutical Benefits Scheme (PBS) has reconfirmed the sanctity of the PBS as the cornerstone of Australia’s healthcare system, the domestic pharma trade group stressed. 11 April 2025
Pharmaceutical
The US Centers for Medicare & Medicaid Services (CMS) has announced action intended to preserve the core mission of the Medicaid program against a wider backdrop of wider cost-cutting under the regime of President Donald Trump. 11 April 2025
Biotechnology
Licensing agreements for Chinese drug candidates hit a record high in 2024, with large pharma in-licensing 28% of innovator drugs from Chinese biopharma companies. 9 April 2025
Biotechnology
A federal commission has urged the US government to invest $15 billion to protect the country’s leadership in biotechnology and prevent China from outpacing American innovation in the field. The warning comes amid rising concern over growing reliance on foreign manufacturing and increasing Chinese activity in licensing biotech assets. 9 April 2025
Pharmaceutical
Ireland’s government remains confident in its ability to retain the country’s strategic position in pharmaceutical manufacturing, despite rising tensions between the European Union and the United States over trade policy. 8 April 2025
Pharmaceutical
Thousands of workers dismissed from the US Department of Health and Human Services this week may soon be reinstated, after health secretary Robert F Kennedy Jr admitted that a significant share of the job cuts were made in error. 7 April 2025
Pharmaceutical
In the news last week, US Center for Biologics Evaluation and Research (CBER) Dr Peter Marks quit his post after reported pressure from a Human Health Services (HHS) official. On the research front, Merck & Co presented positive Phase III data on its Winrevair in pulmonary arterial hypertension (PAH) at the American College of Cardiology (ACC) meeting. Also, Swiss biotech AC Immune shared new Phase II data on its Parkinson’s disease candidate ACI-7104-056. Late last Wednesday, US President Donald Trump dropped a bombshell of tariffs of various amounts on countries around the world, although there was ambiguity as to how and when they would impact pharma and biotech products. 6 April 2025
Biotechnology
US biotech Novavax is still waiting on a decision from the Food and Drug Administration over full approval of its protein-based COVID-19 vaccine, despite the agency having set an April 1 target date to complete its review. 4 April 2025
Pharmaceutical
Pharmaceuticals will be exempt from the tariffs on imports to the USA that were announced by US President Donald Trump Wednesday, according to a White House fact sheet. 3 April 2025
Pharmaceutical
Freed from their former obligations to remain loyal to agency and state, a number of high-profile figures from the US Food and Drug Administration (FDA) have sounded the alarm about its direction of travel under Robert Francis Kennedy Jr (RFK Jr), the new Secretary of Health and Human Services. 2 April 2025
Pharmaceutical
The US government is reclaiming over $11 billion in unspent public health funds originally allocated during the COVID-19 emergency, a move that has drawn sharp criticism from lawmakers and public health advocates who warn it will weaken the country’s ability to respond to future health threats and disrupt essential care services. 31 March 2025
Pharmaceutical
There has been talk of the job cuts impacting US health agencies for weeks. 27 March 2025
Pharmaceutical
The US Senate has confirmed President Donald Trump’s nominees to lead two of the country’s top health agencies, approving surgeon Marty Makary as Commissioner of the Food and Drug Administration and economist and physician Jay Bhattacharya as director of the National Institutes of Health. 27 March 2025
Biotechnology
The US Biotechnology Innovation Organization (BIO) has released results from a membership survey that underscores the significant, global integration of the biomedical supply chain. 27 March 2025
Pharmaceutical
The Trump administration plans to pull US funding from Gavi, the global vaccine alliance that helps deliver immunizations to children in lower-income countries, according to internal documents obtained by the New York Times. 26 March 2025
Biotechnology
The Trump administration's moves to reduce government funding for the US Food and Drug Administration (FDA) and other agencies, such as the National Institutes of Health, will impact the biotech sector in several important ways, making it likely that companies will seek to combine with peers or be acquired by large pharma players, according to Andrew Goodman, a partner in the M&A practice at law firm Paul Hastings, in a client alert. 22 March 2025
Pharmaceutical
US healthcare giant Johnson & Johnson has announced manufacturing, research and development and technology investments of more than $55 billion in the USA over the next four years. 21 March 2025
Pharmaceutical
Newly-appointed US Health and Human Services (HHS) Secretary Robert F Kennedy Jr has renewed the public health emergency declaration addressing the USA’s opioid crisis, which will allow sustained federal coordination efforts and preserve key flexibilities that enable HHS to continue leveraging expanded authorities to conduct certain activities in response to the opioid overdose crisis. 19 March 2025
Pharmaceutical
Hours before his confirmation hearing, the Trump Administration pulled the nomination of Dr Dave Weldon to be the director of the Centers for Disease Control and Prevention (CDC). 14 March 2025
Pharmaceutical
As the new White House seeks to push ahead with swingeing cuts to government spending, a federal judge in Massachusetts has thrown a wrench in the works. 6 March 2025
Pharmaceutical
The Department of Government Efficiency (DOGE), led by Tesla chief executive Elon Musk, has terminated leases for 30 US Food and Drug Administration facilities across the USA. 5 March 2025
Generics
Even as the spectre of tariffs looms over the pharmaceutical trade between India and the USA, presenting a complex scenario with potential repercussions for both regions, its implementation would necessitate a rapid recalibration of supply chains and pricing strategies, reports The Pharma Letter’s India correspondent. 3 March 2025
Biotechnology
The US President Donald Trump began his second term with a series of directives targeting the US National Institutes of Health (NIH), creating uncertainty around NIH grant funding for biopharmaceutical drug development. 1 March 2025
Pharmaceutical
A pair of Republicans have reintroduced the bicameral Reciprocity Ensures Streamlined Use of Lifesaving Treatments (RESULT) Act. 28 February 2025
Pharmaceutical
The new US President has repealed an executive order from October 2023, signed by the Biden administration, that sought to establish rigorous safeguards for artificial intelligence (AI) development. 22 February 2025
Pharmaceutical
The pharmaceutical industry is preparing for ‘major disruptions’ following US President Donald Trump’s announcement on tariffs, says data and analytics firm GlobalData. 20 February 2025
Pharmaceutical
New US President Donald Trump has started to cut jobs at federal health agencies. 17 February 2025
Pharmaceutical
Robert F.Kennedy Jr. has been confirmed as the new secretary of the Department of Health and Human Services (HHS) after a closely contested vote in the US Senate. 14 February 2025
Pharmaceutical
A federal judge has temporarily blocked the National Institutes of Health (NIH) from implementing research funding cuts in 22 states after a lawsuit argued the move would cripple studies on cancer, Alzheimer’s, and other diseases. 11 February 2025
Pharmaceutical
In a statement on Friday, the USA’s National Institutes of Health (NIH) said it would cut grants for "indirect costs" related to research - such as buildings, utilities and equipment. 10 February 2025
Generics
US President Donald Trump has implemented a series of tariffs on imports from Canada, Mexico and China, but the additional taxes could affect the price Americans pay for generic drugs, with pharma trade groups expressing their fears about the consequences. 4 February 2025
Pharmaceutical
Robert F Kennedy Jr faced pointed questioning during his nomination hearing for secretary of health and human services, as lawmakers sought to reconcile his past controversial statements with the more evidence-based approach he now appears to endorse. 31 January 2025
Pharmaceutical
US public health officials have been ordered to immediately suspend all collaboration with the World Health Organization (WHO) following an executive order by President Donald Trump, which initiates the country’s withdrawal from the global health body. 30 January 2025
Pharmaceutical
New US President Donald Trump and his administration have confirmed that lowering the cost of prescription drugs for Americans is a top priority, suggesting that they will continue the work of the previous regime. 30 January 2025
Pharmaceutical
The US Food and Drug Administration (FDA) has named Sara Brenner, a physician and senior official in its medical device division, as acting Commissioner. 28 January 2025
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