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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
Pharmaceutical
A key vote in the US House of Representatives this week could open up research opportunities in the USA for drugmakers exploring the clinical potential of cannabis. 11 September 2018
Pharmaceutical
US President Donald Trump’s recently initiated trade war with China has divided opinion between those who see it as a potentially industry-damaging misstep, and those who view the Chinese state as an aggressive opponent increasingly willing to rig the global trading system in its favor. 4 September 2018
Pharmaceutical
Perhaps not surprisingly, the HHS report starts with a comment congratulating the President and the plan, with the department’s Secretary Alex Azar quoted as saying: “The President’s blueprint for lower drug prices is working, drug prices are coming down, and American patients are going to see the savings in their pocketbook.” 21 August 2018
Pharmaceutical
As the US Trump Administration considers modifying price concessions for prescription drugs in Medicare and federal programs, the Pharmaceutical Care Management Association (PCMA) is releasing new data, "Reconsidering Drug Prices, Rebates, and PBMs," showing drug manufacturers alone set prices – independent of rebates. 16 August 2018
Pharmaceutical
Indianan firm Eli Lilly has expressed concerns over US Health Secretary Alex Azar’s proposal to import drugs from overseas to prevent price hikes on products with limited competition. 25 July 2018
Pharmaceutical
Joining US pharma majors Pfizer and Merck & Co, as well as Europe’s Bayer, Merck KGaA, Novartis and Sanofi, Swiss pharma giant Roche is the latest company to announce its restraint on drug pricing and price hikes in the USA. 23 July 2018
Pharmaceutical
As Novartis and now Merck & Co move to grab the price-cutting spotlight from Pfizer, US Health Secretary Alex Azar revealed a new approach to drug importation on Thursday that could have a more far reaching impact on prices. 20 July 2018
Pharmaceutical
Following Pfizer’s promised price hike deferral and Novartis’ (NOVN: VX) decision to do the same, New Jersey’s Merck & Co has announced that it too will hold off on raising prices for now. 20 July 2018
Pharmaceutical
Deal-making news last week included Benitec Biopharma’s collaboration with Axovant Sciences on rare disease drug BB-301, which sent the Australian firm’s shares more than doubling. On the M&A front, BioCryst’s merger with Idera was resisted by shareholders. Company news included disappointment for Regulus Therapeutics when it paused clinical studies and slashed its work force. Also attracting attention was Pfizer’s announcement to defer planned drug price hikes and Pfizer’s decision to reorganize its business. 15 July 2018
Pharmaceutical
At the annual meeting of 340B Health, a trade body representing hospitals participating in the 340B scheme, Health Secretary Alex Azar promised greater oversight in an effort to reign in costs. 11 July 2018
Pharmaceutical
Having come under direct castigation from the US president, pharma giant Pfizer said yesterday that it will pull back on planned drug prices increases. 11 July 2018
Pharmaceutical
With medicine affordability in the USA again becoming headline news on Monday due to President Trump’s tweeting on Pfizer’s pricing, another big day for pharma and patients is potentially in store on Wednesday. 10 July 2018
Pharmaceutical
In a sign that pharma investors are becoming increasingly inured to outpourings from US President Donald Trump around drug pricing, markets were unrattled on Monday by a furious tweet singling out New York’s Pfizer. 10 July 2018
Pharmaceutical
Fairly or not – and perhaps partly to do with the fact that it is simply the biggest and best-known big pharma company – Pfizer is normally one of the first to get hit when the US media and public hit out at the drug industry over the price of its products. 3 July 2018
Pharmaceutical
Following a US Senate Finance Committee hearing on the challenges surrounding prescription drug affordability and innovation earlier this week, the Pharmaceutical Care Management Association (PCMA) has issued a statement that might not surprise long-term critics of pharmacy benefit managers (PBMs). 27 June 2018
Pharmaceutical
A ruling in the Supreme Court of the United States (SCOTUS) on Thursday found that foreign law deserves ‘respectful consideration’ but should not determine a class action’s outcome. 15 June 2018
Generics
Indian pharma majors selling copycat drugs in the USA are facing the heat given the steep competition and pricing pressure, and President Donald Trump's new policy on lowering drug prices, reports The Pharma Letter’s India correspondent. 12 June 2018
Pharmaceutical
For patients with serious or immediately life-threatening diseases, the US Food and Drug Administration remains committed to enhancing access to promising investigational medicines for those unable to access products through clinical trials. 31 May 2018
Pharmaceutical
After several failed congressional attempts to meet US President Donald Trump’s request for a so-called ‘right to try’ bill earlier this year, lawmakers have finally succeeded in delivering legislation for him to sign. 24 May 2018
Pharmaceutical
US President Donald Trump at last revealed his ‘Blueprint for drug pricing’ which was not as bad as some in the investment community and pharma industry had expected. On the M&A and deal-making front, Eli Lilly announced a second acquisition within a matter of days, that of AurKa Pharma, while bluebird bio entered into a new agreement with Medigene for two additional TCR targets to take a lead in immuno-oncology. Research and regulatory news attracting attention last week included positive trial results for Eli Lilly’s neurological candidate galcanezumab in epsodic cluster headache, which is currently under Food and Drug Administration review for migraine, and the landmark US approval of Aimovig from Amgen and Novartis for migraine, a rival to Lilly’s candidate. 20 May 2018
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