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Biotechnology
Legend Biotech has removed Genscript Biotech as its majority shareholder, in a move coinciding with rising US concerns over Chinese ties within the biotech sector. 24 October 2024
Pharmaceutical
The US Department of Health and Human Services (HHS), through the Office of Assistant Secretary for Planning and Evaluation (ASPE), yesterday released new data showing that nearly 1.5 million people with Medicare Part D saved nearly $1 billion in out-of-pocket prescription drugs costs in the first half of 2024 because of the Biden-Harris Administration’s Inflation Reduction Act. 23 October 2024
Pharmaceutical
Pharmaceutical Research and Manufacturers of America (PhRMA) says it has submitted comments to the Office of the United States Trade Representative (USTR) to inform the agency’s 2025 National Trade Estimate (NTE) Report on Foreign Trade Barriers. 21 October 2024
Generics
CMS released a Request for Information (RFI) and a sample list of prescription drugs that the agency preliminarily intends to include under the proposed Medicare $2 Drug List Model. 10 October 2024
Pharmaceutical
The US Department of Health and Human Services (HHS) has released final guidance for the second cycle of Medicare drug price negotiations. 3 October 2024
Pharmaceutical
The Pharmaceutical Research and Manufacturers of America (PhRMA) is continuing its legal challenge against the US government’s drug pricing reforms. 24 September 2024
Pharmaceutical
Scarcely anything unites lawmakers in America these days, but the ostensible iniquities of Big Pharma could be a rare exception. 22 September 2024
Pharmaceutical
Research from AARP has found that around $1,100 in prescription drug costs could be saved by more than a million seniors, due to the Inflation Reduction Act (IRA). 2 September 2024
Pharmaceutical
US President Joe Biden has announced an additional $150 million in funding as part of the ongoing Cancer Moonshot initiative. 15 August 2024
Biotechnology
Efforts to end US business deals with certain foreign biotechs considered threats are gaining traction again, with House Speaker Mike Johnson stating his intention to hold a vote on the BIOSECURE act this year. 11 July 2024
Pharmaceutical
A report released by the non-profit group No Patient Left Behind has claimed that it has found critical flaws in a key metric used by US insurance companies and foreign governments to determine whether to cover prescribed treatments at low out-of-pocket costs. 2 April 2024
Pharmaceutical
An attempt from the conservative Alliance for Hippocratic Medicine to ban mifepristone, a medicine used to induce an abortion, threatens to undermine confidence in the American regulatory regime. 27 March 2024
Biotechnology
Politics has entered the scientific realm in the form of new US legislation that has prompted the Biotechnology Innovation Organization (BIO) to come into line with Congress’s position on Chinese companies. 14 March 2024
Pharmaceutical
President Joe Biden’s actions to cut prescription drug prices through the Inflation Reduction Act (IRA) and other means have been far from popular with big pharma and its lobbyists. 7 March 2024
Pharmaceutical
All manufacturers participating in the first cycle of the US Medicare drug price negotiations have responded with counter offers, according to the US Department of Health and Human Services’ (HHS) Centers for Medicare and Medicaid Services (CMS). 5 March 2024
Pharmaceutical
In another legal blow for opponents of the Inflation Reduction Act (IRA), a federal judge has now rejected a bid from AstraZeneca to prevent price negotiations on its diabetes med Farxiga (dapagliflozin). 4 March 2024
Pharmaceutical
In the USA, there is growing resistance to a bid from the White House to exercise so-called march-in rights, a process whereby the federal government requires patent holders to agree to a licence. 27 February 2024
Pharmaceutical
US trade group Pharmaceutical Research and Manufacturers of America (PhRMA) has made clear its opposition to the drug price-setting provisions in the Biden administration’s Inflation Reduction Act (IRA). 14 February 2024
Pharmaceutical
An Expert View from Ross Maclean, Precision Health Economics, Outcomes Research and Head of Medical Affairs,
Precision Value and Health, and the same company's Jon Bambalas, Senior Vice President Business Development, Products Senior Vice President Business Development. 5 February 2024
Pharmaceutical
In the USA, the House of Representatives have voted overwhelmingly in favor of legislation which would restore the ability of drugmakers to fully expense R&D costs incurred within the same tax year. 5 February 2024
Biotechnology
A stern letter has been written to the US Food and Drug Administration (FDA) by the chairs of two US congressional committees, demanding answers in relation to the approval of Biogen and Eisai’s Alzheimer’s drug, Aduhelm (aducanumab). 3 September 2021
Biotechnology
All signs point to an M&A boom in late 2021 and throughout 2022. In this episode, Lance Minor, principal and national co-leader of the life sciences practice at BDO, provides valuable insight into current and emerging trends in the biotech investing landscape. 1 September 2021
Biotechnology
While people in many parts of the world wait in the hope of receiving their first shot of a COVID-19 vaccine, Americans are to be offered their third dose in an attempt to boost immunity to the virus. 19 August 2021
Pharmaceutical
US President Joe Biden believes that health care is a right, not a privilege. No American should have to face difficult choices between paying for their prescription medications or other essential needs., he said, as he announced his vision for reducing the high cost of prescription drugs. 14 August 2021
Pharmaceutical
On Friday, US President Joe Biden issued a wide ranging Executive Order seeking to address overconcentration, monopolization, and unfair competition in the US economy. 13 July 2021
Biotechnology
The controversy over the approval of Alzheimer’s med Aduhelm (aducanumab) has deepened, as the acting head of the US Food and Drug Administration called for an investigation into her agency’s own actions. 12 July 2021
Pharmaceutical
The US government has announced it will invest more than $3 billion to boost discovery and development of new antiviral medicines for the novel coronavirus. 18 June 2021
Biotechnology
The US government has purchased an additional 200 million doses of the coronavirus vaccine developed by Moderna, in case boosters are needed. 17 June 2021
Biotechnology
In the USA, Cambridge-based Moderna has requested an emergency use authorization (EUA) for its COVID-19 vaccine in adolescents. 11 June 2021
Biotechnology
The US government has committed to buying 500 million doses of Comirnaty, the vaccine provided by Pfizer and BioNTech, for lower-income countries. 10 June 2021
Pharmaceutical
The White House, the US Department of Health and Human Services (HHS) Office of the Assistant Secretary for Preparedness and Response (ASPR) and the US Food and Drug Administration have released a series of policy recommendations to address the vulnerabilities in U.S. pharmaceutical supply chains. Led by FDA and ASPR, the White House report - PDF and its recommendations have been accepted by President Joe Biden. 9 June 2021
Biotechnology
The adjectives that accompanied the US approval of the first drug to treat Alzheimer’s disease in nearly two decades sought to sum up the apparent magnitude of the moment. 8 June 2021
Pharmaceutical
New bipartisan legislation has been proposed by two US Representatives that would fund critical research on treatments and cures for diseases including Alzheimer’s, cancer, blindness, juvenile diabetes, and sickle-cell anemia amid research delays caused by the pandemic. 25 May 2021
Pharmaceutical
To the surprise of many, the US government has backed a World Trade Organization (WTO) proposal to disclaim certain intellectual property (IP) rights to coronavirus vaccines, after previously opposing it. 6 May 2021
Pharmaceutical
The US White House on Friday sent to Congress President Joe Biden’s discretionary funding request for the fiscal year 2022. 12 April 2021
Pharmaceutical
US Senators on Thursday approved California Attorney General Xavier Becerra as Health and Human Services (HHS) Secretary on a razor-thin vote that broke almost entirely along party lines and followed searing debate over the lawyer's qualifications and support for abortion rights. 19 March 2021
Pharmaceutical
As part of the USA’s $1.9 trillion American Rescue Plan Act that cleared its final congressional hurdle Wednesday, and President Joe Biden signed off on Thursday, $3.5 billion is earmarked for the Global Fund to Fight AIDS, Tuberculosis and Malaria. 12 March 2021
Biosimilars
The US Association for Accessible Medicines (AAM) says it strongly supports President Joe Biden’s America’s Supply Chains Executive Order as an important step toward strengthening the US pharmaceutical supply chain and improving patient access to lower-cost generic and biosimilar medicines. 1 March 2021
Biotechnology
At the request of US President Joe Biden, the US Department of Health and Human Services (HHS) and Department of Defense (DoD) yesterday said they have purchased an additional 100 million doses of COVID-19 vaccines from both Pfizer and Moderna to help meet demand for COVID-19 vaccines in the USA. 12 February 2021
Biotechnology
US President Joe Biden has announced plans to boost vaccine supplies to US states by around 1.4 million doses per week, as the country scrambles to protect itself from the novel coronavirus. 27 January 2021
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