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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
Pharmaceutical
The US drug industry is not happy with the Inflation Reduction Act (IRA) and is pursuing broad legal action in an attempt to limit its impact. 22 June 2023
Pharmaceutical
The Biden administration has provided more evidence of its desire to follow rhetoric with action on lowering drug prices through the Inflation Reduction Act (IRA). 12 June 2023
Pharmaceutical
Findings of a study funded by the US biotech industry suggest the Inflation Reduction Act could have a negative impact on drug development. 2 June 2023
Pharmaceutical
A new proposal from the US Department of Health and Human Services (HHS) is proposing steps to further drive down prescription drug costs in Medicaid, building on the Biden administration’s widespread efforts to lower medicine prices. 24 May 2023
Pharmaceutical
A US program worth at least $5 billion is on its way to power development of new COVID-19 vaccines and treatments. 12 April 2023
Pharmaceutical
A Texas federal judge on Friday ruled that the US Food and Drug Administration (FDA) "stonewalled judicial review" of its decades-old approval of the ‘morning after’ abortion pill mifepristone (marketed by Danco Laboratories under the trade name Mifeprex) and agreed to stay the effective date of the drug's approval. 11 April 2023
Pharmaceutical
The administrators of the USA’s public insurance scheme, Medicare, are getting ready to implement the measures included in the Inflation Reduction Act. 4 April 2023
Pharmaceutical
Implementation is moving forward on President Joe Biden’s Inflation Reduction Act (IRA) policy that allows Medicare to negotiate lower prescription drug prices. 16 March 2023
Pharmaceutical
The impact of US President Joe Biden's Inflation Reduction Act is beginning to be felt, as Danish diabetes giant Novo Nordisk announced plans to slash the cost of insulin. 15 March 2023
Biotechnology
The US Department of Health and Human Services (HHS), through the Centers for Medicare and Medicaid Services (CMS), has announced 27 prescription drugs for which Part B beneficiary coinsurances may be lower from April 1 to June 30. 15 March 2023
Pharmaceutical
The Secretary of the US Department of Health and Human Services (HHS) has selected three new models for testing by the Centers for Medicare & Medicaid Services’ (CMS) Innovation Center to help lower the high cost of medicines in the USA. 15 February 2023
Pharmaceutical
In the USA, the Department of Health and Human Services (HHS) has released its initial guidance for the implementation of a rebate program capping the price of certain medications provided under the Medicare insurance program. 10 February 2023
Biotechnology
Administrators at the US Department of Health and Human Services (HHS) have announced key dates in its planned negotiation of certain prescription drug prices available through Medicare. 12 January 2023
Pharmaceutical
The outcome of the recent midterm elections in the USA surprised many by returning a Democrat-led Senate, preventing Republicans from gaining control of the next Congress. We look at the consequences for pharma and biotech. 28 November 2022
Biotechnology
Alnylam has announced that it will not presently be taking its drug Amvuttra (vutrisiran) into a Phase III trial for Stargardt disease. 28 October 2022
Pharmaceutical
Drug pricing policy changes in the USA were signed into law as part of the Inflation Reduction Act last month in one of the most impactful acts of the Biden administration so far. 21 September 2022
Pharmaceutical
US agencies the Food and Drug Administration (FDA) and the National Institutes of Health (NIH) have announced the launch of the Critical Path for Rare Neurodegenerative Diseases (CP-RND). 16 September 2022
Pharmaceutical
American president Joe Biden has announced his intent to appoint Dr Renee Wegrzyn as the first director of the Advanced Research Projects Agency for Health (ARPA-H), a new agency established to drive biomedical innovation that supports the health of all Americans. 13 September 2022
Pharmaceutical
The passing of the $740 billion Inflation Reduction Act, which aims to control and lower prescription drug costs, will be welcome news for patients feeling the repercussions of rising inflation and a cost-of-living crunch in the US. However, GlobalData predicts that few pharma companies will be left unaffected by its provisions, with its full effects only being felt in 2026. 24 August 2022
Pharmaceutical
US Department of Health and Human Services (HHS) Secretary Xavier Becerra has announced more than $20 million in funding to expand HIV prevention, testing, and treatment services at health centers nationwide. 24 August 2022
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