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Pharmaceutical
The US Food and Drug Administration has authorized a drug importation program in Florida, as the state seeks to benefit from lower cost medicines across the border. 8 January 2024
Biosimilars
US pharma trade group the Pharmaceutical Research and Manufacturers of America (PhRMA) has offered research suggesting the Inflation Reduction Act (IRA) could undermine the development of biosimilars. 18 December 2023
Pharmaceutical
In the USA, the Biden administration announced a framework yesterday that proposes including prices as a factor when deciding if the public can easily obtain a taxpayer-funded drug and allowing government agencies to license the patent behind the product to another party if the cost is determined to be too high. 8 December 2023
Pharmaceutical
In the USA, the Biden Administration is currently conducting a government-wide review of the use of “march-in” authority under the Bayh-Dole Act. 28 November 2023
Pharmaceutical
An Expert View from Cynthia Miller, vice president, medical director of the access experience team, PRECISIONvalue. 8 November 2023
Pharmaceutical
In the USA, the National Institutes of Health has outlined significant new investments to support research into amyotrophic lateral sclerosis (ALS). 10 October 2023
Pharmaceutical
While legal challenges surrounding the implementation of the Inflation Reduction Act (IRA) continue to mount, the Centers for Medicare & Medicaid Services (CMS) has touted the success of the program. 15 September 2023
Pharmaceutical
Swiss drugmaker Novartis has launched legal action against the US government, after administrators revealed the first drugs to be subject to pricing regulations mandated by the Inflation Reduction Act (IRA). 7 September 2023
Pharmaceutical
Japanese pharma major Astellas Pharma revealed that it has requested that the Court dismiss the company’s lawsuit challenging the constitutionality of certain provisions of the US government’s Inflation Reduction Act (IRA). 7 September 2023
Pharmaceutical
Today, the US Centers for Medicare & Medicaid Services (CMS) has for the first time selected 10 drugs for negotiation. Seniors paid $3.4 billion in out-of-pocket costs for these drugs in 2022, the CMS stated. 29 August 2023
Pharmaceutical
The list of companies and groups that are suing the US government over its Medicare price-setting policies continues to grow. 25 August 2023
Biotechnology
In the latest reminder about the lingering presence of COVID-19, the US Department of Health and Human Services (HHS) has awarded more than $1.4 billion for Project NextGen to support the development of new tools and technologies to protect against the virus. 23 August 2023
Pharmaceutical
The US Supreme Court is to hear a challenge from the Biden administration to the settlement agreed by Purdue Pharma that would protect owners the Sackler family from civil lawsuits over their role in the opioid epidemic. 11 August 2023
Pharmaceutical
US healthcare conglomerate Johnson & Johnson and Japanese drugmaker Astellas have joined a growing list of companies and groups that are suing the US government over its Medicare price-setting policies. 20 July 2023
Pharmaceutical
A report commissioned by Pharmaceutical Research and Manufacturers of America (PhRMA), the trade group representing big pharma in the USA, has highlighted the role of post-approval research and development (R&D) in advancing cancer treatment options. 10 July 2023
Pharmaceutical
The US Department of Health and Human Services (HHS) today announced actions to protect consumers from junk health plans, surprise medical bills, and excess costs that lead to medical debt. 7 July 2023
Pharmaceutical
An Expert View from Chris Blanchette, Novo Nordisk, Kathy Lang, PRECISIONheor, Ross Maclean, Precision Value & Health. 29 June 2023
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
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 new cell and gene therapy initiative from the USA's White House will launch with an initial focus on treatments for sickle cell disease (SCD). 1 February 2024
Pharmaceutical
In early December, the USA’s Biden administration announced a proposed framework under the Bayh-Dole Act that would allow the government to seize patent rights on products developed with any federal funding if they don’t agree with the price, using the “march-in” provision. 26 January 2024
Pharmaceutical
US healthcare lobbyist Vital Transformation has released a document outlining objections to the expansion of drug pricing policies under the Inflation Reduction Act (IRA). 19 January 2024
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