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
The Russian government has finalized the rules for granting preference to domestic drugs in public procurements, which will come into force in 2025. 1 October 2024
The Danish government is to remove the rules that currently prohibit the purchase of medicines from countries outside the European Union (EU) in a move that has not been welcomed by pharma. 30 September 2024
India is set to complete 50 new greenfield pharma manufacturing plants in the next two years under its Production-linked Incentive (PLI) scheme for pharma and medical devices. 30 September 2024
Global leaders have approved a political declaration at the 79th United Nations General Assembly (UNGA) High-Level Meeting on Antimicrobial Resistance (AMR). 30 September 2024
The generics and biosimilars trade group, Medicines for Europe, has put out a strong message amid ongoing discussions on a European Union (EU) Critical Medicines Act. 26 September 2024
US biotech Emergent BioSolutions revealed it has secured approximately $400 million in orders in 2024 and 2025 associated with its vaccinia, smallpox and mpox product portfolio. 26 September 2024
The UK government has released a position paper outlining its vision for Framework Programme 10 (FP10), a successor to Horizon Europe, the EU's flagship research collaboration program. 26 September 2024
President Biden has said the USA will commit at least $500 million to support African countries in battling the ongoing mpox outbreak in Central and Eastern Africa. 25 September 2024
The Pharmaceutical Research and Manufacturers of America (PhRMA) is continuing its legal challenge against the US government’s drug pricing reforms. 24 September 2024
The Foundation for Economic and Industrial Research and Greek pharma trade group the Hellenic Association of Pharmaceutical Companies have presented two studies reflecting the industry’s importance. 23 September 2024
Basilea Pharmaceutica announced that the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) has awarded Basilea an Other Transaction Agreement (OTA), under OTA number 75A50124C00033. 20 September 2024
Novo Nordisk is under increasing pressure over the cost of its blockbuster drugs in the USA, as chief executive Lars Fruergaard Jørgensen prepares to testify before a powerful Senate committee. 18 September 2024
The research based pharmaceutical industry has welcomed Mario Draghi’s report, published by the European Commission, outlining proposals on how Europe can regain its competitive edge and the critical role of innovative industries in achieving this. 11 September 2024
Even as emerging signs of a thaw in the broader Indian start-up funding landscape were evident, the Competition Commission of India (CCI) has tightened its exemption list under new combination rules. 11 September 2024
The US House of Representatives has passed the BIOSECURE Act, gaining bipartisan support with a vote of 306–81. Nearly all of the votes against the bill came from Democrats. 10 September 2024
The Cell and Gene Therapy Catapult (CGT Catapult) has highlighted what it regards as the UK's potential to lead the global cell and gene therapy sector. 5 September 2024
The budget on October 30 is an opportunity to end short-termism, cut waste, and attract long-term investment to the country’s economy with a sector-targeted R&D tax relief policy, according to the UK BioIndustry Association (BIA). 3 September 2024
The Danish Pharmaceutical Industry Association, Lif, has given its verdict on the government financial bill setting out new priorities in health in 2025. 2 September 2024
Marseille-based ImCheck Therapeutics has received 20.2 million euros ($22.4 million) in non-dilutive funding as part of the i-Démo call for projects under the France 2030 Plan operated by Bpifrance on behalf of the French government. 29 August 2024
The UK’s leading pharmaceutical and biotechnology trade groups welcomed Chancellor Jeremy Hunt’s Spring Budget to unlock investment in medical research and manufacturing that was announced on Wednesday. 6 March 2024
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
Drugmakers, patient advocate groups, policymakers and others have come together for Rare Disease Day, which took place at the end of February, to both celebrate progress and call for more action in this therapy area. 4 March 2024
The European Free Trade Association (EFTA) aims to conclude a trade agreement with India "within weeks," with the four-nation bloc showing a steadfast commitment to seal the deal before the Asian country enters its election cycle. However, concerns persist over a clause that may delay access to generic drugs in India for up to six years. 26 February 2024
The US Department of Justice on Thursday released its latest data on recoveries under the False Claims Act, saying there were nearly $2.7 billion in settlements and judgments in the 2023 fiscal year, an increase from the prior year's haul. 23 February 2024
The USA’s Creating Hope Reauthorization Act of 2024 was introduced in the House of Representatives last week, prompting US trade group Biotechnology Innovation Organization (BIO) chief executive and president, Rachel King, to make the following statement following the bill's introduction: 21 February 2024
Reform of the procurement policies applied to generic medicines is needed to ensure greater security of supply for patients and health systems, according to Medicines for Europe. 19 February 2024
The USA’s Federal Trade Commission (FTC) and Department of Health and Human Services (HHS) yesterday jointly issued a Request for Information to understand how the practices of two types of pharmaceutical drug middlemen groups - group purchasing organizations (GPOs) and drug wholesalers - may be contributing to generic drug shortages. 15 February 2024
India has achieved a notable milestone in the field of cancer treatment with its indigenously developed CAR-T cell therapy, resulting in the first patient being declared cancer-free post treatment. 15 February 2024
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
Non-governmental organization Médecins Sans Frontières (MSF) has issued a warning about the details of a trade deal that is about to be agreed by India and the European Free Trade Association (EFTA). 14 February 2024
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
Yesterday, the US Department of Health and Human Services (HHS), through the Centers for Medicare & Medicaid Services (CMS), said it is sending initial offers to the participating drug companies of the first 10 prescription drugs selected for negotiation in the first cycle of the Medicare Drug Price Negotiation Program. 2 February 2024
A response from the Ministry of the Interior and Health confirms that Denmark – compared to other European countries – has lower medical expenses per inhabitant, according to Danish trade group Lif. 29 January 2024
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
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
The Cell and Gene Therapy Catapult (CGT Catapult), a government-funded body encouraging the development of the advanced therapy sector, has published a report into trial activity in the UK. 18 January 2024
The Medicines Control Authority of Zimbabwe (MCAZ) has signed a Memorandum of Understanding (MoU) with the South African Health Products Regulatory Authority (SAHPRA). 18 January 2024
The Indian government has urged the United States to enhance the frequency of inspections carried out by the US Food and Drug Administration (FDA) in India, aiming to boost pharmaceutical exports. 16 January 2024