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
Inflation across Europe has now risen above 10%. As a result, this has increased the manufacturing costs of essential, off patent medicines, which account for 70% of those dispensed in Europe. 12 October 2022
Commenting on a much-anticipated meeting of representatives of the Greek pharmaceutical sector with the Ministry of Health, the national trade group, the Hellenic Association of Pharmaceutical Companies (SFEE), concluded that it was fruitless. 10 October 2022
CPI, a social enterprise backed by UK government funding, has opened the doors of its new RNA Centre of Excellence and RNA Training Academy. 7 October 2022
The Russian government plans to speed up the development and production of domestic drugs against rare diseases amid the ever tightening pressure caused by sanctions on the country due to its military conflict with Ukraine. 6 October 2022
The US Government has expressed a vote of confidence in Vir Biotechnology, awarding the company a multi-year contract to advance the development of a full portfolio of innovative medicines. 5 October 2022
The US Department of Health and Human Services (HHS) said yesterday that it is implementing Medicare Part B payment changes for certain biosimilars, one of the first Medicare provisions of the Inflation Reduction Act to go into effect. 4 October 2022
In the USA, the Biden-Harris Administration announced yesterday that it has made expanding access to health insurance and lowering health care costs for America’s families a top priority. 30 September 2022
Russia plans to accelerate the production of active pharmaceutical ingredients (APIs) for antibiotics, as well as to pay more attention to the development of drugs against chronic infections, as part of a new State Concept for the Development of Pharmaceutical industry in Russia that is designed until 2030, reports The Pharma Letter’s local correspondent. 29 September 2022
Increasing access to capital has resulted in a surge of Indian biopharmaceutical companies focusing on research and development. A think-tank has advised the government that it is imperative to streamline regulatory approval procedures for the biotechnology industry and eliminate redundant steps so as to expedite the approval process, reports The Pharma Letter’s India correspondent. 28 September 2022
Drugmakers in Europe are arguing for a new economic model for reimbursement of antibiotics, paving the way for a breakthrough in the fight against antimicrobial resistance. 28 September 2022
The Russian Parliament (State Duma) has said it will consider establishing the priority of using domestic reference materials in the pharmaceutical industry. 28 September 2022
Australia’s National Medicines Policy (NMP) Review started in August 2021 but was paused until after the Federal Election to allow stakeholders more time to provide feedback. 26 September 2022
The UK Chancellor of the Exchequer today announced at the mini-Budget the Long-Term Investment for Technology & Science (LIFTS) competition. 23 September 2022
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
German biotech Evotec has been awarded a contract valued at up to $49.9 million by the US Department of Defense (DOD) for the rapid development of monoclonal antibody (MAb)-based drug product prototypes targeting plague. 20 September 2022
In an effort to bring clarity to the use of biosimilars in Europe, health authorities have issued a statement confirming their interchangeability with reference medicines. 20 September 2022
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
As global pharma majors exit South America after the coronavirus pandemic, India's Pharmexcil (Pharmaceuticals Export Promotion Council of India) is looking to promote Indian pharmaceutical exports in the Latin American and Caribbean Region. 14 September 2022
Sophisticated products in the form of biologics and large molecules, produced by living materials from humans, animals, plants, or microorganisms, are increasingly prevalent in today’s market. These types of drugs may include cell and gene therapy (CGT) products typically produced in low numbers. 13 September 2022
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