Rather like Kite’s registrational Zuma-1 trial of KTE-C19 in lymphoma, Novartis’ Eliana study has generated a fileable response rate. In the case of the Swiss firm’s rival CAR-T therapy, CTL019, this is in childhood leukemia patients, says EP Vantage, the editorial arm of the Evaluate group. 10 December 2016
A wide-ranging bill promising to fund biomedical research, establish a council to speed up the discovery, development, and delivery of innovative medicines and advance precision medicine, has been passed in the US Senate. 8 December 2016
Global drugmakers operating their plants in Russia have criticized the latest state initiative to introduce new restrictions on the participation of foreign drug manufacturers in tenders for the public procurement of drugs for state needs, reports The Pharma Letter’s local correspondent. 6 December 2016
Legislation introduced to Parliament on the final sitting day of 2016 will enable faster access to certain new medicines for Australian patients and help to cut unnecessary red tape for industry too. 2 December 2016
US President-elect Donald Trump has chosen a fierce critic of the Affordable Care Act and a proponent of overhauling the nation’s entitlement programs, to lead the Department of Health and Human Services. 30 November 2016
The European Federation of Pharmaceutical Industries and Associations (EFPIA) has welcomed the three main economic objectives of a strategy on what more can be done to support growth, reinforce economic convergence, create jobs and strengthen social fairness in European Union (EU) countries. 28 November 2016
Trade group Medicines for Europe, which represents the generics and biosimilars sector, has taken issue with the report ‘Health at a Glance 2016’ launched yesterday prepared by the Organization for Economic Co-operation and Development (OECD) for the European Commission. 28 November 2016
The Russian government has designed new restrictions for the participation of foreign drugmakers in state tenders for the purchase of drugs for state needs, reports The Pharma Letter’s local correspondent. 25 November 2016
Trade group the Association of the British Pharmaceutical Industry (ABPI) has welcomed the likely impact of the UK Chancellor’s Autumn Statement on the sector. 23 November 2016
Even as Astellas Pharma and Pfizer have received the green signal on a supplemental New Drug Application from the US Food and Drug Administration for Xtandi (enzalutamide) to treat advanced prostate cancer, the Indian patent office has denied Xtandi a patent, opening up the market to generic versions of the drug, reports The Pharma Letter’s India correspondent. 23 November 2016
The US trade group the Biotechnology Innovation Organization, has declared its disappointment in Japan's price modification of innovative drugs undermining predictable system. 23 November 2016
The proposed A$2 million cap on the R&D Tax Incentive will seriously damage clinical trials activity in Australia, should the Federal government proceed with the measure, says the trade group AugBiotech. 22 November 2016
UK Prime Minister Theresa May today outlined the first steps in a modern, ambitious Industrial Strategy which will build on the UK’s strengths and address the long-term structural challenges which can hold British businesses back. 21 November 2016
The Russian pharmaceutical market is one of the fastest growing in the world, and this overview describes the main regulatory trends, associated legal risks and opportunities for pharma manufacturers in 2016-2017 in Russia. 21 November 2016
Speculation is rife about what Donald Trump’s election win means for pharma and health care in the USA, but what of its potential impact on the industry in Europe? Novasecta’s Salma Ajraoui analyzes the issue. 15 November 2016
With the coming of the 25th“World Diabetes Day,” R&D Based Pharmaceutical Association Committee of China Association of Enterprises with Foreign Investment (RDPAC) released Faces of Innovation: Meeting the Challenge of Diabetes today in Beijing. 14 November 2016
Investors in the beaten down biotech sector finally got an unexpected reprieve this week, thanks mainly due to the unexpected "clean sweep" of the US Congress and the presidency by the Republican party. 13 November 2016
The UK’s Court of Appeal has ruled that National Health Service (NHS) in England has the power to fund Pre-Exposure Prophylaxis (PrEP) for HIV. 10 November 2016
Rather than uncertainty about what the Presidency of Donald Trump might mean for drug prices, many pharma and biotech stocks jumped considerably after the Republican nominee gained a shock election victory over Democrat Hillary Clinton. 9 November 2016
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