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Pharmaceutical
Russian drugmaker and global pharma companies will significantly reduce the production of anti-COVID-19 vaccines, however the same plans are not considered in case of other drugs, according to recent statements by representatives of producers and some media, reports The Pharma Letter’s local correspondent. 1 March 2022
Pharmaceutical
Pharmacy Benefit Managers (PBMs) and other middle men have been blamed, particularly by pharmaceutical companies operating in the American market, for the high drug prices in the USA. 25 February 2022
Biotechnology
The long-awaited confirmation from the US Senate of Robert Califf’s nomination to become Food and Drug Administration Commissioner was announced last Tuesday, but on a tight vote. On the research front, Sage Therapeutics and Biogen announced confident results for their depressive disorder candidate zuranolone but questioned were raised on its commercial potential. Regulatory developments included the FDA granting accelerated approval for Agios Pharmaceuticals’ Pyrukynd (mitapivat) for a rare form of anemia. But BioMarin had a setback last Thursday when the FDA said it needed more information to lift the clinical hold on the firm’s gene therapy BMN 307 clinical trial. 20 February 2022
Pharmaceutical
Members of the US House of Representatives have written a letter to Secretary of Health and Human Services (HHS) Xavier Becerra urging him to follow through with the Biden administration’s commitment to lowering exorbitant prescription drug costs. 11 February 2022
Pharmaceutical
Following consultation with members – and heeding the concerns of the Consumers Health Forum (CHF) and patient groups – pharma trade group Medicines Australia reiterates its call to have finalization of the new National Medicines Policy (NMP) delayed until after the federal election. 10 February 2022
Generics
India’s domestic pharmaceutical market is estimated at $42 billion in 2021 and likely to reach $65 billion by 2024 and further expand to reach $120-130 billion by 2030, according to India's Economic Survey. 8 February 2022
Biotechnology
US biotech company Biogen’s troubles over the Alzheimer’s product Aduhelm (aducanumab) show no sign of abating. 7 February 2022
Pharmaceutical
Pharma trade group Medicines Australia is calling for the new National Medicines Policy (NMP) to be pushed back until after the federal election, expected in May. 4 February 2022
Biotechnology
India's national biotech development strategy has called for more engagement with start-ups and seeks to leverage the public-private partnership model to take the industry to $150 billion by 2025. As India prepares to capitalize on the altering nature of global value chains, different states have been made relevant stakeholders with the formation of new investment hotspots, reports The Pharma Letter’s India correspondent. 2 February 2022
Pharmaceutical
Thousands of those most at-risk to COVID-19 will soon be able to access the UK’s second ground-breaking antiviral, the Department of Health and Social Care announced on Friday. 31 January 2022
Pharmaceutical
Trade group Medicines Australia has called for the country’s government to deliver a plan that shortens the time that patients wait for access to the latest innovative treatments and vaccines. 28 January 2022
Biotechnology
The Indian government is looking to amend the New Drugs and Clinical Trial Rules, 2019, act to enable manufacturing of unapproved new drugs while they are still under development. 25 January 2022
Biosimilars
Hailing the benefits of 15 years of biosimilar prescribing in Europe, The Biosimilar Medicines Group has called on the European Medicines Agency to take stronger action to widen access to this type of medicine. 25 January 2022
Generics
Generic medicines in India have received a new impetus with both Prime Minister Narendra Modi and Venkaiah Naidu, Vice President of India, calling on the domestic pharmaceutical industry to work towards making India an international capital of generic drugs. 24 January 2022
Pharmaceutical
The Russian government plans to stimulate the level of competition during public procurements of drugs for the domestic market, that will take place through the splitting of purchases and the introduction of limits on the volume of lots during state tenders. 21 January 2022
Pharmaceutical
The Russian government will consider increasing funding of “Circle of Kindness,” the national public foundation specializing on the procurement of drugs for the treatment of children with rare diseases, reports The Pharma Letter’s local correspondent. 13 January 2022
Biotechnology
The UK life science sector is playing a leading role at this year’s JP Morgan healthcare conference, being held virtually, the traditional kick off annual event for the global life science investment community. 11 January 2022
Pharmaceutical
The Indian government is exploring ways to offer financial support to pharmaceutical players engaged in the areas of research and innovation for new drugs. Health Minister Mansukh Mandaviya said the government is engaging with global regulators for increased acceptance of Indian Pharmacopeia, even as he pitched for investments at an event on the pharmaceutical sector. 10 January 2022
Pharmaceutical
Russia is increasing state procurement of Veklury (remdesivir), a drug against COVID-19, which is produced by US biotech Gilead Sciences - due to interruptions of supplies of its generic from local firm Pharmsynthez to domestic market. 6 January 2022
Pharmaceutical
A new draft government decree, which was developed by Russia’s Ministry of Industry and Trade, will restrict state purchases of drugs against some serious diseases, among which are HIV, oncology, diabetes and tuberculosis and will lead to their shortage in the Russian market, according to recent statements by representatives of the All-Russian Union of Patients (ARUP), one of Russia’s leading public associations representing interests of patients, reports The Pharma Letter’s local correspondent. 5 January 2022
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 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
Pharmaceutical
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
Pharmaceutical
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
Pharmaceutical
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
Generics
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
Biotechnology
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
Pharmaceutical
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
Biotechnology
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
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
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
Pharmaceutical
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
Pharmaceutical
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
Pharmaceutical
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
Pharmaceutical
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
Biotechnology
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
Biotechnology
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
Biotechnology
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
Pharmaceutical
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
Biotechnology
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
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