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Pharmaceutical
As the Indian government works on a comprehensive national policy on rare diseases, involved organizations have urged the Health Ministry to create a special fund and exempt the medicines and equipment required for treatment from import duties. 17 August 2020
Pharmaceutical
Last week’s notable regulatory news included the US Food and Drug Administration granting approval for Evrysdi (risdiplam), developed Roche by subsidiary Genentech and PTC Therapeutics, for the treatment of spinal muscular atrophy (SMA). Also, Russia has won the race to approve a vaccine against COVID-19, calling it Sputnik V. Moderna has been granted another government award for its COVID-19 vaccine, mRNA-1273. On the M&A front, Sweden’s Calliditas set out plans to acquire French firm Genkyotex, initially with a controlling equity stake and full acquisition thereafter. 16 August 2020
Pharmaceutical
In what could be a major decision, the Indian government is looking to tweak an existing provision that allows new medicines developed by foreign companies to be exempt from price control for five years. 15 August 2020
Biotechnology
The UK government has secured millions more doses of COVID-19 vaccine candidates for the British population. 14 August 2020
Biotechnology
US mRNA company Moderna was trading more than 10% higher before markets opened on Wednesday. 12 August 2020
Pharmaceutical
An expert has warned that diverting malaria resources and interrupting prevention programs could kill thousands. 12 August 2020
Generics
Leading Russian public associations representing the interests of patients, together with local pharma sector analysts, have again criticized the currently implemented import substitution state policy in the domestic drug market, reports The Pharma Letter’s local correspondent. 11 August 2020
Biotechnology
US biotech Novavax saw its shares gain as much as 6% on Friday, after it revealed it has entered into a partnership with Japan’s largest drugmaker Takeda Pharmaceutical for the development, manufacturing and commercialization of NVX CoV2373, Novavax’ COVID 19 vaccine candidate, in Japan. 8 August 2020
Generics
US President Donald Trump on Thursday signed an Executive Order to increase American production of essential medical supplies and cut down the nation’s reliance on foreign producers of medicines. 7 August 2020
Pharmaceutical
US pharma trade group Pharmaceutical Research and Manufacturers of America (PhRMA) has responded to a report on drug pricing from industry analyst IQVIA. 7 August 2020
Pharmaceutical
The Indian government is drawing up an exhaustive research and development (R&D) policy for the pharmaceutical sector as it aims to propel India’s drug industry to be on par with countries like the USA and Europe. 6 August 2020
Biotechnology
Adding to mega-dollar deals signed last month with the governments of the USA, UK and Japan for supplies of their COVID-19 vaccine candidate, US pharma giant Pfizer and Germany’s BioNTech today announced an agreement with the government of Canada to supply their BNT162 mRNA-based vaccine candidate against SARS-CoV-2, subject to clinical success and Health Canada approval. 5 August 2020
Biotechnology
Boston, USA-based biotech Partner Therapeutics (PTx) today announced a $35 million milestone-based Other Transaction Agreement (OTA) with the US Department of Defense (DoD) to fund two clinical studies of inhaled Leukine (sargramostim; rhu-granulocyte macrophage-colony stimulating factor "GM-CSF") in patients with COVID-19 associated acute hypoxemia. 4 August 2020
Pharmaceutical
Having missed out on the first round of the US Trump Administration Operation Warp Speed COVID-19 initiative awards, France’s Sanofi and Britain’s GlaxoSmithKline on Friday announced a collaboration with the US government to accelerate the development and manufacturing of a COVID-19 recombinant protein-based vaccine. 1 August 2020
Biotechnology
Pfizer and BioNTech have received a third major order in a month for their BNT162 mRNA-based vaccine candidate against SARS-CoV-2, subject to clinical success and regulatory approval. 31 July 2020
Pharmaceutical
A parliamentary committee has advised the government to create a parallel domestic supply chain for certain medicines to ensure the UK can cope with future health crises. 29 July 2020
Pharmaceutical
The Franco-English pairing of Sanofi and GlaxoSmithKline have agreed with the UK government to supply up to 60 million doses of a COVID-19 vaccine. 29 July 2020
Generics
As the scheme to make India self-reliant in bulk drug supply gets underway, the Department of Pharmaceuticals (DoP) is to shift its focus to encourage research and development of novel drugs in the country. While a new policy is in the works, the government has announced a $1.33 billion booster for ramping up domestic production of raw materials for producing drugs, reports The Pharma Letter’s India correspondent. 28 July 2020
Pharmaceutical
GBA Group Pharma, a European service provider for pharma and biotech companies, has warned of risks to drugmakers’ clinical trial plans caused by Brexit. 28 July 2020
Biotechnology
The US Department of Health and Human Services has reserved the available advanced manufacturing capability and capacities of the Center for Innovation in Advanced Development and Manufacturing (CIADM) at the Texas A&M University System for use in manufacturing COVID-19 vaccines. 28 July 2020
Pharmaceutical
The nomination of Robert F Kennedy Jr — known as RFK Jr — for the role of US Secretary of the Department of Health and Human Services (HHS) President-elect Donald Trump sent shares in vaccine companies sharply downwards. 22 November 2024
article
The UK government has reappointed BioIndustry Association (BIA) chairman Daniel Mahony as its Life Sciences Investment Envoy. 21 November 2024
Pharmaceutical
The Danish government’s newly-unveiled health reform has been praised for tackling chronic disease care and health inequalities while driving health innovation. 18 November 2024
Pharmaceutical
New research published by the European Federation of Pharmaceutical Industries and Associations (EFPIA) provides in-depth analysis of the economic footprint of the pharmaceutical industry in Europe, across member states and compares Europe to other regions of the world. 18 November 2024
Pharmaceutical
Johnson & Johnson has taken legal action to defend a contentious rebate initiative, filing a lawsuit in the US District Court for the District of Columbia. 15 November 2024
Pharmaceutical
The share prices of Pfizer, GSK, Novavax and other vaccine companies were all markedly lower on Friday. This was not due to the publication of disappointing research results in the sphere, or an ominous stance taken by a major regulator on a key filing, but rather a political development that could spell trouble for the vaccines field as a whole. 15 November 2024
Biotechnology
BeiGene has announced plans to rebrand as BeOne Medicines, a move the cancer specialist says reflects its commitment to fighting cancer through collaboration. 15 November 2024
Pharmaceutical
Danish patients are being offered fewer innovative treatments than Norwegians and Swedes, a new estimate from the Danish Medicines Council shows. 11 November 2024
Pharmaceutical
According to the Swedish pharma trade group Lif, it is positive that, in the updated life science strategy, the government expresses an ambition for Sweden to become more attractive for research investments. 11 November 2024
Pharmaceutical
Li Li, Commissioner of China's National Medical Products Administration (NMPA), and Mette Aaboe Hansen, interim director general of Danish Medicines Agency, have signed a letter of intent to promote bilateral cooperation in regulation of drugs and medical devices. 11 November 2024
Pharmaceutical
Following the news that Donald Trump is the winner of the 2024 US Presidential Election, Morningstar Equity analyst Julie Utterback has published a new note about the impact of this on the managed-care industry. 7 November 2024
Pharmaceutical
UK pharma major AstraZeneca, which has invested heavily in China, hosted a sell-side analyst call on Wednesday (November 6) to discuss the recent media reports about ongoing investigations in China. 7 November 2024
Pharmaceutical
Some of the UK’s leading academics and industry professionals have welcomed Chancellor Rachel Reeves’ £520 million ($669 million) pledge to develop the country’s medicine manufacturing capabilities. 6 November 2024
Pharmaceutical
European regulators will decide by December 6 whether Novo Holdings, the controlling shareholder of Danish pharma giant Novo Nordisk, can finalize its $16.5 billion acquisition of contract drug manufacturer Catalent. 5 November 2024
Pharmaceutical
The Danish government is rolling out the red carpet and welcomes several pharmaceutical companies. 4 November 2024
Generics
Medicines for Europe has launched a study of market barriers faced by European generics and biosimilar pharmaceutical companies operating in 11 key third-country markets. 31 October 2024
Pharmaceutical
Following the first Labour budget for 14 years, the Association of the British Pharmaceutical Industry (ABPI) welcomes Chancellor Rachel Reeves’ measures to improve UK life sciences competitiveness. 30 October 2024
Pharmaceutical
HOPO Therapeutics has been awarded a contract valued at up to $226 million from the Biomedical Advanced Research and Development Authority (BARDA). 29 October 2024
Pharmaceutical
The Danish government has presented part of the plan for a future life science strategy, which has been welcomed by the industry. 28 October 2024
Biotechnology
Legend Biotech has removed Genscript Biotech as its majority shareholder, in a move coinciding with rising US concerns over Chinese ties within the biotech sector. 24 October 2024
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