Scrip: 世界の医療用医薬品＆製薬産業に関するニュース
Bharat Biotech Gets Shot In Arm With 81% Efficacy For COVID-19 Vaccine
04 Mar 2021
Bharat Biotech’s COVID-19 vaccine has shown 80.6% efficacy in interim data from Phase III clinical trials, slightly better than the...
Sanofi is to expand its vaccines manufacturing and build a new research center in its home market of France, as its CEO Paul Hudson looks to move on from a row over its COVID-19 vaccine candidate.
British-born Hudson got into hot water with political leaders in France last month when he said the US had earned the right to priority supplies of its coronavirus candidate if and when it was approved, thanks to its long-term investment in pandemic preparedness.
The US government’s Biomedical Advanced Research and Development Agency (BARDA) has played a key role in supporting biopharma companies working in infectious diseases in recent decades, and gave Sanofi $30m in February to help it develop its COVID-19 vaccine.
SANOFI CEO PAUL HUDSON
Hudson told Bloomberg in May that the US “has the right to the largest pre-order,” but soon had to backtrack after being summoned to the Élysée Palace by President Emmanuel Macron to explain his remarks. (Also see "Sanofi Calms France's Fears Over COVID-19 Vaccine Access" - Scrip, 15 May, 2020.)
Paris-headquartered Sanofi wants to move on from the episode, and has unveiled an investment of more than €610m ($679m) in a new manufacturing facility in vaccine production site in Neuville sur Saône and a new research center in Marcy-l'Etoile, (both in eastern France near Lyon) dedicated to vaccines.
The company says the investments will strengthen its leadership in the broader vaccines field, where it is the third largest global player by value. It says the new investment will create “massive” manufacturing capacity as well as agility to respond to future pandemics.
“Sanofi’s heart beats in France. We have a long history and exceptional teams working throughout the country, embodying our strong values,” said Paul Hudson unveiling the new investment on 16 June during a visit by President Macron to Marcy-l'Etoile.
Hudson underlined the company’s French credentials further, saying the new investment put the country at the core of its strategy, “aiming to make France a world-class center of excellence in vaccine research and production."
The new sites add to plans unveiled by Sanofi earlier this year to spin out some of its manufacturing capacity into a standalone division. This would help return pharmaceutical production to Europe, following a decades-long migration of manufacturing to lower-cost regions such as India.
Commenting on the investment, President Macron said he wanted production of basic medicines such as paracetamol to return to France.
Macron also indicated that he aimed to finalize an agreement with Sanofi shortly to reserve its own supplies of a potential COVID-19 vaccines.
Sanofi's recombinant protein-based vaccine, which it is co-developing with GSK in combination with its adjuvant technology is set to enter Phase I trials by late 2020/early 2021.
Macron is also understood to be holding a virtual meeting with CEOs from several other COVID-19 vaccine frontrunners about pre-ordering supplies. These including Pfizer, Johnson & Johnson and Moderna, which could bring their vaccines to market ahead of Sanofi if trials prove successful.
The most eye catching of the national drives to secure supplies of the vaccines is President Trump’s Operation Warp Speed. The project was launched in May to much fanfare, though early reports of a shortlist of candidates appear to be premature.
In parallel to national efforts, countries are coming together to agree deals with vaccine companies. France, Germany, Italy and the Netherlands announced a deal to secure 400 million doses of AstraZeneca's potential vaccine on 13 June.
The European Commission is to use an EU emergency fund worth €2.4bn to negotiate advance purchases of up to six vaccines, while in early June vaccines alliance GAVI launched its own Advance Market Commitment mechanism for COVID-19 Vaccines.
Scrip: 世界の医療用医薬品＆製薬産業に関するニュース
04 Mar 2021
Bharat Biotech’s COVID-19 vaccine has shown 80.6% efficacy in interim data from Phase III clinical trials, slightly better than the...
Scrip: 世界の医療用医薬品＆製薬産業に関するニュース
By $name 03 Mar 2021
Arena's Phase IIb CAPTIVATE trial assessing investigational olorinab in IBS missed its primary endpoint.
Scrip: 世界の医療用医薬品＆製薬産業に関するニュース
By Kevin Grogan 03 Mar 2021
Stefan Schulze, CEO of the Swiss iron deficiency and kidney disease specialist, tells Scrip that Vifor's reputation as a go-to...
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Trialtrove(トライアルトローブ)は医療用医薬品の開発状況を常に把握できる医薬品業界随一の臨床試験情報データベースです。計画段階から完了まで、260疾患・29万件の臨床試験をトラッキングし、250以上の学会をカバーしています。4万以上の情報ソースから収録した臨床試験に関するデータを250名のアナリストが精査し、リアルタイムで更新しています。学会発表や企業発のニュースは即日収録されます。アラート機能や可視化ツールを活用することで、特定の臨床試験のモニタリングや資料作成も可能です。
Biomedtracker(バイオメドトラッカー)は開発中の医療用医薬品の承認に影響を与えるイベントをリアルタイムで追跡し、アメリカ食品医薬品局(FDA)の承認確率(LOA: Likelihood of Approval)で示すデータベースです。臨床試験の結果や学会発表、ライセンス活動や規制当局の動きなど、開発中医薬品の商業的可能性に影響を与える過去と未来のイベントを包括的に分析し、承認確率として算出するデータベースサービスです。
