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Pharmaceutical
Japan’s Intellectual Property High Court has ordered Sawai Pharmaceutical and Fuso Pharmaceutical Industries to pay a total of over 20 billion yen ($138.5 million) in damages for infringing the patent of Toray Industries’ pruritus drug Remitch OD tablets (nalfurafine). 29 May 2025
Generics
Russian drugmaker Geropharm has received a compulsory license from the Russian state to produce a generic of Ozempic (semaglutide) developed by Denmark’s Novo Nordisk. As in case of Ozempic, Geropharm’s generics are used to treat diabetes, as well as for weight loss, reports The Pharma Letter’s local correspondent. 28 May 2025
Biotechnology
South Korean vaccine maker SK Bioscience has secured a final court victory over US pharma major Pfizer in a long-running patent dispute concerning exports of its 13-valent pneumococcal conjugate vaccine, SKYPneumo (pneumococcal 13-valent conjugate vaccine). 21 May 2025
Biosimilars
The US Food and Drug Administration’s (FDA biosimilar approvals reached a record 19 in 2024, with projections indicating that 2025 could surpass this milestone trend. 16 May 2025
Generics
India has declined the UK's request to include a 'data exclusivity' clause in the proposed Free Trade Agreement (FTA), as announced on May 6, underscoring its commitment to protect its robust domestic generic drug industry. India's generic drug industry is valued at over $30 billion. 13 May 2025
Pharmaceutical
Trade group the Association of the British Pharmaceutical Industry (ABPI) has spoken out against a new free trade agreement signed by the UK government with India. 7 May 2025
Pharmaceutical
The Russian drugmaker Akrikhin has filed a lawsuit against UK pharma major AstraZeneca to the Moscow Intellectual Property Court asking to recognize its right to use formulas from two patents of Astra Zeneca for production of Forxiga (dapagliflozin), a drug for the treatment of diabetes and cardiovascular diseases, The Pharma Letter’s local correspondent reports. 1 May 2025
Pharmaceutical
Belgium’s General Association of the Pharma Industry, known as pharma.de, has emphasized the importance of intellectual property (IP) in stimulating creativity and innovation in the pharmaceutical industry. 28 April 2025
Biotechnology
California-based biotech Halozyme Therapeutics yesterday revealed it has filed a patent infringement lawsuit against US pharma giant Merck & Co in the US District Court in New Jersey. 25 April 2025
Biotechnology
South Korean vaccine developer SK bioscience has won a final ruling in a patent dispute with Moderna over key technologies used in the manufacture of mRNA vaccines. 23 April 2025
Biosimilars
Swiss generic and biosimilar medicines firm Sandoz today announced it has filed an antitrust lawsuit in the USA against Amgen for extending and entrenching the dominant market position of its blockbuster medicine, Enbrel (etanercept), first approved by the US Food and Drug Administration (FDA) in 1998. 14 April 2025
Pharmaceutical
Deal-making news last week included US drug developer KalVista Pharma signing a licensing agreement with Kaken Pharma to market its investigational hereditary angioedema (HAE) drug sebetralstat in Japan. US biotech firm Cartesian Therapeutics released positive Phase IIb data on its Descartes-08 in myasthenia gravis. The US Appeal Court gave a favorable ruling on Indian drugmaker Sun pharmaceuticals’ alopecia drug Leqselvi. Also of note, the US Food and Drug Administration (FDA) last week approved Bristol Meyers Squibb’s checkpoint therapy Opdivo plus Yervoy. 13 April 2025
Pharmaceutical
Indian drugmaker Sun Pharmaceutical shares were buzzing in trade on the last trading day of the week to April 11, rising as much as 5%. 11 April 2025
Pharmaceutical
With two new lawsuits, Eli Lilly has escalated its legal campaign against the makers of unauthorized versions of its diabetes and weight-loss drugs, Mounjaro (tirzepatide) and Zepbound (tirzepatide), challenging inroads made by drug compounders in what has become a highly lucrative market. 3 April 2025
Pharmaceutical
We live in a world where technology is playing an increasingly significant role in our daily lives. In the biopharmaceutical industry, using artificial intelligence (AI) as a tool can help improve efficiency, discover new cures and treatments and enhance clinical trials. 3 April 2025
Biotechnology
Germany-headquartered CureVac late Thursday announced that the European Patent Office (EPO) has confirmed the validity of CureVac's European patent EP 3 708 668 B1 subject to amendments to specify the scope of protection. 28 March 2025
Biotechnology
Danish biotech on Saturday revealed that US pharma major (AbbVie has filed a complaint in the US District Court for the Western District of Washington, naming Genmab, ProfoundBio and former AbbVie employees as defendants. 22 March 2025
Pharmaceutical
Swiss pharma major Novartis is set to lay off 427 employees at its East Hanover, New Jersey, site as part of a restructuring effort ahead of expected generic competition for its top-selling heart failure drug, Entresto (sacubitril/valsartan). 19 March 2025
Generics
The Russian drugmaker Axelpharm will continue sales of its drug axitinib, which is used in kidney cancer therapy and is a generic of version of US pharma giant Pfizer’s Inlyta, reports The Pharma Letter’s local correspondent.
drug of the US Pfizer. 18 March 2025
Generics
Rajeev Juneja, vice chairman and managing director of Mumbai, Indian-based drugmaker Mankind Pharma, today announced that the company is launching the generic version as well as its fixed dose combination (FDCs) of diabetes drug empagliflozin in India, at a 90% discount to the originator, Boehringer Ingelheim’s drug, Jardiance. The news came as empagliflozin lost patent protection in India. 12 March 2025
Pharmaceutical
Japan’s Intellectual Property High Court has ordered Sawai Pharmaceutical and Fuso Pharmaceutical Industries to pay a total of over 20 billion yen ($138.5 million) in damages for infringing the patent of Toray Industries’ pruritus drug Remitch OD tablets (nalfurafine). 29 May 2025
Generics
Russian drugmaker Geropharm has received a compulsory license from the Russian state to produce a generic of Ozempic (semaglutide) developed by Denmark’s Novo Nordisk. As in case of Ozempic, Geropharm’s generics are used to treat diabetes, as well as for weight loss, reports The Pharma Letter’s local correspondent. 28 May 2025
Biotechnology
South Korean vaccine maker SK Bioscience has secured a final court victory over US pharma major Pfizer in a long-running patent dispute concerning exports of its 13-valent pneumococcal conjugate vaccine, SKYPneumo (pneumococcal 13-valent conjugate vaccine). 21 May 2025
Biosimilars
The US Food and Drug Administration’s (FDA biosimilar approvals reached a record 19 in 2024, with projections indicating that 2025 could surpass this milestone trend. 16 May 2025
Generics
India has declined the UK's request to include a 'data exclusivity' clause in the proposed Free Trade Agreement (FTA), as announced on May 6, underscoring its commitment to protect its robust domestic generic drug industry. India's generic drug industry is valued at over $30 billion. 13 May 2025
Pharmaceutical
Trade group the Association of the British Pharmaceutical Industry (ABPI) has spoken out against a new free trade agreement signed by the UK government with India. 7 May 2025
Pharmaceutical
The Russian drugmaker Akrikhin has filed a lawsuit against UK pharma major AstraZeneca to the Moscow Intellectual Property Court asking to recognize its right to use formulas from two patents of Astra Zeneca for production of Forxiga (dapagliflozin), a drug for the treatment of diabetes and cardiovascular diseases, The Pharma Letter’s local correspondent reports. 1 May 2025
Pharmaceutical
Belgium’s General Association of the Pharma Industry, known as pharma.de, has emphasized the importance of intellectual property (IP) in stimulating creativity and innovation in the pharmaceutical industry. 28 April 2025
Biotechnology
California-based biotech Halozyme Therapeutics yesterday revealed it has filed a patent infringement lawsuit against US pharma giant Merck & Co in the US District Court in New Jersey. 25 April 2025
Biotechnology
South Korean vaccine developer SK bioscience has won a final ruling in a patent dispute with Moderna over key technologies used in the manufacture of mRNA vaccines. 23 April 2025
Biosimilars
Swiss generic and biosimilar medicines firm Sandoz today announced it has filed an antitrust lawsuit in the USA against Amgen for extending and entrenching the dominant market position of its blockbuster medicine, Enbrel (etanercept), first approved by the US Food and Drug Administration (FDA) in 1998. 14 April 2025
Pharmaceutical
Deal-making news last week included US drug developer KalVista Pharma signing a licensing agreement with Kaken Pharma to market its investigational hereditary angioedema (HAE) drug sebetralstat in Japan. US biotech firm Cartesian Therapeutics released positive Phase IIb data on its Descartes-08 in myasthenia gravis. The US Appeal Court gave a favorable ruling on Indian drugmaker Sun pharmaceuticals’ alopecia drug Leqselvi. Also of note, the US Food and Drug Administration (FDA) last week approved Bristol Meyers Squibb’s checkpoint therapy Opdivo plus Yervoy. 13 April 2025
Pharmaceutical
Indian drugmaker Sun Pharmaceutical shares were buzzing in trade on the last trading day of the week to April 11, rising as much as 5%. 11 April 2025
Pharmaceutical
With two new lawsuits, Eli Lilly has escalated its legal campaign against the makers of unauthorized versions of its diabetes and weight-loss drugs, Mounjaro (tirzepatide) and Zepbound (tirzepatide), challenging inroads made by drug compounders in what has become a highly lucrative market. 3 April 2025
Pharmaceutical
We live in a world where technology is playing an increasingly significant role in our daily lives. In the biopharmaceutical industry, using artificial intelligence (AI) as a tool can help improve efficiency, discover new cures and treatments and enhance clinical trials. 3 April 2025
Biotechnology
Germany-headquartered CureVac late Thursday announced that the European Patent Office (EPO) has confirmed the validity of CureVac's European patent EP 3 708 668 B1 subject to amendments to specify the scope of protection. 28 March 2025
Biotechnology
Danish biotech on Saturday revealed that US pharma major (AbbVie has filed a complaint in the US District Court for the Western District of Washington, naming Genmab, ProfoundBio and former AbbVie employees as defendants. 22 March 2025
Pharmaceutical
Swiss pharma major Novartis is set to lay off 427 employees at its East Hanover, New Jersey, site as part of a restructuring effort ahead of expected generic competition for its top-selling heart failure drug, Entresto (sacubitril/valsartan). 19 March 2025
Generics
The Russian drugmaker Axelpharm will continue sales of its drug axitinib, which is used in kidney cancer therapy and is a generic of version of US pharma giant Pfizer’s Inlyta, reports The Pharma Letter’s local correspondent.
drug of the US Pfizer. 18 March 2025
Generics
Rajeev Juneja, vice chairman and managing director of Mumbai, Indian-based drugmaker Mankind Pharma, today announced that the company is launching the generic version as well as its fixed dose combination (FDCs) of diabetes drug empagliflozin in India, at a 90% discount to the originator, Boehringer Ingelheim’s drug, Jardiance. The news came as empagliflozin lost patent protection in India. 12 March 2025
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