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Generics
Medicines for Europe, a manufacturers of generic and biosimilar trade group, today presented five trade policy recommendations to strengthen global access to medicines and enhance the competitiveness of the off-patent pharmaceutical sector in a seminar with the European Commission and Member States representatives. 17 June 2025
Generics
Russian drugmaker Axelpharm has managed to lift the ban on the launch of osimertinib - a drug, which is used in the treatment of lung cancer - in the domestic market, reports The Pharma Letter’s local correspondent. 12 June 2025
Pharmaceutical
The European Council of Minister last week said it is ready to begin negotiations with the European Parliament, having agreed its position on new rules that aim to make the European Union’s (EU) pharmaceutical sector fairer and more competitive. 9 June 2025
Generics
Japanese drugmaker Eisai said yesterday that it has received a favorable decision regarding the lawsuit filed in the US District Court for the District of New Jersey in November 2019 against generic drug manufacturer Shilpa Medicare, which submitted an Abbreviated New Drug Application (ANDA) for a generic version of Lenvima (lenvatinib), for infringement of US Patent No 11,186,547. 30 May 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
Coronavirus vaccine developer Moderna may have to pay royalties on its multi-billion dollar selling jab, thanks to a decision in a US court. 2 December 2021
Biosimilars
Access to off-patent medicines is essential to increase competition, offer accessible and affordable treatments and for the budgetary sustainability of healthcare systems in Europe, as highlighted by a European Parliament report adopted this week, said Medicines for Europe, the trade group representing generic and biosimilars drugmakers. 29 November 2021
Generics
Members of the European Parliament (MEPs) yesterday put forward proposals to make medicines more affordable and boost transparency on prices and promote joint European Union public procurement. 25 November 2021
Pharmaceutical
A couple of trade groups have had their say on the creation of the Health Emergency preparedness and Response Authority (HERA) to make Europe more ready to respond to future pandemics and other threats. 18 November 2021
Pharmaceutical
The European biopharmaceutical industry has signalled its support for a new Trade and Health Initiative, to be discussed by the World Trade Organization (WTO). 15 November 2021
Biotechnology
A row over who was responsible for developing the Spikevax COVID-19 vaccine has spilled out into the public domain. 12 November 2021
Biosimilars
Medicines for Europe, a trade group representing the generic and biosimilars sector in the region, has applauded efforts by the European Commission to improve the current intellectual property regime. 12 November 2021
Generics
German drugmaker Boehringer Ingelheim has obtained two separate interim injunctions against two Indian drugmakers – MSN Laboratories and Dr Reddy’s Laboratories – which launched cheaper, generic versions of their anti-diabetic drug Jardiance (empagliflozin). 28 October 2021
Generics
Nativa, a well-known Russian producer of generics, is challenging the recent cancellation of its patent for its anticancer drug sunitinib in the intellectual property court in Russia, according to some local media, reports The Pharma Letter’s local correspondent. 25 October 2021
Generics
A controversial spin is in the works with MSN Laboratories launching what it terms is the most affordable copies of Jardiance (empagliflozin), the top-selling patented anti-diabetes pills sold by German drugmaker Boehringer Ingelheim (BI) - in India. 22 October 2021
Pharmaceutical
An Expert View from Gary Connors, partner at Oliver Wight, on intellectual property rights protection and drug development. 15 October 2021
Pharmaceutical
Hot on the heels of Merck & Co filing for emergency use of its COVID-19 candidate molnupiravir, the international medical humanitarian organization Médecins Sans Frontières (MSF) has struck out to have affordable access of the drug for poorer countries. 12 October 2021
Biosimilars
Icelandic biosimilars company and Humira (adalimumab) challenger Alvotech has scored a major win in a lawsuit brought by AbbVie, alleging theft of trade secrets. 8 October 2021
Biotechnology
The recent ruling in favor of upholding Amgen’s patents for its phosphodiesterase inhibitor Otezla (apremilast) until its patent expiry in 2028 is an important safeguard for US biotech giant Amgen. 1 October 2021
Biotechnology
Following French pharma major Sanofi’s decision this week to drop out of the race to develop coronavirus vaccines because it admits to being a late comer, the charity Médecins Sans Frontières (MSF) is urging the company to transfer the technology and know-how for the vaccine to the World Health Organization (WHO)-led COVID-19 mRNA vaccine technology transfer hub in South Africa. 1 October 2021
Biosimilars
Establishing a strong presence in biosimilars is the next frontier for Indian life sciences companies. With biosimilars expected to generate major traction in global markets over the next decade, growing from $12 billion in 2020 to at least $36 billion by 2025 at a CAGR of 24%, studies indicate India does have the potential to supply $5 billion worth of biosimilars globally in the next decade if it overcomes some challenges, reports The Pharma Letter’s India correspondent. 28 September 2021
Pharmaceutical
The register of patents for drugs that are currently created in Russia by an initiative of the country’s Ministry of Economy will not allow drugmakers to effectively protect their intellectual property (IP), according to recent statements by representatives of foreign pharmaceutical companies operating in the local market, reports The Pharma Letter’s local correspondent. 28 September 2021
Generics
A huge patent opportunity is supporting the Indian pharmaceutical sector, as several older and once lucrative drugs are losing their patent, presenting a $240 billion opportunity over the next five-six years until 2026. 31 August 2021
Pharmaceutical
The protection of intellectual property (IP) rights currently remains one of the most pressing problems for global drugmakers operating in the Russian market, according to recent statements by Oksana Monzh, general director of French pharma major Sanofi in the Eurasian Region and representatives of other producers. 31 August 2021
Biotechnology
In the USA, an appeals court has overthrown an earlier ruling against Gilead Sciences, a decision which could save the company $1.2 billion in fines. 28 August 2021
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