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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
Alexion, AstraZeneca’s Rare Disease group, has entered into a settlement agreement with Japan’s Chugai Pharmaceutical resolving all patent disputes between the two companies related to Ultomiris (ravulizumab). 17 March 2022
Biotechnology
Krystal Biotech, which is focussed on redosable gene therapies for rare diseases, saw its shares rise as much as 4.6% to $62.61 on Monday, as is said it has reached a binding term sheet with fellow US biotech firm PeriphaGen - and former lab partner - to resolve all claims it copied the latter’s gene therapy technology litigation filed by PeriphaGen on May 20, 2020. 16 March 2022
Biotechnology
US biotech Moderna, the company that came to the world’s attention and earned billions as a result of its development of an mRNA COVID-19 vaccine, has announced a global health strategy as it looks to the next phase of its growth. 9 March 2022
Biosimilars
Privately-held Icelandic biosimilars developer Alvotech Holdings says it has executed a US settlement agreement with AbbVie that grants Alvotech non-exclusive rights to market AVT02 (100mg/mL), its high-concentration, citrate-free biosimilar candidate for Humira (adalimumab) in the USA 9 March 2022
Generics
The COVID-19 pandemic has highlighted the critical link between patient access to medicine and a robust medicines manufacturing sector. As health systems begin to recover from the pandemic, a new crisis threatens stability and secure supply of medicines in Europe. 7 March 2022
Biotechnology
Arbutus Biopharma’s shares were up 4.3% at $3.21 after, along with, Genevant Sciences, today filed a lawsuit in the US District Court for the District of Delaware against Moderna and one of its affiliates. 28 February 2022
Generics
The Federal Court of Appeal has dismissed an appeal by Pharmascience from a decision of the Federal Court that found Canadian patent No 2,760,802 (the 802 patent) valid and infringed by Pharmascience's proposed glatiramer acetate product, a generic of Teva Pharmaceutical Industries’ blockbuster multiple sclerosis drug Copaxone and Pharmascience's Glatect. 16 February 2022
Pharmaceutical
The European Federation of Pharmaceutical Industries and Associations (EFPIA) and its specialist group Vaccines Europe have highlighted a series of statistics to show progress being made in vaccinating the world against COVID-19. 16 February 2022
Biotechnology
There are fears that US biotech company Moderna could undermine the World Health Organization’s (WHO) efforts to manufacture more mRNA vaccines in Africa, after it emerged the company has filed several patents related to its coronavirus jab. 14 February 2022
Pharmaceutical
Pharma trade group Medicines Australia notes the introduction of patent box legislation, Treasury Laws Amendment (Tax Concession for Australian Medical Innovations) Bill 2022, in the Australian Parliament yesterday. 14 February 2022
Pharmaceutical
UK pharma major GlaxoSmithKline today announced that its majority-owned subsidiary ViiV Healthcare has agreed to settle the global patent infringement litigation with US biotech firm Gilead Sciences concerning ViiV’s patents relating to dolutegravir, an antiretroviral medication used together with other medicines, to treat human immunodeficiency virus (HIV). 2 February 2022
Pharmaceutical
In Latin America as with across the globe, the pharmaceutical sector works to consolidate a solid scheme of protection of intellectual property (IP), incentivizing a virtuous ecosystem generating technology and innovation, based on principles of trust and security. 21 January 2022
Biotechnology
The Janus kinase (JAK) inhibitor baricitinib, marketed by US pharma major Eli Lilly as Olumiant, is strongly recommended for patients with severe or critical COVID-19 in combination with corticosteroids, an expert group from the World Health Organization has written in the British Medical Journal (BMJ). 14 January 2022
Pharmaceutical
Recently introduced legislation, the “Restoring the America Invents Act (RAIA),” if enacted, would push the Patent Trial and Appeal Board (PTAB) of the US Patent and Trademark Office to grant more requests to institute administrative patent trials, according to Pharmaceutical Research and Manufacturers of America’s director of public affairs Tom Wilbur, writing on the trade group’s website. 13 January 2022
Pharmaceutical
India's Delhi High Court recently granted an interlocutory injunction to Swiss pharma giant Novartis against Natco Pharma’s use of eltrombopag olamine (EO). 12 January 2022
Pharmaceutical
Adrian Tombling, partner and life sciences sector specialist at European intellectual property firm, Withers & Rogers, offers an Expert View on why patents are not the real barrier and why we need them to guard the human race against the risks posed by COVID-19 mutations or future pandemics. 4 January 2022
Pharmaceutical
The US Court of Appeals for the Federal Circuit (CAFC) issued its decision upholding the validity of US Patent No 9,187,405 covering a dosing regimen for Gilenya (fingolimod). 4 January 2022
Biosimilars
USA-based Viatris announced that it is pleased with decisions issued that affirm the US Patent and Trademark Appeal Board's prior rulings that found the challenged claims of Sanofi's Lantus (insulin glargine) SoloSTAR device patents, US Patent Nos 9,603,044, 8,992,486, 9,526,844, 9,604,008, and 8,679,069, unpatentable. 30 December 2021
Biotechnology
US biotech Moderna has taken a more conciliatory approach in a row with the National Institutes of Health (NIH) over who is responsible for the creation of the Spikevax coronavirus vaccine. 20 December 2021
Generics
Swiss drugmaker Vifor Pharma and its partner American Regent, Daiichi Sankyo’s US subsidiary, today announced that they have reached settlement agreements with Mylan Laboratories, part of Viatris, the newly-formed generics power-house resulting from the merger of Mylan and Pfizer, and Sandoz, which is about to be spun out of Novartis, that resolve the patent litigation brought in response to Abbreviated New Drug Applications seeking approval by the US Food and Drug Administration to market a generic version of Injectafer (ferric carboxymaltose). 20 December 2021
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