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Pharmaceutical
Danish pharma major Novo Nordisk says that it has become aware of several hundred units of Ozempic (semaglutide) injection 1 mg distributed outside its authorized supply chain in the USA. 15 April 2025
Generics
A Texan drug compounder cannot rely on federal law to avoid a lawsuit over copycat sales of a rheumatoid arthritis treatment, clearing the way for Zyla Life Sciences to pursue claims under state competition laws. 14 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
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
Ireland’s government remains confident in its ability to retain the country’s strategic position in pharmaceutical manufacturing, despite rising tensions between the European Union and the United States over trade policy. 8 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
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
Sinovac Biotech, a China-based biopharmaceutical company specializing in vaccine development, has been urged by shareholder Heng Ren Partners to distribute $8.9 billion in cash reserves to shareholders and to resume trading of its shares on Nasdaq. 24 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
Purdue Pharma has filed a Chapter 11 Plan of Reorganization and related disclosure statement with the US Bankruptcy Court for the Southern District of New York. 20 March 2025
Pharmaceutical
As the new White House seeks to push ahead with swingeing cuts to government spending, a federal judge in Massachusetts has thrown a wrench in the works. 6 March 2025
Biotechnology
The US Patent Trial and Appeal Board handed a massive victory to Pfizer and BioNTech on Wednesday, as it invalidated two of Moderna patents covering its Spikevax COVID-19 vaccine, which the challengers stand accused of infringing, according to media reports. 6 March 2025
Biotechnology
Roivant Sciences portfolio company Genevant Sciences and Canada’s Arbutus Biopharma yesterday filed five international lawsuits seeking to enforce patents protecting their innovative LNP technology against Moderna, and certain affiliates. 4 March 2025
Biosimilars
Johnson & Johnson has taken legal action against Samsung Bioepis, accusing the South Korean biotech of violating a settlement agreement by authorizing a third party to market a private-label biosimilar version of Stelara (ustekinumab). 27 February 2025
Pharmaceutical
A group representing compounding pharmacies has filed a lawsuit against the US Food and Drug Administration, arguing that the agency acted unlawfully when it removed Novo Nordisk’s semaglutide-based drugs Ozempic (semaglutide) and Wegovy (semaglutide) from the official shortage lst. 27 February 2025
Pharmaceutical
Danish pharma major Novo Nordisk has sued KBP Biosciences and its founder and executive chairman, Huang Zhenhua, for $830 million in an application to the Singapore International Commercial Court. 19 February 2025
Pharmaceutical
AstraZeneca, Moderna and Novo Nordisk have breached the Association of the British Pharmaceutical Industry (ABPI) Code of Practice for the Pharmaceutical Industry. 17 February 2025
Pharmaceutical
A federal judge has temporarily blocked the National Institutes of Health (NIH) from implementing research funding cuts in 22 states after a lawsuit argued the move would cripple studies on cancer, Alzheimer’s, and other diseases. 11 February 2025
Pharmaceutical
Robert F Kennedy Jr faced pointed questioning during his nomination hearing for secretary of health and human services, as lawmakers sought to reconcile his past controversial statements with the more evidence-based approach he now appears to endorse. 31 January 2025
Biosimilars
US biotech major Amgen =announced that it has reached resolution of its patent infringement litigation related to South Korea-based Celltrion’s denosumab biosimilar products, Amgen brands Prolia and Xgeva. 29 January 2025
Generics
Canada-based Bausch Health saw its shares rise 3.6% to $10.41 after it revealed that, along with its gastroenterology unt Salix Pharmaceuticals, it has filed a lawsuit today in the US District Court for the District of New Jersey against Amneal Pharmaceuticals and its subsidiaries. 6 April 2024
Pharmaceutical
Following its initial investigation into the acquisition by Theramex of certain drug rights held by Viatris, the UK’s antitrust body has said the transaction: “could reduce competition and choice for hormone replacement therapy treatments.” 5 April 2024
Biotechnology
In a filing with the US Securities and Exchange Commission (SEC), Canadian biotech Zymeworks has revealed the sudden replacement of its chief financial officer. 4 April 2024
Pharmaceutical
An attempt from the conservative Alliance for Hippocratic Medicine to ban mifepristone, a medicine used to induce an abortion, threatens to undermine confidence in the American regulatory regime. 27 March 2024
Generics
The US Federal Trade Commission revealed on Friday that it has filed an amicus brief explaining that pharmaceutical maker Teva Pharmaceutical Industries has improperly listed patents in the Orange Book and urged the court to order those listings removed. 25 March 2024
Generics
Japanese drugmaker Eisai says it has entered into a settlement agreement with the US units of India’s Sun Pharmaceutical Industries regarding the lawsuit filed against generic drug manufacturers (Sun Pharma and Shilpa Medicare) for infringement of the patents relating to Lenvima (lenvatinib mesylate). 25 March 2024
Generics
Members of the European Parliament’s health committee (ENVI) yesterday adopted a compromise position on the EU Pharmaceutical legislation review (comprising of a new Pharmaceutical Directive and Regulation). 20 March 2024
Pharmaceutical
More than 86% of the National Pharmaceutical Pricing Authority's (NPPA) total demand for overcharging remains unrecovered from drug majors operating in India. 15 March 2024
Biotechnology
Sino-American biotech BeiGene on March 8 disclosed in stock exchange announcement that it has filed patent infringement suits under the Hatch-Waxman Act against the US subsidiary of Swiss firm Sandoz and separately against Indian-owned companies MSN Pharmaceuticals and MSN Laboratories Private in the US District Court for the District of New Jersey. 9 March 2024
Pharmaceutical
In another legal blow for opponents of the Inflation Reduction Act (IRA), a federal judge has now rejected a bid from AstraZeneca to prevent price negotiations on its diabetes med Farxiga (dapagliflozin). 4 March 2024
Pharmaceutical
Xandra Neuberger, associate director, regulatory affairs and international service lead for clinical trial applications at PharmaLex, provides an Expert View. 29 February 2024
Generics
Swiss generics and biosimilars drugmaker Sandoz today announced that its US subsidiaries – Sandoz Inc and Fougera Pharmaceuticals - have entered into a settlement agreement with the class of direct purchaser plaintiffs in the multidistrict litigation entitled In re Generic Pharmaceuticals Pricing Antitrust Litigation in the US District Court for the Eastern District of Pennsylvania. 29 February 2024
Pharmaceutical
The US Department of Justice on Thursday released its latest data on recoveries under the False Claims Act, saying there were nearly $2.7 billion in settlements and judgments in the 2023 fiscal year, an increase from the prior year's haul. 23 February 2024
Pharmaceutical
Biotech company United Therapeutics Corporation has launched a lawsuit against the US Food and Drug Administration (FDA). 23 February 2024
Biotechnology
The USA’s Creating Hope Reauthorization Act of 2024 was introduced in the House of Representatives last week, prompting US trade group Biotechnology Innovation Organization (BIO) chief executive and president, Rachel King, to make the following statement following the bill's introduction: 21 February 2024
Generics
The Indian Commerce Ministry confirmed has rejected of Switzerland's demand for data exclusivity for medicines in the India-EFTA trade deal, and emphasised the importance of protecting the country’s generic drug production and supply. 16 February 2024
Biotechnology
Tesaro, a subsidiary of UK pharma major GSK, has come up on top in the latest stage of its legal battle with Anglo-Swedish drugmaker AstraZeneca regarding the ovarian cancer drug Zejula (niraparib). 15 February 2024
Pharmaceutical
US trade group Pharmaceutical Research and Manufacturers of America (PhRMA) has made clear its opposition to the drug price-setting provisions in the Biden administration’s Inflation Reduction Act (IRA). 14 February 2024
Pharmaceutical
Novo Nordisk has come out on top in two cases in Florida courts relating to its weight loss drug Wegovy (semaglutide). 13 February 2024
Pharmaceutical
American dermatology company Verrica Pharmaceuticals has filed a lawsuit against Canada’s Dormer Laboratories related to the active ingredient cantharidin. 5 February 2024
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