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Pharmaceutical
Swiss drugmaker Novartis has launched legal action against the US government, after administrators revealed the first drugs to be subject to pricing regulations mandated by the Inflation Reduction Act (IRA). 7 September 2023
Pharmaceutical
Japanese pharma major Astellas Pharma revealed that it has requested that the Court dismiss the company’s lawsuit challenging the constitutionality of certain provisions of the US government’s Inflation Reduction Act (IRA). 7 September 2023
Biotechnology
The US Federal Trade Commission today announced it has reached a proposed consent order with Amgen to address what the agency saw as potential competitive harm that would result from the biotech major’s $27.8 billion acquisition of Horizon Therapeutics. 1 September 2023
Pharmaceutical
Ireland-incorporated specialty pharma firm Mallinckrodt Pharmaceuticals said last week that it planned to file for bankruptcy for the second time in three years. 27 August 2023
Biotechnology
US trade body the Biotechnology Innovation Organization (BIO) said on Friday that it has filed an amicus brief opposing the Federal Trade Commission (FTC) lawsuit to block Amgen’s proposed acquisition of Horizon Therapeutics for $27.8 billion, arguing that the FTC’s overreach threatens the merger and acquisition activity that is the lifeblood of biotech innovation. 26 August 2023
Pharmaceutical
The list of companies and groups that are suing the US government over its Medicare price-setting policies continues to grow. 25 August 2023
Biosimilars
An Expert View from Róbert Wessman, founder and chairman of Icelandic biosimilars company Alvotech and investment fund Aztiq. 23 August 2023
Generics
The US Department of Justice (DoJ) yesterday announced deferred prosecution agreements (DPAs) resolving criminal antitrust charges against the US subsidiaries of Israel’s Teva Pharmaceutical Industries and India’s Glenmark Pharmaceuticals. 22 August 2023
Pharmaceutical
UK addiction treatment specialist Indivior (LSE/Nasdaq: INDV) saw its shares edge up 3% to 1,812 pence by early afternoon, as it revealed a resolution to the claims brought by the end payor class of litigants in the In re Suboxone Antitrust Litigation multi-district litigation (MDL). 21 August 2023
Pharmaceutical
The USA’s Fifth Circuit Court of Appeals on Wednesday rejected an extraordinary decision blocking the US Food and Drug Administration's (FDA) decades-old approval of the widely used abortion medication mifepristone, but also upheld the decision's reinstatement of restrictions on access to the medication. 17 August 2023
Generics
The UK’s Competition and Markets Authority (CMA) has welcomed the landmark judgment, which endorses all the main elements of the CMA’s decision in respect of liothyronine tablets – an essential medicine to treat thyroid hormone deficiency. 17 August 2023
Generics
US pharma giant Pfizer and the Scripps Research Institute have accused generics company Dexcel Pharma Technologies of patent infringement. 14 August 2023
Pharmaceutical
The US Supreme Court is to hear a challenge from the Biden administration to the settlement agreed by Purdue Pharma that would protect owners the Sackler family from civil lawsuits over their role in the opioid epidemic. 11 August 2023
Biotechnology
UK drugmaker GSK is suing Pfizer to add further intensity to the race to grab the lion’s share of the respiratory syncytial virus (RSV) vaccine market. 3 August 2023
Pharmaceutical
The US Federal Trade Commission and the Department of Justice have released a draft update of the Merger Guidelines, which describe and guide the agencies’ review of mergers and acquisitions to determine compliance with federal antitrust laws. 20 July 2023
Pharmaceutical
The US Federal Trade Commission (FTC) is again flexing its muscles in the pharma sector, with the aim of blocking IQVIA Holdings, the world’s largest health care data provider, from acquiring Propel Media (PMI). 19 July 2023
Biotechnology
The US Federal Trade Commission (FTC) has issued a second request to Seagen and Pfizer regarding the $43 billion acquisition of Seagen by Pfizer, the former announced in a Securities and Exchange Commission filing after the close of trading on Friday. 17 July 2023
Generics
The High Court has issued a judgment on the judicial review brought by the British Generic Manufacturers Association (BGMA) dismissing the claim that the organization was improperly excluded from the ongoing negotiations between the government and industry to agree a new Voluntary Scheme for medicine pricing and access (VPAS). 10 July 2023
Pharmaceutical
Swiss pharma giant Novartis yesterday announced that the US District Court for the District of Delaware issued a negative decision regarding the validity of a patent covering its heart failure treatment Entresto and combinations of sacubitril and valsartan, which expires in 2025 with its pediatric exclusivity. 8 July 2023
Pharmaceutical
The US drug industry is not happy with the Inflation Reduction Act (IRA) and is pursuing broad legal action in an attempt to limit its impact. 22 June 2023
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
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