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Biotechnology
Bristol Myers Squibb has scored a major legal victory as a judge in New York dismissed a $6.4 billion lawsuit related to its acquisition of cancer company Celgene. 5 October 2024
Pharmaceutical
The US Department of Health and Human Services (HHS) has released final guidance for the second cycle of Medicare drug price negotiations. 3 October 2024
Pharmaceutical
Texas-based Cassava Sciences was trading 13% lower in Friday’s pre-market trading. 27 September 2024
Pharmaceutical
The Pharmaceutical Research and Manufacturers of America (PhRMA) is continuing its legal challenge against the US government’s drug pricing reforms. 24 September 2024
Pharmaceutical
On Friday, the USA’s Federal Trade Commission (FTC) brought action against the three largest prescription drug benefit managers (PBMs) - Caremark Rx, Express Scripts (ESI), and OptumRx 23 September 2024
Pharmaceutical
In a lawsuit filed in federal court in Missouri, USA, Health insurer Cigna (NYSE: CI) and its pharmacy benefit manager (PBM) Express Scripts demanded that the Federal Trade Commission (FTC) retract its July 2024 report. 18 September 2024
Generics
Several pharma companies that had moved the Delhi High Court against the government’s recent notification banning 156 fixed-dose combination (FDC) drugs have got a breather. 10 September 2024
Generics
Glenmark Pharmaceuticals has agreed to pay $25 million, based on its ability to pay, to resolve its alleged liability under the False Claims Act for conspiring to fix the price of a generic drug, the US Department of Justice announced. 5 September 2024
Generics
German pharma major Bayer has filed a lawsuit against the Russian drugmaker Promomed to protect the patent rights for Xarelto (rivaroxaban), its treatment for stroke prevention which is the best-selling drug in the Russian market at present, The Pharma Letter’s local correspondent reports. 2 September 2024
Biosimilars
Regeneron Pharmaceuticals has filed a lawsuit against Sandoz, alleging that its biosimilar to Eylea (aflibercept) infringes certain patents. 29 August 2024
Pharmaceutical
Ireland-headquartered Avadel Pharmaceuticals has updated on litigation with USA-based Jazz Pharmaceuticals. 29 August 2024
Pharmaceutical
Liquidia Corporation announced Thursday that it has filed litigation in the US District Court of the District of Columbia (Case No. 1:24-cv-02428) that challenges the recent decision by the US Food and Drug Administration (FDA) to grant three-year new clinical investigation (NCI) exclusivity to Tyvaso (treprostinil) DPI.9.6. 23 August 2024
Pharmaceutical
A jury in an Illinois state court has found that UK drugmaker GSK (LSE: GSK) is not liable for causing a plaintiff’s colorectal cancer. 7 August 2024
Biotechnology
French drugmaker Sanofi’s Genzyme subsidiary has launched legal proceedings against US biotech Sarepta Therapeutics. 1 August 2024
Pharmaceutical
Ardelyx has filed a lawsuit against the US Department of Health and Human Services DHSS) and the Centers for Medicare and Medicaid Services (CMS), regarding its Xpohzah. 19 July 2024
Biosimilars
India's Zydus Lifesciences has been barred by the Delhi High Court from selling its breast cancer drug, Sigrima, a biosimilar version of Roche's pertuzumab (brand name Perjeta). 12 July 2024
Biotechnology
The US Senate has unanimously passed the Affordable Prescriptions for Patients Act of 2023 (S-150). 12 July 2024
Biotechnology
Efforts to end US business deals with certain foreign biotechs considered threats are gaining traction again, with House Speaker Mike Johnson stating his intention to hold a vote on the BIOSECURE act this year. 11 July 2024
Generics
Viatris has announced that the antitrust division of the US Department of Justice (DOJ) has concluded its investigation into Mylan and its former president, Rajiv Malik. 3 July 2024
Pharmaceutical
pharma.be, the umbrella organization of innovative biopharma companies active in Belgium, has highlighted the publication of the Transparency Register 2023. 1 July 2024
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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