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
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
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
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
Regeneron Pharmaceuticals has filed a lawsuit against Sandoz, alleging that its biosimilar to Eylea (aflibercept) infringes certain patents. 29 August 2024
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
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
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
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
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
pharma.be, the umbrella organization of innovative biopharma companies active in Belgium, has highlighted the publication of the Transparency Register 2023. 1 July 2024
The European Commission (EC) has accused privately-held API manufacturer Alchem International of breaching European Union antitrust rules by participating in a long-lasting cartel concerning an important pharmaceutical product. 14 June 2024
A New Jersey, USA, federal judge has ruled that five patents covering Israel-based Teva Pharmaceutical Industries-brand asthma inhalers were improperly listed in the Food and Drug Administration’s (FDA) Orange Book, in a win for US drugmaker Amneal Pharmaceuticals. 12 June 2024
Last week, the US Court of Appeals for the District of Columbia (DC) ruled that Section 340B of the Public Health Service Act does not prohibit pharmaceutical manufacturers from imposing conditions on the distribution of discounted drugs to covered entities in the program, noted Sophia Gaulkin and Alan Kirschenbaum of law firm Hyman Phelps & McNamara. 1 June 2024
UK-based Alliance Pharma (AIM: APH) has successfully appealed against a Competition and Markets Authority (CMA) ruling that had found the company guilty of breaching competition law. 24 May 2024
The US lobby group Pharmaceutical Research and Manufacturers of America (PhRMA) has initiated litigation in the US District Court for the Eastern District of California challenging SB 17, describing it as ‘an unprecedented and unconstitutional California law.’ 11 December 2017
Two new patent challenges have been launched by the New York-based patient access and public health activist I-MAK - the Initiative for Medicines, Access & Knowledge - against sofosbuvir-based products. 7 December 2017
The Australian Competition and Consumer Commission (ACCC) has instituted proceedings in the Federal Court of Australia against the local consumer health subsidiaries of GlaxoSmithKline and Novartis, alleging they made false or misleading representations in the marketing of Voltaren Osteo Gel and Voltaren Emulgel pain relief products. 7 December 2017
Aside from issues concerning how to enforce second medical patents, the validity issues at the core of the Warner-Lambert case are on their way to the UK Supreme Court and have potentially significant implications for pharma patents, writes Andrew Hutchinson, a patent litigation partner at Simmons & Simmons LLP, in an Expert View piece. 23 November 2017
International aid agency Médecins Sans Frontières will argue in a Delhi court that New York pharma giant Pfizer ought not to have been awarded a patent for its pneumonia vaccine Prevnar13 (PCV13). 20 November 2017
US healthcare giant Johnson & Johnson has dropped its lawsuit against Samsung Bioepis relating to the latter’s biosimilar of the blockbuster rheumatoid arthritis treatment Remicade (infliximab). 14 November 2017
Following in the footsteps of US drug giant Pfizer, a New York grocery union benefits fund has sued Johnson & Johnson for allegedly abusing its monopoly power to exclude competition and raise prices for Remicade (infliximab). 1 November 2017
Attorneys general from 45 states in the USA have widened the scope of an earlier court action which alleges collusion to fix generic drug prices. 1 November 2017
Ireland-incorporated Endo International has revealed that two of its subsidiaries have filed suit in the US District Court for the District of Columbia against the Food and Drug Administration. 31 October 2017
As US voters demand action to lower prescription drug prices, USA-based nonprofit Initiative for Medicines, Access & Knowledge (I-MAK) is taking its own action against the maker of some of the leading hepatitis C treatments. 27 October 2017
In the week that it announced its latest plans to enter European markets, Russia’s largest biotech company, BIOCAD, has come out on top in a patent dispute in its native country involving rituximab. 25 October 2017
Amid falling sales of its leading diabetes product Lantus (insulin glargine) due to generic competition, French pharma major Sanofi is taking further legal action in the USA. 25 October 2017
US President Donald Trump on Tuesday said his nominee to head the Office of National Drug Control Policy, Representative Tom Marino (Republican, Pennsylvania.), has backed out of the position, two days after media reports revealed the congressman had pushed legislation gutting the US Drug Enforcement Administration's ability to target opioid distributors not abiding by regulations. 18 October 2017
Generic drugmakers and research-based pharma companies are used to facing each other in patent rows that can bring lost or gained earnings totaling many millions of dollars, but billions are riding on a European Union (EU) review of laws affecting exclusivity periods for the industry as a whole. 18 October 2017
The US District Court for the Eastern District of Texas has issued an adverse trial decision finding that the four asserted patents covering Restasis (cyclosporine ophthalmic emulsion) 0.05% are invalid. 17 October 2017
Back in August, US pharma giant Pfizervwelcomed the news that, over a decade after it applied for a patent on its blockbuster vaccine, Prevenar 13 (pneumococcal 7-valent conjugate; PVC), the Indian Patent Office finally granted protection, which expires in 2026, for the product. 13 October 2017
UK biotech firm Redx Pharma is one step closer to being able to exit administration and recommence trading on the London Stock Exchange. 13 October 2017
Shares of specialty pharma firm BioDelivery Sciences International were up mid-morning, after it announced that it has entered into a Settlement Agreement over its opioid dependence treatment. 12 October 2017