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
United Therapeutics Corp was named as a defendant, along with Smiths Medical ASD, in a lawsuit filed in federal court by Sandoz and RareGen, on April 16, 2019. 18 April 2019
A US federal grand jury indicted Indivior on Tuesday on charges the company orchestrated a “nationwide scheme,” with the news sending the shares plunging this morning. 10 April 2019
Pharma needs to pay closer attention to ensuring the integrity of its third-party relationships, writes Kathy Johnson, vice president life sciences, LexisNexis Risk Solutions Health Care, in an Expert View piece. 9 April 2019
Three pharmaceutical companies have agreed to pay $122 million to settle US Department of Justice (DoJ) allegations that kickbacks were paid to promote uptake of their products. 5 April 2019
A three-member panel of the European Patent Office’s (EPO) Opposition Division upheld patent EP 2,949,335 covering Copaxone (glatiramer acetate) 40mg in Europe. 1 April 2019
New York State Attorney General Letitia James has filed to significantly extend a lawsuit against opioid manufacturers and distributors, seeking damages for alleged marketing malpractices. 29 March 2019
The UK Supreme Court has handed down a unanimous decision in a case between generics firm Actavis and Eli Lilly subsidiary ICOS, finding that discoveries from routine research can be rewarded with a patent. 27 March 2019
Privately-held Purdue Pharma has agreed to pay for the establishment of the USA’s leading addiction research center in a settlement with the state of Oklahoma over the opioid crisis that its drug Oxycontin (oxycodone) contributed to. 27 March 2019
The changing intellectual property (IP) landscape for pharmaceuticals was debated at the Legal Affairs Conference in held today in Amsterdam by Medicines for Europe, the lobbying group for biosimilars and generic drugmakers. 27 March 2019
Most commercial executives in the industry thought the discussions over Obamacare were finally at an end, after a monthslong war of attrition between the White House and Congress early in Mr Trump’s presidency. They may need to think again. 27 March 2019
More than five years after the blood thinner Xarelto (rivaroxaban) litigation began, and with Germany’s Bayer and Johnson & Johnson subsidiary Janssen Pharmaceuticals prevailing in all six cases that went to trial, the companies have reached an agreement in principle to settle in the amount of $775 million. 25 March 2019
Germany’s Stada Arzneimittel group says it will be one of the first manufacturers to launch generic amlodipine/valsartan products in Europe. 21 March 2019
Danish diabetes care giant Novo Nordisk and the US subsidiary of Israeli generics major Teva Pharmaceutical Industries have reached a settlement agreement on the US patent litigation case for Victoza (liraglutide). 18 March 2019
The end of a drug’s exclusivity period can result in expensive patent litigation, and IP lawyer Kent Walker has identified an emerging trend that could present a solution for generic challengers seeking to enter the market. 18 March 2019
The UK’s Competition and Markets Authority (CMA) has closed its investigation into a questionable discount scheme introduced to the National Health Service (NHS) by American pharma giant Merck & Co. 15 March 2019
Medical products and generic drugmaker Covidien has agreed to pay just under $17.5 million to resolve allegations that it violated the False Claims Act by providing free or discounted practice development and market development support to physicians located in California and Florida to induce purchases of Covidien’s vein ablation products, the US Department of Justice announced on Monday. 12 March 2019
Research shows some 79% of the American public view the cost of prescription drugs as unreasonable, and lawmakers and regulators are increasingly convinced the industry charges too much for its products. 8 March 2019