The European Union's antitrust enforcer hit Israeli drugmaker Teva Pharmaceutical Industries (NYSE: TEVA) with a 463 million-euro ($502 million) fine Thursday for launching a smear campaign against a rival multiple sclerosis drug and misusing the patent system to thwart the competitor's attempt to entering the market. 31 October 2024
Two US units of Israel’s Teva Pharmaceutical Industries have agreed to pay $450 million to resolve two matters that allege Teva violated the Anti-Kickback Statute (AKS) and the False Claims Act (FCA), the US Department of Justice (DoJ) announced yesterday. 11 October 2024
GSK has reached a settlement with 10 plaintiff firms, resolving 93% of the Zantac (ranitidine) product liability cases it faced in state courts across the USA. 10 October 2024
Novo Nordisk has reached a settlement with Mylan Pharmaceuticals, now part of Viatris, putting an end to a US patent lawsuit over blockbuster diabetes treatment Ozempic (semaglutide). 8 October 2024
Texas Attorney General Ken Paxton has filed a lawsuit against major pharmaceutical companies, including Eli Lilly (NYSE: LLY), alleging a conspiracy to artificially inflate the prices of insulin by up to 1,000%. 7 October 2024
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
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
The Pharmaceutical Research and Manufacturers of America (PhRMA) is continuing its legal challenge against the US government’s drug pricing reforms. 24 September 2024
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
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
Israel-based Teva Pharmaceutical Industries’ application to reopen and modify its decision and order in connection with the 2012 merger of Watson Pharmaceuticals and Actavis has been approved by the US Federal Trade Commission. 19 December 2018
The latest companies to breach the Association of the British Pharmaceutical Industry (ABPI) code of practice have been named and shamed. 17 December 2018
The US Patent and Trademark Appeal Board (PTAB) has ruled in favor of Netherlands-based drugmaker Mylan as it invalidated Sanofi’s Lantus (insulin glargine 100 Units/mL) formulation patents. 14 December 2018
A European court on Wednesday reduced a fine by 102.67 million euros ($116.73 million) that enforcers levied against independent French drugmaker Servier over allegations it reached several anti-competitive agreements to delay cheaper versions of blood pressure medicine perindopril, but rejected appeals of fines from most of the other companies involved. 13 December 2018
The US House of Representatives has approved a bill that would prevent drugmakers from overcharging Medicaid in the way Mylan (Nasdaq: MYL) was famously accused of doing. 12 December 2018
Fresenius saw its worst share price fall ever on Friday, after the German healthcare group issued a profit warning, the previous day. Its share plunged 17.71% to 38.00 euros by close. 8 December 2018
Johnson & Johnson subsidiary Actelion has agreed to pay $360 million to resolve claims that it illegally used a foundation as a conduit to pay the co-pays of thousands of Medicare patients taking Actelion’s pulmonary arterial hypertension drugs, in violation of the False Claims Act, the US Department of Justice announced yesterday. 7 December 2018
A more robust approach will be taken to enforcing intellectual property (IP) in China, new punishments announced by the National Development and Reform Commission show. 6 December 2018
Charlotte Tillett, partner, and Emily Hocken, trainee, at Stevens & Bolton, offer an Expert View on the significance of the UK Supreme Court ruling in Warner-Lambert (WL) v Generics relating to WL’s best-selling pain relief drug, Lyrica (pregabalin). 28 November 2018
In its latest warning over the proposed Supplementary Protection Certification (SPC) manufacturing waiver, the European Federation of Pharmaceutical Industries and Associations (EFPIA) has claimed that these proposals suggest that Europe is weakening its commitment to intellectual property (IP). 28 November 2018
The European Court of Justice will not stand in the way of Roche’s cancer drug Avastin (bevacizumab) being prescribed for an unlicensed indication. 23 November 2018
Shares in Johnson & Johnson tumbled 3% on Wednesday after a US appeals court ruled against blocking generic versions of the blockbuster therapy Zytiga (abiraterone acetate). 22 November 2018
Shares in London-listed Indivior have plummeted after the firm lost a court battle in the USA aimed at stopping Dr Reddy's Laboratories from marketing a generic version of its opioid use disorder therapy Suboxone Film (buprenorphine/naloxone). 21 November 2018
In an Expert View column, Stephen Bennett (pictured) and Mary Foord-Weston, from UK-based law firm Hogan Lovells, consider the questions that new oncology treatments raise around the current intellectual property (IP) system. 16 November 2018
Generic drugmakers Actavis and Mylan have prevailed in a patent dispute against Warner-Lambert, part of the Pfizer group of companies. 14 November 2018
The UK BioIndustry Association (BIA) has been granted permission by the UK Supreme Court to intervene in a case that could have far-reaching impacts on the life sciences sector. The BIA is arguing that medical innovations should be patentable irrespective of how the invention is made. 5 November 2018
The US District Court, District of New Jersey on Friday issued a ruling invalidating all asserted claims of US Patent No 8,822,438 for Zytiga (abiraterone acetate). 27 October 2018
Danish biopharma Forward Pharma says it is considering its options after the US Court of Appeals for the Federal Circuit denied the company rights to royalties relating to the blockbuster multiple sclerosis drug Tecfidera (dimethyl fumarate). 25 October 2018
Israeli drugmaker Teva Pharmaceutical Industries has asked the US Federal Trade Commission (FTC) to modify the ruling that it made in relation to the 2012 merger of Watson Pharmaceuticals and Actavis. 24 October 2018