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
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
Israeli drugmaker Teva Pharmaceutical Industries looks likely to see declining sales of its leading multiple sclerosis drug Copaxone (glatiramer acetate) plummet further following a court ruling on Friday. 15 October 2018
Japan’s Chugai Pharmaceutical filed a lawsuit to the Tokyo District Court as of October 12, and has also filed a petition for provisional disposition order, demanding the suspension of manufacturing and distribution of the biosimilar of anti-HER2 monoclonal antibody Herceptin (trastuzumab). 15 October 2018
Sandoz, the generics business of Swiss pharma giant Novartis, today announced a global resolution of all intellectual property (IP) related litigation with AbbVie concerning the proposed Sandoz biosimilar Hyrimoz (adalimumab) for reference medicine Humira (adalimumab). 12 October 2018
American drugmaker Pfizer has agreed to pay $700,000 to settle allegations that it misled customers with a co-payment coupon program in its home state of New York. 12 October 2018
A leading British clinical research organization (CRO), Richmond Pharmacology, has published a detailed report criticizing current UK immigration policy and supporting proposals to install a skills-based migration system after Brexit. 9 October 2018
Scott Gottlieb, the Commissioner of the US Food and Drug Administration (FDA) and the man with the plan to increase competition in his country’s pharmaceuticals market, has announced a new prong to the agency’s attempts to stop ‘gaming’ of the generic drug approval process. 3 October 2018
AmerisourceBergen Corp and two of its subsidiaries have agreed to pay $625 million to resolve allegations arising from its operation of a facility that improperly repackaged oncology-supportive injectable drugs into pre-filled syringes and improperly distributed those syringes to physicians treating vulnerable cancer patients. 2 October 2018
Legend Biotech, a subsidiary of reagents services provider Genscript Biotech Corporation, regained some of Thursday’s stock market losses on Friday. 1 October 2018
A week after a UK court judged that bevacizumab injections could be prescribed for the treatment of wet age-related macular degeneration (wet AMD), German life sciences group Bayer has appealed against the decision. 28 September 2018
Adding to a busy news week for Gilead Sciences, a court in Brazil has announced it will strip the Californian firm of its exclusivity patent for Sovaldi (sofosbuvir), at the request of presidential candidate Rolando Valcir Spanholo. 26 September 2018
The World Intellectual Property Organization (WIPO) and a global trade body representing research-based pharma have launched an online tool to help procurement agencies better understand the global patent status of medicines. 25 September 2018
A High Court case win by 12 National Health Service (NHS) Clinical Commissioning Groups (CCGs) in favor of prescribing the significantly cheaper anti-vascular endothelial growth factor (anti-VEGF), Avastin (bevacizumab), over Novartis’ (NOVN: VX) and Bayer’s (BAYN: DE) licensed anti-VEGF eye drugs has import implications, says analyst. 24 September 2018
German pharma major Bayer has hit out at a UK court’s judgement that it is potentially lawful to offer patients bevacizumab injections for the treatment of wet age-related macular degeneration (wet AMD). 21 September 2018