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
Ireland-headquartered generics major Actavis yesterday confirmed that the US Court of Appeals for the Federal Circuit has issued a temporary injunction to prevent Actavis from further distribution of its generic version of Pulmicort Respules (budesonide inhalation suspension pending its consideration of AstraZeneca's request for an injunction pending appeal. 18 February 2015
The European Commission has decided to withdraw its investigation into the UK government's Patent Box scheme in a move which is favorable to British innovators and provides greater clarity around the future of the scheme, according to intellectual property firm Withers & Rogers. 17 February 2015
Ireland-based generic drugs major Actavis has launched its generic version of Anglo-Swedish pharma major AstraZeneca's Pulmicort Respules (budesonide inhalation suspension). 14 February 2015
Anglo-Swedish pharma major AstraZeneca has agreed to pay the US government $7.9 million to settle allegations that it engaged in a kickback scheme in violation of the False Claims Act, the Justice Department announced yesterday. 12 February 2015
US generics drugmaker Mylan has confirmed that it has been sued by German pharma major Bayer and partner Onyx Pharmaceuticals (a subsidiary of Amgen), in connection with the filing of an Abbreviated New Drug Application with the US Food and Drug Administration for sorafenib. 10 February 2015
Sweden-based pharma company Orexo has filed a patent infringement law suit in the US District Court for New Jersey against Ireland-headquartered generics major Actavis. 6 February 2015
The Japanese unit of Swiss drug major Novartis is facing suspension following allegations of data manipulation in the results of Diovan (valsartan) clinical trials. 4 February 2015
Indian drugmakers Sun Pharmaceutical Industries Ltd. and Ranbaxy Laboratories have agreed to divest Ranbaxy’s interests in generic minocycline tablets in order to settle US Federal Trade Commission charges that Sun’s $4 billion proposed acquisition of Ranbaxy would likely be anticompetitive. 1 February 2015
In remarks at the Families USA Health Action Conference in Washington DC on January 22, US Senator Elizabeth Warren (Democrat, Massachusetts) announced plans to introduce new legislation to advance medical research. 23 January 2015
US drugmaker Supernus Pharmaceuticals says that it has sued generic drug makers Taiwan-based TWi Pharmaceuticals and TWi International for infringement of four patents covering its antiepileptic drug Oxtellar XR. 22 January 2015
The US Supreme Court has reversed the Federal Circuit Court’s judgment on Israel-based Teva Pharmaceutical Industries’ Copaxone (glatiramer acetate injection). 21 January 2015
Although health care and life sciences companies are aware that they could be hit with federal “whistleblower” law suits, they are ill-prepared for them and any potential consequences, says a national US survey sponsored by law firm Foley Hoag LLP. 21 January 2015
US drugmaker Supernus Pharmaceuticals says it has sued privately-held generics firm Par Pharmaceutical for infringement of four patents covering its antiepileptic drug Trokendi XR (topiramate). 19 January 2015
The Delaware Court of Chancery has entered its Final Order and Judgment in the case brought by US pharma company PharmAthene against SIGA Technologies. 16 January 2015
Japanese pharma company Sumitomo Dainippon and its US subsidiary Sunovion Pharmaceuticals have jointly filed patent infringement law suits against Emcure Pharmaceuticals and InvaGen Pharmaceuticals. 15 January 2015
The Indian Patent Controller yesterday rejected one of US biotech major Gilead Sciences’ key patent applications which covered the firm’s blockbuster drug Sovaldi (sofosbuvir), used to treat hepatitis C (HCV). 15 January 2015
US biotech firm Aegerion Pharmaceuticals has revealed it is the subject of a US Securities and Exchange Commission investigation relating to its sales activities. 14 January 2015
Jordon-headquartered Hikma Pharmaceuticals saw its shares rise 4.2% to a record high of £23.80, after a USA appeals court rejected Japanese drug major Takeda Pharmaceutical’s bid to bock the firm’s launching of its gout drug colchicine. 13 January 2015