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
A cloud continues to loom over the implementation of the Unified Patent Convention, a system permitting a single patent covering numerous European countries, writes barrister Mark Engelman, head of intellectual property at UK-based law firm, Hardwicke, in an Expert View piece. 11 October 2017
Drug pricing, subject of impassioned presidential Tweets not so long ago, has ceded priority in recent months, amid the furore over Obamacare replacement efforts. 10 October 2017
Eliciting comment last week was news that a US judge had reversed an earlier ban on the marketing of cholesterol treatment Praluent in a long-running court battle between Amgen and the drug’s makers – Regeneron and Sanofi and ordering a re-trial. Also attracting attention was mid-stage data on Capricor Therapeutics’ Duchenne muscular dystrophy agent CAP-1002; strong Phase III results with Zogenix’ rare epilepsy drug candidate ZX008; and positive results for Ablynx’ rare blood disorder candidate caplacizumab. 8 October 2017
In its patent infringement case against Sanofi’s new atopic dermatitis drug Dupixent, Amgen has secured a win courtesy of the US Patent and Trademark Office’s Patent Trial and Appeal Board, who refused an inter partes review of its patent on the grounds that not enough evidence had been brought to invalidate it. 6 October 2017
The chances of US pharma major Eli Lilly hanging onto market exclusivity with its chemotherapy drug Alimta (pemetrexed for injection) until 2022 were given a fresh boost on Thursday. 6 October 2017
There have been some challenging days in the recent history of Teva Pharmaceutical Industries, and Wednesday would certainly come into that category. 5 October 2017
The UK High Court has rejected a bid from the the British pharma industry to prevent the National Institute for Health and Care Excellence from imposing new rules around price negotiations. 5 October 2017
Plenty of adjectives have been used to describe the transfer of six patents related to Allergan’s Restasis (cyclosporine ophthalmic emulsion) treatment for chronic dry eye disease to the Saint Regis Mohawk Tribe (SRMT). 4 October 2017
It has not been an uneventful reign for Guido Rasi as executive director of the European Medicines Agency (EMA) since he took over in November 2011, with first his appointment called into question in a saga that saw him stripped of the role and then reinstated, and now the agency facing a disruptive move from its London home due to Brexit. 4 October 2017
Last week saw AbbVie entering a patent settlement with Amgen relating to the latter’s biosimilar version of blockbuster drug Humira. US Food and Drug Administration acceptance for review of Eisai’s cancer drug Lenvima in a new indication, and FDA approval for Eli Lilly’s new breast cancer drug Verzenio also figured in the news. Also attracting attention was news on the failure of Axovant Sciences’ Alzheimer’s disease candidate intepirdine. 1 October 2017
AbbVie today announced a global resolution of all intellectual property-related litigation with biotech major Amgen over the latter’s proposed biosimilar to AbbVie's mega-blockbuster rheumatoid arthritis and inflammatory diseases drug Humira (adalimumab). 28 September 2017
Biosimilar injectables specialist Hospira has been ordered to pay $70 million for infringing a patent belonging to Amgen relating to the anemia treatment Epogen (epoetin alfa). 25 September 2017
On Friday, UD biotech firm Aegerion Pharmaceuticals agreed to plead guilty in the US District Court for the District of Massachusetts to two misdemeanor counts of violating the Federal Food, Drug, and Cosmetic Act (FD&C Act) involving the introduction of misbranded Juxtapid (lomitapide) into interstate commerce. 25 September 2017
American advocacy group Public Citizen is launching a legal bid to force a ruling on a petition it launched three years ago regarding the use of benzocaine in over-the-counter medicines. 22 September 2017
The share price of the world’s biggest pharma company closed 1.5% up on Wednesday while that of Johnson & Johnson, the globe’s largest healthcare firm, decreased by the same percentage. 21 September 2017
In his second Expert View piece, Yungjoon Kwon, patent/trademark attorney and managing director at law firm Kwon & Kim, considers a South Korean court’s view on one of pharma's hottest topics – dosage regime drugs’ patentability. 14 September 2017
Yesterday, in opposition proceedings filed by inter alia Synthon, the Technical Board of Appeal (TBA) of the European Patent Office revoked the last of Teva Pharmaceutical Industries' (NYSE: TEVA) three glatiramer so-called HBr patents which claimed an allegedly improved process for the synthesis of glatiramer acetate. 13 September 2017
In July, the USA’s Ninth Circuit reversed the lower court’s decision to dismiss a False Claims Act (FCA) case against US biotech major Gilead Sciences, relating to its selling of HIV drugs. 11 September 2017
Japan’s Chugai Pharmaceutical saw its shares gain 2.15% to 4,515 yen, after it revealed legislation to protect one of its top-selling drugs from biosimilar competition. 11 September 2017
Novo Nordisk will pay $58.65 million to resolve allegations that the company failed to comply with the Food and Drug Administration-mandated Risk Evaluation and Mitigation Strategy (REMS) for its top-selling type 2 diabetes medication Victoza (liraglutide), the Justice Department announced yesterday. 6 September 2017