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
Privately-held US biotech Allele Biotechnology and Pharmaceuticals has filed two patent infringement lawsuits – one in New York against Regeneron Pharmaceuticals and the other in California against Pfizer and BioNTech. 6 October 2020
US specialty pharma firm Collegium Pharmaceutical has announced a settlement agreement with the US subsidiary of Israel’s Teva Pharmaceutical Industries. 1 October 2020
US biotech major Gilead Sciences has agreed to pay $97 million to resolve claims that it violated the False Claims Act by illegally using a foundation as a conduit to pay the co-pays of thousands of Medicare patients taking Gilead’s pulmonary arterial hypertension drug, Letairis (ambrisentan), the US Justice Department announced yesterday. 24 September 2020
Denmark’s Genmab saw its shares drop over a tenth after it emerged the firm was locked in a legal battle over royalties for cancer drug daratumumab. 23 September 2020
An Expert View from Jonathan Roses (pictured, left), counsel, Wolf, Greenfield & Sacks, and Matthew Birkett, partner, Hoffmann Eitle, on the granting of two patents for a single invention in the USA and Europe. 22 September 2020
Canada-based Bausch Health Companies and its gastroenterology business, Salix Pharmaceuticals, have agreed to resolve a set of outstanding intellectual property disputes with Sun Pharmaceutical. 22 September 2020
When US pharma major Bristol Myers Squibb acquired Celgene last year for $74 billion, one of the assets sure to offer an immediate return was Revlimid (lenalidomide). 17 September 2020
US pharma major Eli Lilly has secured a major win in its long-running patent dispute with Fresenius Kabi over Alimta (pemetrexed for injection), a lung cancer drug that generated global sales of around $2.13 billion in 2019. 16 September 2020
Netherlands-incorporated generic major Mylan and US pharma giant Pfizer today announced that the companies have received final approval from the European Commission (EC) for the proposed combination of Mylan and Pfizer's Upjohn business, which will be called Viatris on completion. 15 September 2020
The US Centers for Medicare & Medicaid Services (CMS) last week finalized a rule that would significantly toughen the penalty if hospitals fail to comply with the price-transparency mandate, which takes effect on January 1, 2021. 7 September 2020
US authorities have been urged to review whether Moderna Therapeutics has been upfront about public sources of funding for some of its work. 4 September 2020
Shares of US drugmaker AbbVie closed down 3.4% at $92.24 yesterday, after it was revealed that US House Committee on Oversight and Government Reform chairwoman Carolyn Maloney intends to subpoena AbbVie for documents related to the committee's investigation into how big-name drugmakers price some of the world's best-selling drugs. 2 September 2020
US pharma giant Merck & Co’s Indian subsidiary, which trades under the name Merck Sharp & Dohme, has sued an Indian company seeking to block it from ploughing ahead with its planned generic that Merck alleges would infringe its patent. 28 August 2020
The US Department of Justice (DoJ) has levelled criminal charges against Teva Pharmaceutical Industries for conspiracy to fix prices, rig bids, and allocate customers for generic drugs. 27 August 2020
The pressure for governments, regulatory agencies and drugmakers to come up with medicines to mitigate or end the coronavirus epidemic is intense, as has been seen on numerous occasions this month alone. 26 August 2020
Massachusetts, USA-based DUSA Pharmaceuticals, a subsidiary of India’s Sun Pharmaceutical Industries, has agreed a settlement with the US Department of Justice (DoJ). 25 August 2020
German pharma giant Bayer has announced the settlement of around 90% of US legal claims related to Essure, a discontinued medical device for female sterilization. 21 August 2020