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
Madrid-based PharmaMar has launched a legal action against the European Commission to try to secure European Medicines Agency (EMA) approval for Aplidin (plitidepsin). 10 January 2019
Imogen Ireland, life sciences IP associate for law firm Hogan Lovells, raises some important issues relating to advances in artificial intelligence (AI) that drugmakers may not have fully considered, in an Expert View piece. 9 January 2019
Israeli generics giant Teva Pharmaceutical Industrie announced that it has resolved its ongoing dispute with Amgen over Teva’s generic cinacalcet HCl, 3 January 2019
Ironwood Pharmaceutical and Allergan have reached an agreement with Mylan Pharmaceuticals resolving patent litigations brought in response to Mylan’s Abbreviated New Drug Applications (ANDAs) approval to market generic versions of Linzess (linaclotide) prior to the expiration of the companies’ applicable patents. 3 January 2019
Endo International today announced that, due to the ongoing federal government shutdown, the US Food and Drug Administration has requested a further stay of Endo's ongoing litigation against the FDA for the duration of the shutdown. 31 December 2018
DUSA Pharmaceuticals, a wholly-owned subsidiary of Sun Pharmaceutical Industries, has been granted preliminary injunctive relief by a federal district court prohibiting defendants Germany-based skin cancer specialist Biofrontera and its subsidiaries from using DUSA's confidential and proprietary trade secret information. 27 December 2018
The US Department of Justice obtained more than $2.8 billion in settlements and judgments from civil cases involving fraud and false claims against the government in the fiscal year ending September 30, 2018, it was announced on Friday. 24 December 2018
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