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 of Ireland-headquartered Shire were down 3.3% at £45.26 mid-morning following the news that it will pay $350 million to settle US federal and state False Claims Act allegations. 12 January 2017
US generic drugmaker Impax Laboratories today confirmed that it has filed an Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration containing a paragraph IV certification for a generic version of Aubagio. 6 January 2017
French pharma major Sanofi and US biotech Regeneron Pharmaceuticals immediately announced their intention to appeal a ruling which will stop them from selling their cholesterol-lowering drug Praluent (alirocumab) in the USA. 6 January 2017
An inter partes review (IPR) is usually an unpleasant business for a patent owner, writes Greg DeLassus, a principal at international intellectual property (IP) firm Harness Dickey, in an expert view piece for The Pharma Letter. 4 January 2017
Boehringer Ingelheim has agreed to divest five types of animal health products in the USA to settle charges that a proposed asset swap with France’s Sanofi would harm competition, the US Federal Trade Commission announced on Wednesday. 29 December 2016
The US Federal Trade Commission has said that its proposed $25 billion acquisition of St Jude Medical would likely be anticompetitive without certain divestments. 28 December 2016
The Russian General Prosecutor's Office will check information about the bribes that were allegedly paid by Teva Russia to a certain Russian top official for the assistance in the promotion its products during state tenders for public procurement of drugs in Russia. 27 December 2016
Israel-based Teva Pharmaceutical Industries and its wholly-owned Russian subsidiary have agreed to resolve criminal charges and to pay a criminal penalty in connection with schemes involving the bribery of government officials in Russia, Ukraine and Mexico in violation of the Foreign Corrupt Practices Act (FCPA). 23 December 2016
Denmark-based allergy specialist ALK-Abelló is to pay up to 238 million Danish kroner ($20 million) to acquire the activities and assets of Allergy Laboratories and Crystal Laboratory in a deal aimed at strengthening its US supply chain. 22 December 2016
Ireland-incorporated drugmaker Allergan has announced that a $38 million settlement fee has been agreed to bring to an end a US federal investigation over the sales and marketing practices of its Forest subsidiary companies. 16 December 2016
The US government has obtained more than $4.7 billion in settlements and judgments from civil cases involving fraud and false claims against the government in fiscal year 2016 ending September 30, with more than half coming from the health care industry. 15 December 2016
The US Department of Justice (DoJ) has announced two former senior generic pharmaceutical executives have been charged over price-fixing of generic medicines. 15 December 2016
The UK regulator has ruled on breaches of the Association of British Pharmaceutical Industry code of conduct by five separate pharma companies. 13 December 2016
US specialty pharma Vanda Pharmaceuticals has come to an agreement with Canadian generics firm Apotex in a patent dispute over the schizophrenia drug Fanapt (iloperidone). 8 December 2016
Leading Indian drugmaker Sun Pharmaceutical Industries was trading 4.5% lower than it was at Tuesday’s close at a current 675.35 rupees after news that the US Food and Drug Administration (FDA) had raised further concerns about its Halol manufacturing plant in Gujarat. 8 December 2016
US drugmaker Abbott has filed a complaint to terminate its proposed acquisition of Alere based on the substantial loss in Alere's value following the merger agreement. 8 December 2016
The Belgian Competition Authority (BCA) has confirmed that it is inspecting several companies involved in the wholesale distribution of pharmaceutical and para-pharmaceuticals products to pharmacies. 25 November 2016