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
The US Federal Trade Commission filed a complaint in federal district court charging Shire ViroPharma Inc with violating the antitrust laws by abusing government processes to delay generic competition to its branded prescription drug, Vancocin (vancomycin capsules. 8 February 2017
Kitov Pharmaceuticals has announced that the Israeli Securities Authority has begun a formal investigation into the company’s public disclosures around its lead drug candidate, KIT-302. 7 February 2017
The Japan IP High Court has confirmed the decisions of the Japan Patent Office and ruled against domestic firm Sawai in the invalidation trials initiated by Sawai regarding vitamin regimen patents for Alimta (pemetrexed for injection). 2 February 2017
Mylan might have had some share-boosting news with a court victory over a rival on Tuesday, but the shadow of a Federal Trade Commission (FTC) investigation continues to hang over the Netherlands-incorporated company. 31 January 2017
The US District Court for the District of Delaware issued a decision finding all asserted claims of four Orange Book-listed patents relating to the top-selling multiple sclerosis drug Copaxone (glatiramer acetate) 40 mg/mL invalid based on obviousness, according to Netherlands-incorporated Mylan. 31 January 2017
As of now, collaborations between healthcare professionals and pharma in Spain are to be published individually, following an update to Code of Good Practice on the pharmaceutical industry. 30 January 2017
Donald Trump’s warnings on drug prices and the tougher stance being taken by governments in Japan and Europe on paying for medicines make this a worrying time for pharma companies, as they nervously keep an eye on leaders’ pledges, policy changes and payer decisions in these mature markets. 30 January 2017
The European Commission has granted clearance for US drugmaker Abbott Laboratories to acquire Alere, a maker of rapid diagnostics, but with conditions. 26 January 2017
Swiss pharma giant Novartis’ subsidiary Sandoz might have received US approval for Erelzi, a biosimilar to US biotech major Amgen’s Enbrel (etanercept), in August 2016, but it will not go on sale until 2018 at the earliest. 25 January 2017
Korean drugmaker Mezzion blames Dr Reddy's Laboratories for the rejection of its udenafil New Drug Application, and is suing for millions of dollars in damages and lost earnings. 25 January 2017
Endo International has resolved its antitrust dispute with the US Federal Trade Commission (FTC), via a joint motion filed in a Californian district court. 24 January 2017
Biogen’s $1.25 billion agreement to license Forward Pharma’s intellectual property was a clear boon for the Copenhagen, Denmark-based company, whose shares rose a stunning 55% in morning trade on Tuesday. 22 January 2017
UK-headquartered Mallinckrodt has reached a $100 million settlement over a Federal Trade Commission complaint that it violated antitrust laws. 19 January 2017
The US Securities and Exchange Commission (SEC) yesterday announced that Ireland-incorporated drugmaker Allergan (NYSE: AGN) has agreed to admit securities law violations and pay a $15 million penalty for disclosure failures in the wake of a hostile takeover bid. 18 January 2017
The United States Supreme Court has agreed to hear a case that will determine whether companies that develop biosimilar versions of biologics must wait six months before launching them in the USA. 16 January 2017
No company makes more money from a drug than US pharma major AbbVie does from its arthritis treatment Humira (adalimumab), but how long that will go on for could be determined by a UK court case starting on Monday. 14 January 2017
US pharma major Eli Lilly today announced a positive result in its ongoing patent infringement dispute with Israel-based Teva Pharmaceutical Industries. 13 January 2017
US drugmaker Baxter Healthcare has agreed to pay $18.158 million to resolve its criminal and civil liability arising from Baxter’s failure to follow current Good Manufacturing Practices (cGMP) when manufacturing sterile drug products in North Carolina, the Department of Justice announced yesterday. 13 January 2017