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 Department of Health and Human Services (HHS) has filed a patent infringement lawsuit against Californian biotech major Gilead Sciences. 7 November 2019
Daiichi Sankyo said today it has filed a Declaratory Judgement action in the District Court of Delaware in response to receiving communications from Seattle Genetics with respect to a collaboration between the two companies from 2008 to 2015 for the development of antibody-drug conjugates (ADCs). 5 November 2019
Maurits Lugard and Anna-Shari Melin from law firm Sidley Austin provide an Expert View on the European Medicines Agency’s (EMA) recent guidance on medicinal product shortages and implications of this guidance. 24 October 2019
US healthcare giant, Johnson & Johnson and its USA-based Janssen Pharmaceutical Companies confirm an agreement in principle to settle opioid litigation as publicly announced and outlined by a committee of State Attorneys General on October 21, 2019, the company revealed in a filing with the Federal Trade Commission. 24 October 2019
Specialty pharma company Pharming Group has announced that CSL Behring has dropped charges relating to the alleged stealing of proprietary information. 24 October 2019
Israeli drugmaker Teva Pharmaceutical Industries has announced progress in its attempts to settle cases that allege the company had a role in the US opioid crisis. 22 October 2019
Dutch specialty pharma company Pharming Group has been named in an injunction secured in the USA by CSL Behring over the alleged stealing of proprietary information. 17 October 2019
Acorda Therapeutics failed in its appeal to have the US Supreme Court overturn a decision that had invalidated patents protecting its multiple sclerosis (MS) drug Ampyra (dalfampridine). 8 October 2019
The Japanese Intellectual Property High Court has ruled in favor of the Roche majority-owned subsidiary Chugai in relation to allegations that its hemophilia A drug Hemlibra (emicizumab-kxwh) breached another company’s patent. 3 October 2019
Africa’s largest drug company will have to pay back ill-gotten gains to the UK’s National Health Service (NHS) after accepting its role in an illegal agreement that resulted in significant price hikes for an essential medicine. 3 October 2019
Japanese drugmaker Asahi Kasei Pharma has filed a complaint requesting a preliminary injunction against Endo Ventures Limited and Endo Pharmaceuticals to require Ireland-incorporated Endo to continue to supply the company with Xiaflex (collagenase clostridium histolyticum), for the treatment of Dupuytren’s contracture. 2 October 2019
US healthcare giant Johnson & Johnson and its Janssen Pharmaceutical Companies yesterday announced a $20.4 million settlement agreement with the Ohio counties of Cuyahoga and Summit that resolves all of the counties’ claims with no admission of liability and removes the company from the bellwether federal trial against drugmakers blamed for the US opioid crisis scheduled to begin October 21, 2019. 2 October 2019
Avanir Pharmaceuticals was charged for paying kickbacks to a physician to induce prescriptions of its drug Nuedexta (dextromethorphan hydrobromide/quinidine sulfate), the US the Department of Justice announced on Thursday. 27 September 2019
The US Federal Trade Commission has sent letters to seven legal practitioners and lead generators expressing concerns that some television advertisements that solicit clients for personal injury lawsuits against drug manufacturers may be deceptive or unfair under the FTC Act. 25 September 2019
The Pfizer subsidiary King Pharmaceuticals and Alissa Healthcare Research have admitted illegally sharing information relating to nortriptyline in order to keep UK prices of the generic drug high. 20 September 2019
Bankrupt US drugmaker Insys Therapeutics received court permission to sell its flagship product Subsys (fentanyl sublingual spray) on Thursday. 20 September 2019
US drugmaker Purdue Pharma has filed for bankruptcy and announced an agreement in principle on a framework for settling the opioid litigation facing the company in the USA. 17 September 2019
UK-based inhaled therapies developer Vectura today said that, following the award of $89.7 million in damages to Vectura by a jury in the US District Court for the District of Delaware on May 3, 2019, presiding US District Judge Richard Andrews has ruled on the parties’ post-trial motions: 13 September 2019