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
Daniel Gallagher – who from November 2011 to October 2015 was Commissioner of the US Securities and Exchange Commission (SEC) – has joined Netherlands-incorporated drugmaker Mylan as the company’s chief legal officer. 28 March 2017
Chugai Pharmaceutical has announced its final victory in a lawsuit in which it sought injunction against generic drug manufacturers based on infringement of the process patent (Patent No 3310301 on Oxarol. 27 March 2017
Key authorities, eminent lawyers and industry leaders this week discussed in London the proposals put forward by the European Commission to stimulate jobs and growth in the pharmaceutical sector in Europe at the Medicines for Europe 13th Legal Affairs Conference. 23 March 2017
Having not only lost out on damages worth C$500 million ($374 million), US pharma major Eli Lilly faces a bill of around C$5 million due to a lost legal fight with the Canadian government. 22 March 2017
A quartet of companies have been named and shamed for breaching the Association of the British Pharmaceutical Industry’s (ABPI) code of practice. 14 March 2017
A Delaware judge has ordered a delay in the closing of a $2 billion drug licensing deal between US biotech companies Immunomedics and Seattle Genetics. 10 March 2017
When a UK High Court judge handed down a judgement to clear the route to market for biosimilar versions of the world’s biggest-selling prescription drug on Friday, the impact on the three companies involved was always going to be significant. 8 March 2017
Swiss customs seized over 1,000 shipments of illegally imported therapeutic products last year, says Swissmedic, the body responsible for the authorisation and supervision of therapeutic products in Switzerland. 8 March 2017
Indian drugmaker Zydus Cadila has announced that it has finalized an agreement with the USA’s Supernus Pharmaceuticals to settle all outstanding patent litigation related to Trokendi XR (topiramate) extended-release capsules. 7 March 2017
On Friday morning, a judgment was handed down in the hard-fought litigation between Japan’s Fujifilm Kyowa Kirin Biologics (FKB) and the USA’s AbbVie. 4 March 2017
The UK’s Competition and Markets Authority (CMA) today alleged that Concordia and Actavis UK signed illegal agreements which enabled high prices for a life-saving drug to be prolonged. 3 March 2017
US Senators Cory Booker (Democrat, New Jersey), Bernie Sanders (Independent, Vermont) and Bob Casey (Dem, Pennsylvania) introduced legislation Tuesday to lower the skyrocketing cost of prescription drugs by allowing Americans to import safe, low-cost medicine from Canada. 1 March 2017
Following a public comment period, the US Federal Trade Commission has approved a final order settling charges that Boehringer Ingelheim’s $13.53 billion asset swap with Paris, France-based Sanofi would likely be anticompetitive. 27 February 2017
Pernix Therapeutics has received a favorable patent infringement ruling against Actavis Laboratories regarding a proposed generic version of opioid pain treatment Zohydro ER (hydrocodone bitartrate). 23 February 2017
An industry trade group representing manufacturers of generic and biosimilar products has urged the US Supreme Court not to grant biotech firms an extra six months of patent exclusivity. 23 February 2017
Debiopharm International has filed an appeal before the Supreme Court of Japan against the decision from the IP High Court (a special branch of the Tokyo High Court),. 23 February 2017
Biocad and R-farm, the exclusive distributor for Swiss pharma giant Roche, continue their legal battles in Russia regarding the sale of Roche’s blockbuster cancer drug Herceptin (trastuzumab) and a biosimilar produced by Biocad. 21 February 2017
The Court of Appeals for the Federal Circuit has stayed (suspended) the permanent injunction for Praluent (alirocumab) Injection granted last month in a patent infringement dispute with US biotech Amgen pending an appeal. 9 February 2017