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 chief executive of Medicines Australia has called for a strengthening of Australia’s intellectual property system in order to restore the country’s place as a global biotech and pharma leader. 26 November 2014
US generic drugmaker Mylan today confirmed that it and several subsidiaries have been sued by US drugmaker Baxter International and two of its affiliates in connection with the filing of an Abbreviated New Drug Application with the US Food and Drug Administration for esmolol HCl in sodium chloride injection. 25 November 2014
US drugmaker Supernus Pharmaceuticals has sued generic drug makers Zydus Pharmaceuticals (USA) and Indian parent Cadila Healthcare for infringement of three patents covering its antiepileptic drug Trokendi (topiramate) XR. 25 November 2014
Commenting on recent evaluations of generic drug prices, Ralph Neas, president and chief executive of the US Generic Pharmaceutical Association (GPhA) argued that generic medicines are a critical part of system-wide efforts to hold down health care costs. 24 November 2014
Indian pharma company Ranbaxy has been denied its request to prevent the US Food and Drug Administration from approving other generic versions of Nexium (esomeprazole) produced by AstraZeneca, and Roche’s Valcyte (valganciclovir). 21 November 2014
Danish biopharmaceutical company Forward Pharma has filed a law suit against US biotech major Biogen Idec and its European subsidiaries alleging infringement of its German utility model DE 20 2005 022 112 due to Biogen Idec's marketing of Tecfidera (dimethyl fumarate) in Germany. 18 November 2014
The European Union Civil Service Tribunal yesterday gave its judgement on a case involving an appeal by an individual against the selection procedure in 2011 for the appointment of the Executive Director of the European Medicines Agency. 14 November 2014
The US District Court for the District of Columbia, presiding in a law suit between Japanese drugmaker Takeda and the US Food and Drug Administration, has set an accelerated hearing to resolve the case. 10 November 2014
Two US Senators have announced their intention to introduce a bill to speed the development of treatments and vaccines for Ebola by adding Ebola to FDA’s priority review “voucher” program, a program at the Food and Drug Administration designed to incentivize the development of new drugs for neglected tropical diseases. 30 October 2014
Danish diabetes care giant Novo Nordis on Friday revealed it had been served with a subpoena by the office of the US Attorney for the District of Massachusetts. 25 October 2014
The US District Court for the District of Delaware has upheld US pharma giant Pfizer’s basic patent and the L-malate salt patent covering Sutent (sunitinib malate) capsules. 23 October 2014
Ireland-headquartered generics major Actavis confirmed that it has prevailed in a court battle over the patent on its contraceptive pill Lo Loestrin FE (norethindrone acetate and ethinyl estradiol tablets, ethinyl estradiol tablets and ferrous fumarate tablets). 23 October 2014
USA-based Amgen has filed a law suit in the US District Court of Delaware against French pharma major Sanofi and US biotech Regeneron Pharmaceuticals for patent infringement of US Patent Numbers 8,563,698, 8,829,165, and 8,859,741. 19 October 2014
Ireland-headquartered generics major Actavis confirmed that it has filed an Abbreviated New Drug Application with the US Food and Drug Administration seeking approval to market a methylphenidate for extended-release oral suspension. 16 October 2014
The patent battle over Israel-based Teva Pharmaceutical Industries’ multiple sclerosis drug Copaxone (glatiramer acetate) was heard by the US Supreme Court yesterday. 16 October 2014
A federal judge from the US District Court for the Southern District of Ohio entered a consent decree for permanent injunction against Ascend Laboratories. The US Department of Justice filed the consent decree on behalf of the Food and Drug Administration. 15 October 2014
Swiss pharma major Novartis has received a penalty charge of 3 billion rupees from the Indian National Pharmaceutical Pricing Authority (NPPA) for overcharging for its painkiller Voveran (diclofenac, also sold under the Voltaren trade name). 14 October 2014
UK specialist health care company BTG says it has settled its US patent infringement complaint against Instituto Bioclon of Mexico and USA-based Rare Disease Therapeutics (RDT) relating to its rattlesnake venom product CroFab. 10 October 2014
One of the main messages from the keynote speech at the UK Bioscience Forum by Paul Drayson, chief executive of Drayson Technologies and previous minister for science and innovation, was that the country needs to give incentives for investors to hold their investment for more than 10 years. 8 October 2014