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
A coalition of several European organizations, including the European Federation of Pharmaceutical Industries and Associations (EFPIA), have been closely monitoring the developments regarding the EU Commission proposal for a regulation on European Union compulsory licensing for crisis management. 17 May 2024
US pharma major Eli Lilly has provided an update on compounding litigation relating to tirzepatide, its drug for type 2 diabetes and weight loss that is marketed as Mounjaro and Zepbound. 16 May 2024
More than 86% of the National Pharmaceutical Pricing Authority's (NPPA) total demand for overcharging remains unrecovered from drug majors operating in India. 15 March 2024
Sino-American biotech BeiGene on March 8 disclosed in stock exchange announcement that it has filed patent infringement suits under the Hatch-Waxman Act against the US subsidiary of Swiss firm Sandoz and separately against Indian-owned companies MSN Pharmaceuticals and MSN Laboratories Private in the US District Court for the District of New Jersey. 9 March 2024
In another legal blow for opponents of the Inflation Reduction Act (IRA), a federal judge has now rejected a bid from AstraZeneca to prevent price negotiations on its diabetes med Farxiga (dapagliflozin). 4 March 2024
Xandra Neuberger, associate director, regulatory affairs and international service lead for clinical trial applications at PharmaLex, provides an Expert View. 29 February 2024
Swiss generics and biosimilars drugmaker Sandoz today announced that its US subsidiaries – Sandoz Inc and Fougera Pharmaceuticals - have entered into a settlement agreement with the class of direct purchaser plaintiffs in the multidistrict litigation entitled In re Generic Pharmaceuticals Pricing Antitrust Litigation in the US District Court for the Eastern District of Pennsylvania. 29 February 2024
The US Department of Justice on Thursday released its latest data on recoveries under the False Claims Act, saying there were nearly $2.7 billion in settlements and judgments in the 2023 fiscal year, an increase from the prior year's haul. 23 February 2024
The USA’s Creating Hope Reauthorization Act of 2024 was introduced in the House of Representatives last week, prompting US trade group Biotechnology Innovation Organization (BIO) chief executive and president, Rachel King, to make the following statement following the bill's introduction: 21 February 2024
The Indian Commerce Ministry confirmed has rejected of Switzerland's demand for data exclusivity for medicines in the India-EFTA trade deal, and emphasised the importance of protecting the country’s generic drug production and supply. 16 February 2024
Tesaro, a subsidiary of UK pharma major GSK, has come up on top in the latest stage of its legal battle with Anglo-Swedish drugmaker AstraZeneca regarding the ovarian cancer drug Zejula (niraparib). 15 February 2024
US trade group Pharmaceutical Research and Manufacturers of America (PhRMA) has made clear its opposition to the drug price-setting provisions in the Biden administration’s Inflation Reduction Act (IRA). 14 February 2024
American dermatology company Verrica Pharmaceuticals has filed a lawsuit against Canada’s Dormer Laboratories related to the active ingredient cantharidin. 5 February 2024
Healthcare giant Johnson & Johnson has reportedly reached a tentative settlement to resolve probes by US states into whether it misled consumers about the safety of its talc products. 24 January 2024
The US Court of Appeals for the Second Circuit yesterday affirmed a district court ruling which ordered “pharma bro” Martin Shkreli to face a lifetime ban from participating in the pharmaceutical industry. 24 January 2024
Generics and biosimilars trade group Medicines for Europe and its members are strongly concerned by the first judgement on the Supplementary Protection Certificate (SPC) manufacturing waiver issued by the Munich District Court, Germany, in October 2023. 19 January 2024
Japanese drugmaker Daiichi Sankyo yesterday announced that the US Patent and Trademark Office (US PTO) rendered a Final Written Decision invalidating all claims of Seagen’s US patent 10,808,039 (the ’039 patent) that were challenged by Daiichi Sankyo in a post-grant review proceeding (PGR). 18 January 2024
A generics drugmaker has had its Abbreviated New Drug Application for the radiopharmaceutical 177Lu-PNT2003 accepted by the US Food and Drug Administration. 12 January 2024
Grifols, the Spanish producer of blood plasma-based products, is not taking the stock market damage done to the company by UK short seller Gotham City Research without a fight. 11 January 2024