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
Privately-held Swiss cancer specialist Helsinn Group say it has entered into a settlement agreement with Sandoz Inc to resolve their patent litigations relating to Helsinn’s Aloxi (palonosetron HCl injection) in the USA. 12 January 2015
US Senators Amy Klobuchar (Democrat, Minnesota) and John McCain (Republican, Arizona) last week resumed their fight to reduce prescription drug costs for American families. 12 January 2015
Ireland-headquartered generics major Actavis has had its motion to expedite its appeal of a lower court ruling requiring it to continue distribution of Namenda (memantine HCl) immediate-release tablets approved. 7 January 2015
Japanese drugmaker Chugai Pharmaceutical says that, on December 24, the Tokyo District Court granted Chugai an overall victory for the first instance demanding the suspension of patent infringement of the manufacturing process patent owned by Chugai (Patent No 3310301), related to Oxarol (maxacalcitol) ointment. 29 December 2014
In fiscal year 2013, companies filed a total of 145 final patent dispute settlements, of which 29 created potential “pay-for-delay” agreements between branded and generic drug companies, according to a new staff report from the USA’s Federal Trade Commission. 23 December 2014
US biopharma firm Vanda Pharmaceuticals says it has reached a settlement agreement with Swiss drug major Novartis related to the ongoing license arbitration proceedings on Fanapt (iloperidone), its drug to treat schizophrenia. 23 December 2014
The United States has filed a civil False Claims Act complaint against Omnicare alleging that it solicited and received millions of dollars in kickbacks from drugmaker Abbott Laboratories, the Justice Department announced yesterday. 23 December 2014
Ireland-headquartered generics major Actavis is filing an emergency appeal to the US Court of Appeals for the Second Circuit to overturn a ruling that it must discontinue distribution of Namenda (memantine HCl). 16 December 2014
The Spanish Supreme Court has reviewed a ruling adopted by the Audiencia Nacional, itself annulling a decision of the Spanish Competition Authority, which declared that dual pricing contracts implemented by US pharma giant Pfizer did not infringe European Union competition rules. 15 December 2014
German pharma major Bayer suffered a significant disappointment on Friday, when India’s Supreme Court rejected the company’s appeal against a Bombay High Court decision, which in July refused to revoke a compulsory licence. 13 December 2014
Ireland-headquartered generic drugmaker Actavis confirmed that Judge Robert Sweet of the US District Court for the Southern District of New York (New York City) has announced an intent to issue a preliminary injunction apparently requiring the company to continue distribution of Namenda (memantine HCl) immediate-release tablets. 12 December 2014
The USA's Generic Pharmaceutical Association (GPhA) has agreed to support compromise automatic substitution legislation that would allow interchangeable biologics to be automatically substituted at the pharmacy. 11 December 2014
US law firm Chimicles & Tikellis of Haverford, PA, has filed a law suit on behalf of the Southeastern Pennsylvania Transportation Authority (SEPTA) in federal court in Philadelphia, PA, against Gilead Sciences related to the sale and pricing of its hepatitis-C drug, Sovaldi (sofosbuvir). 10 December 2014
US Health and Human Services Secretary Sylvia Burwell yesterday announced a declaration under the Public Readiness and Emergency Preparedness (PREP) Act to facilitate the development and availability of experimental Ebola vaccines. 10 December 2014
US biotech giant Amgen saw its shares rise 1.9% to $172.00 yesterday after the top US patent appeal court upheld its dismissal of a law suit by Sandoz, the generics unit of Swiss pharma major Novartis, relating to the blockbuster arthritis and psoriasis drug Enbrel (etanercept). 9 December 2014
Anglo-Swedish pharma major AstraZeneca revealed on Friday that a jury in the US District Court for the District of Massachusetts returned a verdict in favor of the company in a multi-district antitrust case filed by various purchaser groups challenging the previous settlement of Nexium (esomeprazole) patent litigation with India-headquartered generic drugmaker Ranbaxy. 7 December 2014
Allegations have been made that French drug major Sanofi and members of its executive took part in a kickback scheme and illegally paid $34 million in payments to induce prescribers to choose its diabetes medication. 5 December 2014
Swedish pharma company Meda Pharmaceuticals and Indian drugmaker Cipla today have sued Canada-headquartered generics firm Apotex Inc and Apotex Corp in the US Federal District Court in Delaware to enforce the Orange-Book listed patents covering Dymista (azelastine HCl/fluticasone propionate) Nasal Spray. 4 December 2014
The UK is lagging behind other European companies in terms of protecting sensitive information, responding to risks to that information, and has been for three years in a row, according to research from enterprise information management services company Iron Mountain and professional services network PwC. 26 November 2014