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Generics
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
Pharmaceutical
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
Pharmaceutical
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
Pharmaceutical
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
Biosimilars
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
Biotechnology
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
Biotechnology
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
Biosimilars
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
Pharmaceutical
The European Commission has published its fifth Monitoring Report of Patent Settlements in the pharma industry. 8 December 2014
Generics
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
Pharmaceutical
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
Pharmaceutical
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
Pharmaceutical
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
Biotechnology
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
Generics
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
Generics
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
Generics
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
Generics
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
Biotechnology
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
Pharmaceutical
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
Biotechnology
India’s Sun Pharma has been blocked in its efforts to launch its JAK inhibitor Leqselvi (deuruxolitinib) in the USA. 6 November 2024
article
The European Union's antitrust enforcer hit Israeli drugmaker Teva Pharmaceutical Industries (NYSE: TEVA) with a 463 million-euro ($502 million) fine Thursday for launching a smear campaign against a rival multiple sclerosis drug and misusing the patent system to thwart the competitor's attempt to entering the market. 31 October 2024
Biotechnology
UK pharma major GSK has sued USA-based Moderna this week, accusing the latter of violating patents protecting GSK’s COVID-19 vaccine. 16 October 2024
Generics
Two US units of Israel’s Teva Pharmaceutical Industries have agreed to pay $450 million to resolve two matters that allege Teva violated the Anti-Kickback Statute (AKS) and the False Claims Act (FCA), the US Department of Justice (DoJ) announced yesterday. 11 October 2024
Pharmaceutical
GSK has reached a settlement with 10 plaintiff firms, resolving 93% of the Zantac (ranitidine) product liability cases it faced in state courts across the USA. 10 October 2024
Pharmaceutical
Cardiopulmonary diseases specialist Liquidia Corporation closed Monday’s trading 11% higher following a favorable court ruling. 8 October 2024
Generics
Novo Nordisk has reached a settlement with Mylan Pharmaceuticals, now part of Viatris, putting an end to a US patent lawsuit over blockbuster diabetes treatment Ozempic (semaglutide). 8 October 2024
Pharmaceutical
Texas Attorney General Ken Paxton has filed a lawsuit against major pharmaceutical companies, including Eli Lilly (NYSE: LLY), alleging a conspiracy to artificially inflate the prices of insulin by up to 1,000%. 7 October 2024
Biotechnology
Bristol Myers Squibb has scored a major legal victory as a judge in New York dismissed a $6.4 billion lawsuit related to its acquisition of cancer company Celgene. 5 October 2024
Pharmaceutical
The US Department of Health and Human Services (HHS) has released final guidance for the second cycle of Medicare drug price negotiations. 3 October 2024
Pharmaceutical
Texas-based Cassava Sciences was trading 13% lower in Friday’s pre-market trading. 27 September 2024
Pharmaceutical
The Pharmaceutical Research and Manufacturers of America (PhRMA) is continuing its legal challenge against the US government’s drug pricing reforms. 24 September 2024
Pharmaceutical
On Friday, the USA’s Federal Trade Commission (FTC) brought action against the three largest prescription drug benefit managers (PBMs) - Caremark Rx, Express Scripts (ESI), and OptumRx 23 September 2024
Pharmaceutical
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
Generics
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
Generics
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
Generics
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
Biosimilars
Regeneron Pharmaceuticals has filed a lawsuit against Sandoz, alleging that its biosimilar to Eylea (aflibercept) infringes certain patents. 29 August 2024
Pharmaceutical
Ireland-headquartered Avadel Pharmaceuticals has updated on litigation with USA-based Jazz Pharmaceuticals. 29 August 2024
Pharmaceutical
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
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