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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
Pharmaceutical
After two week of trial and two days of deliberation, a Philadelphia jury has up a defense verdict in favor of Germany’s Bayer and Johnson & Johnson subsidiary Janssen Pharmaceuticals, finding that the label on the blood thinner Xarelto (rivaroxaban) adequately warned patients about the danger of severe bleeds, reported the publication Legal Intelligence. 30 April 2018
Generics
The benefits of the European Commission’s proposed Supplementary Protection Certificate (SPC) manufacturing and export exemption have been stressed at an event staged by the group representing the generic, biosimilar and value-added medicines industries across Europe. 25 April 2018
Biosimilars
Since October of 2017, US drugmaker AbbVie has reached two settlements with biosimilar manufacturers over the entry date of their biosimilar versions of Humira (adalimumab) into the US market. 24 April 2018
Generics
Specialty generic drugmaker Akorn is crying foul at news which sent its share price sliding by 30% on Monday. 23 April 2018
Pharmaceutical
Valeant Pharmaceuticals International has announced that the Arbitral Tribunal issued a decision (rendered on April 9, 2018) relating to the arbitration between Santarus and Valeant Pharmaceuticals Ireland (collectively "Valeant"), and Cosmo Technologies, the licensor of certain intellectual property rights in, and supplier of, Valeant's ulcerative colitis drug Uceris (budesonide). 13 April 2018
Biosimilars
Chugai Pharmaceutical] announced today that it has decided to waive its claim in a patent infringement lawsuit against Nippon Kayaku. 11 April 2018
Biotechnology
Japanese drug major Mitsubishi Tanabe Pharma has filed a request for arbitration against Kolon Life Science, a South Korean company that until last month was called TissueGene. 10 April 2018
Generics
The Russian Federal Anti-Monopoly Service (FAS) suspects R-Pharm, one of the country’s suppliers of drugs for state needs, is in illegal collusion with the country’s Ministry of Health, which may allow the company to receive large-scale contracts with the state, reports The Pharma Letter’s local correspondent. 9 April 2018
Biosimilars
The arrival of competition for Humira (adalimumab), the world’s best-selling drug, in its most lucrative market, remains comfortably far away for AbbVie after the settlement of a patent dispute. 5 April 2018
Pharmaceutical
The US business of London-listed Indivior says it has filed patent infringement lawsuits against Dr Reddy's Laboratories, Actavis, Par Pharmaceutical, Alvogen and Teva Pharmaceutical Industries relating to their respective proposed generic versions of Suboxone (buprenorphine and naloxone). 5 April 2018
Pharmaceutical
The US Department of Justice is to weigh in on litigation against opioid manufacturers and distributors, with a motion to act as a ‘friend of the court’ in the ongoing settlement negotiations. 3 April 2018
Pharmaceutical
Daiichi Sankyo has reached an agreement to modify certain aspects of the settlement program, which was entered into and announced on August 1, 2017, on behalf of all defendants, resolving pending product liability litigation related to olmesartan products. 3 April 2018
Biotechnology
A Japanese court has dismissed an allegation that Chugai infringed a patent in relation to its hemophilia A medicine Hemlibra (emicizumab). 28 March 2018
Biotechnology
On Tuesday, US Representative Steve Stivers (Republican, Ohio) and Representative Bill Foster (Democrat, Illinois) introduced HR 5340, the Support Technology & Research for Our Nation’s Growth and Economic Resilience (STRONGER) Patent Act, in order to strengthen the USA’s crippled patent system. 21 March 2018
Pharmaceutical
The US House of Representatives has voted against the so-called "right to try" legislation, a proposal which would have permitted terminally ill patients in the USA to gain direct access to candidate therapies before they have been approved by the US Food and Drug Administration. 15 March 2018
Biotechnology
Police in St Petersburg are said to be investigating former employees of the Russian business of Swiss drugmaker Roche, in connection with theft allegations relating to MabThera (rituximab). 13 March 2018
Pharmaceutical
Right to Try laws give terminally ill patients access to therapies that have passed Phase I testing but have not achieved US Food and Drug Administration approval. The FDA’s current program, expanded access, already gives these patients access to experimental drugs, but Right to Try laws expedite the process and reduce the FDA’s role in it, comments Dr Nicola Davies in her monthly FDA blog for The Pharma Letter. 12 March 2018
Pharmaceutical
Endo International, along with its subsidiaries Par Pharmaceutical and Par Sterile Products, have obtained a preliminary injunction preventing QuVa Pharma from marketing and releasing its planned vasopressin product that would compete with Par's Vasostrict. 2 March 2018
Pharmaceutical
After a US appeals court last year ruled against Helsinn Healthcare in its patent dispute with Israel’s Teva Pharmaceutical Industries, the Swiss company has now announced it will take its legal battle to the highest court in the land. 1 March 2018
Pharmaceutical
A federal jury in New Jersey has ruled against Biogen and in favor of Pfizer and collaboration partner Merck KGaA in an eight year legal battle over competing multiple sclerosis medications. 27 February 2018
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