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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
Generics
Israeli drugmaker Teva Pharmaceutical Industries looks likely to see declining sales of its leading multiple sclerosis drug Copaxone (glatiramer acetate) plummet further following a court ruling on Friday. 15 October 2018
Biosimilars
Japan’s Chugai Pharmaceutical filed a lawsuit to the Tokyo District Court as of October 12, and has also filed a petition for provisional disposition order, demanding the suspension of manufacturing and distribution of the biosimilar of anti-HER2 monoclonal antibody Herceptin (trastuzumab). 15 October 2018
Biosimilars
Sandoz, the generics business of Swiss pharma giant Novartis, today announced a global resolution of all intellectual property (IP) related litigation with AbbVie concerning the proposed Sandoz biosimilar Hyrimoz (adalimumab) for reference medicine Humira (adalimumab). 12 October 2018
Pharmaceutical
American drugmaker Pfizer has agreed to pay $700,000 to settle allegations that it misled customers with a co-payment coupon program in its home state of New York. 12 October 2018
Pharmaceutical
A leading British clinical research organization (CRO), Richmond Pharmacology, has published a detailed report criticizing current UK immigration policy and supporting proposals to install a skills-based migration system after Brexit. 9 October 2018
Generics
Scott Gottlieb, the Commissioner of the US Food and Drug Administration (FDA) and the man with the plan to increase competition in his country’s pharmaceuticals market, has announced a new prong to the agency’s attempts to stop ‘gaming’ of the generic drug approval process. 3 October 2018
Generics
AmerisourceBergen Corp and two of its subsidiaries have agreed to pay $625 million to resolve allegations arising from its operation of a facility that improperly repackaged oncology-supportive injectable drugs into pre-filled syringes and improperly distributed those syringes to physicians treating vulnerable cancer patients. 2 October 2018
Biotechnology
Legend Biotech, a subsidiary of reagents services provider Genscript Biotech Corporation, regained some of Thursday’s stock market losses on Friday. 1 October 2018
Pharmaceutical
A week after a UK court judged that bevacizumab injections could be prescribed for the treatment of wet age-related macular degeneration (wet AMD), German life sciences group Bayer has appealed against the decision. 28 September 2018
Biotechnology
Adding to a busy news week for Gilead Sciences, a court in Brazil has announced it will strip the Californian firm of its exclusivity patent for Sovaldi (sofosbuvir), at the request of presidential candidate Rolando Valcir Spanholo. 26 September 2018
Pharmaceutical
The World Intellectual Property Organization (WIPO) and a global trade body representing research-based pharma have launched an online tool to help procurement agencies better understand the global patent status of medicines. 25 September 2018
Biotechnology
A High Court case win by 12 National Health Service (NHS) Clinical Commissioning Groups (CCGs) in favor of prescribing the significantly cheaper anti-vascular endothelial growth factor (anti-VEGF), Avastin (bevacizumab), over Novartis’ (NOVN: VX) and Bayer’s (BAYN: DE) licensed anti-VEGF eye drugs has import implications, says analyst. 24 September 2018
Pharmaceutical
German pharma major Bayer has hit out at a UK court’s judgement that it is potentially lawful to offer patients bevacizumab injections for the treatment of wet age-related macular degeneration (wet AMD). 21 September 2018
Generics
A review of pending legislation from the non-partisan Congressional Budget Office (CBO) says the bill would allow generics to hit the shelves more quickly and enable the US Government to spend less on prescription drugs. 21 September 2018
Generics
This week’s verdict from Britain’s High Court on Gilead Sciences’ (Nasdaq: GILD) antiretroviral product Truvada (emtricitabine/tenofovir) has been welcomed by Medicines for Europe, the trade group representing generic and biosimilar drugmakers. 21 September 2018
Pharmaceutical
Lawmakers in the US House of Representatives have ditched a widely-supported amendment that would have changed the rules on advertising pharmaceutical products, requiring drugmakers to list prices in TV adverts. 19 September 2018
Generics
UK-based drugmaker Accord Healthcare has won a key decision in the English High Court, paving the way for generic rivals to Gilead’s antiretroviral product Truvada (emtricitabine/tenofovir). 19 September 2018
Pharmaceutical
A key vote in the US House of Representatives this week could open up research opportunities in the USA for drugmakers exploring the clinical potential of cannabis. 11 September 2018
Pharmaceutical
Japan’s highest court for intellectual property disputes has dismissed Shionogi’s lawsuit against a decision by the board of the Japanese Patent Office, related to the firm’s Japanese patent for HIV integrase inhibitors. 7 September 2018
Biotechnology
A US-based former GlaxoSmithKline scientist has pled guilty to a charge of leaking trade secrets, two years after authorities filed a complaint. 5 September 2018
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