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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
When US pharma major Bristol Myers Squibb acquired Celgene last year for $74 billion, one of the assets sure to offer an immediate return was Revlimid (lenalidomide). 17 September 2020
Pharmaceutical
US pharma major Eli Lilly has secured a major win in its long-running patent dispute with Fresenius Kabi over Alimta (pemetrexed for injection), a lung cancer drug that generated global sales of around $2.13 billion in 2019. 16 September 2020
Biosimilars
Netherlands-incorporated generic major Mylan and US pharma giant Pfizer today announced that the companies have received final approval from the European Commission (EC) for the proposed combination of Mylan and Pfizer's Upjohn business, which will be called Viatris on completion. 15 September 2020
Pharmaceutical
The US Centers for Medicare & Medicaid Services (CMS) last week finalized a rule that would significantly toughen the penalty if hospitals fail to comply with the price-transparency mandate, which takes effect on January 1, 2021. 7 September 2020
Biotechnology
US authorities have been urged to review whether Moderna Therapeutics has been upfront about public sources of funding for some of its work. 4 September 2020
Pharmaceutical
Stock in fish oil-based heart drug specialist Amarin fell precipitously on Wednesday, amid fears that key patents could be at risk. 3 September 2020
Biotechnology
Shares of US drugmaker AbbVie closed down 3.4% at $92.24 yesterday, after it was revealed that US House Committee on Oversight and Government Reform chairwoman Carolyn Maloney intends to subpoena AbbVie for documents related to the committee's investigation into how big-name drugmakers price some of the world's best-selling drugs. 2 September 2020
Generics
US pharma giant Merck & Co’s Indian subsidiary, which trades under the name Merck Sharp & Dohme, has sued an Indian company seeking to block it from ploughing ahead with its planned generic that Merck alleges would infringe its patent. 28 August 2020
Generics
The US Department of Justice (DoJ) has levelled criminal charges against Teva Pharmaceutical Industries for conspiracy to fix prices, rig bids, and allocate customers for generic drugs. 27 August 2020
Pharmaceutical
The pressure for governments, regulatory agencies and drugmakers to come up with medicines to mitigate or end the coronavirus epidemic is intense, as has been seen on numerous occasions this month alone. 26 August 2020
Pharmaceutical
Massachusetts, USA-based DUSA Pharmaceuticals, a subsidiary of India’s Sun Pharmaceutical Industries, has agreed a settlement with the US Department of Justice (DoJ). 25 August 2020
Pharmaceutical
German pharma giant Bayer has announced the settlement of around 90% of US legal claims related to Essure, a discontinued medical device for female sterilization. 21 August 2020
Generics
The first generic version of Biogen’s main multiple sclerosis therapy, Tecfidera (dimethyl fumarate), is to launch in the USA. 20 August 2020
Pharmaceutical
The US Department of Justice (DoJ) announced it is suing Teva Pharmaceutical over kickback allegations, shaving a tenth off the Israeli generics giant’s share price on Tuesday. 19 August 2020
Pharmaceutical
The US District Court for the District of Delaware has upheld the validity of the Gilenya (fingolimod) dosage regimen patent, said Swiss pharma giant Novartis. 18 August 2020
Pharmaceutical
In the UK, as the end of the Brexit transition period approaches, the pharmaceutical industry has called on the Government to provide more detailed guidance on the way ahead. 4 August 2020
Pharmaceutical
The High Court has handed down its second judgment in Merck KGaA v Merck Sharp & Dohme, the long-running dispute between two pharmaceutical companies regarding use of the MERCK trade mark. 3 August 2020
Generics
UK-headquartered Indivior has reached an agreement with both the US Department of Justice (DoJ) and the Federal Trade Commission (FTC) to resolve both the Indictment and FTC investigation relating to the company’s branded opioid replacement therapy drug Suboxone Film. 27 July 2020
Pharmaceutical
Catherine Penny, partner, and Elizabeth Butler, associate, Stevens and Bolton LLP, provide an Expert View on an important issue thrown up by the pandemic. 24 July 2020
Generics
Shares of India’s largest drugmaker Sun Pharmaceutical Industries gained 4% to 496 rupees in the early morning trading today, after its US subsidiary, Taro Pharma, reached a settlement agreement with the US Department of Justice. 24 July 2020
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