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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
India continues to be on the 'Priority Watch List' of the US Trade Representative (USTR) for lack of sufficient measurable improvements to its Intellectual Property framework. 4 May 2020
Biotechnology
A UK High Court ruling has invalidated patents held by San Francisco-based FibroGen, clearing the way for Akebia Therapeutics to proceed with a new class of medicine to treat anemia. 20 April 2020
Pharmaceutical
Much as COVID-19 was the focus of news last week, other things were happening too. Among these, Danish CNS specialist Lundbeck suffered a couple of signification setbacks, first with Tourette syndrome candidate Lu AG06466, and then even worse, with Parkinson’s hopeful foliglurax. There was better news for Bayer and Merck & Co, whose heart failure drug vericiguat saw positive results presented at the American College of Cardiology’s meeting. On the legal front, there was a major disappointment for Amarin, when a US court declared that the company’s patents on its fish oil-based cardiovascular drug Vascepa were not valid. Deal-making news included Daiichi Sankyo acquiring gene therapy manufacturing technology from Ultragenyx, signalling an interest in expanding the company’s focus. Also, Fate Therapeutics agreed a deal with Johnson & Johnson for rights to its iPSC platform. 5 April 2020
Biotechnology
The US Food and Drug Administration has dropped an investigation into Novartis company AveXis, related to the novel spinal muscular atrophy (SMA) Zolgensma (onasemnogene abeparvovec-xioi). 1 April 2020
Pharmaceutical
Fish oil-based drug Vascepa (icosapent ethyl) could make a smaller splash than Amarin had hoped, after a US court nixed part of its patent estate. 31 March 2020
Biotechnology
As the world watches aghast, the novel coronavirus continues to spread its tentacles around the globe, with cases of COVID-19 rising to nearly 375,000 on Tuesday, an increase of 75,000 from the day before. 25 March 2020
Pharmaceutical
The German Constitutional Court has published its decision that the German Act implementing the Unified Patent Court system is unconstitutional. 21 March 2020
Biotechnology
A US court in Delaware has ruled in favor of Oxford Nanopore Technologies, in patent litigation between the UK biotech and California’s Pacific Biosciences (PacBio). 19 March 2020
Pharmaceutical
The US Prescription Drug Pricing Reduction Act introduced by Senators Charles Grassley (Republican, Iowa) and Ron Wyden (Democrat, Oregon) could generate over $94 billion in savings over the next decade if enacted, according to an analysis from the Congressional Budget Office. 19 March 2020
Generics
UK-incorporated generics drugmaker Mylan has moved a step nearer to marketing its copy version of Lantus (insulin glargine) in the USA, as the District Court of New Jersey yesterday found the device patent claims (US Patent No 9,526,844) asserted by French pharma major Sanofi against Mylan's insulin glargine product not infringed and invalid for lack of written description. 11 March 2020
Biotechnology
A court has dismissed a class action and related litigation that was filed against USA-based OncoSec Medical Incorporated by an investor that had launched a takeover attempt. 9 March 2020
Generics
The UK’s Competition and Markets Authority (CMA) has found that four pharmaceutical companies broke the law in relation to the supply of the anti-depressant drug nortriptyline. 4 March 2020
Pharmaceutical
Shares in UK-incorporated drugmaker Mallinckrodt were 33% higher after two hours of trading on Tuesday. 25 February 2020
Biosimilars
Last week’s news included Bristol-Myers Squibb deciding to pull its application with the European Medicines Agency for the combination of its top-selling drug Opdivo with Yervoy for certain cancer patients. US biotech Biogen had a boost last Wednesday when it prevailed in a patent dispute with Mylan over multiple sclerosis drug Tecfidera. On the research front and in the face of the ever-increasing impact of the coronavirus epidemic, Gilead Sciences joined the fight with its investigational antiviral remdesivir and entering trials in China, and GlaxoSmithKline linked up with the Coalition for Epidemic Preparedness Innovations. Last week also saw the US Food and Drug Administration and the Federal Trade Commission announce a cooperation on making biosimilars more accessible. And, along with its 2019 financial results, US pharma giant Merck & Co said it plans to spin out its established products into a new company. 9 February 2020
Pharmaceutical
An Expert View on how licensors and licensees can best protect their patent from Charlotte Tillett and Astrid Arnold from Stevens & Bolton. 8 February 2020
Pharmaceutical
Shares in Biogen jumped by around a third on Wednesday, after the company received a positive outcome in an ongoing patent dispute with Netherlands-incorporated generics firm Mylan (Nasdaq: MYL). 6 February 2020
Biotechnology
Shares of US biotech major Gilead Sciences on Wednesday fell as much as 4.9% after the company revealed that its request for an inter partes review (IPR) by the US Patent and Trademark Office (USPTO) of patents granted to the US Department of Health and Human Services (HHS) for HIV pre-exposure prophylaxis (PrEP). 6 February 2020
Generics
The European Court of Justice today issued a ruling in relation to the case that drug companies supplying an antidepressant called paroxetine broke the law. 30 January 2020
Biotechnology
The Roche majority-owned drugmaker Chugai has settled with the UK Research and Innovation agency and associated charity LifeArc, nearly three years after the lawsuit was filed against the company. 29 January 2020
Pharmaceutical
The US Federal Trade Commission has filed a complaint in federal court against Vyera Pharmaceuticals, LLC alleging an elaborate anticompetitive scheme to preserve a monopoly for the life-saving drug Daraprim (pyrimethamine). 28 January 2020
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