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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
Biotechnology
UK novel RNA therapeutics specialist Silence Therapeutics has issued a claim in the UK High Courts of Justice against US biotech firm Alnylam Pharmaceuticals. 5 July 2017
Pharmaceutical
The Cyprus Association of Research and Development Pharmaceutical Companies (KEFEA) has welcomed the vote on the National Health Service (NHS) bill by the House of Representatives Plenum. 3 July 2017
Pharmaceutical
The Italian government has passed a law making childhood vaccinations against 12 diseases mandatory. 26 June 2017
Generics
Mitsubishi Tanabe Pharma has announced that the US District Court of Delaware has ruled that its patent covering Gilenya is valid, and that no generic drug may be approved in the USA before February 2019. 21 June 2017
Generics
The UK Competition and Markets Authority (CMA) has published the full non-confidential decision following its investigation into unfair pricing for phenytoin sodium capsules in the UK. 16 June 2017
Biosimilars
The US Supreme Court has given a potential boost to the biosimilars industry with its ruling in a high-profile case involving the US biotech major Amgen and Sandoz, the generics division of the Swiss pharma giant Novartis. 13 June 2017
article
Maryland will become the first state in the USA to enact a law prohibiting “price gouging” by generic pharmaceutical manufacturers, according to a posting on law firm Hyman, Phelps & McNamara’s FDA Law Blog by David Gibbons and Alan Kirschenbaum. 2 June 2017
Pharmaceutical
A US government estimate suggests that Netherlands-incorporated drugmaker Mylan overcharged American taxpayers by as much as $1.27 billion for its EpiPen (epinephrine) auto-injectors. 1 June 2017
Pharmaceutical
Ohio is to become the second US state to sue the pharmaceutical industry over its role in the opioid epidemic currently facing America, after Mississippi. 1 June 2017
Biotechnology
A cloud is hanging over UK-registered biotech Akari Therapeutics after inaccuracies came to light in a trial comparing its lead product to a rival drug and questions arose over the role of its chief executive in a related report. 31 May 2017
Pharmaceutical
Another New York county has filed a lawsuit against pharma companies and physicians over what it calls ‘aggressive and fraudulent marketing of prescription opium-like painkillers.’ 16 May 2017
Generics
South African drugmaker Aspen Pharma has confirmed that the European Commission has opened proceedings to investigate certain actions of Aspen Holdings and certain of its European subsidiaries. 16 May 2017
Biotechnology
Japanese drug major Chugai Pharmaceutical says that a lawsuit was filed against the company at the US District Court for the District of Delaware. 12 May 2017
Generics
The US Court of Appeals for the Federal Circuit has affirmed judgment in favor of Indian drugmaker Zydus Cadila’s US subsidiary holding that its proposed generic version of Lialda (mesalamine) does not infringe US Patent No 6,773,720. 10 May 2017
Pharmaceutical
Johnson & Johnson revealed in a filing with the Securities and Exchange Commission (SEC) that the US Justice Department has opened an investigation concerning management and advisory services provided to rheumatology and gastroenterology practices that bought its drugs. 9 May 2017
Biotechnology
US drugmaker Alexion Pharmaceuticals took a 3.4% hit to its share price on Monday, reducing its value to $124.48, after news that Brazilian police had raided its Sao Paolo offices in a sales practices probe. 9 May 2017
Pharmaceutical
A company that marketed itself as “the leader in home opiate detox since 2009” and its chief executive have settled US Federal Trade Commission (FTC) charges that the withdrawal treatment claims for their “Withdrawal Ease” and “Recovery Ease” products were false or unsupported by scientific evidence. 5 May 2017
Generics
Generic drugmaker Perrigo lost 5% in its stock-market value on Wednesday, closing at $72.35, amid news of a raid on its corporate offices in relation to the US Department of Justice Antitrust Division investigation into price fixing. 4 May 2017
Pharmaceutical
The Data Monitoring Committee (DMC) appointed in connection with Tel Aviv-based Kitov Pharmaceuticals’ Phase III clinical trial of KIT-302 is the subject of the ongoing Israeli Securities Authority (ISA) investigation, the company has said. 2 May 2017
Pharmaceutical
A panel of the US Court of Appeals for the Federal Circuit yesterday reversed the opinion of the District Court for the District of New Jersey and ruled that certain patent claims covering Aloxi (palonosetron hydrochloride) injection are not valid and are not infringed by Teva Pharmaceutical Industries’ generic palonosetron product, says privately-held Swiss drugmaker Helsinn Healthcare. 2 May 2017
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