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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
The UK Competition and Markets Authority (CMA) launched a competition law investigation into Essential Pharma last month because of suspicions that the firm may have abused its dominant position by proposing to withdraw the supply of bipolar drug, lithium-based Priadel, to UK patients. 26 November 2020
Generics
American pharma giant Pfizer and its group companies have filed a petition in a US court against Aurobindo Pharma and Dr Reddy’s Laboratories, alleging the Indian generic drugmakers were planning separately to come out with generic versions of its blockbuster drug Ibrance (palbociclib) before expiration of its patent. 25 November 2020
Pharmaceutical
Quality control hardware specialist Elementar UK is urging pharmaceutical manufacturers and suppliers to bolster product testing procedures in the face of a growing threat from counterfeit drugs. 25 November 2020
Pharmaceutical
Opioid drug OxyContin manufacturer Purdue Pharma has pleaded guilty in federal court in Newark, New Jersey, to conspiracies to defraud the United States and violate the anti-kickback statute, the US Department of Justice announced yesterday. 25 November 2020
Pharmaceutical
Lawsuits for patent infringement require a showing that an accused product or process includes each and every element of an asserted claim, write Jonathan Roses, counsel, Wolf, Greenfield & Sacks, and Alexander Lee, associate, Hoffmann Eitle, in an Expert View piece. 20 November 2020
Pharmaceutical
French drugmaker Sanofi will face trial in a US court over claims that it misleadingly promoted off-label uses for a cancer drug, Law360 reports. 13 November 2020
Generics
A new white paper has explored the misuse of certain intellectual property (IP) tools that block generic and biosimilar medicines for the first time since the findings of the European Commission Pharmaceutical Sector Enquiry in 2009. 6 November 2020
Generics
The US Federal Trade Commission (FTC) has accepted a proposed consent order, agreeing certain asset divestments, which concludes the FTC’s review of the proposed combination of Netherlands-incorporated generics drugmaker Mylan and US pharma giant Pfizer’s Upjohn Business. 2 November 2020
Biotechnology
The European Patent Office (EPO) Technical Boards of Appeal has ruled in French pharma major Sanofi and US partner Regeneron Pharmaceutical’s favor, invalidating certain claims of Amgen’s European patent (EP 2 215 124) directed to PCSK9 (proprotein convertase subtilisin/kexin type 9) antibodies relevant to Praluent (alirocumab). 30 October 2020
Pharmaceutical
Jonathan Roses, counsel Wolf, Greenfield & Sacks and Matthew Birkett, partner, Hoffmann Eitle, provide an Expert View on general treatment of salt and polymorphic forms in the US Patent and Trademark Office, the European Patent Office and the courts. 23 October 2020
Pharmaceutical
UK-based Shield Therapeutics has provided an update on an ongoing patent dispute with Israeli generics giant Teva Pharmaceutical. 19 October 2020
Generics
India has initiated a probe into alleged dumping of an active pharmaceutical ingredient (API), ceftriaxone sodium sterile, from China, following complaints by domestic manufacturers. 7 October 2020
Pharmaceutical
The UK’s Competition and Markets Authority (CMA) will investigate whether the pharmaceutical company Essential Pharma, which was recently bought by a Swiss private equity firm Gyrus Capital, has abused a dominant position in relation to lithium-based medicines for treating bipolar disorder. 7 October 2020
Biotechnology
Privately-held US biotech Allele Biotechnology and Pharmaceuticals has filed two patent infringement lawsuits – one in New York against Regeneron Pharmaceuticals and the other in California against Pfizer and BioNTech. 6 October 2020
Generics
US specialty pharma firm Collegium Pharmaceutical has announced a settlement agreement with the US subsidiary of Israel’s Teva Pharmaceutical Industries. 1 October 2020
Biotechnology
US biotech major Gilead Sciences has agreed to pay $97 million to resolve claims that it violated the False Claims Act by illegally using a foundation as a conduit to pay the co-pays of thousands of Medicare patients taking Gilead’s pulmonary arterial hypertension drug, Letairis (ambrisentan), the US Justice Department announced yesterday. 24 September 2020
Biotechnology
Denmark’s Genmab saw its shares drop over a tenth after it emerged the firm was locked in a legal battle over royalties for cancer drug daratumumab. 23 September 2020
Pharmaceutical
An Expert View from Jonathan Roses (pictured, left), counsel, Wolf, Greenfield & Sacks, and Matthew Birkett, partner, Hoffmann Eitle, on the granting of two patents for a single invention in the USA and Europe. 22 September 2020
Generics
Canada-based Bausch Health Companies and its gastroenterology business, Salix Pharmaceuticals, have agreed to resolve a set of outstanding intellectual property disputes with Sun Pharmaceutical. 22 September 2020
Biotechnology
Shares in Legend Biotech fell by nearly 16% in the first four hours of trading on Monday. 21 September 2020
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