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Biotechnology
After a run of positive announcements on the clinical side, mRNA therapeutics and vaccines developer Moderna Therapeutics has been struck with a patent blow, knocking 10% off its share price. 24 July 2020
Pharmaceutical
An Expert View from Jonathan Roses, counsel, Wolf, Greenfield & Sacks, and Toby Simpson, partner, Hoffmann Eitle, exploring legal differences between the two major jurisdictions of the USA and Europe that life sciences companies should be aware of. 3 July 2020
Pharmaceutical
Swiss pharma giant Novartis has finalized its $678 million settlement relating to a lawsuit alleging impropriety in its speaker programs and other promotional events conducted from 2002 through 2011 in the USA. 2 July 2020
Biosimilars
The US Court of Appeals for the Federal District has ruled against Sandoz in patent litigation concerning the Sandoz biosimilar Erelzi (etanercept-szzs) for reference medicine Enbrel (etanercept). 2 July 2020
Generics
The US subsidiary of India’s Glenmark Pharmaceuticals has been charged for conspiring to fix prices for generic drugs, the US Department of Justice announced on Monday. 1 July 2020
Pharmaceutical
Shaun Thaxter, the chief executive of Indivior, has pleaded guilty to causing the introduction into interstate commerce of the opioid drug Suboxone Film (buprenorphine) which was misbranded in violation of the Federal Food, Drug, and Cosmetic Act. 1 July 2020
Biotechnology
Swiss pharma giant Novartis late yesterday revealed that it has reached settlements with the US Department of Justice (DoJ) and the US Securities and Exchange Commission (SEC) resolving all Foreign Corrupt Practices Act (FCPA) investigations into historical conduct by the company and its subsidiaries. 26 June 2020
Biotechnology
American biotech firm Regeneron Pharmaceuticals is the subject of a legal action from the US government, alleging kickbacks were paid to a charity to illegally promote sales of Eylea (aflibercept). 25 June 2020
Pharmaceutical
German crop sciences and pharma major Bayer has announced a series of agreements that will substantially resolve major outstanding Monsanto litigation, notably the US Roundup weedkiller product liability claims, that have plagued the company, as well as, dicamba drift litigation and PCB water litigation. 25 June 2020
Biotechnology
UK-based Kymab has won another court ruling, this time in its home country, in its global patent dispute with US biotech Regeneron. 24 June 2020
Pharmaceutical
Authorities in the UK have reclassified Epidyolex (cannabidiol) as a Schedule 5 drug, the lowest level of control, making it easier for the company to distribute the therapy. 24 June 2020
Generics
The US District Court for the Northern District of West Virginia has invalidated biotech major Biogen's Tecfidera (dimethyl fumarate) patent, US Patent No 8,399,514, for lack of written description, Netherlands-headquartered generics firm Mylan announced late yesterday, reversing what had been a string of past victories over this patent for Biogen. 19 June 2020
Pharmaceutical
The European Union’s (EU) top court has said that samples of prescription medicines cannot be handed out to pharmacies. 12 June 2020
Generics
51 states and territories in the USA have banded together to accuse 26 drugmakers of drug price fixing. 11 June 2020
Generics
The US District Court for the District of New Jersey has ruled in favor of the Israel-based generics giant Teva in a patent infringement lawsuit regarding a generic version of Narcan (naloxone HCl) nasal spray for the treatment of opioid overdose. 8 June 2020
Biotechnology
US biotech Regeneron Pharmaceuticals has failed to invalidate a fifth Kymab patent, covering genetically-modified mice used to produce human antibody therapeutics. 3 June 2020
Pharmaceutical
A legal challenge from healthcare professionals in the USA will seek to end “arbitrary interference” from the US regulator over the use of hydroxychloroquine (HCQ). 3 June 2020
Generics
Generic drugmaker Apotex has admitted to fixing the price of a widely-used cholesterol drug and has accepted a $24.1 million fine from a US court. 11 May 2020
Pharmaceutical
Canada-based Bausch Health Companies, along with its wholly-owned subsidiary, Salix Pharmaceuticals and its licensor AlfaSigma, have agreed to resolve the outstanding intellectual property litigation with Sandoz, regarding Xifaxan (rifaximin) 550mg tablets. 6 May 2020
Pharmaceutical
Almost a year after the original announcement, the US Federal Trade Commission (FTC) has accepted the proposed consent order in connection with AbbVie's pending $63 billion acquisition of Ireland-incorporated Allergan. 6 May 2020
Biotechnology
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
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