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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
The European Commission has approved, under the EU Merger Regulation, the acquisition of joint control of Lonza Specialty Ingredients of Switzerland by USA-based Bain Capital Investors and Cinven Capital Management of the UK. 21 June 2021
Biotechnology
Cambridge, UK-based drugmaker AstraZeneca has welcomed a ruling by the Court of First Instance, in Brussels, which appeared to vindicate the company’s approach to the distribution of its coronavirus vaccine. 18 June 2021
Pharmaceutical
The Russian government has changed the requirements for the extension of patents for drugs in the domestic market, according to recent statements, made by some senior state officials and local media, reports The Pharma Letter’s local correspondent. 15 June 2021
Biotechnology
Advanced therapy trade group The Alliance for Regenerative Medicine (ARM) has highlighted the passage of a new piece of legislation designed to accelerate patient access in Germany. 15 June 2021
Pharmaceutical
The UK’s two leading pharma companies are to do battle in the courtroom over royalties from the PARP inhibitor Zejula (niraparib). 8 June 2021
Biotechnology
Bristol Myers Squibb has been sued by the former shareholders of Celgene, the company that it acquired in 2019. 4 June 2021
Pharmaceutical
The Russian Parliament (State Duma) has finally approved legislation that allows the production of original drugs intended for exports without the permission of a patent holder, according to recent statements by the press-service of the Duma and some local media, reports The Pharma Letter’s local correspondent 1 June 2021
Biosimilars
The US Supreme Court has denied the petition to review the Federal Circuit’s July 2020 decision concerning the Sandoz biosimilar Erelzi (etanercept-szzs) for reference medicine Enbrel (etanercept), sold by US biotech major Amgen. 18 May 2021
Pharmaceutical
The mere notion of the US government supporting any policies that might encourage pharmaceutical patents to be ignored would have seemed inconceivable only 18 months ago. 17 May 2021
Biosimilars
US pharma major AbbVie has answered back in its latest row over Humira (adalimumab), the inflammatory diseases drug that it continues to sell without competition in the USA. 14 May 2021
Generics
The UK’s Competition Appeal Tribunal (CAT) has upheld the CMA decision that pharma major GlaxoSmithKline (LSE: GSK) and some generic suppliers of the anti-depressant paroxetine broke competition law. 12 May 2021
Biosimilars
Privately-held Icelandic biopharmaceutical company Alvotech, which is seeking to become one of the leaders in the biosimilar monoclonal antibody market, has made a statement this week by filing a lawsuit against AbbVie. 12 May 2021
Pharmaceutical
Staff from the US Federal Trade Commission, Canada’s Competition Bureau, the European Commission Directorate General for Competition, the UK’s Competition and Markets Authority, the U.S. Department of Justice’s Antitrust Division, and Offices of State Attorneys General has issued a notice seeking public comment to inform their review of how to best update their approaches to analyzing the effects of pharmaceutical mergers. 12 May 2021
Pharmaceutical
To the surprise of many, the US government has backed a World Trade Organization (WTO) proposal to disclaim certain intellectual property (IP) rights to coronavirus vaccines, after previously opposing it. 6 May 2021
Biotechnology
Nearly 18 months on from Enzyvant’s receipt of a Complete Response Letter (CRL) relating to its initial Biologics Licensing Application (BLA) for RVT-802, the company has filed an amended submission. 28 April 2021
Biotechnology
As anticipated, the European Union launched a legal action against AstraZeneca in the Belgian courts on Friday, alleging the British firm failed to live up to its contractual obligations on vaccine supplies. 27 April 2021
Biotechnology
The latest chapter in an ongoing saga over European supplies of AstraZeneca’s coronavirus vaccine looks likely to involve legal action. 23 April 2021
Pharmaceutical
The government must support a patent waiver for COVID-19 vaccines and treatments to protect the UK’s own vaccination program, according to public health experts from the Independent SAGE group. 16 April 2021
Generics
India's famous Institute of Mental Health and Hospital in Agra is turning out to be a hotbed of pharmaceutical opioids and counterfeit drugs. 14 April 2021
Generics
The US Court of Appeals for the Fifth Circuit has upheld the Federal Trade Commission determination that Impax Laboratories engaged in an illegal pay-for-delay, or “reverse payment,” settlement to block consumers’ access to a lower-cost generic version of Endo Pharmaceuticals branded extended-release opioid pain reliever Opana ER (oxymorphone hydrochloride extended release). 14 April 2021
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