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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
Anacor Pharmaceuticals says that the arbitrator appointed to resolve its dispute with Canada-based Valeant Pharmaceuticals successor in interest to Dow Pharmaceutical Sciences (DPS), has issued an Interim Final Award in favor of Anacor, awarding the company $100 million in damages as well as all costs of the arbitration and reasonable attorney’s fees. 18 October 2013
Biosimilars
The Governor of the US state of California, Jerry Brown, on Saturday (October 11) vetoed proposed legislation on the dispensing of biosimilar drugs, copy versions of high-priced biological medicines, to patients in the state. 14 October 2013
Pharmaceutical
Immunomedics says it has received notification from Takeda Pharmaceutical, Japan’s largest drugmaker, of the termination of the licensing agreement signed between Nycomed (acquired by Takeda in 2011) and Immunomedics for the worldwide rights to veltuzumab. 10 October 2013
Pharmaceutical
Australian blood products and vaccine maker CSL has signed an agreement to settle the US antitrust class action litigation, filed by certain US and Puerto Rican hospital groups, which has been ongoing since 2009. 9 October 2013
Generics
The District Court of the Hague has issued a favorable ruling for Teva Pharmaceutical Industries in a patent revocation action brought by Mylan seeking a court judgment that Teva’s patent for its Copaxone is invalid. 4 October 2013
Pharmaceutical
AstraZeneca said that the US Court of Appeals for the Federal Circuit (CAFC) lifted a temporary injunction against the US launch of South Korea-based Hanmi Pharmaceutical's Esomezol (esomeprazole strontium) product, a copy version of the UK-based firm’s Nexium. 3 October 2013
Generics
Actavis has agreed to sell all rights and assets to four generic pharmaceuticals to settle US Federal Trade Commission charges that its proposed $8.5 billion acquisition of Warner Chilcott would be anticompetitive. 28 September 2013
Pharmaceutical
Swiss drug major Novartis has said it regrets the inconvenience caused by its investigator-initiated trails in Japan after it was accused of submitting research papers with manipulated data for the blood pressure drug valsartan. 27 September 2013
Generics
Israel-based Teva Pharmaceutical Industries has gained a favorable ruling in its patent infringement lawsuit against US generic drugmaker Mylan over its Azilect patent which covers methods of treating Parkinson’s disease. 24 September 2013
Pharmaceutical
German pharma and crop sciences major Bayer (BAYN: DE) is being investigated in China over a "potential case of unfair competition," the company confirmed on Friday (September 13), making it the latest foreign drugmaker to come become embroiled in China' sweeping probe into foreign pharmaceutical firms, accusing some of abusing their monopoly positions to boost prices unfairly. 16 September 2013
Generics
Reversing a district court decision last year (The Pharma Letter May 30, 2012), the US Court of Appeals for the Federal Circuit ruled on September 12 that both Israel-based Teva Pharmaceutical Industries (NYSE: TEVA) and Par Pharmaceuticals (NYSE: PRX) can go ahead with plans to launch generic copies of UK pharma giant GlaxoSmithKline (LSE: GSK) subsidiary Pronova's triglyceride lowerer Lovaza (omega-3-acid ethyl esters). 13 September 2013
Pharmaceutical
Chinese drug company Sino Biopharmaceutical is the latest subject of allegations into corruption in the Chinese pharmaceutical market. 13 September 2013
Pharmaceutical
The USA-based AIDS Healthcare Foundation (AHF) said yesterday (September 10) that it has filed a law suit in California against UK pharma giant GlaxoSmithKline (LSE: GSK) alleging that the company failed to fully satisfy its obligations with respect to discounts for drugs it sold to AIDS Healthcare Foundation over a period of many years," under the 340B Program, a federal drug discount program designed to stretch scarce federal resources as far as possible for community health care providers such as AHF. 11 September 2013
Generics
USA-based Avanir Pharmaceuticals (Nasdaq: AVNR) has entered into a settlement agreement with the US unit of Indian drugmaker Wockhardt to resolve pending patent litigation in response to Wockhardt's Abbreviated New Drug Application seeking approval to market generic versions of Avanir's Nuedexta (dextromethorphan hydrobromide/quinidine sulfate) capsules. 8 September 2013
Pharmaceutical
For most multinational companies, it is a no-brainer that they have to be big in China, if their global ambitions are to be taken seriously, said Robert Peston, business editor of UK public broadcast the BBC this morning on the Today program (September 6). 6 September 2013
Biotechnology
A bill updating US State of California's pharmacy substitution law to allow greater patient access to more affordable Food and Drug Administration-approved biologic medicines is headed to the Governor's desk after yesterday's (September 4) overwhelming passage in the Senate in a 30 to two vote (The Pharma Letter August 28). 5 September 2013
Generics
A partial settlement has been reached in a US class action law suit involving the prescription antibiotic Cipro (ciprofloxacin), originated by German drug major Bayer (BAYN: DE), it was announced by a group of US law firms acting in the law suit on September 3. 4 September 2013
Pharmaceutical
The Chinese police have recently revealed more details about suspected economic violations by UK pharma giant GlaxoSmithKline's (LSE: GSK) China subsidiary, which has been under investigation since early July for suspected bribery and tax-related violations (The Pharma Letters passim), actions which reportedly have pushed up drug prices in the country, reports the state news agency Xinhua. 3 September 2013
Generics
USA-based Avanir Pharmaceuticals (Nasdaq: AVNR) says that it has entered into a settlement agreement with Actavis South Atlantic and parent Actavis (NYSE: ACT) to resolve pending patent litigation in response to Actavis' Abbreviated New Drug Application seeking approval to market generic versions of Avanir's Nuedexta (dextromethorphan hydrobromide/quinidine sulfate) capsules. 3 September 2013
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