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Generics
Sino-American oncology company BeOne Medicines, until now known as BeiGene, has entered into a settlement agreement with MSN Pharmaceuticals and MSN Laboratories Private resolving patent litigation related to MSN’s Abbreviated New Drug Application (ANDA) seeking approval to market a generic version of Brukinsa (zanubrutinib) in the USA. 25 November 2024
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
Generics
For the second year running, pay-for-delay deals declined in 2015, the Federal Trade Commission (FTC) has said in a report. 2 November 2017
Biosimilars
Following in the footsteps of US drug giant Pfizer, a New York grocery union benefits fund has sued Johnson & Johnson for allegedly abusing its monopoly power to exclude competition and raise prices for Remicade (infliximab). 1 November 2017
Generics
Attorneys general from 45 states in the USA have widened the scope of an earlier court action which alleges collusion to fix generic drug prices. 1 November 2017
Generics
Ireland-incorporated Endo International has revealed that two of its subsidiaries have filed suit in the US District Court for the District of Columbia against the Food and Drug Administration. 31 October 2017
Biotechnology
As US voters demand action to lower prescription drug prices, USA-based nonprofit Initiative for Medicines, Access & Knowledge (I-MAK) is taking its own action against the maker of some of the leading hepatitis C treatments. 27 October 2017
Generics
Mylan is set to open Thursday’s trading more than 1% up on the previous close. 26 October 2017
Biosimilars
In the week that it announced its latest plans to enter European markets, Russia’s largest biotech company, BIOCAD, has come out on top in a patent dispute in its native country involving rituximab. 25 October 2017
Generics
Amid falling sales of its leading diabetes product Lantus (insulin glargine) due to generic competition, French pharma major Sanofi is taking further legal action in the USA. 25 October 2017
Pharmaceutical
US President Donald Trump on Tuesday said his nominee to head the Office of National Drug Control Policy, Representative Tom Marino (Republican, Pennsylvania.), has backed out of the position, two days after media reports revealed the congressman had pushed legislation gutting the US Drug Enforcement Administration's ability to target opioid distributors not abiding by regulations. 18 October 2017
Biosimilars
Generic drugmakers and research-based pharma companies are used to facing each other in patent rows that can bring lost or gained earnings totaling many millions of dollars, but billions are riding on a European Union (EU) review of laws affecting exclusivity periods for the industry as a whole. 18 October 2017
Pharmaceutical
The US District Court for the Eastern District of Texas has issued an adverse trial decision finding that the four asserted patents covering Restasis (cyclosporine ophthalmic emulsion) 0.05% are invalid. 17 October 2017
Pharmaceutical
Back in August, US pharma giant Pfizervwelcomed the news that, over a decade after it applied for a patent on its blockbuster vaccine, Prevenar 13 (pneumococcal 7-valent conjugate; PVC), the Indian Patent Office finally granted protection, which expires in 2026, for the product. 13 October 2017
Biotechnology
UK biotech firm Redx Pharma is one step closer to being able to exit administration and recommence trading on the London Stock Exchange. 13 October 2017
Generics
Shares of specialty pharma firm BioDelivery Sciences International were up mid-morning, after it announced that it has entered into a Settlement Agreement over its opioid dependence treatment. 12 October 2017
Pharmaceutical
A cloud continues to loom over the implementation of the Unified Patent Convention, a system permitting a single patent covering numerous European countries, writes barrister Mark Engelman, head of intellectual property at UK-based law firm, Hardwicke, in an Expert View piece. 11 October 2017
Biotechnology
Drug pricing, subject of impassioned presidential Tweets not so long ago, has ceded priority in recent months, amid the furore over Obamacare replacement efforts. 10 October 2017
Pharmaceutical
Eliciting comment last week was news that a US judge had reversed an earlier ban on the marketing of cholesterol treatment Praluent in a long-running court battle between Amgen and the drug’s makers – Regeneron and Sanofi and ordering a re-trial. Also attracting attention was mid-stage data on Capricor Therapeutics’ Duchenne muscular dystrophy agent CAP-1002; strong Phase III results with Zogenix’ rare epilepsy drug candidate ZX008; and positive results for Ablynx’ rare blood disorder candidate caplacizumab. 8 October 2017
Biotechnology
In its patent infringement case against Sanofi’s new atopic dermatitis drug Dupixent, Amgen has secured a win courtesy of the US Patent and Trademark Office’s Patent Trial and Appeal Board, who refused an inter partes review of its patent on the grounds that not enough evidence had been brought to invalidate it. 6 October 2017
Generics
The chances of US pharma major Eli Lilly hanging onto market exclusivity with its chemotherapy drug Alimta (pemetrexed for injection) until 2022 were given a fresh boost on Thursday. 6 October 2017
Generics
There have been some challenging days in the recent history of Teva Pharmaceutical Industries, and Wednesday would certainly come into that category. 5 October 2017
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