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UK drugs giant GlaxoSmithKline has agreed to pay about $460 million to resolve a majority of law suits alleging the company's type 2 diabetes drug Avandia (rosiglitazone) had caused heart attacks and strokes, reported the Bloomberg news service quoting 'people familiar with the accords,' just as two days of US Food and Drug Administration hearings on the safety of the drug kicked off in Washington DC. The individual settlements are said to range from $46,000 to almost $70,000, depending on the strength of the claims. 14 July 2010
Pharmaceutical
With all of the hubbub over Patent Use Codes (PUCs) since the US Court of Appeals for the Federal Circuit issued its April 2010 decision in Novo Nordisk A/S v Caraco Pharmaceutical Laboratories, addressing whether the patent delisting counterclaim provisions at FDC Act section 505(j)(5)(C)(ii)(I), as added by the Medicare Modernization Act, may be used to correct or delete an Orange Book-listed PUC, law firm Hyman, Phelps & McNamara says it thought it would be interesting to analyze the growth of PUCs. The comments are posted on HP&M's FDA Law Blog. 12 July 2010
Generics
Ireland-based Shire has filed a law suit in the US District Court for the District of Delaware against Cadila Healthcare, doing business as Zydus Cadila and Zydus Pharmaceuticals (USA), for the infringement of US Patent No 6,773,720 (the '720 patent). 9 July 2010
Biotechnology
USA-based generic drugmaker Impax Laboratories has confirmed initiation of a challenge of a patent listed by Genzyme in connection with Renvela (sevelamer carbonate for suspension), 2.4g and 0.8g. 5 July 2010
Generics
The much anticipated decision by the Luxembourg-based General Court in the appeal case by Anglo-Swedish drug major AstraZeneca against the European Commission - going back to 2005 - relating to blocking or delaying generic copies of the firm's blockbuster anti-ulcerant Losec (omeprazole) has gone in favor of the European Commission, though the proposed fine on the company has been reduced from 60 million euros ($73.7 million) to 52 million euros. 2 July 2010
Pharmaceutical
The US Supreme Court has narrowly voted against agreeing to a settlement with Purdue Pharma over the company’s role in the opioid crisis.
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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