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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
Biotechnology
US biotech firm BioTime says its subsidiary Asterias Biotherapeutics has entered into a settlement agreement with regenerative medicines company ViaCyte concerning certain litigation in the US District Court for the Northern District of California seeking the reversal of two adverse determinations by the US Patent & Trademark Office. 29 May 2014
Pharmaceutical
German family-owned pharma major Boehringer Ingelheim says it has reached a comprehensive settlement of US state and federal cases in the litigation regarding severe and fatal bleeding in patients said to have been caused its blockbuster blood thinner Pradaxa (dabigatran etexilate mesylate), in the amount of $650 million. 28 May 2014
Pharmaceutical
UK pharma giant GlaxoSmithKline, already subject to allegations of bribery of doctors and hospitals in China, declared late yesterday that it is now under investigation by the UK's Serious Fraud Office. 28 May 2014
Generics
Indian generics drugmaker Sun Pharmaceuticals’ proposed $3.2 billion acquisition of loss-making rival Ranbaxy Laboratories looks more likely to proceed after an Indian court lifted the temporary halt to the takeover due to allegations of insider trading (The Pharma Letter May 5). 26 May 2014
Pharmaceutical
The US subsidiary of Japan’s largest drugmaker, Takeda Pharmaceuticals, yesterday announced that in the case of Bertha Triana and Delores Cipriano v Takeda, et al, No. A680556 the jury found in favor of Takeda. The trial began on March 10 in the Nevada state court before Judge Kerry Earley. 23 May 2014
Pharmaceutical
The Legal Daily, the official newspaper of the Chinese Ministry of Justice, on Friday accused UK pharma giant GlaxoSmithKline of manipulating tax deductions to generate more than 100 million renminbi ($16 million) worth of tax benefits between 2005 and 2008. 19 May 2014
Generics
US pharma major Eli Lilly says that the English High Court has determined that the vitamin dosage regimen patents for lung cancer drug Alimta (pemetrexed) would not be infringed by a generic competitor, Ireland-headquartered generic giant ActavisUS pharma major Eli Lilly says that the English High Court has determined that the vitamin dosage regimen patents for Alimta (pemetrexed) would not be infringed by a generic competitor, Ireland-headquartered generic giant Actavis that has stated an intent to market certain alternative salt forms of pemetrexed in several European countries on expiry of the Alimta compound patents in 2015. that has stated an intent to market certain alternative salt forms of pemetrexed in several European countries on expiry of the Alimta compound patents in 2015. 16 May 2014
Generics
A US district court has dismissed a case by Israeli drugmaker Teva Pharmaceutical Industries intended to block the US Food and Drug Administration from approving generic versions of Teva's blockbuster multiple sclerosis drug Copaxone (glatiramer acetate), including from US generics maker Mylan. 15 May 2014
Pharmaceutical
Chinese police have finished the investigation on the suspected bribery case of the local subsidiary of UK pharma giant GlaxoSmithKline and handed it over to prosecutors, local police said there today, reports the state news agency Xinhau. 14 May 2014
Generics
Israel-based Teva Pharmaceutical Industries has complained to the US Food and Drug Administration that generic versions of its blockbuster drug Copaxone (glatiramer acetate) should have clinical trials before they are approved. 12 May 2014
Biotechnology
By a vote of 274 to 131, US House of Representatives passed legislation (the American Research and Competitiveness Act; HR 4438), which increase and make permanent the R&D tax credit. HR 4438 would increase the tax credit to 20% from the 14% credit which expired last year. The bill will now go to the US Senate. 10 May 2014
Pharmaceutical
US drug major Eli Lilly revealed on Friday that the 2nd Circuit of the Labor Court of Paulinia in the state of Sao Paulo, Brazil, has ruled against the company's local subsidiary, Eli Lilly do Brasil. 10 May 2014
Generics
The US Federal Trade Commission filed an Amicus Brief in the US Court of Appeals for the Third Circuit, urging it to reverse a district court dismissal in the case of Lamictal Direct Purchaser Antitrust Litigation. 3 May 2014
Pharmaceutical
US pharmacy benefits manager Express Scripts has revealed that it has received three government subpoenas since February regarding its dealings with USA and European drugmakers. 1 May 2014
Pharmaceutical
Brazil predicts 3.9 billion real in law suits against the Union for the right to access to medicines
Health authorities from all government levels have been charged with law suits filed by consumers of pharmaceutical products in Brazil, writes Juliane Carvalho on Brazil Pharma News. 28 April 2014
Generics
US generics firm Mylan has filed suit against the US Food and Drug Administration, challenging the agency's decision regarding generic drug marketing exclusivity on celecoxib capsules, the generic version of US pharma giant Pfizer's Celebrex. 27 April 2014
Generics
Ireland-headquartered generic major Actavis has entered into an agreement with US pharma giant Pfizer to settle all outstanding patent litigation related to Actavis' generic version of Celebrex (celecoxib) capsules. 24 April 2014
Generics
The US Supreme Court Chief Justice Roberts has denied Israeli generics giant Teva Pharmaceutical Industries’ application for an injunction seeking to prevent USA-based Mylan Laboratories launch of a generic version of the multiple sclerosis product Copaxone (glatiramer acetate) pending the Supreme Court's decision on Teva's appeal. 21 April 2014
Pharmaceutical
The US subsidiary of Japanese drug major Astellas Pharma will pay $7.3 million to resolve allegations that it violated the False Claims Act in connection with its marketing and off-label promotion of the drug Mycamine (micafungin sodium) for pediatric use, the US Justice Department announced yesterday. 17 April 2014
Generics
US generics major Mylan (Nasdaq: MYL) and its partner Famy Care have entered into a settlement and license agreement settling litigation over Mylan’s filing of an Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration for norethindrone and ethinyl estradiol chewable tablets and ferrous fumarate chewable tablets. 16 April 2014
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