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Pharmaceutical
The Securities and Exchange Commission announced last week that it deems it appropriate and in the public interest that public administrative and cease and desist proceedings be issued under the SEC Act against Swiss pharma giant Novartis, alleging bribery activities in China. 26 March 2016
Pharmaceutical
Chugai Pharmaceutical said on Friday that it has won a lawsuit against companies who by the decision must now stop manufacturing and marketing their generic drugs in infringement of the process patent (Patent No 3310301) on Oxarol (maxacalcitol) Ointment. 26 March 2016
Pharmaceutical
A federal jury in California has ordered Gilead Sciences to pay $200 million in damages to Merck & Co and its partner Ionis Pharmaceuticals for patent infringement. 25 March 2016
Pharmaceutical
The US Federal Trade Commission (FTC) has urged the Court of Appeals to correct four errors in a district court’s analysis of an alleged reverse-payment agreement involving UK pharma giant GlaxoSmithKline and generics firms Teva Pharmaceuticals and Anchen Pharmaceuticals. 17 March 2016
Pharmaceutical
Two patents protecting Amgen’s recently-approved cholesterol-lowering drug Repatha (evolocumab) have been declared valid by a US jury. 17 March 2016
Pharmaceutical
Amarin says that settlement terms have been reached among the parties to resolve the Amarin First Amendment litigation (Amarin Pharma Inc et al v FDA et al, relating to off-label promotion of its prescription-grade omega-3 fatty acid Vascepa (icosapent). 9 March 2016
Pharmaceutical
Switzerland-based biopharma company Debiopharm says that the Tokyo District Court granted Debiopharm an overall victory for the first instance demanding the suspension of patent infringement of the formulation patent owned by Debiopharm (Patent No 4430229) related to cancer drug Elplat (oxaliplatin) Drip Infusion of 50, 100 and 200mg. 4 March 2016
Generics
Hikma Pharmaceuticals will sell the rights and assets for two generic drugs, and relinquish its US marketing rights to a third generic drug, in order to settle US Federal Trade Commission charges that Hikma’s proposed acquisition of Roxane from German family-owned pharma major Boehringer Ingelheim would likely be anticompetitive. 29 February 2016
Generics
The US Federal Trade Commission has approved a modified final order settling charges that Mylan’s proposed hostile takeover of Ireland-based Perrigo would harm competition. 23 February 2016
Pharmaceutical
Pfizer revealed today that its Wyeth subsidiary has reached an agreement in principle to resolve claims alleging that Wyeth’s practices relating to the calculation of Medicaid rebates for its heartburn drug Protonix (pantoprazole sodium) between 2001 and 2006. 16 February 2016
Pharmaceutical
The UK High Court decided the Alimta (pemetrexed disodium) vitamin regimen patent held by US pharma major Eli Lilly (NYSE: LLY) would not presently be infringed by Actavis marketing pemetrexed trometamol in the UK, France, Italy and Spain with instructions to dilute the product only with dextrose solution. 12 February 2016
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US specialty drugmaker Depomed has received a favorable Markman claim construction ruling by Judge Claire Cecchi of the US District Court for the District of New Jersey, which has been issued in the ongoing patent infringement case against the three filers of Abbreviated New Drug Applications (ANDA) with Depomed prevailing on all disputed claims. 9 February 2016
Pharmaceutical
USA-based, China-focused specialty pharmaceutical company SciClone Pharmaceuticals says it has entered into a settlement agreement with the US Securities and Exchange Commission fully resolving the SEC's investigation into possible violations of the Foreign Corrupt Practices Act (FCPA). 6 February 2016
Pharmaceutical
The State Fiscal Service of Ukraine (DFS) within its jurisdiction supported the proposal of the trade association APRaD (the Association of Pharmaceutical Research and Development in Ukraine) and the American Chamber of Commerce in Ukraine for the establishment of the Interdepartmental Working Group on combating illegal trafficking of drugs in Ukraine. 25 January 2016
Pharmaceutical
Following the news that five people, including two insiders, have been charged with conspiracy to steal millions of dollars in secret research from GlaxoSmithKline (The Pharma Letter January 21), internal security expert Jens Puhle, managing director of 8MAN, comments: “The attempted theft of millions of dollars worth of secret information from GlaxoSmithKline underlines the need for constant vigilance within the pharmaceutical industry. 23 January 2016
Pharmaceutical
The US Attorney's Office in Philadelphia has charged five people including two former researchers at UK drug major GlaxoSmithKline of scheming to steal trade secrets from the company with the intention of selling them in China. 21 January 2016
Pharmaceutical
German pharma and sciences company Merck KGaA has secured a win in the UK Court following three years of litigation with USA-based Merck Sharp & Dohme (MSD) – or Merck & Co - regarding the use of the term "Merck." 16 January 2016
Pharmaceutical
US pharma giant Merck & Co revealed on Friday that it has reached an agreement with plaintiffs to resolve multi-district class action lawsuit pending in New Jersey federal court. 16 January 2016
Pharmaceutical
USA-based biodefense company PharmAthene announced today that the Delaware Supreme Court affirmed the Delaware Court of Chancery's decision (The Pharma Letter January 16) to award PharmAthene lump sum expectation damages for the value of PharmAthene's lost profits for SIGA's smallpox antiviral, Tecovirimat (ST-246). 24 December 2015
Generics
The insolvency administrator of Velefarm Holding as well as Velefarm VFB and the Serbian Hemofarm, a subsidiary of German drugmaker Stada Arzneimittel (SAZ: Xetra), have agreed on the resolution of a legal dispute. 24 December 2015
Biotechnology
India’s Sun Pharma has been blocked in its efforts to launch its JAK inhibitor Leqselvi (deuruxolitinib) in the USA. 6 November 2024
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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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