New York State Attorney General Letitia James has filed to significantly extend a lawsuit against opioid manufacturers and distributors, seeking damages for alleged marketing malpractices. 29 March 2019
The UK Supreme Court has handed down a unanimous decision in a case between generics firm Actavis and Eli Lilly subsidiary ICOS, finding that discoveries from routine research can be rewarded with a patent. 27 March 2019
Privately-held Purdue Pharma has agreed to pay for the establishment of the USA’s leading addiction research center in a settlement with the state of Oklahoma over the opioid crisis that its drug Oxycontin (oxycodone) contributed to. 27 March 2019
The changing intellectual property (IP) landscape for pharmaceuticals was debated at the Legal Affairs Conference in held today in Amsterdam by Medicines for Europe, the lobbying group for biosimilars and generic drugmakers. 27 March 2019
Most commercial executives in the industry thought the discussions over Obamacare were finally at an end, after a monthslong war of attrition between the White House and Congress early in Mr Trump’s presidency. They may need to think again. 27 March 2019
More than five years after the blood thinner Xarelto (rivaroxaban) litigation began, and with Germany’s Bayer and Johnson & Johnson subsidiary Janssen Pharmaceuticals prevailing in all six cases that went to trial, the companies have reached an agreement in principle to settle in the amount of $775 million. 25 March 2019
Germany’s Stada Arzneimittel group says it will be one of the first manufacturers to launch generic amlodipine/valsartan products in Europe. 21 March 2019
Danish diabetes care giant Novo Nordisk and the US subsidiary of Israeli generics major Teva Pharmaceutical Industries have reached a settlement agreement on the US patent litigation case for Victoza (liraglutide). 18 March 2019
The end of a drug’s exclusivity period can result in expensive patent litigation, and IP lawyer Kent Walker has identified an emerging trend that could present a solution for generic challengers seeking to enter the market. 18 March 2019
The UK’s Competition and Markets Authority (CMA) has closed its investigation into a questionable discount scheme introduced to the National Health Service (NHS) by American pharma giant Merck & Co. 15 March 2019
Medical products and generic drugmaker Covidien has agreed to pay just under $17.5 million to resolve allegations that it violated the False Claims Act by providing free or discounted practice development and market development support to physicians located in California and Florida to induce purchases of Covidien’s vein ablation products, the US Department of Justice announced on Monday. 12 March 2019
Research shows some 79% of the American public view the cost of prescription drugs as unreasonable, and lawmakers and regulators are increasingly convinced the industry charges too much for its products. 8 March 2019
Embattled Oxycontin (oxycodone) manufacturer Purdue Pharma is reportedly exploring the option of filing for bankruptcy as legal challenges mount over the firm’s marketing practices. 5 March 2019
Six Sanofi employees in the Philippines are to face criminal prosecution over a number of deaths related to the dengue fever vaccine Dengvaxia (dengue tetravalent vaccine). 4 March 2019
The UK’s Competition and Markets Authority (CMA) has provisionally found that, from July 2011 to April 2015, the sole supplier of hydrocortisone tablets in the UK, Auden Mckenzie, and its rival, Waymade, entered into anti-competitive agreements. 28 February 2019
On Monday, another chapter in the years-long legal saga between Amgen and Sanofi was written by a District Court jury, which upheld certain patents for Amgen’s Repatha (evolocumab). 26 February 2019
The Canadian Competition Bureau announced yesterday that it is closing an investigation into allegations of abuse of dominance by Janssen, a Canadian subsidiary of US healthcare giant Johnson & Johnson. 21 February 2019
The USA’s Federal Trade Commission (FTC) said on Tuesday that it has reached an agreement with Israeli generics giant Teva Pharmaceutical Industries that would prevent the company from entering into certain reverse-payment patent settlements that can delay the availability of generic versions of drugs. 20 February 2019
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
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
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
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
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
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
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
The Pharmaceutical Research and Manufacturers of America (PhRMA) is continuing its legal challenge against the US government’s drug pricing reforms. 24 September 2024
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
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
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
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
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
Regeneron Pharmaceuticals has filed a lawsuit against Sandoz, alleging that its biosimilar to Eylea (aflibercept) infringes certain patents. 29 August 2024
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