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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
Pharmaceutical
The Japanese unit of Swiss drug major Novartis is facing suspension following allegations of data manipulation in the results of Diovan (valsartan) clinical trials. 4 February 2015
Generics
Indian drugmakers Sun Pharmaceutical Industries Ltd. and Ranbaxy Laboratories have agreed to divest Ranbaxy’s interests in generic minocycline tablets in order to settle US Federal Trade Commission charges that Sun’s $4 billion proposed acquisition of Ranbaxy would likely be anticompetitive. 1 February 2015
Pharmaceutical
In remarks at the Families USA Health Action Conference in Washington DC on January 22, US Senator Elizabeth Warren (Democrat, Massachusetts) announced plans to introduce new legislation to advance medical research. 23 January 2015
Generics
US drugmaker Supernus Pharmaceuticals says that it has sued generic drug makers Taiwan-based TWi Pharmaceuticals and TWi International for infringement of four patents covering its antiepileptic drug Oxtellar XR. 22 January 2015
Pharmaceutical
Belgian drug developer Ablynx has successfully opposed the appeal lodged by Domantis over its European patent. 22 January 2015
Pharmaceutical
The US Supreme Court has reversed the Federal Circuit Court’s judgment on Israel-based Teva Pharmaceutical Industries’ Copaxone (glatiramer acetate injection). 21 January 2015
Pharmaceutical
Although health care and life sciences companies are aware that they could be hit with federal “whistleblower” law suits, they are ill-prepared for them and any potential consequences, says a national US survey sponsored by law firm Foley Hoag LLP. 21 January 2015
Generics
US drugmaker Supernus Pharmaceuticals says it has sued privately-held generics firm Par Pharmaceutical for infringement of four patents covering its antiepileptic drug Trokendi XR (topiramate). 19 January 2015
Pharmaceutical
The Delaware Court of Chancery has entered its Final Order and Judgment in the case brought by US pharma company PharmAthene against SIGA Technologies. 16 January 2015
Pharmaceutical
Japanese pharma company Sumitomo Dainippon and its US subsidiary Sunovion Pharmaceuticals have jointly filed patent infringement law suits against Emcure Pharmaceuticals and InvaGen Pharmaceuticals. 15 January 2015
Biotechnology
The Indian Patent Controller yesterday rejected one of US biotech major Gilead Sciences’ key patent applications which covered the firm’s blockbuster drug Sovaldi (sofosbuvir), used to treat hepatitis C (HCV). 15 January 2015
Biotechnology
US biotech firm Aegerion Pharmaceuticals has revealed it is the subject of a US Securities and Exchange Commission investigation relating to its sales activities. 14 January 2015
Generics
Jordon-headquartered Hikma Pharmaceuticals saw its shares rise 4.2% to a record high of £23.80, after a USA appeals court rejected Japanese drug major Takeda Pharmaceutical’s bid to bock the firm’s launching of its gout drug colchicine. 13 January 2015
Generics
Privately-held Swiss cancer specialist Helsinn Group say it has entered into a settlement agreement with Sandoz Inc to resolve their patent litigations relating to Helsinn’s Aloxi (palonosetron HCl injection) in the USA. 12 January 2015
Pharmaceutical
US Senators Amy Klobuchar (Democrat, Minnesota) and John McCain (Republican, Arizona) last week resumed their fight to reduce prescription drug costs for American families. 12 January 2015
Pharmaceutical
Ireland-headquartered generics major Actavis has had its motion to expedite its appeal of a lower court ruling requiring it to continue distribution of Namenda (memantine HCl) immediate-release tablets approved. 7 January 2015
Generics
Japanese drugmaker Chugai Pharmaceutical says that, on December 24, the Tokyo District Court granted Chugai an overall victory for the first instance demanding the suspension of patent infringement of the manufacturing process patent owned by Chugai (Patent No 3310301), related to Oxarol (maxacalcitol) ointment. 29 December 2014
Generics
In fiscal year 2013, companies filed a total of 145 final patent dispute settlements, of which 29 created potential “pay-for-delay” agreements between branded and generic drug companies, according to a new staff report from the USA’s Federal Trade Commission. 23 December 2014
Pharmaceutical
US biopharma firm Vanda Pharmaceuticals says it has reached a settlement agreement with Swiss drug major Novartis related to the ongoing license arbitration proceedings on Fanapt (iloperidone), its drug to treat schizophrenia. 23 December 2014
Pharmaceutical
The United States has filed a civil False Claims Act complaint against Omnicare alleging that it solicited and received millions of dollars in kickbacks from drugmaker Abbott Laboratories, the Justice Department announced yesterday. 23 December 2014
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