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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
US Senator Elizabeth Warren (Democrat, Massachusetts) has urged the Federal Trade Commission to look closely at two pending pharmaceutical mergers, insisting that the deals could lead to higher drug prices and prevent "affordable alternatives from entering the market." 30 January 2023
Pharmaceutical
In a sudden turn of events, Novartis' Entresto (sacubitril/valsartan) patent has been reinstated in India, after a two-judge bench stayed a previous order that invalidated it. 24 January 2023
Generics
As a blockbuster heart failure drug by Swiss pharma giant Novartis goes off-patent, several Indian drug majors are rushing to market with their generic applications. The patent loss of Entresto (sacubitril/valsartan) has brought on significant disruptions in India’s cardiology sector. High courtroom drama ensued a few days before the patent loss and had everyone on tenterhooks, reports The Pharma Letter’s India correspondent. 20 January 2023
Biotechnology
SFJ Pharmaceuticals is claiming victory in its legal dispute with cardiopulmonary diseases focussed US firm PhaseBio Pharmaceuticals regarding a blood thinner reversal agent, announcing the closing of the sale and transfer of assets related to bentracimab from PhaseBio to SFJ. 18 January 2023
Pharmaceutical
The Kerela High Court in India has directed the Department for Promotion of Industry and Internal Trade to consider compulsory licensing of breast cancer drug ribociclib. 11 January 2023
Biotechnology
Another chapter in the long-running immunotherapy patent dispute between Bristol Myers Squibb and Gilead Sciences has been written. 10 January 2023
Biosimilars
Canada’s largest public drug plan has announced a transition to cost-saving biosimilar medicines. 21 December 2022
Pharmaceutical
A US court has dismissed allegations that the heartburn drug Zantac (ranitidine) causes cancer. 7 December 2022
Pharmaceutical
Ireland-headquartered Avadel Pharmaceuticals saw its shares gain more than 12% to $8.03 on Friday, after it announced a positive patent dispute ruling. 21 November 2022
Pharmaceutical
Switzerland’s Relief Therapeutics was up 6.5% this morning after it announced definitive settlement agreements with NRx Pharmaceuticals to resolve their pending litigation. 14 November 2022
Pharmaceutical
Following a four to zero vote for the action, the US Federal Trade Commission (FTC) has filed an amicus brief with the US District Court for the District of Delaware in the case of US drugmaker Jazz Pharmaceuticals versus Ireland-incorporated Avadel Pharmaceuticals 12 November 2022
Generics
New York Attorney General Letitia James last Friday marked a major milestone in her fight against the opioid crisis in New York state, when she announced that her office has secured up to $523 million from the US subsidiary and affiliates of Israeli generics giant Teva Pharmaceutical Industries for their role in fueling the opioid crisis. 7 November 2022
Pharmaceutical
US neurological diseases specialist Acorda Therapeutics saw its shares go stratospheric yesterday, after it revealed it has been awarded $16.5 million by an arbitral panel following a dispute with Ireland-incorporated drugmaker Alkermes over licensing royalties for the multiple sclerosis drug Ampyra (dalfampridine). 18 October 2022
Pharmaceutical
The challenges of tackling international crime with national law enforcement are legion, writes John Binns, partner in the Financial Crime team at BCL Solicitors, in an Expert View piece. He considers how Interpol’s Operation Pangea illustrates how they can be overcome in the context of the global fight against illicit medicines. 17 October 2022
Pharmaceutical
The European Commission has informed Israel-based generics behemoth Teva Pharmaceutical Industries of its preliminary view that the company has breached EU antitrust rules by engaging in practices intended to delay competition to its blockbuster multiple sclerosis drug Copaxone (glatiramer acetate). 10 October 2022
Biotechnology
In the USA, Eli Lilly and Teva Pharmaceutical will meet in court after a federal judge slapped down an attempt to invalidate three of the latter’s patents. 6 October 2022
Biotechnology
US biotech Gilead Sciences has filed an anti-counterfeiting lawsuit against pharmaceutical suppliers and distributors for selling what it describes as ‘fake’ versions of its HIV medications. 30 September 2022
Pharmaceutical
Japanese drug major Sumitomo Pharma has filed an appeal with the US Court of Appeals for the Federal Circuit (CAFC) seeking revocation of the decision of the US Patent and Trademark Office (USPTO) relating to the proprietary atypical antipsychotic agent Latuda (lurasidone HCl tablets). 29 September 2022
Biotechnology
In what is the biggest ‘whistleblower’ settlement, US major Biogen has agreed to pay $900 million to resolve allegations that it caused the submission of false claims to Medicare and Medicaid by paying kickbacks to physicians to induce them to prescribe its multiple sclerosis drugs. 27 September 2022
Generics
Astellas Pharma saw its share gain 1.6% in early trading, though it later drifted back, as it revealed it has won a reprieve in its patent dispute with generics and biosimilar injectables specialist Hospira, albeit just short term. 26 September 2022
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