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Biosimilars
The US Association for Accessible Medicines’ (AAM) Biosimilars Council has released an update on major developments in the biosimilars sector by executive director Craig Burten. 6 July 2022
Pharmaceutical
An Expert View from Robert Sackin, a chartered and European patent attorney, and partner at Reddie & Grose. 5 July 2022
Pharmaceutical
Ireland-domiciled American drugmaker Endo International looks set to enter bankruptcy, after the firm failed to make an interest payment. 1 July 2022
Generics
This week Kelly Del Dotto, principal at USA-based patent firm Fish & Richardson P.C., provides context on the all-important Orange Book. 30 June 2022
Pharmaceutical
The pharmaceutical industry is facing the prospect of an increase in disputes in the coming months. A combination of recent events such as the pandemic, the changes arising from Brexit and the war in Ukraine have all had an impact on supply lines. The energy crisis and other economic conditions are contributing to inflationary pressures across the board. 30 June 2022
Pharmaceutical
US clinical-stage biotech Enanta Pharmaceuticals yesterday announced that it has filed suit in US District Court for the District of Massachusetts against pharma giant Pfizer seeking damages for infringement of US Patent No. 11,358,953 (the '953 Patent) in the manufacture, use and sale of Pfizer's COVID-19 antiviral, Paxlovid (nirmatrelvir tablets; ritonavir tablets). 22 June 2022
Pharmaceutical
The European Commission has opened a formal antitrust investigation to assess whether Switzerland-based Vifor Pharma has restricted competition by illegally disparaging its closest – and potentially only – competitor in Europe on the market for intravenous iron treatment, Danish iron metabolism specialist Pharmacosmos. 20 June 2022
Generics
Even as Germany’s Boehringer Ingelheim has obtained ad-interim injunctions against four Indian pharma companies that launched generic versions of the multinational's patent-protected drug linagliptin, Indian generic major Natco said that US firms Johnson & Johnson and Momenta Pharmaceuticals have filed a patent infringement lawsuit against it on two old patents associated with its glatiramer acetate injection. 13 June 2022
Biotechnology
Danish biotech Genmab has started new legal proceedings against Janssen relating to their license agreement for daratumumab, just a couple of months after losing a previous dispute with the Johnson & Johnson subsidiary over the same drug. 10 June 2022
Generics
Israeli generics giant Teva Pharmaceutical Industries and its affiliates have reached an agreement with Indian drugmaker Aurobindo Pharma to resolve the dispute over Aurobindo’s Abbreviated New Drug Application (ANDA) for a generic deutetrabenazine product, a copy of the branded drug Austedo. 10 June 2022
Biotechnology
US biopharma Emergent Biosolutions and healthcare giant Johnson & Johnson’s Janssen subsidiary are accusing one another of breaching a contract signed in 2020 for large-scale drug substance manufacturing of J&J’s SARS-CoV-2 vaccine, Ad26.COV2-S. 8 June 2022
Pharmaceutical
Israel-based Teva Pharmaceutical Industries and US biotech AbbVie's Allergan unit reached a settlement worth $161.5 million to resolve claims the companies fueled an opioid epidemic in West Virginia. 25 May 2022
Pharmaceutical
The Himachal Pradesh High Court in India has restrained Macleods Pharmaceuticals, from infringing on the patent rights of Boehringer Ingelheim's linagliptin, marketed under the trade name Trulicity. 4 May 2022
Pharmaceutical
Biotechnology Innovation Organization (BIO) has hit out at the US Trade Representative’s (USTR) continued support for a waiver of IP protections for COVID-19 vaccines under the WTO (World Trade Organization) Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). 3 May 2022
Biosimilars
Pressure has long been mounting on European union’s health systems. More and more patients are affected by major non-communicable diseases (NCDs) like diabetes, cancer, cardiovascular disease, and lung illnesses while the COVID-19 pandemic has challenged the sustainability of our healthcare model, said the trade group Medicines for Europe, which adds: “We need impactful solutions that think long term and biosimilar medicines are part of it.” 28 April 2022
Pharmaceutical
Ireland-headquartered Endo International yesterday announced that the US Tennessee Court of Appeals has reversed a trial court judge's order denying a motion for recusal by Endo's wholly-owned subsidiaries Endo Health Solutions and Endo Pharmaceuticals (collectively Endo) in Clay County et al v Purdue Pharma, et al, pending in the Circuit Court for Cumberland County, Tennessee, and remanded the case for transfer to a different judge. 21 April 2022
Pharmaceutical
Johnson & Johnson has agreed to pay $99 million to settle litigation in West Virginia, USA, related to the company’s involvement in the marketing of opioids. 19 April 2022
Biotechnology
Among notable news last week, US biotech Seagen won a $41.8 million award through a US District Court ruling in its patent dispute with Japan’s Daiichi Sankyo over cancer drug Enhertu. USA-based Veru scored a big hit with Phase III data for its COVID-19 treatment candidate sabizabulin. On the M&A front, UK pharma major GlaxoSmithKline last Wednesday announced a $1.9 billion acquisition of Sierra Oncology, along with its myelofibrosis candidate momelotinib. Also announcing an M&A deal last Wednesday was specialty pharma company Halozyme Therapeutics, with a $960 million bid for Antares Pharma. 17 April 2022
Pharmaceutical
The Delhi High Court has issued a permanent injunction against two Indian companies protesting Novartis patent for eltrombopag olamine, an active pharmaceutical ingredient in its brand Revolade, till May 21, 2023. 13 April 2022
Biotechnology
US biotech Seagen announced that a jury in the US District Court for the Eastern District of Texas found that Japanese pharma major Daiichi Sankyo infringed Seagen’s US Patent No 10,808,039 by selling its cancer drug Enhertu (trastuzumab deruxtecan; DS-8201) in the USA. 11 April 2022
Biotechnology
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
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