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Generics
The US Federal Trade Commission has filed an amicus brief before the US Court of Appeals for the Third Circuit explaining that the district court made significant analytical errors in ruling for defendants in a dispute involving allegations of pharmaceutical “product hopping.” 2 October 2015
Generics
US drugmaker United Therapeutics has entered into a settlement agreement with Sandoz Inc, a US generics unit of Swiss pharma giant Novartis, relating to ongoing litigation concerning certain patents relating to its Remodulin (treprostinil) Injection. 30 September 2015
Biosimilars
Eli Lilly has entered into a settlement agreement to resolve patent litigation with French peer Sanofi regarding its insulin glargine product, Basaglar. 29 September 2015
Pharmaceutical
Ireland-headquartered drugmaker Shire has had its patent upheld for Vyvanse (lisdexamfetamine) by the US Court of Appeals. 25 September 2015
Generics
US biotech company BioMarin and Indian pharma company Dr Reddy’s have settled their patent litigation over Kuvan tablets (sapropterin). 21 September 2015
Pharmaceutical
As many of you will already be aware, the Irish pharmaceutical company Amarin Corp is suing the US Food and Drug Administration, writes Dr Nicola Davies in her exclusive series for The Pharma Letter. 11 September 2015
Pharmaceutical
The UK High Court in London dealt a major blow to US pharma giant Pfizer when it ruled that claims of patent protection for the use of its Lyrica (pregabalin) as a pain treatment were invalid, according to reports by Reuters and other newswires. 10 September 2015
Biotechnology
Genzyme agreed to resolve criminal charges that it violated the US Food, Drug and Cosmetic Act with regard to the unlawful distribution of Seprafilm, a surgical device it markets and promotes, the Justice Department announced. 5 September 2015
Biosimilars
Swiss pharma giant Novartis’ generics subsidiary Sandoz announced today that Zarxio (filgrastim-sndz) is now available in the USA. 3 September 2015
Pharmaceutical
The European Federation of Pharmaceutical Industries and Associations (EFPIA), the European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) and the European Association for Bioindustries (EuropaBio), have filed a complaint with the European Commission against the French “RTU Regime,” the first implementing act of which became effective as of September 1, 2015. 1 September 2015
Pharmaceutical
The US District Court for the Southern District of Indiana has ruled in pharma major Eli Lilly’s favor regarding infringement of the vitamin regimen patent for its lung cancer drug Alimta (pemetrexed for injection). 26 August 2015
Biotechnology
Acorda Therapeutics yesterday announced that the US Patent and Trademark Office (USPTO) Patent Trials and Appeal Board (PTAB) will not institute the inter partes review (IPR) of US Patent Nos 8,663,685 and 8,007,826. 25 August 2015
Pharmaceutical
Japan’s largest drugmaker Takeda Pharmaceutical suffered a major setback, when US District of Delaware Judge Gregory Sleet ruled against the company on the validity of a patent on its best-selling drug Velcade (bortezomib), according to a report by Bloomberg. 25 August 2015
Generics
Concordia Pharmaceuticals and Par Pharmaceutical have settled Federal Trade Commission charges that they entered into an unlawful agreement not to compete in the sale of generic versions of Kapvay (clonidine hydrochloride). 19 August 2015
Biotechnology
US biotech company Amgen has reached an agreement to pay $71 million to 48 US states and the District of Columbia over the marketing of Enbrel (etanercept) and Aranesp (darbepoetin alfa). 19 August 2015
Pharmaceutical
Avanir Pharmaceuticals has received a favorable ruling from the US Court of Appeals regarding Nuedexta (dextromethorphan hydrobromide/quinidine sulfate). 19 August 2015
Generics
Mylan has confirmed that it has been sued by BTG and Johnson & Johnson subsidiaries in connection with the filing of an Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration for abiraterone acetate tablets, 250mg. 18 August 2015
Pharmaceutical
The District Court for the Southern District of New York has issued a ruling upholding two Endo International patents covering its top-selling opioid analgesic Opana ER (oxymorphone hydrochloride). 15 August 2015
Pharmaceutical
US pharma giant Pfizer said today that it has been granted approval from the Canadian Competition Bureau with respect to its pending $17 billion acquisition of Hospira. 14 August 2015
Biotechnology
Dutch biotechnology company Merus, a developer of bispecific antibody therapeutics to treat cancer patients, says that it won its inequitable conduct trial against US biotech major Regeneron Pharmaceuticals. 11 August 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
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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