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Generics
Sino-American oncology company BeOne Medicines, until now known as BeiGene, has entered into a settlement agreement with MSN Pharmaceuticals and MSN Laboratories Private resolving patent litigation related to MSN’s Abbreviated New Drug Application (ANDA) seeking approval to market a generic version of Brukinsa (zanubrutinib) in the USA. 25 November 2024
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
Generics
The insolvency administrator of Velefarm Holding as well as Velefarm VFB and the Serbian Hemofarm, a subsidiary of German drugmaker Stada Arzneimittel (SAZ: Xetra), have agreed on the resolution of a legal dispute. 24 December 2015
Pharmaceutical
USA-based Pacira Pharmaceuticals has announced a US Food and Drug Administration U-turn, allowing the company to market its post-surgical analgesia treatment as not being limited to a specific surgery. 16 December 2015
Pharmaceutical
The US Department of Justice obtained more than $3.5 billion in settlements and judgments from civil cases involving fraud and false claims against the government in the fiscal year ending September 30. 4 December 2015
Pharmaceutical
Roche has prevailed in a patent challenge law suit against Indian drug major Cipla, with the Delhi High Court today holding that the company was infringing Roche's patent on lung cancer drug erlotinib hydrochloride, sold under the trade name Tarceva, reports the Business Standard and other local media. 27 November 2015
Pharmaceutical
Allergan has reached an agreement with the New York State Attorney General's Office to end the litigation over the decision of subsidiary Forest Laboratories, announced in February 2014, to cease marketing and selling the now generic version of memantine immediate release tablets. 26 November 2015
Pharmaceutical
The US subsidiary of Swiss pharma giant Novartis has finalized the settlement in principle, which was previously disclosed, to resolve a civil suit filed by the US Attorney's Office for the Southern District of New York related to Novartis Pharmaceutical Corp’s (NPC) interactions with specialty pharmacies for the drugs Exjade (deferasirox) and Myfortic (mycophenolate mofetil) . 21 November 2015
Generics
The USA’s Federal Trade Commission has filed an amicus brief in the US Court of Appeals for the Third Circuit urging the court to reverse a district court ruling that an alleged reverse-payment settlement of patent litigation did not violate the antitrust laws, in part, because the FTC did not object to the proposed settlement when the companies submitted it to the agency. 20 November 2015
Pharmaceutical
Japan’s Chugai Pharmaceutical, majority-owned by Swiss pharma giant Roche, today announced an update regarding an application for patent term extension for Avastin (bevacizumab). 17 November 2015
Pharmaceutical
US pharma giant Merck & Co received a slightly mixed response to its appeal against a court ruling on patent litigation yesterday. 13 November 2015
Pharmaceutical
Ireland-incorporated Horizon Pharma (Nasdaq: HZNP) today commented on Express Scripts' business practices. In light of Express Scripts' actions, Horizon says it will evaluate all legal and other remedies and options. 11 November 2015
Generics
Dr Reddy’s Laboratories today said that it has been made aware of an order passed by the District Court of Delaware, USA, granting a temporary restraining order (TRO) with immediate effect on sales, delivery, transfer, or other disposition of its generic esomeprazole product in the US market. 10 November 2015
Generics
Following a public comment period, the US Federal Trade Commission has approved final orders settling charges that pharmaceutical companies Concordia Pharmaceuticals and Par Pharmaceutical entered into an unlawful agreement not to compete in the sale of generic versions of Kapvay, a prescription drug used to treat attention deficit hyperactivity disorder. 2 November 2015
Pharmaceutical
Botox maker Allergan said its unit Warner Chilcott US Sales LLC has agreed to pay $125 million and plead guilty to felony healthcare fraud charges to resolve the US federal government charges that it bribed the doctors in return for prescription of several of its drugs. 30 October 2015
Generics
Commenting on legislative moves in the US House of Representatives, US Generic Pharmaceutical Association (GPhA) president and chief executive Chip Davis said: “Today’s House proposal seeks in part to balance the budget on the backs of America’s vulnerable Medicaid population, and will reduce patient access to affordable generic medicines 29 October 2015
Generics
Ireland-headquartered Horizon Pharma has received a favorable Markman ruling issued by Judge Roy Payne in the US District Court for the Eastern District of Texas Marshall Division in the patent infringement lawsuit filed by Horizon against Par Pharmaceutical. 21 October 2015
Generics
Supernus Pharmaceutical’s has entered into a settlement agreement with privately-held generics firm Par Pharmaceutical involving the ongoing patent litigation regarding Trokendi XR. 16 October 2015
Pharmaceutical
Canadian drugmaker Valeant Pharmaceuticals International has responded to a letter from US Senator Claire McCaskill (Democrat, Missouri) concerning pricing of the company's products Nitropress (nitroprusside) and Isuprel (isoproterenol). 15 October 2015
Generics
An Indian court has banned Indian pharma company Glenmark from selling generics of Januvia (sitagliptin) from Merck & Co. 8 October 2015
Pharmaceutical
The European Court of Justice has ruled that Supplementary Protection Certificates (SPCs) for pharma patents start on the date they are notified to the applicant. 7 October 2015
Biotechnology
The Australian High Court has ruled to disallow patenting of isolated genetic materials. 7 October 2015
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