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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
Pharmaceutical
News flow last week was dominated by hints as to what is coming up at the prestigious JP Morgan annual healthcare conference which starts today. Elsewhere, a US court is questioning the Valeant Pharmaceuticals and Pershing Square settlement with Allergan; and Novartis has bagged another Breakthrough therapy designation for its Kisqali. Two licensing deals also attracted attention, that of AstraZeneca with ANI Pharmaceutical, and Takeda Pharmaceutical buying rights to early-stage neurodegenerative disease compounds from Denali Therapeutics. 7 January 2018
Biotechnology
The US Food and Drug Administration (FDA) has issued a warning to American CryoStem Corporation for marketing an adipose derived stem cell product without FDA approval and for significant deviations from current good manufacturing practice (GMP), including some that risk patient safety. 5 January 2018
Pharmaceutical
Canada’s Valeant Pharmaceuticals International and Pershing Square Capital Management have preliminarily agreed to resolve the claims of the litigation for $290 million, subject to the court's approval, to settle a lawsuit that accused them of insider trading in making an unsolicited $51 billion bid for Ireland-domiciled Allergan. 31 December 2017
Generics
US pharmacy firm Kmart Corp, a wholly-owned subsidiary of Sears Holdings, has agreed to pay $32.3 million to the United States to settle allegations that in-store pharmacies in Kmart stores failed to report discounted generic prescription drug prices to Medicare Part D, Medicaid, and TRICARE, the health program for uniformed service members and their families, says the Justice Department. 28 December 2017
Generics
The Russian national Parliament (State Duma) plans to approve a bill that will ease imports of active pharmaceutical ingredients (APIs) to the country, according to press-service of the Russian Duma, reports The Pharma Letter’s local correspondent. 26 December 2017
Pharmaceutical
Boehringer Ingelheim Pharmaceuticals Inc (BIPI) has agreed to distribute $13.5 million among all 50 US states and the District of Columbia to end allegations that it marketed four of its prescription drugs for off-label uses, attorneys general announced Wednesday. 21 December 2017
Pharmaceutical
In light of a recent case, David Prange and Christopher Pinahs, from USA-based law firm Robins Kaplan, provide an Expert View piece containing potentially crucial insights into improving trade secret protection. 19 December 2017
Biotechnology
Top US Republicans Senator John Cornyn and Representative Kevin Brady said on Sunday morning talk shows that they were confident their tax overhaul would become law by the end of the week. 18 December 2017
Biotechnology
A legal challenge against Gilead Sciences’ patent application for the combination of sofosbuvir and velpatasvir has been launched by Médecins Sans Frontières (MSF), a therapy which is marketed as Epclusa. 18 December 2017
Generics
The US Patent and Trademark Appeal Board (PTAB) has instituted inter partes review (IPR) proceedings on all claims against two patents owned by French pharma major Sanofi for the diabetes treatment Lantus (insulin glargine injection) 100 Units/mL, according to Mylan. 15 December 2017
Pharmaceutical
In an Expert View piece, Rosanne Kay, partner at international law firm Reed Smith, considers when to escalate matters to an internal investigation, and how best to carry them out. 14 December 2017
Biotechnology
Clinical-stage US biotech Provectus Biopharmaceuticals has reached a settlement with the US Securities and Exchange Commission (SEC) in connection with investigations relating to two former executives and the company. 13 December 2017
Pharmaceutical
German pharma major Bayer is among the four latest companies named and shamed for breaching the Code of Practice of the Association of the British Pharmaceutical Industry (ABPI). 12 December 2017
Pharmaceutical
The US lobby group Pharmaceutical Research and Manufacturers of America (PhRMA) has initiated litigation in the US District Court for the Eastern District of California challenging SB 17, describing it as ‘an unprecedented and unconstitutional California law.’ 11 December 2017
Biotechnology
Two new patent challenges have been launched by the New York-based patient access and public health activist I-MAK - the Initiative for Medicines, Access & Knowledge - against sofosbuvir-based products. 7 December 2017
Pharmaceutical
The Australian Competition and Consumer Commission (ACCC) has instituted proceedings in the Federal Court of Australia against the local consumer health subsidiaries of GlaxoSmithKline and Novartis, alleging they made false or misleading representations in the marketing of Voltaren Osteo Gel and Voltaren Emulgel pain relief products. 7 December 2017
Pharmaceutical
Aside from issues concerning how to enforce second medical patents, the validity issues at the core of the Warner-Lambert case are on their way to the UK Supreme Court and have potentially significant implications for pharma patents, writes Andrew Hutchinson, a patent litigation partner at Simmons & Simmons LLP, in an Expert View piece. 23 November 2017
Biotechnology
International aid agency Médecins Sans Frontières will argue in a Delhi court that New York pharma giant Pfizer ought not to have been awarded a patent for its pneumonia vaccine Prevnar13 (PCV13). 20 November 2017
Biosimilars
US healthcare giant Johnson & Johnson has dropped its lawsuit against Samsung Bioepis relating to the latter’s biosimilar of the blockbuster rheumatoid arthritis treatment Remicade (infliximab). 14 November 2017
Generics
For the second year running, pay-for-delay deals declined in 2015, the Federal Trade Commission (FTC) has said in a report. 2 November 2017
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