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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
The US Supreme Court yesterday granted Swiss drugmaker Helsinn’s petition for certiorari to review a Federal Circuit Panel decision, holding that certain patent claims covering Aloxi (palonosetron hydrochloride) injection are not valid and are not infringed by Israeli generics drug giant Teva Pharmaceutical Industries’ generic palonosetron product. 26 June 2018
Generics
Eli Lilly on Friday announced that the US District Court for the Southern District of Indiana ruled in favor of Lilly that the Alimta (pemetrexed for injection) vitamin regimen patent would be infringed by a competitor that had stated its intent to market alternative salt forms of pemetrexed prior to the patent's expiration in
2022. 23 June 2018
Pharmaceutical
A ruling in the Supreme Court of the United States (SCOTUS) on Thursday found that foreign law deserves ‘respectful consideration’ but should not determine a class action’s outcome. 15 June 2018
Pharmaceutical
Shares in Ireland-incorporated Endo International opened up on Tuesday morning following the news that all known testosterone replacement therapy product liability claims against the company had been settled. 12 June 2018
Pharmaceutical
Drugmakers Pfizer and Flynn Pharma have successfully overturned fines of nearly nearly £90 million ($120 million) levied by the UK’s competition authority in 2016 over allegations of price gouging. 8 June 2018
Generics
The UK’s National Audit Office (NAO) is investigating unexpected rises in the prices of certain generic medicines bought by pharmacies for the National Health Service (NHS) last year, it was announced on Friday. 8 June 2018
Pharmaceutical
Danish CNS specialist Lundbeck says its US subsidiary has reached an agreement in principle to resolve the US Department of Justice (DoJ) investigation related to Lundbeck LLC's relationship with and donations to independent patient assistance charitable foundations. 7 June 2018
Pharmaceutical
Japanese pharma major Daiichi Sankyo today announced that more than 97% of eligible claimants have opted into the product liability litigation settlement program announced on March 30, 2018 for cases brought against various Daiichi Sankyo and Forest entities. 6 June 2018
Pharmaceutical
In an expert view piece, Ronald Wisor and Hein van den Bos — partners at the global law firm Hogan Lovells — discuss the challenges created by Europe's evolving transparency laws. 1 June 2018
Pharmaceutical
News that the South African government is to release a new intellectual property (IP) policy has been praised by campaigners. 31 May 2018
Pharmaceutical
While the financial damage from a court settlement announced on Thursday will barely cause a ripple at US drug giant Pfizer, the reputational damage for paying illegal kickbacks could be more noticeable. 25 May 2018
Generics
In an Initial Decision announced on May 18, 2018, Chief Administrative Law Judge D Michael Chappell dismissed the antitrust charges in a complaint issued by the Federal Trade Commission against generic pharmaceutical company Impax Laboratories. 25 May 2018
Pharmaceutical
The European Commission has decided to close its infringement procedures and the treatment of complaints in the area of parallel trade of medicines for human use against Poland, Romania and Slovakia. 18 May 2018
Pharmaceutical
For the second time, Anglo-Swedish pharma major AstraZeneca is trying to stop the marketing of a generic produced by a Russian drugmaker Nativa which is a copy version of AstraZeneca’s original drug Iressa (gefitinib), the patent for which has not yet expired, reports The Pharma Letter’s local correspondent. 17 May 2018
Pharmaceutical
On April 13, 2018, the United States intervened in five lawsuits accusing Insys Therapeutics of violating the False Claims Act in connection with the marketing of Subsys, an opioid painkiller manufactured and sold by Insys, the Department of Justice announced yesterday. 16 May 2018
Generics
Under the terms of a settlement, drugmakers Ironwood Pharmaceuticals and Allergan have granted Aurobindo Pharma a license to market a generic version of Linzess (linaclotide) in the USA – but not until August 5, 2030. 4 May 2018
Pharmaceutical
Speaking at the annual get-together of the Food and Drug Law Institute, US Food and Drug Commissioner Scott Gottlieb suggested on Thursday that the federal law on kickbacks could be applied in order to lower prescription drug prices. 4 May 2018
Biotechnology
Shares in contract manufacturing organization Samsung BioLogics (KRX: 207940) slumped almost a fifth this week after financial regulators said the biopharmaceutical firm was in violation of accounting rules. 3 May 2018
Pharmaceutical
The European Commission has conditionally approved under the EU Merger Regulation the acquisition of parts of Bayer's Crop Science business by fellow Germany-based BASF. 30 April 2018
Generics
The US Federal Trade Commission will require generic drug marketers privately-held Amneal Pharmaceuticals and Impax Laboratories to divest Impax’ rights and assets for 10 products to three other companies, as part of a settlement resolving charges that Amneal’s $1.45 billion acquisition of an equity share in Impax, announced last October, likely would be anticompetitive. 30 April 2018
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