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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
Biotechnology
Danish drugmaker Genmab (OMX: GEN) says that the US Court of Appeals for the Federal Circuit has declined the request for re-hearing in connection with the Arzerra (ofatumumab) patent infringement case. 16 July 2013
Pharmaceutical
Investigations in China relating to alleged bribery and tax-related crimes by UK pharma giant GlaxoSmithKline (LSE: GSK; The Pharma Letter July 11)) escalated yesterday, when Gao Feng, head of economic crimes at the Ministry of Public Security, said that police were examining some 3 billion renminbi (around $490 million) worth of transfers to travel agencies and consultancies going back as far as 2007 that were channelled to bribe doctor to prescribe the companies drugs. 16 July 2013
Generics
Impax Laboratories (Nasdaq: IPXL) today announced yesterday (July 15) that it is commencing shipment of authorized generic Trilipix (fenofibric acid) delayed release capsules, 45mg and 135 mg, through its generics division Global Pharmaceuticals. 16 July 2013
Generics
US generics major Actavis (NYSE: ACT) confirmed on Friday (July 12) that it has filed an Abbreviated New Drug Application with the US Food and Drug Administration seeking approval to market lacosamide tablets. 50mg, 100mg, 150mg and 200mg, a generic version of Belgian drugmaker UCB's (Euronext Brussels: UCB) Vimpat, an anticonvulsant drug approved to treat partial-onset seizures of people diagnosed with epilepsy aged 17 years and older. 15 July 2013
Generics
US generics major Actavis (NYSE: ACT) and Ireland-based Warner Chilcott (Nasdaq: WCRX) have each received a request for additional information from the US Federal Trade Commission in connection with Actavis' pending $8.5 billion acquisition of Warner Chilcott (The Pharma Letter May 20). The information request was issued under notification requirements of the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended (HSR Act). 11 July 2013
Generics
US generics and specialty drugmaker Mylan (Nasdaq: MYL) revealed yesterday (July 8) that the US District Court for the Southern District of New York has issued a Final Judgment and Order following a ruling by the Court of Appeals for the Federal Circuit in favor of Mylan Specialty, Dey Pharma 9 July 2013
Generics
In what must be seen as a major victory for the generic drug industry in the USA, the US Supreme Court, in a five to four decision penned by Justice Alito (and joined in by Chief Justice Roberts and Justices Scalia, Kennedy, and Thomas), held that state law design-defect claims that turn on the adequacy of a drug's warnings are pre-empted by the FDC Act and under the Court's 2011 decision in PLIVA Inc v Mensing, 131 SCt. 2567 (2011). 25 June 2013
Generics
In a much awaited decision following its investigations of patent settlements (or pay-for-delay deals) between pharmaceutical companies and generic drugmakers started in 2008, the European Commission revealed today (June 19) that it has imposed a fine of 93.8 million euros ($125 million) on Danish pharmaceutical company Lundbeck (LUND: CO) and fines totalling 52.2 million euros on several producers of generic medicines. 19 June 2013
Generics
Denmark-based insulin giant Novo Nordisk (NOV: N) says that the US Court of Appeals for the Federal Circuit partially affirmed a 2011 District Court decision, with a two to one ruling that a claim in a company patent related to the use of repaglinide (trade name Prandin) in combination with metformin for the treatment of type 2 diabetes was invalid. This decision favors approval and launch of a generic repaglinide product. 19 June 2013
Generics
In a long awaited ruling in the USA, the US Supreme Court yesterday (June 17) ruled in the patent settlement litigation - or "pay-for-delay" case, in the case of Federal Trade Commission v Actavis Inc, voting by five to three that the FTC has the right to challenge such deals by brand-name drugmakers with generics companies, which are said to delay the advent of cheaper copy medicines coming to market, a situation long refuted by the originator companies, which claim that these accords actually speed the arrivals of generics. 18 June 2013
Generics
InSite Vision (OTC BB: INSV) that it will US pharma giants join Merck & CO (NYSE: MRK) and Pfizer (NYSE: PFE) in filing a patent infringement law suit against generic drugmaker Mylan (Nasdaq: MYL). 17 June 2013
Biotechnology
The US Supreme Court yesterday (June 13) delivered its unanimous decision regarding the Association for Molecular Pathology versus Myriad Genetics case on patent claims on isolated DNA molecules, stating that companies cannot patent specific DNA, but that synthetically produced genetic material can be patented. 14 June 2013
Generics
Global pharma behemoth Pfizer (NYSE: PFE) today (June 12) said it has reached a $2.15 billion settlement reached with Israel-based Teva Pharmaceuticals Industries (NYSE: TEVA) and India's Sun Pharmaceutical Industries (SUNP: IN) for patent-infringement damages resulting from their "at-risk" launches of generic Protonix (pantoprazole) in the USA. 12 June 2013
Biotechnology
USA-based PDL BioPharma (Nasdaq: PDLI) revealed today (June 11) that it has filed a Notice of Arbitration against Genentech, the US biotech subsidiary of Swiss drug major Roche (ROG: SIX), with the American Arbitration Association in Voorhees, New Jersey, alleging, inter alia, that Genentech underpaid royalties going back to at least 2007 and impeded PDL's attempts to have Genentech's books and records inspected to determine whether Genentech's past payments to PDL were accurately calculated. 11 June 2013
Biotechnology
Legislation amending the US state of Florida's existing prescription drug substitution law has the potential to create a pathway for biosimilar product substitution at the pharmacy. The bill, House Bill 365, passed both houses of the state's legislature in late April with nearly unanimous support, and has now must be signed by Governor Rick Scott. 6 June 2013
Pharmaceutical
Ireland-based Elan Corp (NYSE: ELN) has won an order from a US judge temporarily blocking Royalty Pharma from attempting a $6.4 billion hostile takeover after Elan sued to halt what it called a "coercive" tender offer (The Pharma Letter June 4). 5 June 2013
Pharmaceutical
The saga of Royalty Pharma's hostile attempts to acquire Ireland-headquartered Elan Corp (NYSE: ELN) continues, with Elan issuing a formal response document to the US private equity firm's revised offer made on May 23. The Irish drugmaker is also suing Royalty Pharma in a New York federal court seeking to block what it described as a "coercive" tender that gives stockholders until June 6 to determine whether or not to waive their shares. 4 June 2013
Generics
Anglo-Swedish drug major AstraZeneca (LSE: AZN) today (May 3) said it has entered into an agreement with South Korean firm Hanmi Pharmaceutical and its US marketing partner, privately-held generics drugmaker Amneal Pharmaceuticals, to resolve certain issues and appeal others in US Nexium (esomeprazole) patent litigation regarding Hanmi's Esomeprazole Strontium 505(b)2 NDA product. The agreement eliminates the need for a trial at the US District Court for the District of New Jersey, thus avoiding considerable trial costs. 3 June 2013
Generics
Ireland-headquartered drugmaker Shire (LSE: SHP) has settled its litigation against the US subsidiary of Israel's Teva Pharmaceutical Industries (NYSE: TEVA) in connection with Teva's Abbreviated New Drug Application for a generic version of Shire's Intuniv (guanfacine) extended release Tablets for the treatment of attention-deficit hyperactivity disorder (ADHD). 3 June 2013
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