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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
Generics
The USA's Generic Pharmaceutical Association (GPhA) has written to House Appropriations Committee Chairman Hal Rogers (Republican, Kentucky.) and Ranking Member Norm Dicks (Democrat, Washington) expressing concern with the $285 million in proposed cuts to the Food and Drug Administration's Fiscal Year 2012 Budget. 30 May 2011
Pharmaceutical
US health care major Abbott Laboratories (NYSE: ABT) last week won a US appeals court ruling that will make it harder for patents to be declared invalid because of gaps or errors in patent applications. 30 May 2011
Pharmaceutical
In an initial win for US biotech firm Amylin Pharmaceuticals (Nasdaq: AMLN), the US District Court for the Southern District of California has issued a temporary restraining order (TRO) against drug major Eli Lilly (NYSE: LLY) relating to its litigation with respect to the two companies diabetes collaboration agreement established in 2002. 27 May 2011
Pharmaceutical
Patient access and industry competitiveness at stake in EU Transparency Directive review, says EFPIA
With the review of the European Union's Transparency Directive (Directive 89/105/EEC) gaining momentum, improving the competitive environment for pharmaceuticals and strengthening access to innovation for patients must remain core objectives in the review's next steps, says the European Federation of Pharmaceutical Industries and Associations (EFPIA), which represents the research-based drug industry. 26 May 2011
Generics
Swiss drug major Novartis (NOVN: VX) says that that two affiliates of its Alcon Division have prevailed in a US patent infringement law suit filed along with Japan's Kyowa Hakko Kirin (TYO: 4151) against generic drugmaker Apotex in the US District Court for the Southern District of Indiana. 26 May 2011
Generics
Continuing its battle against pay-for-delay between drug originators and generic makers, the US Federal Trade Commission revealed yesterday that it has filed an amicus brief before the US Court of Appeals for the Third Circuit in support of private class action plaintiffs who have challenged the legality of patent settlements between branded and generic manufacturers. 25 May 2011
Pharmaceutical
San Diego, USA-based Amylin Pharmaceuticals (Nasdaq: AMLN) has filed a law suit against drug major Eli Lilly (NYSE: LLY) in the US District Court for the Southern District of California, alleging that Lilly is engaging in anticompetitive activity and breaching its strategic alliance agreements with Amylin to maximize commercialization of exenatide. 17 May 2011
Generics
According to press reports emerging ahead of the weekend, two US drug giants, Pfizer (NYSE: PFE) and Johnsons & Johnson (NYSE: JNJ) have each made filings with the Securities and Exchange Commission outlining expected costs. 16 May 2011
Pharmaceutical
In a stunning ruling this week, US District Court Judge Roger Titus ruled from the bench in Greenbelt, Maryland, granting a Motion for a Judgment of Acquittal filed by the defendant, Lauren Stevens, who was formerly an in-house lawyer for UK drugs giant GlaxoSmithKline (LSE: GSK), writes John Fleder of Hyman, Phelps & McNamara on the law firm's FDA aw Blog. 12 May 2011
Generics
The Federal Trade Commission's Bureau of Competition has notified Sanofi-Aventis US, a subsidiary of French drug major Sanofi (Euronext: SAN), US generics firm Watson Pharmaceuticals(NYSE: WPI) and privately-held Netherlands-based Synthon Holding, that it believes the companies violated federal law by failing to inform antitrust authorities about drug patent agreements involving Sanofi's insomnia drug Ambien CR (zolpidem). 11 May 2011
Generics
USA-based Impax Laboratories (Nasdaq: IPXL) confirmed on Friday that Alza Corp, a division of health care giant Johnson & Johnson (NYSE: JNJ) has filed a second suit for patent infringement against the firm in the US District Court for the District of Delaware with regard to Concerta (methylphenidate hydrochloride) extended-release 18, 27 and 36mg tablets. 9 May 2011
Pharmaceutical
A bipartisan bill, S 733, designed to address a Medicare reimbursement flaw and seeking to reverse cancer care payment shortfalls has been introduced in the USA by Senator Pat Roberts (Republican, Kansas) and lead co-sponsor Senator Debbie Stabenow (Democrat, Michigan). 9 May 2011
Generics
The Office of the United States Trade Representative (USTR) released its annual Special 301 Report on the adequacy and effectiveness of US trading partners' protection of intellectual property rights (IPR). Despite its efforts Chile remains on the Priority Watch List for fifth year. Argentina and Venezuela are included too. 6 May 2011
Pharmaceutical
Four US subsidiaries of German drug major Merck KGaA (MRK: DE) - Serono Laboratories, EMD Serono, Merck Serono and Ares Trading - have agreed to pay $44.3 million to resolve False Claims Act allegations in connection with the marketing of the multiple sclerosis drug Rebif (interferon beta-1b), the US Department of Justice revealed yesterday. 5 May 2011
Biotechnology
Switzerland-based Actelion (SIX: ATLN) today commented on the verdict issued with regard to Japan's Asahi Kasei Pharma Corp versus Actelion et al (case number CIV 478533, Superior Court of the State of California, County of San Mateo) (the matter) in which the jury last week awarded Asahi up to $547 million in compensatory damages. 4 May 2011
Generics
The European Commission has opened a formal antitrust investigation to assess whether an agreement between US-based pharmaceutical company Cephalon (Nasdaq: CEPH) and Israel-based generic drugs firm Teva Pharmaceutical Industries (Nasdaq: TEVA) may have had the object or effect of hindering the entry of generic modafinil (Cephalon's Provigil brand) in the European Economic Area. 3 May 2011
Generics
The USA's Federal Trade Commission will require Jordan-based drugmaker Hikma Pharmaceuticals (LSE: HIK; Dubai: HIK) to divest two generic injectable pharmaceuticals - phenytoin and promethazine - as part of a settlement allowing it to acquire certain assets from Baxter Healthcare. Hikma proposes to acquire Baxter's entire generic injectable pharmaceutical business for $111.5 million, including Baxter's Cherry Hill, New Jersey, manufacturing facility and a warehouse and distribution center in Memphis, Tennessee (The Pharma Letter October 29, 2010). 29 April 2011
Pharmaceutical
After revealing a more than $1 billion loss for the fourth quarter of 2010 as a result of legal charges (mostly associated with its diabetes drug Avandia [rosiglitazone]; The Pharma Letter February 4), UK pharma giant GlaxoSmithKline (LSE: GSK) reported first-quarter 2011 results showing that, despite a downturn in both sales and earnings, the company was back in profit. 28 April 2011
Generics
Anglo-Swedish drug major AstraZeneca (LSE: AZN and USA-based Pozen (Nasdaq; POZN) have filed a law suit against India headquartered Dr Reddy's Laboratories (NYSE: RDY) in the US District Court for the District of New Jersey, for infringement of US Patent No. 6,926,907 relating to Vimovo (naproxen/esomeprazole magnesium) delayed-release tablets. 27 April 2011
Pharmaceutical
The European Alliance for Access to Safe Medicines (EAASM) has submitted a report to European Parliament, calling for enhanced legislation to improve the protection of Europe's patients against the intensifying risks and dangers of counterfeit medicines. 20 April 2011
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