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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 has ruled that private health care providers cannot sue states to force them to increase their Medicaid reimbursement rates in keeping with increasing medical costs. 31 March 2015
Pharmaceutical
Following an in-depth investigation, the European Commission has concluded that a German scheme exempting pharmaceutical companies from mandatory rebates was in line with European Union State aid rules. 27 March 2015
Pharmaceutical
South Korea's anti-trust regulator this week ordered the local subsidiary of German pharma major Bayer to sell off its oral contraceptive pill operation that was acquired when its parent bought Merck & Co (NYSE: MRK) over-the- counter medicines business. 26 March 2015
Generics
Indian drugmaker Aurobindo Pharma has received tentative approval from the US Food and Drug Administration for generic lacosamide tablets 50mg, 100mg, 150mg and 200mg. 21 March 2015
Biosimilars
The US district court has rejected Amgen’s request for a preliminary injunction to block Sandoz’s Neupogen (fligrastim) biosimilar Zarxio (fligrastim-sndz). 20 March 2015
Generics
Ireland-headquartered generics major Actavis has confirmed that the US Court of Appeals for the Federal Circuit has granted AstraZeneca’s request for an injunction pending appeal preventing Actavis from further distribution of its generic version of Pulmicort Respules (budesonide inhalation suspension). 13 March 2015
Generics
In a ‘landmark’ case, India's Patent Office has revoked a patent on family-owned German pharma major Boehringer Ingelheim’s asthma drug Spiriva (tiotropium bromide monohydrate), after it was challenged by Indian generics company Cipla. 11 March 2015
Pharmaceutical
The German Court of Appeal has ruled that US pharma major Eli Lilly’s vitamin regimen patent for its lung cancer drug Alimta (pemetrexed disodium) would not be infringed by generic competitor Actavis. 7 March 2015
Generics
The US District Court for the District of New Jersey has found that Ireland-headquartered Actavis’ US Patent Nos 7,645,459 and 7,645,460 protecting Atelvia (risedronate sodium delayed-release tablets, 35mg) in the USA are invalid. 5 March 2015
Pharmaceutical
US Senators Chris Coons (Democrat, Delaware) and Dick Durbin (Democrat, Illinois), members of the Senate Judiciary Committee, and Mazie Hirono (Democrat, Hawaii), member of the Senate Committee on Small Business and Entrepreneurship, have introduced legislation to strengthen America’s patent system and target abusers. 4 March 2015
Pharmaceutical
Swiss drug major Novartis has been ordered to suspend operations in Japan for 15 days as of March 5, the first penalty of its kind for a pharma company in Japan. 2 March 2015
Pharmaceutical
Privately-held Italian drugmaker Chiesi Farmaceutici has been publicly reprimanded for providing inaccurate information to the UK’s Prescription Medicines Code Of Practice Authority (PMCPA), breaching the ABPI Code of Practice for the Pharmaceutical Industry. 27 February 2015
Biotechnology
The European Patent Office (EPO) has reported an increase in the number of patent filings for the fifth consecutive year. According to the EPO’s annual report, released today, both the biotech and pharma sectors remain in the top ten for applications at eighth and tenth respectively. 26 February 2015
Pharmaceutical
The US Federal Trade Commission has put conditions on the proposed acquisition by Novartis of GlaxoSmithKline’s oncology drugs. 24 February 2015
Generics
Ireland-headquartered generics major Actavis yesterday confirmed that the US Court of Appeals for the Federal Circuit has issued a temporary injunction to prevent Actavis from further distribution of its generic version of Pulmicort Respules (budesonide inhalation suspension pending its consideration of AstraZeneca's request for an injunction pending appeal. 18 February 2015
Pharmaceutical
The European Commission has decided to withdraw its investigation into the UK government's Patent Box scheme in a move which is favorable to British innovators and provides greater clarity around the future of the scheme, according to intellectual property firm Withers & Rogers. 17 February 2015
Generics
Ireland-based generic drugs major Actavis has launched its generic version of Anglo-Swedish pharma major AstraZeneca's Pulmicort Respules (budesonide inhalation suspension). 14 February 2015
Pharmaceutical
Anglo-Swedish pharma major AstraZeneca has agreed to pay the US government $7.9 million to settle allegations that it engaged in a kickback scheme in violation of the False Claims Act, the Justice Department announced yesterday. 12 February 2015
Generics
US generics drugmaker Mylan has confirmed that it has been sued by German pharma major Bayer and partner Onyx Pharmaceuticals (a subsidiary of Amgen), in connection with the filing of an Abbreviated New Drug Application with the US Food and Drug Administration for sorafenib. 10 February 2015
Generics
Sweden-based pharma company Orexo has filed a patent infringement law suit in the US District Court for New Jersey against Ireland-headquartered generics major Actavis. 6 February 2015
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