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Generics
The Brazilian Supreme Court of Justice is expected to deliver a potentially ground-breaking verdict on the constitutionality of a provision in the country’s intellectual property (IP) law allowing patent term extensions this week, according to Médecins Sans Frontières (MSF). 6 April 2021
Pharmaceutical
The Delhi High Court in India has set out three major directives with regard to patients suffering from rare diseases. 29 March 2021
Pharmaceutical
The US District Court for the Northern District of West Virginia has decided in favour of AstraZeneca in litigation against Mylan Pharmaceuticals and Kindeva Drug Delivery, determining that asserted claims in three of AstraZeneca’s patents protecting Symbicort (budesonide/formoterol) in the US are not invalid. 3 March 2021
Pharmaceutical
In the UK, a tribunal has upheld a finding from the country’s antitrust regulator, the Competition and Markets Authority (CMA), which found that the wholesaler Lexon broke competition law. 25 February 2021
Pharmaceutical
Japanese drugmaker Chugai Pharmaceutical announced today that it has refiled a patent infringement lawsuit with the Tokyo District Court, based on the substance patent owned by Chugai, regarding the generic drugs of an osteoporosis agent, active vitamin D3 derivative Edirol capsule 0.5 g / 0.75 g (eldecalcitol). 17 February 2021
Biotechnology
The US Court of Appeals for the Federal Circuit has upheld the decision by the US District Court for the District of Delaware that Amgen's asserted patent claims directed toward PCSK9 (proprotein convertase subtilisin/kexin type 9) antibodies are invalid based on lack of enablement. 15 February 2021
Pharmaceutical
Fresenius Kabi Oncology Limited (FKOL), the Indian unit of Germany-headquartered Fresenius Kabi, has agreed to plead guilty to concealing and destroying records prior to a 2013 US Food and Drug Administration plant inspection and pay $50 million in fines and forfeiture, the Department of Justice announced yesterday. 10 February 2021
Pharmaceutical
Sarah Ellson, co-head of regulatory and life sciences and healthcare lawyer, Fieldfisher and her colleague Laura Penny, associate and regulatory lawyer, provide an Expert View on the topical issue of the use of medicines off-label. 8 February 2021
Pharmaceutical
The US Patent and Trademark Office (USPTO) recently issued a US Patent Term Extension (PTE) certificate for Ibrance (palbociclib), US pharma giant Pfizer announced on Friday. 8 February 2021
Biotechnology
Following the renewed request from the European Commission on January 27, 2021, UK pharma major AstraZeneca has agreed to publish the redacted contract signed between the two parties on August 27, 2020, relating to the supply of AZD1222, the COVID-19 vaccine it has developed with Oxford University. 29 January 2021
Generics
The US Federal Trade Commission (FTC) yesterday filed a new antitrust complaint accusing Endo Pharmaceuticals and Impax Laboratories, as well as the latter’s owner, Amneal Pharmaceuticals, of striking a second deal to stave off competition to the Opana ER (oxymorphone hydrochloride extended release) opioid pain medication even as an earlier FTC enforcement action over the same drug was moving forward. 26 January 2021
Pharmaceutical
The US Department of Justice collected more than $2.2 billion in settlements and judgments from civil cases involving fraud and false claims against the government in the fiscal year ending September 30, 2020, Acting Assistant Attorney General Jeffrey Bossert Clark of the Department of Justice’s Civil Division announced yesterday. 15 January 2021
Pharmaceutical
The International Court of Arbitration of the International Chamber of Commerce has ordered Korea’s Kolon Life Science to pay a total of $33 million to Mitsubishi Tanabe Pharma Corporation. 14 January 2021
Pharmaceutical
The US Department of Health and Human Services (HHS) Office of the General Counsel this week released an advisory opinion concluding that drug manufacturers are required to deliver discounts under the 340B Drug Pricing Program (340B Program) on covered outpatient drugs when contract pharmacies are acting as agents of 340B covered entities. 31 December 2020
Pharmaceutical
Two US district courts – Maryland and the Northern District of California - recently dealt what may become fatal blows to the Trump administration’s Most Favored Nation (MFN) rule for Medicare Part B drug payment on procedural grounds, according to a posting on Hyman, Phelps & McNamara’s (HP&M) FDA Law Blog. 31 December 2020
Generics
Hyderabad, India-based Natco Pharma is seeking to file a compulsory licensing application for a generic version of Eli Lilly's arthritis drug baricitinib, in a move that could potentially lead to a legal battle over intellectual property rights (IPR), reports The Pharma Letter’s local correspondent. 23 December 2020
Biotechnology
US biotech major Biogen has agreed to pay $22 million to resolve claims that it violated the False Claims Act by illegally using charitable foundations as a conduit to pay the co-pays of Medicare patients taking Biogen’s multiple sclerosis drugs, Avonex (interferon beta 1a) and Tysabri (natalizumab), according to the US Justice Department. 19 December 2020
Pharmaceutical
President-elect Joe Biden has nominated former Congressman and California Attorney General Xavier Becerra for the position of HHS Secretary. 7 December 2020
Pharmaceutical
UK-headquartered Indivior says it has reviewed the £1.07 billion ($1.4 billion) claim by former parent Reckitt Benckiser Group filed against the company in the Commercial High Court in London on November 13, 2020. 1 December 2020
Generics
The European Commission has fined the pharmaceutical companies Israel-based Teva Pharmaceutical Industries 60.5 million euros ($72 million) for agreeing to delay for several years the market entry of a cheaper generic version of Cephalon's drug for sleep disorders, modafinil, after Cephalon's main patents had expired. 26 November 2020
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
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