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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 French National Assembly yesterday voted on the draft law proposal, which would potentially allow doctors to use off-label drugs even if there is an alternative drug approved. This draft law has still to be reviewed by the French Senate and a review by the French Constitutional Court is also possible. 9 July 2014
Generics
The European Generic Medicines Association (EGA) has expressed concerns over the European Commission’s policy regarding competition law investigations on patent settlements in pharmaceuticals, following the EC’s decision on the perindopril case. 9 July 2014
Generics
Ireland-headquartered generics major Actavis has confirmed filing an Abbreviated New Drug Application with the US Food and Drug Administration for dalfampridine, as announced last month. 9 July 2014
Pharmaceutical
The French pharmaceutical trade group Les Entreprises du Medicament (Leem) has joined forces with a police department, the central office to combat threats to the environment and public health, in a bid to combat counterfeit medicines. 8 July 2014
Pharmaceutical
Teva Pharmaceutical Industries says it has filed a citizen petition regarding the approvability of purported generic versions of its blockbuster multiple sclerosis drug Copaxone (glatiramer acetate). 3 July 2014
Pharmaceutical
Swiss drug major Novartis (NOVN: VX) said yesterday that Novartis Pharma K.K. (NPKK) understands that the Tokyo District Prosecutor’s Office (TPO) has publicly disclosed that it will proceed with charges against a former employee regarding the publication of an article containing manipulated data related to a sub-analysis of the Kyoto Heart Study in violation of Japan’s Pharmaceutical Affairs Law. 2 July 2014
Pharmaceutical
Ireland-headquartered drugmaker Shire, which is defending itself from a $46 billion unsolicited bid from the USA’ AbbVie, says that Judge Stanley Chesler of the US District Court for the District of New Jersey granted Shire’s summary judgment motion in a patent infringement law suit, holding that certain claims of the patents protecting attention-deficit hyperactivity disorder (ADHD) drug Vyvanse (lisdexamfetamine dimesylate) were both infringed and valid. 25 June 2014
Pharmaceutical
Swiss drug maker Novartis is the subject of a new investigation by Italian authorities. The company’s offices in Italy were searched by Italian authorities looking for pricing information on two influenza vaccines. 23 June 2014
Generics
Israeli generics giant Teva Pharmaceutical Industries has reached a settlement with Perrigo Pharmaceutical and privately-held Catalent Pharma Solutions with respect to four patents for Teva’s ProAir HFA (albuterol sulfate) inhalation aerosol product. 20 June 2014
Generics
The US Federal Trade Commission has filed an amicus brief in the New Jersey US District Court explaining that a brand name drug manufacturer’s improper use of a restricted drug distribution program to impede generic competition could violate the antitrust laws. 20 June 2014
Pharmaceutical
The European Commission has cleared under the EU Merger Regulation the creation of a joint venture between Germany’s Fresenius KGaA and Sistema JSFC of the Russian Federation. 19 June 2014
Pharmaceutical
William Ackman's Pershing Square Capital Management has filed a law suit in the Delaware Court of Chancery seeking a declaratory judgment confirming that its actions in connection with the solicitation and receipt of revocable proxies to call a special meeting of shareholders of Allergan will not trigger Allergan’s recently adopted rights plan, or “poison pill”. 15 June 2014
Generics
US pharma major Bristol-Myers Squibb yesterday announced that the US Court of Appeals for the Federal Circuit has denied the company’s appeal of a February 2013 ruling by the US District Court for the District of Delaware that found the patent covering the company’s hepatitis C drug Baraclude (entecavir), US patent 5,206,244 invalid. 13 June 2014
Generics
Indian drugmaker Lupin seems to have abandoned plans to bring to market generic versions of Gilead Sciences’ blockbuster AIDS drugs Truvada (emtricitabine and tenofovir disoproxil fumarate) and Viread (tenofovir disoproxil fumarate) before patent expiries. 8 June 2014
Pharmaceutical
UK pharma giant GlaxoSmithKline has agreed to a $105 million settlement with 44 US states and the District of Columbia over allegations that it mis-promoted three drugs. 5 June 2014
Pharmaceutical
US pharma giant Pfizer has agreed a $325 million settlement over a trial regarding the marketing of Neurontin (gabapentin) for epilepsy. 3 June 2014
Pharmaceutical
After facing more than 2,000 law suits in the USA, claiming Pradaxa (dabigatran) caused severe or fatal bleeding, German family-owned pharma major Boehringer Ingelheim has reached a $650 million settlement of all state and federal cases in the US litigation regarding Pradaxa (The Pharma Letter May 28). 2 June 2014
Pharmaceutical
There is growing support for Europe’s hotly debated Unified Patent Court, with almost three-quarters of those responsible for overseeing preparations for the new system in pharma and life sciences expecting it to be positive for their company, according to new research from Allen & Overy today. 2 June 2014
Generics
Ireland-headquartered generics major Actavis says it has entered into an agreement with Cephalon to settle all outstanding patent litigation related to Actavis' generic version of Nuvigil. 1 June 2014
Generics
Israel-based Teva Pharmaceutical Industries received positive news on Friday, when the US District Court for the Northern District of West Virginia denied a motion filed by US generic drugmaker Mylan. 31 May 2014
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