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Danish firm Genmab was trading nearly 4% lower on Friday afternoon after the company lost out in a dispute with the Johnson & Johnson subsidiary Janssen. 8 April 2022
Biosimilars
Iceland-based Alvotech Holdings today announced the resolution of all intellectual property disputes with AbbVie in Europe and selected markets outside of Europe, related to its AVT02 biosimilar candidate. 6 April 2022
Pharmaceutical
The Rhode Island attorney general on Monday announced a settlement with Israeli generics giant Teva Pharmaceutical Industries and several of its affiliates worth about $100 million, including $28.5 million in cash in addition to drug donations to treat opioid addiction, that was reached ahead of opening arguments in the state's trial over the company's alleged role in the opioid crisis. 22 March 2022
Biotechnology
Regulatory news last week included the US Food and Drug Administration granting approval for AstraZeneca and Merck & Co’s Lynparza, for an important new indication in breast cancer. Following disappointing Phase III clinical trial results, Nektar Therapeutics and Bristol Myers Squibb have decided to discontinue enrolment in the study of bempegaldesleukin (bempeg) with Opdivo in the treatment of melanoma. Japan’s Eisai has significantly revised its licensing deal with Biogen on the controversially approved Alzheimer’s disease drug Aduhelm, retreating from a major role and instead concentrating on the development of lecanemab. US RNAi specialist Alnylam is suing Pfizer and Moderna for patent infringement, seeking to gain a share of the massive profits that have been made by their respective COVID-19 vaccines, Comirnaty and Spikevax. 20 March 2022
Biotechnology
Alexion, AstraZeneca’s Rare Disease group, has entered into a settlement agreement with Japan’s Chugai Pharmaceutical resolving all patent disputes between the two companies related to Ultomiris (ravulizumab). 17 March 2022
Biotechnology
Krystal Biotech, which is focussed on redosable gene therapies for rare diseases, saw its shares rise as much as 4.6% to $62.61 on Monday, as is said it has reached a binding term sheet with fellow US biotech firm PeriphaGen - and former lab partner - to resolve all claims it copied the latter’s gene therapy technology litigation filed by PeriphaGen on May 20, 2020. 16 March 2022
Pharmaceutical
Pharmaceutical company Mallinckrodt has agreed to pay $260 million to resolve allegations that it violated the False Claims Act. 10 March 2022
Biosimilars
Privately-held Icelandic biosimilars developer Alvotech Holdings says it has executed a US settlement agreement with AbbVie that grants Alvotech non-exclusive rights to market AVT02 (100mg/mL), its high-concentration, citrate-free biosimilar candidate for Humira (adalimumab) in the USA 9 March 2022
Pharmaceutical
An upgraded compensation package will see the owners of Purdue Pharma pay around $6 billion to bring an end to civil litigation related to the opioid epidemic in the USA. 4 March 2022
Biotechnology
Arbutus Biopharma’s shares were up 4.3% at $3.21 after, along with, Genevant Sciences, today filed a lawsuit in the US District Court for the District of Delaware against Moderna and one of its affiliates. 28 February 2022
Generics
The High Court in London has ruled against attempts by Servier to limit damages it owes for infringements of competition law in the sale and supply of a widely-prescribed blood pressure drug. 22 February 2022
Generics
The Federal Court of Appeal has dismissed an appeal by Pharmascience from a decision of the Federal Court that found Canadian patent No 2,760,802 (the 802 patent) valid and infringed by Pharmascience's proposed glatiramer acetate product, a generic of Teva Pharmaceutical Industries’ blockbuster multiple sclerosis drug Copaxone and Pharmascience's Glatect. 16 February 2022
Biotechnology
There are fears that US biotech company Moderna could undermine the World Health Organization’s (WHO) efforts to manufacture more mRNA vaccines in Africa, after it emerged the company has filed several patents related to its coronavirus jab. 14 February 2022
Pharmaceutical
Pharma trade group Medicines Australia notes the introduction of patent box legislation, Treasury Laws Amendment (Tax Concession for Australian Medical Innovations) Bill 2022, in the Australian Parliament yesterday. 14 February 2022
Biotechnology
US biotech company Biogen’s troubles over the Alzheimer’s product Aduhelm (aducanumab) show no sign of abating. 7 February 2022
Generics
UK-based Alliance Pharma (AIM: APH) saw its shares close down 6.9% at 105.54 pence today, after it provided an update on the Competition and Markets Authority (CMA) investigation first announced in May 2019 in which four companies, including Alliance, have been subject to a lengthy investigation. 3 February 2022
Pharmaceutical
UK pharma major GlaxoSmithKline today announced that its majority-owned subsidiary ViiV Healthcare has agreed to settle the global patent infringement litigation with US biotech firm Gilead Sciences concerning ViiV’s patents relating to dolutegravir, an antiretroviral medication used together with other medicines, to treat human immunodeficiency virus (HIV). 2 February 2022
Pharmaceutical
In Latin America as with across the globe, the pharmaceutical sector works to consolidate a solid scheme of protection of intellectual property (IP), incentivizing a virtuous ecosystem generating technology and innovation, based on principles of trust and security. 21 January 2022
Pharmaceutical
So-called ‘pharma bro’ Martin Shkreli has been held liable for antitrust claims brought by the US Federal Trade Commission (FTC) and a group of seven state enforcers. 18 January 2022
Pharmaceutical
Recently introduced legislation, the “Restoring the America Invents Act (RAIA),” if enacted, would push the Patent Trial and Appeal Board (PTAB) of the US Patent and Trademark Office to grant more requests to institute administrative patent trials, according to Pharmaceutical Research and Manufacturers of America’s director of public affairs Tom Wilbur, writing on the trade group’s website. 13 January 2022
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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