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Pharmaceutical
Plenty of adjectives have been used to describe the transfer of six patents related to Allergan’s Restasis (cyclosporine ophthalmic emulsion) treatment for chronic dry eye disease to the Saint Regis Mohawk Tribe (SRMT). 4 October 2017
Pharmaceutical
It has not been an uneventful reign for Guido Rasi as executive director of the European Medicines Agency (EMA) since he took over in November 2011, with first his appointment called into question in a saga that saw him stripped of the role and then reinstated, and now the agency facing a disruptive move from its London home due to Brexit. 4 October 2017
Pharmaceutical
Last week saw AbbVie entering a patent settlement with Amgen relating to the latter’s biosimilar version of blockbuster drug Humira. US Food and Drug Administration acceptance for review of Eisai’s cancer drug Lenvima in a new indication, and FDA approval for Eli Lilly’s new breast cancer drug Verzenio also figured in the news. Also attracting attention was news on the failure of Axovant Sciences’ Alzheimer’s disease candidate intepirdine. 1 October 2017
Biosimilars
AbbVie today announced a global resolution of all intellectual property-related litigation with biotech major Amgen over the latter’s proposed biosimilar to AbbVie's mega-blockbuster rheumatoid arthritis and inflammatory diseases drug Humira (adalimumab). 28 September 2017
Biosimilars
Biosimilar injectables specialist Hospira has been ordered to pay $70 million for infringing a patent belonging to Amgen relating to the anemia treatment Epogen (epoetin alfa). 25 September 2017
Pharmaceutical
On Friday, UD biotech firm Aegerion Pharmaceuticals agreed to plead guilty in the US District Court for the District of Massachusetts to two misdemeanor counts of violating the Federal Food, Drug, and Cosmetic Act (FD&C Act) involving the introduction of misbranded Juxtapid (lomitapide) into interstate commerce. 25 September 2017
Pharmaceutical
American advocacy group Public Citizen is launching a legal bid to force a ruling on a petition it launched three years ago regarding the use of benzocaine in over-the-counter medicines. 22 September 2017
Biosimilars
The share price of the world’s biggest pharma company closed 1.5% up on Wednesday while that of Johnson & Johnson, the globe’s largest healthcare firm, decreased by the same percentage. 21 September 2017
Pharmaceutical
In his second Expert View piece, Yungjoon Kwon, patent/trademark attorney and managing director at law firm Kwon & Kim, considers a South Korean court’s view on one of pharma's hottest topics – dosage regime drugs’ patentability. 14 September 2017
Generics
Yesterday, in opposition proceedings filed by inter alia Synthon, the Technical Board of Appeal (TBA) of the European Patent Office revoked the last of Teva Pharmaceutical Industries' (NYSE: TEVA) three glatiramer so-called HBr patents which claimed an allegedly improved process for the synthesis of glatiramer acetate. 13 September 2017
Biotechnology
In July, the USA’s Ninth Circuit reversed the lower court’s decision to dismiss a False Claims Act (FCA) case against US biotech major Gilead Sciences, relating to its selling of HIV drugs. 11 September 2017
Biosimilars
Japan’s Chugai Pharmaceutical saw its shares gain 2.15% to 4,515 yen, after it revealed legislation to protect one of its top-selling drugs from biosimilar competition. 11 September 2017
Pharmaceutical
Novo Nordisk will pay $58.65 million to resolve allegations that the company failed to comply with the Food and Drug Administration-mandated Risk Evaluation and Mitigation Strategy (REMS) for its top-selling type 2 diabetes medication Victoza (liraglutide), the Justice Department announced yesterday. 6 September 2017
Generics
Mark Engelman, head of intellectual property at UK-based law firm Hardwicke, offers his interpretation on a landmark ruling in an Expert View piece. 5 September 2017
Pharmaceutical
Drugmaker Indivior saw is market capitalization slashed by as much as £1 billion ($1.29 billion) on Friday, when its shares closed down 38% at 258.35 pence following news of an unfavorable patent ruling for its top-selling opioid addiction treatment Suboxone Film (buprenorphine and naloxone), thus opening the way for generic competition. 4 September 2017
Pharmaceutical
Changes affecting the patentability of precision medicines could open the door to more research activity and lead to the discovery of new, targeted treatments that are more efficient and effective for some of the most serious health conditions, write Dr Nicholas Jones and Andrew Evitt, patent attorneys at intellectual property firm, Withers & Rogers, in an Expert View piece. 31 August 2017
Pharmaceutical
In another blow to embattled drugmaker Valeant Pharmaceuticals, a major mutual fund launched a legal bid Wednesday to recoup $80 billion in losses it says it incurred through misinformation provided by the Canadian drugmaker. 25 August 2017
Biosimilars
After a pharma view on biosimilars was provided in our previous Expert View column, a legal perspective is provided by Nick Beckett, managing partner at CMS Beijing and global co-head of the firm's lifesciences sector group. 22 August 2017
Pharmaceutical
Eliciting considerable comment last week was news of UK pharma major GlaxoSmithKline pulling out of its deal with Ionis Pharmaceuticals on inotersen; Mylan reaching a settlement with the US Justice Department over classification of its EpiPen; another setback for Ophthotech’s eye drug Fovista; expanded indications for AstraZeneca and Merck & Co’s cancer drug Lynparza; and US approval for Pfizer’s leukemia treatment Besponsa. 20 August 2017
Pharmaceutical
On Friday, US President Donald Trump signed the Food and Drug Administration Reauthorization Act of 2017 (FDARA) into law, which in effect reauthorized the Prescription Drug User Fee Act (PDUFA) and user fees for biosimilars, generic drugs and medical devices. 19 August 2017
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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