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Generics
A new US Federal Trade Commission staff report found that, despite a considerable increase in the total number of final Hatch-Waxman patent settlements in fiscal year 2016, significantly fewer settlements included the types of reverse payments that are likely to be anticompetitive. 24 May 2019
Pharmaceutical
British drugmaker GlaxoSmithKline has reintroduced its bonus program for sales staff, to “better recognise and reward individual effort.” 24 May 2019
Pharmaceutical
The US Supreme Court on Monday ruled that a lower court should consider dismissing the claims of more than 500 patients who blame pharma giant Merck & Co for not warning them about the risks of femoral fractures related to the company’s drug Fosamax (alendronate). 21 May 2019
Pharmaceutical
US drugmaker Mallinckrodt today revealed that, through a subsidiary, it has filed suit in federal district court against the Health and Human Services (HHS) Department and Centers of Medicare and Medicaid Services (CMS). 21 May 2019
Biosimilars
In the news last week was new guidance from the US Food and Drug Administration on the interchangeability of biosimilars, but there are still challenges ahead. ImmunoGen had a major setback with the FDA calling for a further study on its cancer drug mirvetuximab. Boehringer Ingelheim’s patent settlement with AbbVie over Cyltezo, its copy version of Humira, marks the eighth such deal as to when biosimilars of the world’s biggest selling inflammatory diseases drug can come to the US market. Research news was a ‘tale of two stories, with Agios Pharmaceuticals presenting positive new data on Tibsovo in cholangio carcinoma, while AbbVie’s Depatux-M failed to meet the primary endpoint of a Phase III glioblastoma study. 19 May 2019
Generics
Connecticut Attorney General William Tong has led a coalition of 44 US states in announcing a fresh lawsuit against Teva Pharmaceutical Industries and 19 other generic drugmakers. 15 May 2019
Generics
Shares of Indian pharmaceutical companies continued their downward slide on reports that a lawsuit has been filed against Teva Pharmaceuticals Industries and other generic companies in the USA, including many Indian drugmakers, by 44 US states. 15 May 2019
Biosimilars
Boehringer Ingelheim today announced the resolution of all intellectual property-related litigation with US major AbbVie concerning the German drugmaker’s biosimilar Cyltezo (adalimumab-adbm) and the reference medicine Humira (adalimumab). 14 May 2019
Pharmaceutical
An Expert View column on how a valuable patent protection encourages development and helps to fund future battles provided by Robert Watson, partner, and Sarah Kostiuk-Smith, European patent attorney, from Mewburn Ellis. 8 May 2019
Pharmaceutical
Vectura confirmed over the weekend that, on May 3, 2019, following a jury trial in the US District Court for the District of Delaware, the relevant asserted claim of Vectura’s US patent 8303991 was found valid. 5 May 2019
Pharmaceutical
The US Justice Department (DoJ) announced yesterday that US WorldMeds (USWM) has agreed to pay $17.5 million to resolve allegations that it violated the False Claims Act, by paying kickbacks to patients and physicians to improperly induce prescriptions of its drugs, Apokyn (apomorphine) and Myobloc (botulinum toxin type B). 1 May 2019
Biosimilars
An executive and another employee at Korean biosimilars powerhouse Samsung Bioepis have been arrested, according to The Financial Times and other sources. 30 April 2019
Pharmaceutical
Japanese drugmaker Astellas and US biotech Amgen have agreed to pay a total of $124.75 million to the Department of Justice (DoJ) in the USA over alleged kickbacks. 26 April 2019
Pharmaceutical
In an Expert View piece, Oliver Kidd, senior associate at Stevens & Bolton, provides an overview of an ever-more complex landscape. 24 April 2019
Pharmaceutical
United Therapeutics Corp was named as a defendant, along with Smiths Medical ASD, in a lawsuit filed in federal court by Sandoz and RareGen, on April 16, 2019. 18 April 2019
Pharmaceutical
A US federal grand jury indicted Indivior on Tuesday on charges the company orchestrated a “nationwide scheme,” with the news sending the shares plunging this morning. 10 April 2019
Pharmaceutical
Pharma needs to pay closer attention to ensuring the integrity of its third-party relationships, writes Kathy Johnson, vice president life sciences, LexisNexis Risk Solutions Health Care, in an Expert View piece. 9 April 2019
Biotechnology
A bitter dispute has broken out over Aimovig (erenumab), the leader in the new class of migraine treatments. 5 April 2019
Pharmaceutical
Three pharmaceutical companies have agreed to pay $122 million to settle US Department of Justice (DoJ) allegations that kickbacks were paid to promote uptake of their products. 5 April 2019
Pharmaceutical
A three-member panel of the European Patent Office’s (EPO) Opposition Division upheld patent EP 2,949,335 covering Copaxone (glatiramer acetate) 40mg in Europe. 1 April 2019
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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