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Pharmaceutical
Donald Trump’s warnings on drug prices and the tougher stance being taken by governments in Japan and Europe on paying for medicines make this a worrying time for pharma companies, as they nervously keep an eye on leaders’ pledges, policy changes and payer decisions in these mature markets. 30 January 2017
Generics
Teva Pharmaceutical Industries is to pay $225 million to settle a pay-for-delay case dating back to the 1990s. 30 January 2017
Pharmaceutical
The European Commission has granted clearance for US drugmaker Abbott Laboratories to acquire Alere, a maker of rapid diagnostics, but with conditions. 26 January 2017
Biosimilars
Swiss pharma giant Novartis’ subsidiary Sandoz might have received US approval for Erelzi, a biosimilar to US biotech major Amgen’s Enbrel (etanercept), in August 2016, but it will not go on sale until 2018 at the earliest. 25 January 2017
Pharmaceutical
Korean drugmaker Mezzion blames Dr Reddy's Laboratories for the rejection of its udenafil New Drug Application, and is suing for millions of dollars in damages and lost earnings. 25 January 2017
Generics
Endo International has resolved its antitrust dispute with the US Federal Trade Commission (FTC), via a joint motion filed in a Californian district court. 24 January 2017
Pharmaceutical
Biogen’s $1.25 billion agreement to license Forward Pharma’s intellectual property was a clear boon for the Copenhagen, Denmark-based company, whose shares rose a stunning 55% in morning trade on Tuesday. 22 January 2017
Generics
UK-headquartered Mallinckrodt has reached a $100 million settlement over a Federal Trade Commission complaint that it violated antitrust laws. 19 January 2017
Pharmaceutical
The US Securities and Exchange Commission (SEC) yesterday announced that Ireland-incorporated drugmaker Allergan (NYSE: AGN) has agreed to admit securities law violations and pay a $15 million penalty for disclosure failures in the wake of a hostile takeover bid. 18 January 2017
Biosimilars
The United States Supreme Court has agreed to hear a case that will determine whether companies that develop biosimilar versions of biologics must wait six months before launching them in the USA. 16 January 2017
Biosimilars
No company makes more money from a drug than US pharma major AbbVie does from its arthritis treatment Humira (adalimumab), but how long that will go on for could be determined by a UK court case starting on Monday. 14 January 2017
Pharmaceutical
US pharma major Eli Lilly today announced a positive result in its ongoing patent infringement dispute with Israel-based Teva Pharmaceutical Industries. 13 January 2017
Pharmaceutical
US drugmaker Baxter Healthcare has agreed to pay $18.158 million to resolve its criminal and civil liability arising from Baxter’s failure to follow current Good Manufacturing Practices (cGMP) when manufacturing sterile drug products in North Carolina, the Department of Justice announced yesterday. 13 January 2017
Pharmaceutical
Shares of Ireland-headquartered Shire were down 3.3% at £45.26 mid-morning following the news that it will pay $350 million to settle US federal and state False Claims Act allegations. 12 January 2017
Pharmaceutical
Notorious former pharma boss Martin Shkreli has been banned from the social media site Twitter. 9 January 2017
Generics
US generic drugmaker Impax Laboratories today confirmed that it has filed an Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration containing a paragraph IV certification for a generic version of Aubagio. 6 January 2017
Biotechnology
French pharma major Sanofi and US biotech Regeneron Pharmaceuticals immediately announced their intention to appeal a ruling which will stop them from selling their cholesterol-lowering drug Praluent (alirocumab) in the USA. 6 January 2017
Biotechnology
The clear-up looks to have begun at Alexion Pharmaceuticals after an alarming few months. 5 January 2017
Pharmaceutical
An appealing set of options: when should pharma innovators appeal invalidation by the patent office?
An inter partes review (IPR) is usually an unpleasant business for a patent owner, writes Greg DeLassus, a principal at international intellectual property (IP) firm Harness Dickey, in an expert view piece for The Pharma Letter. 4 January 2017
Pharmaceutical
Boehringer Ingelheim has agreed to divest five types of animal health products in the USA to settle charges that a proposed asset swap with France’s Sanofi would harm competition, the US Federal Trade Commission announced on Wednesday. 29 December 2016
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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