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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
Anglo-Swedish drug major AstraZeneca has received confirmation from the US Department of Justice that it is closing its investigation into PLATO, a clinical trial with cardiovascular drug Brilinta (ticagrelor). The government is not planning any further action. 19 August 2014
Biotechnology
US biotech major Gilead Sciences said on Friday in a Security and Exchange Commission filing that an arbitration panel has ruled in its favor, rejecting patent infringement claims from Swiss drug giant Roche relating to its new hepatitis C drug, Sovaldi (sofosbuvir) which has already generated sales of $5.8 billion in its first six months of marketing. 17 August 2014
Pharmaceutical
USA-based biodefense company PharmAthene says that, on Friday, the Delaware Court of Chancery issued a Memorandum Opinion and awarded it lump sum expectation damages for the value of PharmAthene's lost profits for SIGA Technologies smallpox antiviral, Tecovirimat (formerly known as ST-246 and Arestvyr). 11 August 2014
Pharmaceutical
Global generics leader Teva Pharmaceutical Industries yesterday confirmed that it has received the first paragraph IV notice for its three-times-a-week Copaxone (glatiramer acetate) injection 40mg/mL product from Indian drugmaker Dr Reddy’s Laboratories. 8 August 2014
Pharmaceutical
US pharma giant Pfizer has reached a $35 million settlement with 41 states in the USA and the District of Columbia for improper marketing and promotion of the immunosuppressive drug Rapamune (sirolimus). 7 August 2014
Pharmaceutical
US Botox maker Allergan, the subject of a hostile $53 billion takeover attempt by Canada’s Valeant Pharmaceuticals International, is suing the latter, alleging insider trading. 2 August 2014
Generics
The pharmaceutical sector is still reeling from the latest fines imposed by the European Competition Commission as part of its crackdown on so-called ‘pay-for-delay’ agreements. As a result, such practices could be used less frequently in the future but they are unlikely to disappear altogether, according to patent and trade mark attorneys Withers & Rogers. 1 August 2014
Generics
US generic drugmaker Mylan has announced that the US District Court for New Jersey granted its motion for a temporary restraining order against Apotex Inc and Apotex Corporation in litigation surrounding Paroxetine CR, the authorized generic of GSK’s Paxil CR. 23 July 2014
Generics
Judge Joel Pisano of the US District Court for the District of New Jersey has entered an order preliminarily enjoining generics major Actavis from marketing a generic version of US specialty drugmaker Depomed’s Gralise (gabapentin) prior to the court's issuance of an opinion in the matter. 18 July 2014
Pharmaceutical
The US Attorney for the Northern District of California yesterday charged the FedEx Corporation with conspiring with two separate but related online pharmacy organizations to distribute controlled substances and prescription drugs to US consumers without requiring their customers to have a valid prescription, as required by the Federal Food, Drug and Cosmetic Act. 18 July 2014
Generics
US generics drug major Mylan says that the US District Court for the District of New Jersey granted its motion for a permanent injunction against UK pharma major GlaxoSmithKline in relation to paroxetine CR, the generic version of GSK's antidepressant Paxil CR. 17 July 2014
Generics
US generic drugmaker Impax Laboratories revealed in a Securities Exchange Commission filing that, on July 14, it received a subpoena and interrogatories from the State of Connecticut Attorney General concerning its investigation into sales of the company’s generic product, digoxin, which is used to treat arrhythmias (atrial fibrillation and atrial flutter) and heart failure. 16 July 2014
Pharmaceutical
German drug major Bayer is just one of the latest companies to be facing lawsuits over its anticoagulants, according to Reuters. 16 July 2014
Pharmaceutical
Four elderly French people who had taken Praxada to present strokes died of hemorrhages last year, although studies from the Agency for the Safety of Health Products (ANSM) and the National Health Insurance Fund for Employees (CNAMTS) has concluded that modern oral anticoagulants are not more dangerous than older treatments like vitamin K antagonists. 15 July 2014
Pharmaceutical
The counsel for the Pharmaceutical Research and Manufacturers of America (PhRMA), joined by the Biotechnology Industry Organization (BIO) and the Generic Pharmaceutical Association (GPhA), participated in oral arguments in the US Court of Appeals for the Ninth Circuit, in appeal of the district court ruling in favor of Alameda County's Safe Drug Disposal ordinance. 15 July 2014
Pharmaceutical
A couple allegedly working for UK pharma major GlaxoSmithKline in China have been indicted in Shanghai for illegally obtaining private information from Chinese citizens, reported Xinhua News Agency. 15 July 2014
Pharmaceutical
USA-based Medac Pharma, a wholly-owned subsidiary of privately-held German firm medac GmbH, says that the US Food and Drug Administration has approved Rasuvo, a subcutaneous injectable methotrexate (MTX) therapy. 14 July 2014
Pharmaceutical
UK Business Secretary Vince Cable is shortly to announce new regulations to deal with foreign takeover of British firms, telling the national broadcaster, the BBC, that any commitments must have no "wiggle room" for companies to evade legal responsibilities during takeovers. 13 July 2014
Pharmaceutical
The European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) says it is very concerned about legislative developments that have occurred in France on the use of off-label medicines. 12 July 2014
Pharmaceutical
French privately-held drugmaker Servier has said it will appeal before the European Union Court of Justice the decision of the European Commission to impose a fine of 331 million euros ($450 million) on Servier and a total amount of 96.7 million euros on the manufacturers of competing generics with regards to patent settlements (or pay-for-delay deals) relating to the company’s blood pressure drug perindopril. 11 July 2014
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