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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
Pharmaceutical
The Russian Parliament (State Duma) plans to significantly tighten responsibility for the production and distribution of counterfeit drugs, through the adoption of a special bill, which is expected to take place by the end of the current year. 29 November 2013
Biosimilars
The Superior Court of Justice in Brazil recently annulled marketing approval for a sub-standard biosimilar (branded copy) of Aventis' (a Sanofi legacy company) Taxotere (docetaxel) chemotherapy drug, writes attorney Otto Licks on the International Law Office web site. 28 November 2013
Pharmaceutical
In further legal action against drugmakers allegedly over pricing AIDS drugs in the USA, the AIDS Healthcare Foundation (AHF) has filed a law suit in the Superior Court of the State of California alleging that between 2005and-2013, Abbott Laboratories and its spinoff AbbVie failed to provide legally required discounts for HIV drugs. 28 November 2013
Biotechnology
The Japanese legislature (Diet) has approved new legislation targeted at regenerative medicine therapies. The Regenerative Medicine Law directs the Ministry of Health, Labor and Welfare to adopt new procedures and rules that would accelerate the clinical development of regenerative medicine and cell therapies. 22 November 2013
article
Starting next year, supplemental and private health insurance companies in Brazil will be required to cover the costs of oral administered medicines for the treatment of cancer patients at home, reports Juliane Carvalho, writing on the Brazil Pharma News. 20 November 2013
Pharmaceutical
US health care giant Johnson & Johnson’s subsidiary DePuy Orthopaedics and the Court-appointed committee of lawyers representing ASR Hip System plaintiffs have confirmed a settlement agreement to compensate eligible ASR patients in the USA who had surgery to replace their ASR hip, known as revision surgery, as of August 31, 2013. 20 November 2013
Pharmaceutical
After months of discussion in the US Congress, finally HR 3204, the Drug Quality and Security Act, which mandates a federal, interoperable electronic track-and-trace system, has been passed by the Senate. The bill, which passed the House of Representatives on September 28, will now be sent to President Barack Obama to sign into law. 20 November 2013
Generics
The US District Court for the District of Delaware has ruled in favor of Cadence Pharmaceuticals in the company's patent infringement law suit against Exela Pharma Sciences relating to its Ofirmev (acetaminophen) Injectable, a drug used for the management of mild-to-moderate pain. 17 November 2013
Pharmaceutical
The USA’s Federal Trade Commission described its ongoing efforts to protect competition and consumers in many important sectors of the economy, including health care, pharmaceuticals, and technology, in testimony to a House of Representatives Judiciary subcommittee on Friday. 17 November 2013
Pharmaceutical
Clinical trials in Switzerland have been the subject of a new report carried out by the Swiss Federal Office of Public Health (FOPH). 15 November 2013
Generics
US generics major Actavis confirms that it has filed an Abbreviated New Drug Application with the US Food and Drug Administration seeking approval to market testosterone topical solution, 30mg/1.5mL. 14 November 2013
Biosimilars
The US state of Pennsylvania’s Senate Public Health and Welfare Committee has approved Senate Bill 405, which would require a pharmacist to notify the patient and, within 72 hours, the patient’s physician of any biologic product, or biosimilars, substitution. 14 November 2013
Generics
US drugmaker Forest Laboratories has entered into a settlement agreement with generics drug major Actavis and related companies and subsidiaries, in patent infringement litigation relating to its antihypertensive drug Bystolic (nebivolol). 7 November 2013
Pharmaceutical
The US Federal Trade Commission yesterday (November 6) issued final changes to the premerger notification rules that require companies in the pharmaceutical industry to report certain proposed acquisitions of exclusive patent rights to the FTC and the Department of Justice for antitrust review. 7 November 2013
Generics
US ophthalmic care specialist InSite Vision says that Sandoz Inc, the US generics unit of Swiss drug major Novartis, has filed an appeal of the court judgment that recently upheld the patents protecting AzaSite (azithromycin 1% ophthalmic solution). 6 November 2013
Pharmaceutical
Global health care giant Johnson & Johnson and its subsidiaries will pay more than $2.2 billion to resolve criminal and civil liability arising from allegations relating to the prescription drugs Risperdal (risperidone), Invega (paliperidone) and Natrecor (nesiritide), the US Department of Justice announced yesterday. 5 November 2013
Pharmaceutical
The Washington DC, USA-based AIDS Healthcare Foundation (AHF) has filed a law suit in the Superior Court of the State of California alleging that, between 2005-2012, US health care giant Johnson & Johnson and its subsidiaries failed to provide legally required discounts for HIV drugs, overcharging the AHF by as much as $2 million during the seven year period. 1 November 2013
Pharmaceutical
AstraZeneca said it is cooperating with the US Department of Justice after an investigation has been launched into a clinical trial for its cardiovascular drug Brilinta. 1 November 2013
Generics
The US Court of Appeals for the Federal Circuit has reversed and remanded for further proceedings a trial court decision that generic defendants involved in litigation with AstraZeneca do not infringe a patent protecting Pulmicort Respules in the USA. 31 October 2013
Pharmaceutical
Anacor Pharmaceuticals says it has entered into a $142,5 million settlement agreement with Canada-based Valeant Pharmaceuticals International related to all outstanding litigation. 28 October 2013
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