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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
Two US lawmakers sent a letter last Thursday to the Justice Department and the Federal Trade Commission asking them to investigate potential collusion or anticompetitive behavior among pharmaceutical companies that manufacture diabetes products in setting their drug prices. 5 November 2016
Generics
News that charges could be filed in a US Justice Department antitrust investigation into generic pharma companies by the end of the year – and could extend to high-level executives – have sent shares prices plummeting. 4 November 2016
Generics
More than 12% was wiped off the share price of Valeant Pharmaceuticals after a report that former bosses at the Canadian drugmaker were the subject of a criminal investigation. 1 November 2016
Pharmaceutical
The European Court of Justice has issued a ruling that strikes against fixed prices for prescription drugs in Germany. The specific case dealt with mail-order prescriptions from the Netherlands used to treat Parkinson's, reports Deutsche Welle. 20 October 2016
Generics
Astellas Pharma and its subsidiaries jointly filed a lawsuit against Actavis Elizabeth and its affiliates, who filed an Abbreviated New Drug Application (ANDA) for a generic version of Astellas’ Myrbetriq (mirabegron) in the USA. 10 October 2016
Generics
Mylan said on Friday that its subsidiary, Mylan Inc, has agreed to the terms of a $465 million settlement with the US Department of Justice and other government agencies. 8 October 2016
Pharmaceutical
specialist Shiresays that the US Patent & Trademark Office’s Patent Trial and Appeal Board (PTAB) has issued its decision upholding the validity of US Patent No 6,773,720, related to Shire’s Lialda (mesalamine) product. 6 October 2016
Pharmaceutical
The US Securities and Exchange Commission said on Friday that UK pharma major GlaxoSmithKline has agreed to pay $20 million to settle charges that its Chinese subsidiaries engaged in bribery schemes to increase sales in China. 3 October 2016
Pharmaceutical
The US District Court for the District of New Jersey has ruled in favor of US specialty drugmaker Depomed in the company's patent litigation against all three filers of Abbreviated New Drug Applications (ANDAs) for Depomed's Nucynta (tapentadol) franchise. 3 October 2016
Pharmaceutical
The European Medicines Agency has appealed two interim orders by the President of the General Court of the European Union to suspend the release of documents requested by third parties under Regulation (EC) no 1049/2001, the so-called “Transparency Regulation.” 1 October 2016
Pharmaceutical
Ireland-based drugmaker Horizon Pharma saw its share price drop by more than 5% in a day following news that it will pay US pharmacy benefit manager Express Scripts $65 million to settle rebate litigation. 30 September 2016
Pharmaceutical
The European Federation of Pharmaceutical Industries and Associations (EFPIA) has highlighted the findings of a new report in calling for a global response to the problem of counterfeit medicines. 30 September 2016
Pharmaceutical
When testifying before US Congress last week, the chief executive of Netherlands-incorporated drugmaker Mylan told members that her company’s profits from the EpiPenAuto-Injector (epinephrine injection, USP) were 60% lower than they actually were. 27 September 2016
Generics
Indivior Reckitt Benckiser face legal action in the USA for allegedly abusing its monopoly to keep generic versions of the opioid addiction drug Suboxone (buprenorphine and naloxone) off the market. 23 September 2016
Biosimilars
Sanofi said today that it filed a patent infringement suit against US peer Merck & Co on September 16, 2016 in the USA District Court for the District of Delaware. In its suit Sanofi alleges infringement of 10 patents relating to its blockbuster diabetes treatment Lantus (insulin glargine). 19 September 2016
Pharmaceutical
Cancer and other patients in Australia could potentially have access to some new medicines two years earlier than at present under changes to the regulation of medicines and medical devices announced today by the Turnbull government. 15 September 2016
Pharmaceutical
Australia’s Turnbull government has today introduced important legislation to ensure security and law and order is maintained, as the Coalition leads the way in allowing for the cultivation of a safe, legal and reliable local supply of cannabis for medicinal products. 14 September 2016
Generics
On September 8, 2016, Taro Pharmaceuticals USA Inc, as well as two senior officers in its commercial team, received grand jury subpoenas from the US Department of Justice, Antitrust Division, the Israel-headquartered company revealed in a Securities and Exchange Commission filing. 12 September 2016
Biosimilars
Announcing an “unprecedented” positive court decision in its patent Infringement litigation against Amgen concerning its Grastofil (filgrastim) – a biosimilar of Amgen’s Neupogen - and Lapelga (pegfilgrastim) – Amgen’s Neulasta - products, Apobiologix also indicates that the company has filed a Petition for Certiorari with the US Supreme Court. 10 September 2016
Generics
The European Federation of Pharmaceutical Industries and Associations (EFPIA) has come out in support of the Danish company, saying it regrets the General Court (GC) of the European Union’s decision to uphold the European Commission’s classification of the Lundbeck patent settlement agreements as restrictions of competition “by object” thereby judging them to be unlawful. 9 September 2016
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