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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
Biotechnology
In the ongoing Australian debates regarding legislation to outlaw the patenting of human genes, which has been introduced into the federal parliament (The Pharma Letter February 24), an open letter with signatories including interested parties from industry and research, urging legislators to reject the Patent Amendment (Human Genes and Biological Materials) Bill 2010 as it misses the point on patient access and research exemption. 3 March 2011
Biotechnology
There was bad news for Centocor Ortho Biotech, a Johnson & Johnson (NYSE: JNJ) company, yesterday, after it received a decision from the US Court of Appeals for the Federal Circuit in Washington DC overturning a 2009 federal court jury verdict that awarded the company $1.67 billion after finding Abbott Laboratories (NYSE: ABT) liable for patent infringement involving Abbott's biggest selling product, Humira (adalimumab), which generated sales of $6.55 billion last year, including $2.87 billion in the USA. 24 February 2011
Pharmaceutical
In a six to two vote, the USA's Supreme Court affirmed the ruling of the US Court of Appeals for the Third Circuit in favor of Wyeth versus Bruesewitz. The Third Circuit had determined that the National Childhood Vaccine Injury Act prevents civil suits against manufacturers of FDA-approved childhood vaccines based on a claim that a particular vaccine should have been designed differently. In so doing, it rejected plaintiffs' arguments that they should be able to sue global drug's behemoth Pfizer's (NYSE: PFE) Wyeth unit over allegations that the company could have marketed a safer vaccine but decided not to. 24 February 2011
Generics
The Australian pharmaceutical industry landscape is set to dramatically alter as a result of government changes to the Pharmaceutical Benefits Scheme (PBS), suggests independent market analyst Datamonitor, whose outlook for the future includes withdrawn products, a struggling generics sector and wholesaler reorganization, as PBS reforms take effect. 23 February 2011
Generics
Last week, substantively identical legislation was introduced in both the US House of Representatives and in the Senate to amend the FDC Act to prohibit the manufacture, marketing, sale or distribution of an authorized generic version of a New Drug Application-approved drug until any period of 180-day exclusivity associated with an Abbreviated NDA for a generic version of that NDA-approved drug has expired or has been forfeited, explains Kurt Karst of law firm Hyman, Phelps & McNamara. 23 February 2011
Biotechnology
The European Parliament gave its consent last week for a common European Union patent system to be created using the enhanced cooperation procedure, by a vote of 471 to 160, with 42 abstentions. 21 February 2011
Pharmaceutical
In the USA, the House of Representatives Judiciary Committee passed legislation - HR 5, the Help Efficient, Accessible, Low-cost, Timely Healthcare (HEALTH) Act (The Pharma Letter January 24) ' on Wednesday by a vote of 18 to 15 and the bill now goes to the full House of Representatives for consideration. 18 February 2011
Pharmaceutical
As had been widely expected, the European Parliament yesterday voted for a new law ' the Falsified Medicines Directive - to prevent fake medicines from entering the legal supply chain. Internet sales will be covered by the law, which also introduces new safety and traceability measures, as well as sanctions against counterfeiters. This law still needs to be formally approved by the Council of Ministers. The vote follows months of intensive negotiations between the Parliament and member states. 17 February 2011
Pharmaceutical
Danish insulin giant Novo Nordisk says it has received a subpoena from the office of the US Attorney for the District of Massachusetts calling for the production of documents regarding potential criminal offences relating to the company's marketing and promotion practices for its diabetes treatments NovoLog (insulin aspart [rDNA origin] injection), Levemir (insulin detemir [rDNA origin] injection) and Victoza (liraglutide). 16 February 2011
Pharmaceutical
US drugs giant Merck & Co (NYSE: MRK) said yesterday that a state court jury in New Jersey found in its favor in the Rosenberg versus Merck case, rejecting the claims of a woman who blamed her dental and jaw related problems on her use of the company's bisphosphonate drug Fosamax (alendronate) use. 15 February 2011
Pharmaceutical
The European Medicines Agency (EMA) will focus on preparing for the implementation of the new pharmacovigilance legislation during 2011, while continuing to carry out its core business efficiently and effectively, according to the work program 2011, published on Friday. 14 February 2011
Pharmaceutical
The ability of families to sue vaccine producers for faulty design could lead to a rise in litigation and force manufacturers to abandon the market, which, in turn, could cause disastrous public health consequences in the USA, assert Daniel Gage, assistant director, and Alison Perencevich, legislative assistant, at the American Academy of Pediatrics' Department of Federal Affairs. 10 February 2011
Generics
Brussels, Belgium-based UCB SA (Euronext Brussels: UCB) has entered into a definitive settlement agreement with US firm PDL BioPharma (Nasdaq: PDLI) that resolves all legal disputes between them, including those relating to UCB's pegylated humanized antibody fragment, Cimzia (certolizumab pegol), for the treatment of Crohn's disease and rheumatoid arthritis, and PDL's patents known as the Queen et al patents. 8 February 2011
Pharmaceutical
On behalf of six death-row prisoners from California, Arizona, and Tennessee in the USA, law firm Sidley Austin has filed suit against the Food and Drug Administration seeking to prohibit FDA from allowing the importation or use of unapproved sodium thiopental. 4 February 2011
Pharmaceutical
As had been largely expected, the USA's Republican Senators failed to get enough votes to repeal President Barack Obama's signature health care reform law in a 47-51 party-line vote. But a vote to delete a small, revenue-raising provision of the sweeping law did pass, in a bipartisan vote. The House of Representatives, where Republicans have a majority, voted to repeal the legislation last month (The Pharma Letter January 20 and 25). 3 February 2011
Pharmaceutical
Global drugs behemoth Pfizer (NYSE: PFE) has been ordered to pay a total of $142.1 million in damages for violating federal laws in the off-label marketing of its epilepsy drug Neurontin (gabapentin), reports Bloomberg. The company plans to appeal the verdict, said the news service. 31 January 2011
Pharmaceutical
A US House Judiciary Committee, which held its first hearing, titled, "Medical Liability Reform - Cutting Costs, Spurring Investment, Creating Job," last Thursday, is focussing on ways to eliminate 'frivolous' law suits against medical personnel. Chairman Lamar Smith (Republican, Texas) said he would introduce a reform bill as early as this week that would save 'tens of billions every year.' Beyond that, Mr Smith said his committee would also hold hearings to tackle broader questions about the law's constitutionality. 24 January 2011
Pharmaceutical
The US District Court for the Southern District of Texas has entered a consent decree of permanent injunction against privately-held US contract drug manufacturer Deltex Pharmaceuticals of Rosenberg, Texas, its president Kabir Ahmed and vice president, Mohidur Khan. 19 January 2011
Pharmaceutical
In an announcement to the London Stock Exchange yesterday, pharma giant GlaxoSmithKline (LSE: GSK) revealed that it expects to take a legal charge for the fourth quarter of 2010 of a record-breaking 2.2 billion ($3.49 billion) - equal to an after tax cost of 1.8 billion). The news saw GSK's shares fall 2% in afternoon trading yesterday, before closing the day down 1.6% at 12.05. 18 January 2011
Pharmaceutical
The Chinese government plans to double the annual medical insurance premium for rural residents in the coming five years, giving these people a bigger reimbursement on their medical bills, reports the local Xinhau news agency. 7 January 2011
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