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Pharmaceutical
Danish pharma major Novo Nordisk says that it has become aware of several hundred units of Ozempic (semaglutide) injection 1 mg distributed outside its authorized supply chain in the USA. 15 April 2025
Generics
A Texan drug compounder cannot rely on federal law to avoid a lawsuit over copycat sales of a rheumatoid arthritis treatment, clearing the way for Zyla Life Sciences to pursue claims under state competition laws. 14 April 2025
Biosimilars
Swiss generic and biosimilar medicines firm Sandoz today announced it has filed an antitrust lawsuit in the USA against Amgen for extending and entrenching the dominant market position of its blockbuster medicine, Enbrel (etanercept), first approved by the US Food and Drug Administration (FDA) in 1998. 14 April 2025
Pharmaceutical
Indian drugmaker Sun Pharmaceutical shares were buzzing in trade on the last trading day of the week to April 11, rising as much as 5%. 11 April 2025
Pharmaceutical
Ireland’s government remains confident in its ability to retain the country’s strategic position in pharmaceutical manufacturing, despite rising tensions between the European Union and the United States over trade policy. 8 April 2025
Pharmaceutical
With two new lawsuits, Eli Lilly has escalated its legal campaign against the makers of unauthorized versions of its diabetes and weight-loss drugs, Mounjaro (tirzepatide) and Zepbound (tirzepatide), challenging inroads made by drug compounders in what has become a highly lucrative market. 3 April 2025
Biotechnology
Germany-headquartered CureVac late Thursday announced that the European Patent Office (EPO) has confirmed the validity of CureVac's European patent EP 3 708 668 B1 subject to amendments to specify the scope of protection. 28 March 2025
Biotechnology
Sinovac Biotech, a China-based biopharmaceutical company specializing in vaccine development, has been urged by shareholder Heng Ren Partners to distribute $8.9 billion in cash reserves to shareholders and to resume trading of its shares on Nasdaq. 24 March 2025
Biotechnology
Danish biotech on Saturday revealed that US pharma major (AbbVie has filed a complaint in the US District Court for the Western District of Washington, naming Genmab, ProfoundBio and former AbbVie employees as defendants. 22 March 2025
Pharmaceutical
Purdue Pharma has filed a Chapter 11 Plan of Reorganization and related disclosure statement with the US Bankruptcy Court for the Southern District of New York. 20 March 2025
Pharmaceutical
As the new White House seeks to push ahead with swingeing cuts to government spending, a federal judge in Massachusetts has thrown a wrench in the works. 6 March 2025
Biotechnology
The US Patent Trial and Appeal Board handed a massive victory to Pfizer and BioNTech on Wednesday, as it invalidated two of Moderna patents covering its Spikevax COVID-19 vaccine, which the challengers stand accused of infringing, according to media reports. 6 March 2025
Biotechnology
Roivant Sciences portfolio company Genevant Sciences and Canada’s Arbutus Biopharma yesterday filed five international lawsuits seeking to enforce patents protecting their innovative LNP technology against Moderna, and certain affiliates. 4 March 2025
Biosimilars
Johnson & Johnson has taken legal action against Samsung Bioepis, accusing the South Korean biotech of violating a settlement agreement by authorizing a third party to market a private-label biosimilar version of Stelara (ustekinumab). 27 February 2025
Pharmaceutical
A group representing compounding pharmacies has filed a lawsuit against the US Food and Drug Administration, arguing that the agency acted unlawfully when it removed Novo Nordisk’s semaglutide-based drugs Ozempic (semaglutide) and Wegovy (semaglutide) from the official shortage lst. 27 February 2025
Pharmaceutical
Danish pharma major Novo Nordisk has sued KBP Biosciences and its founder and executive chairman, Huang Zhenhua, for $830 million in an application to the Singapore International Commercial Court. 19 February 2025
Pharmaceutical
AstraZeneca, Moderna and Novo Nordisk have breached the Association of the British Pharmaceutical Industry (ABPI) Code of Practice for the Pharmaceutical Industry. 17 February 2025
Pharmaceutical
A federal judge has temporarily blocked the National Institutes of Health (NIH) from implementing research funding cuts in 22 states after a lawsuit argued the move would cripple studies on cancer, Alzheimer’s, and other diseases. 11 February 2025
Pharmaceutical
Robert F Kennedy Jr faced pointed questioning during his nomination hearing for secretary of health and human services, as lawmakers sought to reconcile his past controversial statements with the more evidence-based approach he now appears to endorse. 31 January 2025
Biosimilars
US biotech major Amgen =announced that it has reached resolution of its patent infringement litigation related to South Korea-based Celltrion’s denosumab biosimilar products, Amgen brands Prolia and Xgeva. 29 January 2025
Pharmaceutical
Healthcare giant Johnson & Johnson has reportedly reached a tentative settlement to resolve probes by US states into whether it misled consumers about the safety of its talc products. 24 January 2024
Pharmaceutical
The US Court of Appeals for the Second Circuit yesterday affirmed a district court ruling which ordered “pharma bro” Martin Shkreli to face a lifetime ban from participating in the pharmaceutical industry. 24 January 2024
Biosimilars
Generics and biosimilars trade group Medicines for Europe and its members are strongly concerned by the first judgement on the Supplementary Protection Certificate (SPC) manufacturing waiver issued by the Munich District Court, Germany, in October 2023. 19 January 2024
Biotechnology
Japanese drugmaker Daiichi Sankyo yesterday announced that the US Patent and Trademark Office (US PTO) rendered a Final Written Decision invalidating all claims of Seagen’s US patent 10,808,039 (the ’039 patent) that were challenged by Daiichi Sankyo in a post-grant review proceeding (PGR). 18 January 2024
Generics
A generics drugmaker has had its Abbreviated New Drug Application for the radiopharmaceutical 177Lu-PNT2003 accepted by the US Food and Drug Administration. 12 January 2024
Pharmaceutical
Grifols, the Spanish producer of blood plasma-based products, is not taking the stock market damage done to the company by UK short seller Gotham City Research without a fight. 11 January 2024
Pharmaceutical
Tuesday was a tough day for Grifols, the Spanish producer of blood plasma-based products, as it lost 14% of its stock market value. 10 January 2024
Pharmaceutical
US pharma company Esperion Therapeutics on Wednesday announced a $125 million deal with Japanese drugmaker Daiichi Sankyo’s European subsidiary (DSE) to resolve Esperion's demand for $300 million from the company over Esperion's cholesterol reduction drugs. 4 January 2024
Biotechnology
Shares in German biopharma CureVac closed nearly 30% lower on Tuesday. 20 December 2023
Generics
With sales of lucrative immunology medicine Rinvoq (upadacitinib) topping $1 billion in the third quarter, developer AbbVie is taking action to shore up its patent estate. 23 November 2023
Pharmaceutical
The USA’s Federal Trade Commission (FTC) says it has filed an amicus brief to address the anticompetitive harm that stems from improperly listed patents in the Food and Drug Administration’s (FDA) publication of “Approved Drug Products with Therapeutic Equivalence Evaluations,” commonly known as the “Orange Book.” 21 November 2023
Biotechnology
The European Commission has unconditionally approved the proposed $43 billion acquisition of US biotech Seagen by pharma giant Pfizer, under the EU Merger Regulation. 21 October 2023
Biotechnology
Japanese drugmaker Daiichi Sankyo revealed that it has been ordered by a Texas district court to pay royalties on its antibody-drug conjugate (ADC) to US biotech Seagen. 19 October 2023
Biotechnology
One big challenge for pharma companies doing cross-border businesses in China and the USA is the respective cybersecurity law imposed by the two countries. 12 October 2023
Biotechnology
Privately-held Swiss dermatology company Galderma has announced some bad news relating to its pending Biologics License Application (BLA) for relabotulinumtoxinA (QM-1114) to the US Food and Drug Administration (FDA). 3 October 2023
Pharmaceutical
In the USA, British drugmaker AstraZeneca has brought to an end certain product liability lawsuits for the gastrointestinal meds Nexium (esomeprazole) and Prilosec (omeprazole). 3 October 2023
Biotechnology
The US Court of Appeals for the Federal Circuit has quashed an appeal from the Takeda unit Baxalta in relation to Roche’s hemophilia treatment Hemlibra (emicizumab). 22 September 2023
Pharmaceutical
US pharma major Eli Lilly has revealed it suing spas, wellness centers and compounding pharmacies selling unapproved and compounded versions of its type 2 diabetes drug Mounjaro (tirzepatide). 20 September 2023
Generics
Following scrutiny from Democratic senators in Congress, the US Federal Trade Commission has issued a policy statement on the proper listing of pharmaceutical patents. 18 September 2023
Pharmaceutical
While legal challenges surrounding the implementation of the Inflation Reduction Act (IRA) continue to mount, the Centers for Medicare & Medicaid Services (CMS) has touted the success of the program. 15 September 2023
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