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Generics
The US affiliate of Teva Pharmaceutical Industries announced today the launch of an authorized generic of Victoza (liraglutide injection 1.8mg), in the USA. 24 June 2024
Generics
Danish specialty pharma company Xellia Pharmaceuticals, which is owned by Novo Holdings, today revealed that the US Court has vacated the Modified Consent Decree imposed on Xellia’s Cleveland, Ohio, USA facility in 2016. 29 April 2024
Generics
Swiss generic and biosimilar medicines maker Sandoz today opened a new production facility in Kundl, Austria, to serve more patients with affordable life-saving drugs produced entirely in Europe. 21 March 2024
Generics
Advancing complex generic drug development is a critical part of the US Food and Drug Administration’s (FDA) goal to help patients access safe, effective and high-quality generic medicines, the agency stated. 9 February 2024
Generics
Indian drugmaker Sun Pharmaceutical has increased its bid to acquire Israeli generics firm Taro Pharma, up to $43 per share from its previous offer of $38 per share. 14 December 2023
Generics
Although safety risks for Lotronex (alosetron hydrochloride) and approved generics still exist, the US Food and Drug Administration (FDA) has determined the risk evaluation and mitigation strategy (REMS) for the drugs are no longer necessary to ensure the benefits outweigh the serious risks of ischemic colitis and serious complications of constipation. 9 September 2023
Generics
Privately-held UK headquartered Advanz Pharma has signed an exclusive licensing and supply agreement with GP Pharm for a peptide specialty injectable generic in a rare disease indication for multiple European countries. 4 September 2023
Generics
A California federal jury cleared Gilead Sciences and Teva Pharmaceutical Industries on Friday in a $3.6 billion antitrust case claiming the pharmaceutical giants struck an illegal "pay for delay" patent deal that inflated prices for two HIV medications. 1 July 2023
Generics
Indian drugmaker Lupin Limited has received approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application for tiotropium bromide inhalation powder, 18 mcg/capsule, a generic equivalent of German pharma major Boehringer Ingelheim’s Spiriva HandiHale. 22 June 2023
Generics
Today, the US Food and Drug Administration published an update to the “List of Off-Patent, Off-Exclusivity Drugs without an Approved Generic” (OPOE list). 13 June 2023
Generics
Juno Pharmaceuticals Canada has purchased Omega Laboratories, a specialist injectable pharmaceutical manufacturer in Canada, for an undisclosed sum. 19 May 2023
Generics
Japanese drug major Astellas Pharma today confirmed that the US Court of Appeals for the Federal Circuit (CAFC) issued a Mandate that officially ends the CAFC appeal on patent infringement of Lexiscan (regadenoson injection) 0.4mg/mL. 11 May 2023
Generics
RedHill Biopharma has published new data for its antibiotic Talicia (omeprazole/amoxicillin/rifabutin), focused on differentiating the brand from generic alternatives. 10 May 2023
Generics
Indian drugmaker Lupin Limited says it has received approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application for glycopyrrolate Injection USP, a generic equivalent of Robinul Injection, 0.2mg/mL of Hikma Pharmaceuticals. 9 February 2023
Generics
Japanese drugmaker Chugai Pharmaceuticals, which is majority-owned by Roche, says that the Intellectual Property High Court has rendered judgment to dismiss the plaintiff’s appeal filed on June 9, 2022, regarding generic drugs to an osteoporosis agent, active vitamin D3 derivative Edirol (eldecalcitol) Capsule 0.5µg/0.75µg. 14 December 2022
Generics
The US Food and Drug Administration (FDA) yesterday published the draft guidance for industry, titled “Statistical Approaches to Establishing Bioequivalence,” which provides recommendations to sponsors and applicants who intend to use equivalence criteria in analyzing in vivo or in vitro bioequivalence (BE) studies for investigational new drugs (INDs), new drug applications (NDAs), abbreviated new drug applications (ANDAs), and supplements to these applications. 3 December 2022
Generics
New Jersey, USA-based Amneal Pharmaceuticals today said it has launched commercial operations in India. 10 October 2022
Generics
The US Food and Drug Administration has published more information related to recent changes to Generic Drug User Fee Amendments (GDUFA). 7 October 2022
Generics
UK provider of niche generic and branded specialty pharmaceuticals Aspire Pharma says it has completed its acquisition of privately-held Morningside Pharmaceuticals (Loughborough), Morningside Healthcare (Leicester) and Morningside Healthcare (India). 3 October 2022
Generics
The Court of Appeals for the Federal Circuit ruled in favor of Merck & Co in a patent challenge brought by Mylan Pharmaceuticals (now Viatris) related to sitagliptin dihydrogen phosphate, an active ingredient in Januvia (sitagliptin), Janumet (sitagliptin and metformin hydrochloride) and Janumet XR (sitagliptin and metformin hydrochloride extended-release). 30 September 2022
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
Generics
For more than four decades since the passage of the Hatch-Waxman Act, the US generic drug market has provided patients with low-cost alternatives to brand-name medicines, saving the health care system billions while preserving incentives for biopharmaceutical innovation. 9 April 2025
Generics
US generic manufacturer Padagis has received clearance to extend the shelf life of its over-the-counter naloxone nasal spray to 36 months, as the company looks to bolster value and accessibility in a crowded but critical public health market. 3 April 2025
Generics
German tech conglomerate Siemens has signed an agreement with Miko Pharma to develop facilities for the local production of generic pharmaceuticals in Ghana. 2 April 2025
Generics
The Danish Medicines Agency's new analysis shows that generic prescribing will not necessarily lead to financial savings or increased patient safety. 31 March 2025
Generics
German family-owned pain specialist Grünenthal today published its 2024 financial results, marking a year of impressive resilience, strategic growth and operational excellence. 27 March 2025
Generics
Russian drug manufacturers are eliminating global players from the domestic insulin market, as their sales are steadily growing, The Pharma Letter’s local correspondent reports. 26 March 2025
Generics
Russia may face a new wave of drugs’ shortages, particularly those, which are used for the treatment of rare diseases, as sanctions continue to bite, reports The Pharma Letter’s local correspondent. 25 March 2025
Generics
The Russian drugmaker Axelpharm will continue sales of its drug axitinib, which is used in kidney cancer therapy and is a generic of version of US pharma giant Pfizer’s Inlyta, reports The Pharma Letter’s local correspondent.
drug of the US Pfizer. 18 March 2025
Generics
Rajeev Juneja, vice chairman and managing director of Mumbai, Indian-based drugmaker Mankind Pharma, today announced that the company is launching the generic version as well as its fixed dose combination (FDCs) of diabetes drug empagliflozin in India, at a 90% discount to the originator, Boehringer Ingelheim’s drug, Jardiance. The news came as empagliflozin lost patent protection in India. 12 March 2025
Generics
The US Food and Drug Administration (FDA) has approved the first generics of Xarelto (rivaroxaban), a cardio vascular drug developed by Germany’s Bayer and marketed in the USA by Johnson & Johnson. 11 March 2025
Generics
German generics and consumer healthcare major STADA Arzneimittel today released financial results, which the firm said continued its profitable growth journey in 2024 – supported by its strong commercial network in Europe, and complemented by a growing presence in the MENA, Eurasia and Asia-Pacific regions. 7 March 2025
Generics
Indian drugmaker Biocon’s Biocon Biologics unit and USA-based Civica Rx, a not-for-profit generic drug and pharmaceutical company, have announced a strategic collaboration agreement to expand access and affordability of Insulin Aspart in the USA, with the news sending Biocon’s shares up nearly 4% to 333 rupees. 6 March 2025
Generics
Czech Republic-based Zentiva Pharma, a generics and over-the-counter medicines company that is wholly-owned by private equity firm Advent International and was formerly a subsidiary of Sanofi , has announced a major UK launch. 4 March 2025
Generics
Even as the spectre of tariffs looms over the pharmaceutical trade between India and the USA, presenting a complex scenario with potential repercussions for both regions, its implementation would necessitate a rapid recalibration of supply chains and pricing strategies, reports The Pharma Letter’s India correspondent. 3 March 2025
Generics
Israeli drug manufacturer Teva Pharmaceutical Industries has resumed the deliveries of the scarce epilepsy drug Finlepsin retard (carbamazepine) to the Russian market, which is aimed to alleviate shortages of the product, reports The Pharma Letter’s local correspondent. 28 February 2025
Generics
The 3rd Bioequivalence Conference, co-hosted by the International Generic and Biosimilar Medicines Association (IGBA) and Medicines for Europe, concluded yesterday in the Netherlands. 27 February 2025
Generics
New research shows that 46% of generic drugs from the European Union (EU) critical list of medicines are supplied by just one provider. 20 February 2025
Generics
The International Generic and Biosimilar Medicines Association (IGBA), in line with its goals of promoting the widest possible access to safe, effective, and quality-assured medicines and of promoting intellectual property (IP) regimes which foster innovation and allow the timely entry of generic and biosimilar medicines, has released its report called “GAMING THE SYSTEM - An overview of originator companies’ evergreening strategies used to hinder access to generic and biosimilar products”. 20 February 2025
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