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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
US biotech major Biogen today announced that the European Commission has revoked the centralized marketing authorizations for generic versions of the company’s multiple sclerosis therapy, Tecfidera (dimethyl fumarate). 19 December 2023
Generics
Protek, one of Russia's leading pharmaceutical distributors, will begin the supplies of an Ozempic (semaglutide) generic, originated by Danish diabetes care and obesity giant Novo Nordisk against diabetes mellitus to the Russian market by the end of this year, reports The Pharma Letter’s local correspondent. 12 December 2023
Generics
South Africa's largest drugmaker Aspen Pharmacare has announced an agreement with newly-independent generics drugmaker Sandoz, related to its Chinese business. 7 December 2023
Generics
In a major crackdown, the US Food and Drug Administration (FDA) has been conducting an increased number of inspections of pharmaceutical manufacturing facilities in India. 7 December 2023
Generics
Russian drugmaker Basis-Metigreens together with the India’s Synmedic company plan to launch the production of an analogue of Ingavirin (pentandioici imidazolylaethanamidum), one of the most popular antiviral drugs in Russia, which is produced by the local Valenta Pharm, The Pharma Letter’s local correspondent reports. 5 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
Generics
A new partnership in China will see German generics drugmaker Arzneimittel STADA expand and bolster its distribution and promotion of cough and cold brands in the country. 23 November 2023
Generics
Portuguese contract development and manufacturing organization (CDMO) Hovione has acquired the start-up ExtremoChem for an undisclosed amount. 20 November 2023
Generics
Even as India's drug pricing authority, the National Pharmaceutical Pricing Authority (NPPA) last week brought 33 fixed-dose combination (FDC) drugs under its price regulation, in an initiative to make these drugs more cost-effective, a recent comprehensive analysis reveals a concerning trend, that the Indian government's efforts to eliminate centrally unapproved and banned antibiotic FDC drugs have experienced limited success, reports The Pharma Letter’s India correspondent. 20 November 2023
Generics
The US unit of Israeli generics giant Teva Pharmaceutical Industries has received US Food and Drug Administration (FDA) approval of a generic version of Forteo (teriparatide). 17 November 2023
Generics
Project completions in India's drugs and pharmaceuticals sector are set to reach a decade-high during financial year 2024, estimated at around $516 million. 15 November 2023
Generics
The Russian Medical Research Company, which is a subsidiary of Swiss firm Genfa Global, is considering the production of Trilexa, which is a generic of Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor), a drug for treatment of cystic fibrosis from the USA’s Vertex Pharmaceuticals, The Pharma Letter’s local correspond reports. 15 November 2023
Generics
German pharmaceutical major Bayer has refused compensation of more than 400 million roubles ($4.3 million) from Russian Nativa (renamed Spectrum) for the use of patents on the anticancer drug Nexavar (sorafenib), reports The Pharma Letter’s local correspondent. 9 November 2023
Generics
Hungarian drugmaker Gedeon Richter has begun supplying generics of foreign drugs for diabetics to Russia – in a move to take the share of those global drugmakers that have left Russia, reports The Pharma Letter’s local correspondent. 8 November 2023
Generics
Israeli generics giant Teva Pharmaceutical Industries has reported its latest quarterly financial results against a backdrop of war in its home region. 8 November 2023
Generics
The Indian pharma and healthcare sector has witnessed a 298% jump in deals during the third quarter of 2023 compared to the same period last year. 8 November 2023
Generics
The Slovenian generics drugmaker KRKA has achieved a rehearing of its case in the Russian Presidium of the Intellectual Rights Court (IPR), which could lead to the revocation of US pharma major AstraZeneca's patent for dapagliflozin - a drug for the treatment of type 2 diabetes, reports The Pharma Letter’s local correspondent. 30 October 2023
Generics
Indian generics major Zydus Lifesciences has announced the US Food and Drug Administration (FDA) approval of its New Drug Application (NDA) for Zituvio (sitagliptin) tablets, 25mg, 50mg, and 100mg. 25 October 2023
Generics
The European Commission has today adopted a set of actions to better prevent and mitigate critical medicine shortages in the European Union (EU), this winter, next winter and beyond. 24 October 2023
Generics
A confluence of factors is creating a conducive environment for mergers and acquisitions (M&As) to pick up pace in India. 23 October 2023
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