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Generics
The US Court of Appeals for the Federal Circuit affirmed the US District Court for the District of Delaware’s decision that US drugmaker Eagle Pharmaceuticals’ vasopressin product does not infringe on any of the patents asserted by Par Pharmaceutical, a subsidiary of Endo International. 19 August 2022
Generics
Long Grove Pharmaceuticals has announced the launch of a new generic intended for multiple conditions including arthritis. 20 July 2022
Generics
Chinese drugmaker Hengrui has received approval from the National Medical Products Administration (NMPA) for its generic version of Santen's Diquas (diquafosol) to treat dry eye. 31 May 2022
Generics
Israeli generics giant Teva Pharmaceutical Industries says that its US subsidiary has reached an agreement with the Attorney General of Florida that settles the state’s and its subdivisions opioid-related claims. 31 March 2022
Generics
Indian drugmaker Sun Pharmaceutical Industries says it will pay $485 million to settle a multidistrict suit claiming that its subsidiary Ranbaxy manipulated the US Food and Drug Administration's generic-drug approval process to stop competitors from developing generic versions of three medicines. 24 March 2022
Generics
India’s Strides Pharma Science today announced that its stepdown wholly owned subsidiary, Strides Pharma Global Pte, Singapore, has received approval for Colchicine Tablets USP, 0.6mg from the US Food and Drug Administration. 11 March 2022
Generics
Bright Way Group, the Russian investment company and pharmaceutical producer, plans to invest up to 3 billion roubles ($38 million) in the building of a large-scale pharmaceutical factory in the city of Moscow within the Technopolis Moscow special economic zone (SEZ), according to recent statements by Moscow authorities and local media reports. 26 January 2022
Generics
A review of recent litigation from Sara Koblitz, a director at Hyman, Phelps & McNamara, provides reason to think that so-called skinny-labeled drugs will continue to be an option for generics manufacturers. 12 January 2022
Generics
The US Food and Drug Administration has determined that Eagle Pharmaceuticals has maintained its 180 days of marketing exclusivity for its recently approved abbreviated new drug application (ANDA) for vasopressin. 30 December 2021
Generics
German active pharmaceutical ingredient (API) maker PharmaZell and France-based Novasep, a contract development and manufacturing organization (CDMO) have entered into exclusive negotiations to create a leading European platform in the attractive API manufacturing and CDMO space with a complementary set of differentiated technologies and highly diversified base of blue-chip pharma and biotech customers. 16 September 2021
Generics
The US District Court for the District of Delaware has held that Eagle Pharmaceuticals’ proposed vasopressin product does not infringe any of the patents that Par Pharmaceutical had claimed that it did. 1 September 2021
Generics
India’s Lupin has launched Luforbec (beclometasone/formoterol) in the UK, making it the first branded generic alternative to Chiesi’s Fostair. This follows the granting of regulatory approval earlier this year. 25 August 2021
Generics
US trade group the Association for Accessible Medicines has appointed Joe Russo as senior director, federal government affairs, in order to help develop the association’s strategy and implement the initiatives of AAM’s government affairs department. 13 August 2021
Generics
Heraeus Pharmaceutical Ingredients’ additional production line for platinum-based highly potent active pharmaceutical ingredients (Pt hAPIs) is now fully operational at the company’s headquarters in Hanau, Germany. 10 August 2021
Generics
Germany’s Bayer entered a strategic partnership with the Chinese major online pharmacy 111. 5 August 2021
Generics
The US Food and Drug Administration (FDA) has published a revision to its Manual of Policies and Procedures (MAPP), Generic Drug Labeling Revisions Under Section 505(j)(10) of the Federal Food, Drug, and Cosmetic (FD&C) Act. 27 July 2021
Generics
Indian drugmaker Glenmark Pharmaceuticals has become one of the first companies to launch a bioequivalent version of tiotropium bromide dry powder inhaler (DPI), under the brand name Tiogiva, in UK for the treatment of chronic obstructive pulmonary disease (COPD). 16 June 2021
Generics
Indian pharma major Lupin Limited has announced that it has received approval for its emtricitabine and tenofovir disoproxil fumarate tablets, 200mg/300mg, from the US Food and Drug Administration, to be marketed as a generic equivalent of Gilead Sciences’ Truvada. 9 June 2021
Generics
Fresenius Kabi today announced the immediate availability in the USA of foscarnet sodium Injection. 15 March 2021
Generics
Sandoz, the generic and biosimilar medicines unit of Novartis, announced the US launch of generic icatibant injection pre-filled syringe to treat acute attacks of rare disease hereditary angioedema (HAE) in adults 18 years and older, making it available immediately for US patients. 29 January 2021
Generics
The US Food and Drug Administration (FDA) yesterday announced its Fiscal Year 2025 Generic Drug User Fee Amendments (GDUFA). 28 November 2024
Generics
Sino-American oncology company BeOne Medicines, until now known as BeiGene, has entered into a settlement agreement with MSN Pharmaceuticals and MSN Laboratories Private resolving patent litigation related to MSN’s Abbreviated New Drug Application (ANDA) seeking approval to market a generic version of Brukinsa (zanubrutinib) in the USA. 25 November 2024
Generics
Indian drugmaker Aurobindo Pharma has taken on the might of China in terms of Penicillin G pricing, and is doing so by leveraging a fully integrated production process at its new plant. Anticipating the price erosion of Penicillin G, the company has put up an integrated plant from scratch. 10 November 2024
Generics
Indian markets are abuzz with a singular refrain. Donald Trump's Presidency of the United States is set to open new opportunities for India, especially in the pharmaceutical sector. 8 November 2024
Generics
US generic drugmaker Viatris announced robust financial results for the third quarter of 2024, driven by positive momentum against all three pillars of its strategy. The company’s shares shot up 13.5% to $13.18 following the announcement. 8 November 2024
Generics
Teva Pharmaceutical Industries’ shares were up 4% at 7,323 shekels today reported results for the quarter ended September 30, 2024. 6 November 2024
Generics
Medicines for Europe has launched a study of market barriers faced by European generics and biosimilar pharmaceutical companies operating in 11 key third-country markets. 31 October 2024
Generics
Swiss biosimilars and generics group Sandoz today reported net sales for the third quarter ended September 30, 2024. 30 October 2024
Generics
Lexicon Pharmaceuticals announced that Viatris has obtained an exclusive license from Lexicon to commercialize sotagliflozin outside of the USA and Europe in all indications. 18 October 2024
Generics
The US Food and Drug Administration (FDA) yesterday published the guidance for industry, “Requests for Reconsideration at the Division Level Under GDUFA.” 17 October 2024
Generics
Swiss generic and biosimilar medicines major Sandoz today announced that it has launched a generic paclitaxel formulation in the USA, the first generic to its reference medicine to be approved by the US Food and Drug Administration (FDA). 11 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
Generics
CMS released a Request for Information (RFI) and a sample list of prescription drugs that the agency preliminarily intends to include under the proposed Medicare $2 Drug List Model. 10 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
Generics
Aspire Pharma, a UK-based niche generics business, has announced the acquisition of all assets from Canute Pharma, further expanding its product range. 4 October 2024
Generics
US antivirals giant Gilead Sciences today announced that it has signed non-exclusive, royalty-free voluntary licensing agreements with six generic drugmakers to make and sell generic lenacapavir 2 October 2024
Generics
The US Food and Drug Administration (FDA) yesterday released its fiscal year 2023 (FY23) Generic Drug User Fee Amendments (GDUFA) Science and Research Outcomes Report. 2 October 2024
Generics
The number of clinical trials of new drugs in Russia is steadily declining, which could be mainly related with the overall reduction of investment activities in the local pharmaceutical market, reports The Pharma Letter’s local correspondent. 30 September 2024
Generics
The generics and biosimilars trade group, Medicines for Europe, has put out a strong message amid ongoing discussions on a European Union (EU) Critical Medicines Act. 26 September 2024
Generics
The protection of intellectual property (IP) rights of foreign pharmaceutical companies in Russia remains complex situation, according to recent statements by Konstantin Panurovsky, legal director of AstraZeneca’s Russian subsidiary, reports The Pharma Letter’s local correspondent. 13 September 2024
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