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2 July 2025 A federal judge has blocked the US Department of Health and Human Services from moving forward with a major workforce reduction and agency overhaul, finding that the changes may violate federal law and cause lasting disruption.
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Generics
In its ongoing mission to help meet America’s growing need for high-quality US-made medicines, London listed Jordanian drugmaker Hikma Pharmaceuticals announced its US unit will invest $1 billion by 2030 to further expand its manufacturing and R&D capabilities in the country. 30 June 2025
Generics
US insurance giant Cigna has taken fresh legal action against Bristol Myers Squibb, accusing the drugmaker of manipulating the patent system to preserve its monopoly on the multiple myeloma treatment Pomalyst (pomalidomide). 26 June 2025
Generics
Israeli generics major Teva Pharmaceutical Industries has highlighted that Europe is experiencing increasing pressure on its medicines supply. 25 June 2025
Generics
The revision of the European pharmaceutical legislation, the reform of the Supplementary Protection Certificate (SPC) system and the review of the SPC manufacturing waiver are now fundamental reforms to stimulate a strong off-patent pharmaceutical industry in Europe whose medicines account for the vast majority of those dispensed in Europe, trade group Medicines for Europe announced today. 24 June 2025
Generics
Medicines for Europe, a manufacturers of generic and biosimilar trade group, today presented five trade policy recommendations to strengthen global access to medicines and enhance the competitiveness of the off-patent pharmaceutical sector in a seminar with the European Commission and Member States representatives. 17 June 2025
Generics
Russian drugmaker Axelpharm has managed to lift the ban on the launch of osimertinib - a drug, which is used in the treatment of lung cancer - in the domestic market, reports The Pharma Letter’s local correspondent. 12 June 2025
Generics
The Russian pharmaceutical market, valued at around $41 billion, continues to be a magnet for Indian pharmaceutical companies. 9 June 2025
Generics
German drugmaker STADA Arzneimittel has reported record earnings on revenues growth in its financial first quarter. 3 June 2025
Generics
Japanese drugmaker Eisai said yesterday that it has received a favorable decision regarding the lawsuit filed in the US District Court for the District of New Jersey in November 2019 against generic drug manufacturer Shilpa Medicare, which submitted an Abbreviated New Drug Application (ANDA) for a generic version of Lenvima (lenvatinib), for infringement of US Patent No 11,186,547. 30 May 2025
Generics
Russian drugmaker Geropharm has received a compulsory license from the Russian state to produce a generic of Ozempic (semaglutide) developed by Denmark’s Novo Nordisk. As in case of Ozempic, Geropharm’s generics are used to treat diabetes, as well as for weight loss, reports The Pharma Letter’s local correspondent. 28 May 2025
Generics
The share of generics in the Russian pharmaceutical market is steadily growing despite the efforts of the local state to create conditions for the production of original drugs, The Pharma Letter’s local correspondent reports. 22 May 2025
Generics
Representatives of Russian patent unions have sent an appeal to the Russian Scientific Center for Expertise of Medical Products to provide a protocol for the compliance of Lantesens, a drug for the treatment for spinal muscular atrophy (SMA), which is produced by the Russian drugmaker Generium, a copy of the original drug Spinraza (nusinersen) from US biotech Biogen, reports The Pharma Letter’s local correspondent. 14 May 2025
Generics
India has declined the UK's request to include a 'data exclusivity' clause in the proposed Free Trade Agreement (FTA), as announced on May 6, underscoring its commitment to protect its robust domestic generic drug industry. India's generic drug industry is valued at over $30 billion. 13 May 2025
Generics
Israel’s Teva Pharmaceutical Industries today reported results for the quarter ended March 31, 2025. 7 May 2025
Generics
Swiss generics and biosimilars major Sandoz today presented its net sales update for the first quarter of 2025. 30 April 2025
Generics
The Russian pharma trade group Innovative Pharma (Inpharma) has sent an official letter to the Ministry of Industry and Trade of Russia with proposals for revising the criteria for including drugs in the list of strategically important drugs, The Pharma Letter’s local correspondent reports. 23 April 2025
Generics
Russian public procurements of drugs based on the active ingredient semaglutide, which is an original drug from Denmark’s Novo Nordisk and marketed as Ozempic for diabetes and Wegovy for obesity, increased by 28% in 2024 compared to the previous year to 2.3 billion roubles ($28.1 million), according to latest data of the Russian analytical system for tender management Tenderplan, reports The Pharma Letter’s local correspondent. 22 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
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
All news
Generics
USA-based drugmaker Viatris has announced a series of divestitures as part of a strategy to narrow the company’s focus. 3 October 2023
Generics
US healthcare giant Johnson & Johnson has confirmed it will not enforce its patents for the multidrug-resistant tuberculosis med Sirturo (bedaquiline) in certain lower-income countries. 3 October 2023
Generics
The US Food and Drug Administration has revised its Manual of Policies and Procedures (MAPP), in relation to suitability petitions for generic drug regulatory submissions. 3 October 2023
Generics
Israeli generics giant Teva Pharmaceutical Industries today announced changes to its leadership team. 29 September 2023
Generics
A report from industry analyst GlobalData finds that a range of new generic products in idiopathic pulmonary fibrosis (IPF) will likely shake up the market in coming years. 27 September 2023
Generics
The inaugural report from the Access to Medicine Foundation's Generic and Biosimilar Medicines Program has taken a look at what five major industry players are doing to expand access to their products in low- and middle-income countries (LMICs). 26 September 2023
Generics
India's Department of Pharmaceuticals is seeking innovative technologies to reduce the cost of producing Active Pharmaceutical Ingredients (APIs) that are currently imported. 26 September 2023
Generics
Indian drugmaker Glenmark Pharmaceuticals has entered into a definitive agreement with Nirma Limited to divest a 75% stake in its subsidiary, Glenmark Life Sciences Limited (GLS), which focuses on producing active pharmaceutical ingredients (APIs). 22 September 2023
Generics
In September 2022, the US President re-authorized the Generic Drug User Fee Amendments (GDUFA). This new iteration is known as GDUFA III and takes effect from October 2022 to September 2027.1 21 September 2023
Generics
Pharmasyntez, one of Russia’s leading drugmakers, is preparing a new project in the domestic market, which involves commercial production of dialysis drugs, reports The Pharma Letter’s local correspondent. 19 September 2023
Generics
Shares of Hyderabad, India-headquartered Suven Pharmaceuticals hit a fresh 52-week high on the bourses after the Indian government gave the green signal to foreign direct investment (FDI) of up to $1.15 billion by drug major Cyprus-based Berhyanda. 19 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
Generics
Russia is still experiencing a shortage of active ingredients for its pharmaceutical sector due to a low interest of local producers in the establishment of their own production, despite the support that has been provided to the industry by the state in recent years, reports The Pharma Letter’s local correspondent. 12 September 2023
Generics
Russian drugmaker Geropharm once again failed to challenge the patent for Toujeo (long-acting insulin glargine) produced by the French pharma major Sanofi, reports The Pharma Letter’s local correspondent. 5 September 2023
Generics
Indian generic drugmaker Strides Pharma Science announced that its stepdown wholly-owned subsidiary, Strides Pharma Global Pte Limited, Singapore, has received approval for mycophenolate mofetil for oral suspension USP, 200mg/mL, from the US Food and Drug Administration (FDA). 4 September 2023
Generics
The US Food and Drug Administration (FDA) on Friday announced a draft guidance for industry, “Post-Warning Letter Meetings Under GDUFA.” 2 September 2023
Generics
In a major reprieve, India's National Medical Commission (NMC) has put on hold with immediate effect its recent regulation mandating doctors to prescribe only generic drugs or face strict punishment. 30 August 2023
Generics
Russian drugmaker R-Pharm is considering acquiring the manufacturing facility of Japanese pharma giant Takeda located in Yaroslavl, Russia, The Pharma Letters local correspondent reports. 30 August 2023
Generics
Shares of Indian generic drugmaker Mankind Pharma (edged up 1% today, after it boasted a significant stride with the introduction of 120 DMF (Drug Master File) Quality Medicines in the Indian market. 29 August 2023
Generics
The US Department of Justice (DoJ) yesterday announced deferred prosecution agreements (DPAs) resolving criminal antitrust charges against the US subsidiaries of Israel’s Teva Pharmaceutical Industries and India’s Glenmark Pharmaceuticals. 22 August 2023
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