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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
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Generics
Japanese pharma major Shionogi has signed seven sublicence agreements with the Medicines Patent Pool (MPP), a United Nations-backed international public health organization, for generic version of Shionogi's ensitrelvir fumaric acid, a COVID antiviral, to be manufactured by generics companies. 26 June 2023
Generics
India has made it clear that it will not compromise on intellectual property, regulatory data protection, and patent extension as part of ongoing trade negotiations with the UK and the European Union. 22 June 2023
Generics
Four companies in the Asia Pacific region have taken out licenses with The Medicines Patent Pool (MPP) to manufacture generic versions of Tasigna (nilotinib). 22 June 2023
Generics
The US Federal Trade Commission has filed a friend-of-the-court (amicus) brief in the US Court of Appeals for the Second Circuit, clarifying the legal standards that apply in certain antitrust cases involving the pharmaceutical sector. 21 June 2023
Generics
The Delhi High Court has sought the Indian government's position regarding a petition that challenges the ban on fixed-dose combination (FDC) drugs, reports The Pharma letter’s local correspondent. 20 June 2023
Generics
The total contribution that the pharmaceutical industry has provided for the Bulgarian economy in 2021 is estimated at around 2.8 billion Bulgarian lev ($1.57 billion) or 2.2% of the country's gross domestic product (GDP), which is in line with the average level for Europe. 19 June 2023
Generics
German generics major STADA Arzneimittel has named Christos Gallis as head of Eastern Europe, effective July 1, 2023. 15 June 2023
Generics
The UK subsidiary of Hungarian drugmaker Gedeon Richter today announced that full marketing and distribution rights to an oral contraceptive range of branded generics, acquired from Ireland-headquartered Consilient Health, have been transferred to the company. 14 June 2023
Generics
Russian pharmaceutical companies will receive additional subsidies from the state for the development of analogues of foreign drugs, as part of the current state plans for the reduction of import dependence in the country’s pharmaceutical sector, The Pharma Letter’s local correspondent reports. 9 June 2023
Generics
The Indian government is exploring the possibility of introducing a Production Linked Incentive (PLI) scheme for basic chemicals and active pharmaceutical ingredients (API) industries. 8 June 2023
Generics
Israeli generics giant Teva Pharmaceutical Industries said today that its US subsidiary has fully resolved its nationwide settlement agreement related to opioid claims. 8 June 2023
Generics
Even as Tariq Ahmad, UK Minister of State for Foreign, Commonwealth and Development Affairs and India's External Affairs Minister S Jaishankar held talks in Delhi on Monday, and discussed the India-UK Free Trade Agreement (FTA), Indian pharmaceutical companies have joined forces to urge the government to maintain a strong stance on the Patents Act as it negotiates FTAs with key global partners. 30 May 2023
Generics
Leading Indian drugmaker Sun Pharmaceutical Industries has reported financials for the full year ending March 31, 2023 (FY23). 30 May 2023
Generics
In an effort to decrease pharmaceutical companies profiteering, India's National Pharmaceutical Pricing Authority (NPPA) has said the ceiling price of off-patent pharmaceuticals will be slashed by 50%. 26 May 2023
Generics
Leading Russian drugmakers have called on the state to simplify the launch of their generics to the domestic market by reducing the number of so-called evergreen patents of global majors, reports The Pharma Letter’s local correspondent. 22 May 2023
Generics
German pharma major Bayer has filed a lawsuit against the Russian manufacturer of generic drugs Medisorb, The Pharma Letter’s local correspondent reports. 19 May 2023
Generics
Shares of Canada-based Bausch Health Companies were up 14.6% at $8.56 on Wednesday, after it said that a US district court stuck with an earlier judgment that prevented an application for a rival generic version of its Xifaxan (rifaximin) irritable bowel syndrome drug from getting US Food and Drug Administration (FDA) approval until 2029. 19 May 2023
Generics
The US Food and Drug Administration has published product-specific guidance for generics drugmakers with the goal of facilitating pipeline development and promoting access. 19 May 2023
Generics
Famed as a great success story of the generics sector in previous decades, Israel’s Teva Pharmaceutical Industries has seen its growth and share price tail off since the mid-2010s. 18 May 2023
Generics
India's pharmaceutical industry captains have voiced their plea to the government, urging an expansion of the bulk drugs park scheme beyond its current scope. 16 May 2023
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