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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
There has been a substantial backlash from major pharmaceutical trade associations and companies to the European Commission’s (EC) feedback initiative on the introduction of a pan-European compulsory license, which would allow for the invalidation of existing drug patents across the European Union (EU) in emergency situations. 18 August 2023
Generics
The UK’s Competition and Markets Authority (CMA) has welcomed the landmark judgment, which endorses all the main elements of the CMA’s decision in respect of liothyronine tablets – an essential medicine to treat thyroid hormone deficiency. 17 August 2023
Generics
STADA Arzneimittel announced impressive sales growth for the first half of 2023 on Tuesday. 15 August 2023
Generics
US pharma giant Pfizer and the Scripps Research Institute have accused generics company Dexcel Pharma Technologies of patent infringement. 14 August 2023
Generics
Even as a parliamentary panel in India has asked the government to rationalize the annual price hike limit for cancer drugs, its call for subsidizing cancer drugs in India carries multi-faceted implications for the pharmaceutical industry. 14 August 2023
Generics
In a major crackdown in India, manufacturing has been halted in at least 40 pharmaceutical companies, followed by the suspension or cancellation of licenses for 66 other firms, following a risk-based assessment of 162 drug firms. 11 August 2023
Generics
The Indian pharmaceutical industry has made significant progress in reducing its dependency on China for active pharmaceutical ingredients (APIs). 8 August 2023
Generics
Israeli generics giant Teva Pharmaceutical Industries made stock market gains of around 12% during Wednesday morning’s trading. 2 August 2023
Generics
USA-based generics major Viatris and Kindeva Drug Delivery today announced the launch of Breyna (budesonide and formoterol fumarate dihydrate) Inhalation Aerosol, the first generic version of AstraZeneca's Symbicort with an Abbreviated New Drug Application (ANDA) approved by the US Food and Drug Administration (FDA). 1 August 2023
Generics
Building up on its sizeable global presence in the oncology space, Venus Remedies, an India-based provider of affordable cancer drugs worldwide, has extended its reach with marketing approvals for key cancer drugs from Philippines, Paraguay, Georgia and Moldova. 31 July 2023
Generics
Prices for imported active pharmaceutical ingredients (APIs) are rising again in Russia after the decline in 2022. This year the growth is equivalent to by 40%-100% year-on-year due to the devaluation of the rouble and the need to use intermediaries for these procurements, reports The Pharma Letter’s local correspondent. 20 July 2023
Generics
As the US market prepares to go through a major upcycle following a seven-year downcycle, with numerous key indicators aligning at the same time, Indian pharmaceutical companies are waiting in the wings, poised to leverage the significant opportunity in the small molecule patented drugs segment, reports The Pharma Letter’s India correspondent. 17 July 2023
Generics
Colombia, which is home to a $4.8 billion pharma market, will soon decide whether to authorize price-cutting generic competition with a critical patented AIDS drug, directly challenging pharmaceutical industry power under a new health ministry resolution in one of the hemisphere’s most influential states. 14 July 2023
Generics
Global drugmakers continue to defend the rights for their original drugs in Russia by participating in legal disputes with local generics’ producers, The Pharma Letter’s local correspondent reports. 12 July 2023
Generics
The High Court has issued a judgment on the judicial review brought by the British Generic Manufacturers Association (BGMA) dismissing the claim that the organization was improperly excluded from the ongoing negotiations between the government and industry to agree a new Voluntary Scheme for medicine pricing and access (VPAS). 10 July 2023
Generics
The Russian Ministry of Health has called on domestic drugmakers to accelerate efforts for the development and production of cheaper analogues of expensive drugs, particularly those that are used for the treatment of socially significant diseases, according to recent statements made by Sergey Glagolev, deputy head of the Ministry. 4 July 2023
Generics
Mumbai, India-based generic drugmaker Lupin Limited saw US regulatory approval for two of its copy medicines in the space of two days. 4 July 2023
Generics
Swiss generic drugmaker Dipharma today announced that its product Sapropterin Dipharma is now available in main European countries including in Switzerland. 3 July 2023
Generics
As part of an initiative to reduce global dependence on China for the supply of crucial pharmaceutical and active pharmaceutical ingredient (API) requirements, India and the USA have agreed to collaborate on the development of APIs and vaccine materials. 28 June 2023
Generics
AstraZeneca has called on the Russian Ministry of Health to change the conditions for registering prices for generics in Russia, as the current rules, according to the company, prevent original drugmakers from participating in public procurements, reports The Pharma Letter’s local correspondent. 27 June 2023
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