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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
Effective June 1, 2023, prescribing of oral ivermectin for ‘off-label’ uses will no longer be limited to specialists such as dermatologists, gastroenterologists and infectious diseases specialists, in Australia. 10 May 2023
Generics
India’s Venus Remedies has won separate marketing authorizations for off-patent cancer drugs in the Philippines and Iraq. 9 May 2023
Generics
As many as 26% of all generics have disappeared across Europe over the past decade, according to trade group Medicines for Europe. 4 May 2023
Generics
Sandoz, the soon to be divested generics and biosimilars business of Swiss pharma giant Novartis, today announced the signing of a distribution and collaboration agreement with Adalvo for exclusive Sandoz rights to commercialize six products in the USA across key therapeutic areas, including antifungal/antibiotic, oncology and pulmonary. 4 May 2023
Generics
Two Indian pharma companies have reached a mutual settlement with Bristol Myers Squibb in connection with a patent dispute over BMS' oral anticoagulant drug apixaban, even as the Delhi High Court has dismissed BMS' another request for an injunction against Zee Laboratories. 2 May 2023
Generics
The International Council for Harmonization (ICH) has initiated the process for a new guideline on bioequivalence requirements for the approval of medicines, which is an important milestone for global convergence. 26 April 2023
Generics
The British Generic Manufacturers Association (BGMA) is seeking a judicial review of the decision on the part of the UK government to exclude it from negotiations over a future pricing framework. 24 April 2023
Generics
In 2022, 91% of prescriptions in the USA were filled by generic drugs, which in turn accounted for only 18.2% of the country’s pharmaceutical spending.1 17 April 2023
Generics
Several international investors and fund managers have expressed an interest in investing in the Indian pharmaceutical and biotechnology sectors, underlining the need to establish a platform to facilitate the transition of global capital flows into the domestic economy. 14 April 2023
Generics
The Indian government's cap on drug prices has brought down the cost of 651 essential medicines by an average of 6.7%. 11 April 2023
Generics
The Russian government plans to take additional measures to further increase the share of domestic drugs in the local market, as pressure from the West on the country and its pharmaceutical sector is growing. 7 April 2023
Generics
The expiration of the patent for palbociclib, a leading anti-breast cancer drug, in India has opened up new opportunities for generic versions of the drug. The Indian government highlighted this development in Parliament and intensely discussed the endless possibilities that could arise from the availability of generic palbociclib and other similar generic oncology drugs, reports The Pharma Letter’s India correspondent. 30 March 2023
Generics
After announcing the start of discussions early last year relating to its cabotegravir long-acting (LA) for HIV pre-exposure prophylaxis (PrEP), ViiV Healthcare, which is majority-owned by UK pharma major GSK, says an accord has now been struck with the Medicines Patent Pool (MPP). 30 March 2023
Generics
Russia will allow domestic drugmakers to develop generics of original foreign drugs under patent protection only in case of exodus of their producers from the Russian market. 29 March 2023
Generics
Indian generic drug major Dr Reddy's Laboratories has been strategizing to become a top company in the Indian pharmaceutical market. 24 March 2023
Generics
Even as the World Trade Organization (WTO) members continue to remain divided on the waiver of intellectual property (IP) rights for Covid-related vaccine technologies, India, South Africa, and other developing countries have resuscitated their campaign to extend the temporary waiver of IP for Covid vaccines to coronavirus drugs at the WTO. 22 March 2023
Generics
Zydus Lifesciences today revealed it has received final approval for Tofacitinib Tablets, 5mg and tentative approval for Tofacitinib Tablets, 10mg, generic versions of US pharma giant Pfizer’s Xeljanz from the US Food and Drug Administration (FDA). 21 March 2023
Generics
Attempts to curb drug shortages in Germany may not be sufficient to prevent a crisis, the government has been warned. 14 March 2023
Generics
Zeta Pharma is a fast-growing branded generic pharmaceutical company in the Egyptian market that was established in 2010 and started its production and marketing activities in 2015 on the hepatitis C virus products products Sofocivir, Zetaciver and Sofocivir Plus. 10 March 2023
Generics
Original drugs have begun to be massively replaced by generics in the Russian pharmaceutical market, which is mainly due to falling real incomes of local customers and the overall negative situation in the country’s economy, reports The Pharma Letter’s local correspondent. 7 March 2023
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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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