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16 June 2025 Supernus Pharmaceuticals is to buy Sage Therapeutics for total consideration of around $795 million.
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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
Generics
The US Food and Drug Administration (FDA) yesterday announced revised final guidance for industry entitled, “ANDA Submissions – Amendments to Abbreviated New Drug Applications under GDUFA.” 12 September 2024
Generics
Several pharma companies that had moved the Delhi High Court against the government’s recent notification banning 156 fixed-dose combination (FDC) drugs have got a breather. 10 September 2024
Generics
A significant drop has been noticed in the prices of active pharmaceutical ingredients (APIs), bringing much-needed relief to the pharmaceutical industry and potentially translating to lower drug costs for consumers. 9 September 2024
Generics
Glenmark Pharmaceuticals has agreed to pay $25 million, based on its ability to pay, to resolve its alleged liability under the False Claims Act for conspiring to fix the price of a generic drug, the US Department of Justice announced. 5 September 2024
Generics
German pharma major Bayer has filed a lawsuit against the Russian drugmaker Promomed to protect the patent rights for Xarelto (rivaroxaban), its treatment for stroke prevention which is the best-selling drug in the Russian market at present, The Pharma Letter’s local correspondent reports. 2 September 2024
Generics
German generics major STADA Arzneimittel today announced that it achieved sales of more than 2 billion euros ($2.23 billion) in the first half of 2024. 28 August 2024
Generics
In a major crackdown, the Indian government has imposed an immediate ban on 156 fixed-dose combination (FDC) drugs, including commonly used antibiotics, pain relievers,and multivitamins. 27 August 2024
Generics
Swipha, a leading Nigerian pharmaceutical manufacturer, has received prequalification from the World Health Organization (WHO) for its sulfadoxine-pyrimethamine (SP) drug. 21 August 2024
Generics
One of the largest pharmaceutical production facilities in the Russian North-West region will soon be built in the city of Pushkino by the local drugmaker Active Component enterprise, The Pharma Letter’s local correspondent reports. 14 August 2024
Generics
Going into the second half of 2024, Swiss generics and biosimilars major Sandoz has announcing some senior leadership changes. 8 August 2024
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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
Generics
German tech conglomerate Siemens has signed an agreement with Miko Pharma to develop facilities for the local production of generic pharmaceuticals in Ghana. 2 April 2025
Generics
The Danish Medicines Agency's new analysis shows that generic prescribing will not necessarily lead to financial savings or increased patient safety. 31 March 2025
Generics
German family-owned pain specialist Grünenthal today published its 2024 financial results, marking a year of impressive resilience, strategic growth and operational excellence. 27 March 2025
Generics
Russian drug manufacturers are eliminating global players from the domestic insulin market, as their sales are steadily growing, The Pharma Letter’s local correspondent reports. 26 March 2025
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