3 October 2024 F2G’s September $100m funding round provides the company with crucial funds to
renavigate approval of its lead drug, olorofim. The substantial financing also
highlights the paucity of novel antifungal products in the clinic.
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
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
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
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
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
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
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
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
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
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
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
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
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
Swipha, a leading Nigerian pharmaceutical manufacturer, has received prequalification from the World Health Organization (WHO) for its sulfadoxine-pyrimethamine (SP) drug. 21 August 2024
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
Even as Novartis (NOVN: VX) is locked in a high-stakes battle with the US Food and Drug Administration (FDA) to protect its blockbuster heart failure drug Entresto (sacubitril and valsartan) from generic competition, generic versions of valsartan are making hay in India 8 August 2024
The Russian Ministry of Health has registered the third Russian generic of the original drug Ozempic (semaglutide) from Danish drugmaker Novo Nordisk. 8 August 2024
US biotech major Biogen is disputing the launch of a Russian generic of Spinraza (nusinersen), a drug, which is used to treat spinal muscular atrophy (SMA), reports The Pharma Letter’s local correspondent. 7 August 2024
Imports of bulk drugs from China have jumped, potentially undermining India's efforts to boost domestic pharmaceutical manufacturing through its Production Linked Incentive (PLI) scheme. 5 August 2024
German pharmaceutical major Bayer has refused compensation of more than 400 million roubles ($4.3 million) from Russian Nativa (renamed Spectrum) for the use of patents on the anticancer drug Nexavar (sorafenib), reports The Pharma Letter’s local correspondent. 9 November 2023
Hungarian drugmaker Gedeon Richter has begun supplying generics of foreign drugs for diabetics to Russia – in a move to take the share of those global drugmakers that have left Russia, reports The Pharma Letter’s local correspondent. 8 November 2023
Israeli generics giant Teva Pharmaceutical Industries has reported its latest quarterly financial results against a backdrop of war in its home region. 8 November 2023
The Indian pharma and healthcare sector has witnessed a 298% jump in deals during the third quarter of 2023 compared to the same period last year. 8 November 2023
The Slovenian generics drugmaker KRKA has achieved a rehearing of its case in the Russian Presidium of the Intellectual Rights Court (IPR), which could lead to the revocation of US pharma major AstraZeneca's patent for dapagliflozin - a drug for the treatment of type 2 diabetes, reports The Pharma Letter’s local correspondent. 30 October 2023
Indian generics major Zydus Lifesciences has announced the US Food and Drug Administration (FDA) approval of its New Drug Application (NDA) for Zituvio (sitagliptin) tablets, 25mg, 50mg, and 100mg. 25 October 2023
The European Commission has today adopted a set of actions to better prevent and mitigate critical medicine shortages in the European Union (EU), this winter, next winter and beyond. 24 October 2023
Even as India's National Pharmaceutical Pricing Authority (NPPA) is currently deliberating a threshold price for 10 formulations, including a significant 70% price reduction for a brain cancer drug, poor patients at the AIIMS hospital in Delhi are to get 63 more drugs, including 45 cancer drugs for free. 20 October 2023
The first generic version of the popular drug for controlling glucose levels, Ozempic (semaglutide), which is produced by the Danish diabetes care giant Novo Nordisk, has been registered in Russia by a local drugmaker, the Pharma Letter’s local correspondent reports. 18 October 2023
India’s Biocon has signed a partnership agreement with Canadian specialty pharma company Juno Pharmaceuticals, for the commercialization of its vertically integrated, complex formulation, liraglutide, a drug-device combination for the treatment and management of type 2 diabetes and obesity. 9 October 2023
On Friday, the US Food and Drug Administration (FDA) announced a revised Manual of Policies and Procedures (MAPP 5241.3), “Good ANDA Assessment Practices.” 9 October 2023
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
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
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
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
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
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
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A pre-clinical stage biopharmaceutical group developing new medicines and treatments to treat blood and autoimmune disease and to bring the curative power of bone marrow transplantation to a greater number of patients suffering from otherwise incurable life-threatening diseases.