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
Israeli generics giant Teva Pharmaceutical Industries has appointed Matthew Shields as executive vice president of Teva Global Operations (TGO), the company’s manufacturing and supply division, effective June 3, 2024. 15 May 2024
Norwich Pharmaceuticals has submitted to the US regulator for approval to market a generic version of Xifaxan (rifaximin), a treatment for irritable bowel syndrome. 15 May 2024
The Russian Ministry of Health has registered domestic generic of Spinraza (nusinersen), an expensive drug used for the treatment of all types of spinal muscular atrophy (SMA) in children and adults, reports The Pharma Letter’s local correspondent. 14 May 2024
Indian biotech Biocon today announced the signing of a semi-exclusive distribution and supply agreement with Medix, a specialty pharmaceutical company in Mexico, for the commercialization of its vertically integrated drug product, Liraglutide (gSaxenda), used in the treatment of chronic weight management. 13 May 2024
Israeli drugmaker Teva Pharmaceutical Industries missed estimates relating to earnings and exceeded expected revenue levels in presenting its first-quarter financial results. 9 May 2024
The COVID-19 pandemic has underscored the vulnerabilities inherent in global supply chains, particularly those predicated on single-country reliance. 2 May 2024
The level of competition in the Russian market of anti-HIV drugs is tightening, due to the plans of global drugmakers to launch their products and expand their existing portfolios, The Pharma Letter’s local correspondent reports. 1 May 2024
Colombia’s government yesterday issued its first-ever compulsory license (CL) for use by the country’s Ministry of Health, to improve access to less-expensive generic versions of the key HIV medicine dolutegravir. 25 April 2024
UK pharma major AstraZeneca has appealed to the Russian Investigative Committee and the Federal Anti-Monopoly Service (FAS) against Russian drug firm Akrikhin, which produces a generic of the diabetes drug Forxiga (dapagliflozin) during the validity of the patent. 24 April 2024
Global drugmakers are losing their market share in the Russian market for erectile dysfunction drug, which is rapidly being taken over by local players, reports The Pharma Letter’s local correspondent. 23 April 2024
Indian pharma exports to the US market are rebounding strongly in the current fiscal year, showing a notable double-digit growth after a lull. 23 April 2024
The USA’s Association for Accessible Medicines (AAM), the trade association that represents generic and biosimilar drug manufacturers, commented on an analysis released by Avalere showing that Medicare plans increase patient costs for generic medicines by moving those medicines to more expensive formulary tiers. 20 April 2024
Indian drugmaker Biocon has entered an exclusive licensing and supply agreement with Brazil’s Biomm for the commercialization of its vertically integrated drug product, semaglutide. 18 April 2024
The prices of certain active pharmaceutical ingredients (APIs) have experienced a significant decline over the past two months, as compared to the elevated prices reigning during the Covid pandemic. 18 April 2024
The Russian government is considering designing additional measures aimed at creating conditions for the growth of domestic pharmaceutical market during the period of 2024-2025, reports The Pharma Letter’s local correspondent. 17 April 2024
Canada-based Bausch Health, and its gastroenterology business Salix Pharmaceuticals, announced that the US Court of Appeals for the Federal Circuit announced a positive ruling on its patent dispute with Norwich Pharmaceuticals. 12 April 2024
For the last three decades, the availability of cost-effective generic medicines has driven increased access to life-saving treatments for millions of patients in Europe. 10 April 2024
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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.