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.
In a posting on the Pharmaceutical Research and Manufacturers of America website, Tom Wilbur, a director of public affairs at PhRMA, explains the intellectual property scene, taking a look at how Hatch-Waxman successfully streamlined the process for generic medicine approvals while preserving incentives for innovation. 23 May 2019
The US Food and Drug Administration (FDA) wants to hear feedback on its product-specific guidances aimed at stimulating generic drug development. 17 May 2019
Connecticut Attorney General William Tong has led a coalition of 44 US states in announcing a fresh lawsuit against Teva Pharmaceutical Industries and 19 other generic drugmakers. 15 May 2019
Shares of Indian pharmaceutical companies continued their downward slide on reports that a lawsuit has been filed against Teva Pharmaceuticals Industries and other generic companies in the USA, including many Indian drugmakers, by 44 US states. 15 May 2019
Civica Rx has inked a supply deal with Danish firm Xellia Pharmaceuticals for the manufacture of essential generic antibiotics, including vancomycin and daptomycin, for Civica’s member health systems. 15 May 2019
CPhI Middle East & Africa (CPhI MEA) expert Madhukar Tanna, chief executive of Pharmax, a United Arab Emirates (UAE) based branded generic manufacturer, says favorable conditions in the UAE are resulting in a boom of pharmaceutical manufacturing throughout the region. 14 May 2019
The US Food and Drug Administration (FDA) has released final guidance on the basis for generic drugmakers to determine whether to submit an Abbreviated New Drug Application (ANDA) or 505(b)(2) application for products. 13 May 2019
The Dutch Medicines Evaluation Board (MEB) will no longer publish the full product information about the active substance of generic medicinal products on its website if an indication is still subject to a patent. 13 May 2019
Israeli generics giant Teva Pharmaceutical Industries over the last couple of days announced the launch of two new generic copy drugs in the USA. 11 May 2019
A miss in first quarter revenue estimates, coupled with manufacturing troubles at one of its US facilities, conspired to send Mylan shares plummeting nearly 20% on Tuesday morning in New York. 7 May 2019
Leading Russian drugmaker Biocad plans to commission its new large-scale production facility in the St Petersburg Neudorf special economic zone next month, with the aim to significantly increase its domestic production capacities. according to the company, reports The Pharma Letter’s local correspondent. 7 May 2019
Israeli generics giant Teva Pharmaceutical Industries today posted first-quarter 2019 financials, showing declines but these were slightly less than observers had expected. 2 May 2019
The issuing of a compulsory license for the production of a patent-protected drug in Russia may take place shortly, due to the recent victory of several legal disputes with US pharma giant Pfizer by local drugmaker Nativa, reports The Pharma Letter’s local correspondent. 30 April 2019
UK-based asset manager Investment Group Capital (IGC) and French healthcare-focused investment platform Mérieux Equity Partners have agreed to acquire DOC Generici from CVC Capital Partners. 9 April 2019
The Russian government plans to support the development of the domestic production of active pharmaceutical ingredients (APIs) by the provision of subsidies for their exports, according to Denis Manturov, an official spokesman of the Russian Minister of Industry and Trade, reports The Pharma Letter’s local correspondent. 9 April 2019
In a second acquisition this year, Czech Republic-based generics drugmaker Zentiva Group announced it has bought Creo Pharmaceuticals in the UK, a subsidiary of Amneal Pharmaceuticals. 1 April 2019
The Louisiana Department of Health and Department of Corrections has selected Asegua Therapeutics, a subsidiary of Gilead Sciences, as its hepatitis C “Netflix” subscription model pharmaceutical partner, to provide the State with unrestricted access to its direct-acting antiviral medication. 28 March 2019
Japanese pharma giant Takeda has officially announced the suspension of supplies of at least three branded generic drugs to the Russian market this year, reports The Pharma Letter’s local correspondent. 25 March 2019
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
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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.