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
The Netherlands Medicines Evaluation Board (MEB) wants to continue publishing the complete SmPC (Summary of Product Characteristics) and package leaflet of generic medicinal products on the MEB website, even if a patent still rests on an indication. 15 February 2016
The UK’s Competition and Markets Authority announced this morning that it has fined a number of pharmaceutical companies for anti-competitive conduct and agreements relating to the supply of the antidepressant drug paroxetine. 12 February 2016
Teva Pharmaceutical Industries, the world’s largest generics maker, has reported a decline in fourth quarter profits as sales of its best-selling drug face competition. 11 February 2016
HIV-specialist company Viiv Healthcare is facing opposition in India to two patent applications it has submitted for dolutegravir and cabotegravir. 10 February 2016
Following receipt of new financial performance information from Boehringer Ingelheim, Jordon-based drugmaker Hikma Pharmaceuticals said today that is revising the terms of the acquisition of the family-owned German pharma major’s Roxane Laboratories unit. 10 February 2016
Chip Davis, president and chief executive of the US Generic Pharmaceutical Association (GPhA), on Monday briefed Congress about the ways generic drugs and biosimilars can drive savings in terms of healthcare cost, at a hearing of the Senate Committee on Health, Education, Labor and Pensions (HELP). 3 February 2016
Gedeon Richter says it has acquired from its partner, Rxmidas Pharmaceuticals Holdings, its outstanding 50% stake in Gedeon Richter Rxmidas Joint Venture Co Ltd following the setting up of a joint venture with an initial 50% share of equity announced in December 2010. 1 February 2016
The Czech Republic’s biggest pharmaceutical company Zentiva says that it is looking to develop 11 new generic drugs for treatment of cardiovascular and respiratory illnesses throughout this year and going forward into 2017, the Pharma Letter's Czech Republic correspondent reports. 27 January 2016
Netherlands-incorporated Mylan has announced the US launch of felbamate tablets USP, 400mg and 600mg, which is the generic version of Swedish drugmaker Meda Pharma’s Felbatol Tablets. 21 January 2016
India’s Glenmark Pharma on Thursday said it has received final approval from the US Food and Drug Administration to manufacture and market Potassium Chloride extended release capsules and oral contraceptive Norethindrone Acetate and Ethinyl Estradiol tablets in the US market. 21 January 2016
At their joint executive meeting in Barcelona yesterday, the Spanish Generic Medicines Association (AESEG) and the European Generic and Biosimilar Medicines Association (EGA) confirmed their commitment to join forces and bring access to generic medicines to the Spanish market. 20 January 2016
Shares in Indian drug maker Wockhardt closed down 6% Monday after the company said it expects to comply with all the US Food and Drug Administration’s observations on its Shendra unit in two months. 19 January 2016
As reported in Indian media, senior officials from the European Commission and India are expected to meet today in Brussels to hold talks on resuming negotiations on the proposed European Union-India free trade agreement. 18 January 2016
Pharmaceutical companies entered into substantially fewer potential pay-for-delay patent dispute settlements in fiscal year 2014, according to a new report from staff at the US Federal Trade Commission. 14 January 2016
Netherlands-incorporated Mylan said it has filed an application with the US Food and Drug Administration seeking approval for a generic version of UK pharma major GlaxoSmithKline's best-selling lung drug Advair Diskus (fluticasone/salmeterol). 13 January 2016
Chinese drugmaker Yabao Pharmaceutical and USA-based Sciecure Pharma yesterday announced a strategic partnership to co-develop, manufacture and commercialize high technological barrier generics medicines for both the US and China markets. 13 January 2016
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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.