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
Vizient, the USA’s largest member-driven health care performance improvement has firm, has signed an agreement with Fresenius Kabi to supply six critical care drugs under Vizient’s successful Novaplus private label pharmacy program. 22 November 2019
India's war on drug prices has been pushed up another notch. Given that the list of drugs under price control has steadily expanded from 74 in 1995 to nearly 860 by 2019, the prevailing mood of the government is to further bring down prices. The price of drugs used to treat cancer and cardiac issues could soon face the axe, reports The Pharma Letter’s India correspondent. 19 November 2019
Medicines for Europe and APOGEN have this week held an Open Industry Day in Portugal to showcase the quality and safety of generic, biosimilar and value-added medicines production in Europe and to discuss current and future market challenges. 15 November 2019
The US Food and Drug Administration has sent a warning letter to Netherlands-incorporated drugmaker Mylan over procedures at an Indian manufacturing facility. 14 November 2019
US healthcare and medical devices company Abbott today announced that Miles White will be stepping down as chief executive on March 31, 2020, after a remarkable 21-year tenure, the second longest for a non-founder in today's S&P 100, according to the company. 13 November 2019
Indian pharma company Lupin has confirmed that it has entered into a definitive agreement for the sale of its entire stake in its Japanese subsidiary Kyowa Pharmaceutical Industry to Unison Capital Partners. 13 November 2019
Sandoz, the generics and biosimilars arm of Swiss pharma giant Novartis, today announced a binding agreement for the acquisition of the Japanese business of Aspen Global Incorporated (AGI), a wholly-owned subsidiary of South Africa’s Aspen Pharmacare 11 November 2019
Health expenditure will outpace GDP growth over the next 15 years in almost every OECD (Organization for Economic Cooperation and Development) country, according to new OECD forecasts. 8 November 2019
Shares in Teva Pharmaceutical Industries were up by 11% after 100 minutes of New York trading on Thursday, following the company’s presentation of its third-quarter financial results. 7 November 2019
Shares of London-listed Hikma Pharmaceuticals were down 2% at 1,984.50 pence in mid-morning trading, after the company issued an update on current trading. 7 November 2019
Netherlands-based drugmaker Mylan was trading 4% lower in the stock market by mid-morning on Tuesday as investors digested the company’s third-quarter financial results. 5 November 2019
There was good news today for Shanghai-based WuXi AppTec subsidiary WuXi STA Pharmaceutical, with the announcement that its Jinshan manufacturing facility in Shanghai, China, has successfully passed an inspection by the European Medicines Agency (EMA) with no critical and no major findings. 28 October 2019
Indian drugmaker Cipla Limited has acquired a novel and patented anti-infective product, Elores, from Venus Remedies for the Indian market to further strengthen its presence in the branded domestic critical care space and as a part of its agenda to contribute to the fight against anti-microbial resistance (AMR). 28 October 2019
The Amsterdam headquarters of the European Medicines Agency hosted an important meeting between European and Chinese medicines regulators on Friday. 25 October 2019
On Wednesday, the US Food and Drug Administration announced that, in fiscal year 2019, the agency approved a total of 1,171 generic drugs, an all-time record, following a record 971 approvals in fiscal year 2018 and a record 937 approvals in fiscal year 2017. 17 October 2019
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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.