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
With strong momentum in Japanese research for novel coronavirus candidate favipiravir, Russian efforts to confirm the use of the drug in this setting are also progressing. 14 May 2020
The Russian government plans to provide support to producers of cheap drugs, with the aim to prevent their disappearance from the domestic market, according to recent statements by representatives of some senior state officials and industry’s analysts, reports The Pharma Letter’s local correspondent. 12 May 2020
Generic drugmaker Apotex has admitted to fixing the price of a widely-used cholesterol drug and has accepted a $24.1 million fine from a US court. 11 May 2020
Like diabetes specialist Novo Nordisk, generics firm Mylan was on the receiving end of COVID-19-related stockpiling revenues in the first quarter. 11 May 2020
Israel-based Teva Pharmaceutical Industries today reported results for the quarter ended March 31, 2020, showing that revenues were $4,357 million, an increase of 5% in both US dollar and local currency terms, compared to the first quarter of 2019. 7 May 2020
Specialty chemicals company Evonik has kicked off a major expansion project at two German facilities, aimed at serving the European market for active pharmaceutical ingredients (APIs) and advanced intermediates. 5 May 2020
India continues to be on the 'Priority Watch List' of the US Trade Representative (USTR) for lack of sufficient measurable improvements to its Intellectual Property framework. 4 May 2020
Indian drugmaker Strides Pharma Science today announced that it has developed and commercialized favipiravir antiviral tablets, with the company’s shares jumping 13.4% to 425.00 rupees on the news. 29 April 2020
India-based Natco Pharma has recently launched a generic version of AstraZeneca’s (LSE: AZN) patented anti-diabetes drug Forxiga (dapagliflozin). 28 April 2020
Leading Russian drugmakers and foreign companies operating in Russia have opposed the introduction of amendments to the existing rules for registration and examination of drugs in the domestic market which create a single register of patented active ingredients in the market of Russia as well as some other post-Soviet states, reports The Pharma Letter’s local correspondent. 28 April 2020
The US Food and Drug Administration on Friday issued a Drug Safety Communication regarding known side effects of hydroxychloroquine and chloroquine, including serious and potentially life-threatening heart rhythm problems, that have been reported with their use for the treatment or prevention of COVID-19, for which they are not approved by the FDA. 25 April 2020
European regulators have approved the merger of Pfizer’s generics division, Upjohn, with Netherlands-headquartered generics company Mylan. 23 April 2020
Approvals from the US Food and Drug Administration are coming in thick and fast, in what has come as a major relief for Indian pharmaceutical companies. 20 April 2020
Generics drugmaker Beximco says its pharmaceutical division and fellow Bangladesh-based Beacon Pharmaceuticals have developed favipiravir, an antiviral drug that is being used by China to treat COVID-19 patients. 14 April 2020
As COVID-19 spreads, the search for a treatment is ramping up. The antimalarial and immunosuppressant hydroxychloroquine has received some attention, including that of US President Trump. 9 April 2020
Indian generic drugs major Cipla has received final approval for its Abbreviated New Drug Application (ANDA) for albuterol sulfate Inhalation aerosol 90mcg from the US Food and Drug Administration. 9 April 2020
Among several actions take this week in in its ongoing response effort to the COVID-19 pandemic, the Food and Drug Administration approved an Abbreviated New Drug Application (ANDA) for Hydroxychloroquine Sulfate Tablets USP, 200mg. for the treatment of: 8 April 2020
Indian drugmaker Cipla Limited saw its shares close up more than 8% at 448.00 rupees on Friday, after it announced the successful completion of Phase III clinical end-point study for fluticasone propionate and salmeterol inhalation powder, a generic version of UK pharma major GlaxoSmithKline’s Advair Diskus. 4 April 2020
As China’s active pharmaceutical ingredient (APIs) makers restart operations, the first consignment of raw materials has already touched Indian shores. Imports from all Chinese provinces, barring one, have commenced to India, with supplies expected to buck up in the coming weeks, reports The Pharma Letter’s India correspondent. 1 April 2020
The US Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for two malaria drugs donated to the Strategic National Stockpile (SNS) to be distributed and used for certain hospitalized patients with COVID-19. 31 March 2020
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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.