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 Russian Direct Investment Fund (RDIF), Russia's sovereign wealth fund specializing in equity investments in the high-tech sector, together with the local drugmaker ChemRar Group, will start the production of a new drug designed for treatment of COVID-19, according to the companies, reports The Pharma Letter’s local correspondent. 31 March 2020
India’s Department of Pharmaceuticals (DoP) has proposed an incentive scheme worth around 10,000 billion rupees ($1.3 billion) aiming to strengthen the domestic active pharmaceutical ingredients (APIs) facilites to boost domestic manufacturing in India to compensate for dwindling Chinese supply because of the coronavirus outbreak. 26 March 2020
Generics companies Mylan and Teva Pharmaceutical Industries have shown their commitment to fighting the COVID-19 pandemic by making announcements around hydroxychloroquine sulfate tablets, which they both manufacture. 20 March 2020
Indian drugmaker Dr Reddy’s Laboratories has announced the launch of ziprasidone mesylate for injection, 20mg (base)/mL single-dose vials, the therapeutic generic equivalent of Geodon Injection, 20mg/mL, in the USA, where it is approved by the US Food and Drug Administration 18 March 2020
Farmak, the leading Ukrainian drugmaker, plans to accelerate its foreign expansion within the next several years, according to recent statements of some sources close to the company and local media, reports The Pharma Letter’s Russia correspondent. 17 March 2020
Medicines for Europe, the generics trade association, has made three requests as it attempts to ensure continued drug supply apply across the continent amid the ongoing COVID-19 outbreak. 13 March 2020
UK-incorporated generics drugmaker Mylan has moved a step nearer to marketing its copy version of Lantus (insulin glargine) in the USA, as the District Court of New Jersey yesterday found the device patent claims (US Patent No 9,526,844) asserted by French pharma major Sanofi against Mylan's insulin glargine product not infringed and invalid for lack of written description. 11 March 2020
As India looks to avert a potential drug shortage crisis in the wake of escalating COVID-19 cases in the country, a standing committee set up by the Department of Pharmaceuticals and government think-tank Niti Aayog has proposed a $409 million scheme to boost the bulk drug industry. 6 March 2020
As the Indian government scouts for options to deal with any potential active pharmaceutical ingredient (API) scarcity that can arise in the future to counter the new coronavirus (COVID-19), the country's oldest public sector pharmaceutical company, Hindustan Antibiotics Limited (HAL), has submitted a proposal to the government to reduce dependence on China for fermentation-based bulk drugs. 5 March 2020
A worrying aspect of the COVID-19 outbreak, so far as drugmakers and patients are concerned, is that the virus has taken an unerring liking to regions that also happen to be the major production centers for many of the world’s medicines. 5 March 2020
Germany’s Stada Arzneimittel says it is now the largest foreign investor in the Russian pharmaceutical industry, following the completion of a $660 million transaction for a Russian brand portfolio from Japan’s Takeda. 5 March 2020
The UK’s Competition and Markets Authority (CMA) has found that four pharmaceutical companies broke the law in relation to the supply of the anti-depressant drug nortriptyline. 4 March 2020
The production of drugs in Russia may decline significantly this year, due to the almost complete suspension of the supplies of raw materials for their production from China, according to recent statements by representatives of some leading drugmakers in Russia and local analysts, reports The Pharma Letter’s local correspondent. 3 March 2020
The US Food and Drug Administration has approved an application for the first generic of Daraprim (pyrimethamine) tablets for the treatment of toxoplasmosis (an infection caused by the parasite Toxoplasma gondii) when used with a sulfonamide (a group of medicines used to treat bacterial infections). 2 March 2020
The generic injectables market will benefit from increased patent expiry of blockbuster drugs as it enjoys double-digit compound annual growth rate (CAGR) through 2029, according to a report from Future Market Insights. 26 February 2020
Global efforts to stop the spread of the Coronavirus, or COVID-19, have been stepped up in recent days, with the combined situation in South Korea, Italy and Iran as well as the tens of thousands of people infected in China, causing the BBC to call the outbreak “the early stages of pandemic”. 25 February 2020
In a surprise turn of events, the US Food and Drug Administration has rescinded the 90-day VAI (voluntary action indicated) letter that was issued to Indian drugmaker Aurobindo's Unit IV facility. 25 February 2020
As the world is gripped by an escalating epidemic originating in China – the novel coronavirus dubbed COVID-19 that is threatening not just lives but also medicines supplies - French pharma major Sanofi today announced its intention to establish its own manufacturing company for drug ingredients. 24 February 2020
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Company Spotlight
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.