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
Indian generics major Zydus Lifesciences has received tentative approval from the US Food and Drug Administration (FDA) to market canagliflozin tablets, 100mg and 300mg. 15 February 2023
The courts in India have come down heavily against certain domestic pharmaceutical companies who have been accused of allegedly flagrantly violating patent policies, with many launching drugs that are still covered by patents, reports The Pharma Letter’s India correspondent. 11 February 2023
Teva Pharmaceutical took in $3.9 billion in revenues in the fourth quarter, around what the majority of analysts had forecast, making for annual sales of $14.9 billion. 8 February 2023
The number of clinical trials of drugs in Russia in 2022 significantly declined, according to latest data from the Russian Ministry of Health, reports The Pharma Letter’s local correspondent. 8 February 2023
Mumbai, India-based generic drugmaker Lupin Limited revealed that it has received tentative approval from Food and Drug Administration (FDA), under the US President’s Emergency Plan for AIDS Relief (PEPFAR), for its New Drug Application for dolutegravir, emtricitabine and tenofovir alafenamide (DETAF) tablets. 1 February 2023
The existing interruptions in the supply of active pharmaceutical ingredients (APIs) to Russia and lack of their production within the country currently remains one of the major reasons for a shortage of various drugs in the local market, reports The Pharma Letter’s local correspondent. 31 January 2023
US tech giant Amazon has announced RxPass, a new Prime membership benefit from Amazon Pharmacy that offers patients affordable access to commonly prescribed generic medications that treat more than 80 common health conditions. 25 January 2023
Sandoz, the generic and biosimilar medicines business of Swiss pharma giant Novartis, has signed an agreement to acquire worldwide product rights for leading systemic antifungal agent Mycamine (micafungin sodium, Funguard in Japan) from Astellas Pharma. 24 January 2023
As a blockbuster heart failure drug by Swiss pharma giant Novartis goes off-patent, several Indian drug majors are rushing to market with their generic applications. The patent loss of Entresto (sacubitril/valsartan) has brought on significant disruptions in India’s cardiology sector. High courtroom drama ensued a few days before the patent loss and had everyone on tenterhooks, reports The Pharma Letter’s India correspondent. 20 January 2023
India's interim free trade agreement with Australia is set to offer a significant relaxation of factory inspections, which could pave the way for many more commercial deals with developed countries, according to Pharmexcil, India's pharmaceutical export promotion council. 16 January 2023
A sudden surge in Covid cases in China has made anti-Covid generic drugs from India attractive, including the generic version of Pfizer's anti-Covid oral drug Paxlovid (nirmatrelvir/ritonavir), which is in high demand and needs to be reserved weeks in advance, reports The Pharma Letter's local correspondent, 12 January 2023
Drug imports to Russia are ongoing almost in the same volumes as in the past, despite the current situation in Russia, according to recent statements by Viktor Dmitriev, general director of the Association of Russian Pharmaceutical Manufacturers (ARPM) and some independent local analysts in the field of pharmaceuticals. 10 January 2023
PSK Pharma, a Russian drugmaker that is part of the local Rus Biopharm Group, is looking to become one of the leading pharmaceutical companies in Russia in the coming years to come, achieving this by a significant increase of its output and expansion of its range, reports The Pharma Letter’s local correspondent. 10 January 2023
Finnish drugmaker Orion Corporation says it has signed a long-term license agreement with US drugmaker Amneal Pharmaceuticals, to commercialize Amneal’s generic products in Orion territories. 5 January 2023
In November 2022, the US Food and Drug Administration (FDA) hosted a webinar on the topic Understanding Generic Narrow Therapeutic Index (NTI) Drugs. The aim of the webinar was to educate healthcare professionals on NTI drugs and the FDA’s efforts to ensure therapeutic equivalence of generic NTI drugs.1 3 January 2023
The supervisory board of German drugmaker STADA Arzneimittel has appointed Boris Döbler as group chief financial officer (CFO) with effect from January 1, 2023. 3 January 2023
A growing number of key starting materials (KSMs) and active pharmaceutical ingredients (APIs) coming into India have become 25% to 35% more expensive as reports of Covid infections spiral out of control in China, squeezing margins and increasing drug prices. The Indian government's production linked incentive (PLI) scheme for the promotion of domestic manufacturing of critical KSMs, drug intermediates (DIs) and APIs is soon set to come to the aid of many domestic players, reports The Pharma Letter’s India correspondent. 29 December 2022
Global drugmakers have significantly cut their portfolios in the Russian market in recent years due to the decline of profitability and low prices under public procurement programs. 28 December 2022
Indian generics major Zydus Lifesciences, formerly known as Cadila Healthcare, subsidiary Zydus Worldwide has received final approval from the US Food and Drug Administration (FDA) to market Selexipag Tablets, 200mcg, 400mcg, 600mcg, 800mcg, 1,000mcg, 1,200mcg, 1,400mcg, and 1,600mcg. 22 December 2022
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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.