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
Piramal Pharma Limited’s Pharma Solutions business, a leading Indian Contract Development and Manufacturing Organization (CDMO), has announced that the company’s site in Digwal in the state of Telangana, India, has implemented various tools to unlock Active Pharmaceutical Ingredient (API) manufacturing capacity and support client needs in drug development and on-patent projects. 15 June 2022
Amid the ever-growing pressure from the West and its sanctions on the country following the invasion of Ukraine, leading Russian drugmakers plan to expand the production of basic drugs, that will help to generate additional revenues on the bleak domestic market. 15 June 2022
Even as Germany’s Boehringer Ingelheim has obtained ad-interim injunctions against four Indian pharma companies that launched generic versions of the multinational's patent-protected drug linagliptin, Indian generic major Natco said that US firms Johnson & Johnson and Momenta Pharmaceuticals have filed a patent infringement lawsuit against it on two old patents associated with its glatiramer acetate injection. 13 June 2022
Israeli generics giant Teva Pharmaceutical Industries and its affiliates have reached an agreement with Indian drugmaker Aurobindo Pharma to resolve the dispute over Aurobindo’s Abbreviated New Drug Application (ANDA) for a generic deutetrabenazine product, a copy of the branded drug Austedo. 10 June 2022
As Januvia/Janumet (sitagliptin), a Merck & Co drug, nears patent expiry, India's drug price regulator National Pharmaceutical Pricing Authority (NPPA) has fixed the prices of fixed-dose combinations of several anti-diabetic drugs with a 50% reduction on the patented component in a move set to increase the price war in India's $2.3 billion anti-diabetic drugs market. Howls of protest have followed the move, reports The Pharma Letter’s India correspondent. 30 May 2022
London-headquartered generics company Hikma Pharmaceuticals has announced that its chief executive Siggi Olafsson has resigned in order to ‘pursue other opportunities’. 26 May 2022
China-based R&D service provider for the pharmaceutical and biotech industries Pharmaron Beijing has entered into a definitive asset purchase agreement to acquire the Coventry active pharmaceutical ingredients (API) manufacturing site in the USA from Noramco. 25 May 2022
At the 2022 American Psychiatric Association (APA) annual meeting, Israeli generics giant Teva Pharmaceutical will present new data for Austedo (deutetrabenazine). 24 May 2022
Piramal Pharma Limited's Pharma Solutions business, a leading Contract Development and Manufacturing Organization (CDMO), has announced that a new active pharmaceutical ingredient (API) plant at the company's site in Aurora, Ontario, Canada, has come online and successfully completed its initial production runs. 24 May 2022
About 100 generic medicines are set to be suspended from use in Europe, after a scientific panel of the European Medicines Agency reviewed evidence of irregularities at an Indian contract research organization (CRO). 23 May 2022
Along with all the other medicines supply problems that the country has recently encountered, Russia is now facing a shortage of anti-HIV drugs, despite a significant increase of their procurements by the state in recent years, reports The Pharma Letter’s local correspondent. 18 May 2022
Indian pharmaceutical companies are concerned about the increase in warning letters and OAIs (official action indicated) from the US Food and Drug Administration, which could potentially delay product launches and can push up regulatory uncertainty and compliance costs. As the number of US FDA inspections increases, so does the number of good manufacturing practices ( 17 May 2022
Japanese drugmaker Kyowa Kirin has decided to build a new active pharmaceutical ingredient (API) manufacturing building (HB7 Building) at its Takasaki plant that is responsible for manufacturing biopharmaceuticals. 17 May 2022
Russian drug manufacturers and laboratories are faced with serious shortage of excipients, which is mainly due to serious interruptions in their deliveries to the Russian market, reports The Pharma Letter’s local correspondent. 12 May 2022
India continues to establish itself as the pharmacy of the world as exports swell by 103% since 2013-14. The pharmaceutical industry is now being urged to work toward becoming the healthcare custodian of the world by adhering to good manufacturing practices, reports The Pharma Letter’s India correspondent. 3 May 2022
Illinois, USA-based Long Grove Pharmaceuticals, founded in 2019 by strategic health care investor Water Street Healthcare Partners, will begin shipping its first products in mid-2022. 22 April 2022
India is well on its way to becoming a global hub for pharmaceuticals. Around 35 active pharmaceutical ingredients (API), which were previously imported into India, are now being manufactured across the country. Applied research for investigational new drugs has also quadrupled in India, reports The Pharma Letter’s India correspondent. 21 April 2022
The US Federal Trade Commission on Tuesday said it required – as a condition of London-listed Jordanian drugmaker Hikma Pharmaceuticals’ $375 million acquisition of Custopharm announced in September 2021 – that Custopharm’s parent company retain and transfer Custopharm’s assets related to the corticosteroid drug triamcinolone acetonide, or TCA, to another subsidiary, Long Grove Pharmaceuticals. 20 April 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.