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
In September 2022, the US President re-authorized the Generic Drug User Fee Amendments (GDUFA). This new iteration is known as GDUFA III and takes effect from October 2022 to September 2027.1 21 September 2023
Pharmasyntez, one of Russia’s leading drugmakers, is preparing a new project in the domestic market, which involves commercial production of dialysis drugs, reports The Pharma Letter’s local correspondent. 19 September 2023
Shares of Hyderabad, India-headquartered Suven Pharmaceuticals hit a fresh 52-week high on the bourses after the Indian government gave the green signal to foreign direct investment (FDI) of up to $1.15 billion by drug major Cyprus-based Berhyanda. 19 September 2023
Following scrutiny from Democratic senators in Congress, the US Federal Trade Commission has issued a policy statement on the proper listing of pharmaceutical patents. 18 September 2023
Russia is still experiencing a shortage of active ingredients for its pharmaceutical sector due to a low interest of local producers in the establishment of their own production, despite the support that has been provided to the industry by the state in recent years, reports The Pharma Letter’s local correspondent. 12 September 2023
Russian drugmaker Geropharm once again failed to challenge the patent for Toujeo (long-acting insulin glargine) produced by the French pharma major Sanofi, reports The Pharma Letter’s local correspondent. 5 September 2023
Indian generic drugmaker Strides Pharma Science announced that its stepdown wholly-owned subsidiary, Strides Pharma Global Pte Limited, Singapore, has received approval for mycophenolate mofetil for oral suspension USP, 200mg/mL, from the US Food and Drug Administration (FDA). 4 September 2023
The US Food and Drug Administration (FDA) on Friday announced a draft guidance for industry, “Post-Warning Letter Meetings Under GDUFA.” 2 September 2023
In a major reprieve, India's National Medical Commission (NMC) has put on hold with immediate effect its recent regulation mandating doctors to prescribe only generic drugs or face strict punishment. 30 August 2023
Russian drugmaker R-Pharm is considering acquiring the manufacturing facility of Japanese pharma giant Takeda located in Yaroslavl, Russia, The Pharma Letters local correspondent reports. 30 August 2023
Shares of Indian generic drugmaker Mankind Pharma (edged up 1% today, after it boasted a significant stride with the introduction of 120 DMF (Drug Master File) Quality Medicines in the Indian market. 29 August 2023
The US Department of Justice (DoJ) yesterday announced deferred prosecution agreements (DPAs) resolving criminal antitrust charges against the US subsidiaries of Israel’s Teva Pharmaceutical Industries and India’s Glenmark Pharmaceuticals. 22 August 2023
There has been a substantial backlash from major pharmaceutical trade associations and companies to the European Commission’s (EC) feedback initiative on the introduction of a pan-European compulsory license, which would allow for the invalidation of existing drug patents across the European Union (EU) in emergency situations. 18 August 2023
The UK’s Competition and Markets Authority (CMA) has welcomed the landmark judgment, which endorses all the main elements of the CMA’s decision in respect of liothyronine tablets – an essential medicine to treat thyroid hormone deficiency. 17 August 2023
US pharma giant Pfizer and the Scripps Research Institute have accused generics company Dexcel Pharma Technologies of patent infringement. 14 August 2023
Even as a parliamentary panel in India has asked the government to rationalize the annual price hike limit for cancer drugs, its call for subsidizing cancer drugs in India carries multi-faceted implications for the pharmaceutical industry. 14 August 2023
In a major crackdown in India, manufacturing has been halted in at least 40 pharmaceutical companies, followed by the suspension or cancellation of licenses for 66 other firms, following a risk-based assessment of 162 drug firms. 11 August 2023
The Indian pharmaceutical industry has made significant progress in reducing its dependency on China for active pharmaceutical ingredients (APIs). 8 August 2023
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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.