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 UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Friday approved the first generic raltegravir medicines to treat adult and pediatric HIV patients 20 July 2024
Russian drugmaker Promomed is aiming to accelerate expansion in both domestic and foreign markets in the coming years, reports The Pharma Letter’s local correspondent. 18 July 2024
India-based generic drugmaker Lupin Limited says it has received approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for topiramate extended-release capsules. 15 July 2024
The Russian drugmaker Geropharm has demanded a compulsory license from Denmark’s Novo Nordisk to produce a generic of Ozempic (semaglutide), which is a drug used for diabetes and the active ingredient is marketed as Wegovy for weight loss, reports The Pharma Letter’s local correspondent. 12 July 2024
GlaxoSmithKline Trading, the distribution division of the British pharma major GSK, has filed a complaint to the Russian anti-trust regulator FAS on the recent auction for state procurements of GSK’s anti-HIV drug Tivicay (dolutegravir). 12 July 2024
UK pharma major AstraZeneca is defending a patent for its diabetes drug Forxiga (dapagliflozin) in Russia, as part of the recent decision taken by the Russian Supreme Court, reports The Pharma Letter’s local correspondent. 4 July 2024
Viatris has announced that the antitrust division of the US Department of Justice (DOJ) has concluded its investigation into Mylan and its former president, Rajiv Malik. 3 July 2024
India's Production Linked Incentive (PLI) scheme has struck gold with the inclusion of semaglutide, a key GLP-1 receptor agonist used in the treatment of diabetes and obesity. 30 June 2024
Kotak Alt, part of India's Kotak Mahindra Group, has invested $173 million in Matrix Pharma to facilitate its acquisition of Viatris’ (Nasdaq: VTRS) active pharmaceutical ingredient (API) business, a major US-based company. 19 June 2024
The European Commission (EC) has accused privately-held API manufacturer Alchem International of breaching European Union antitrust rules by participating in a long-lasting cartel concerning an important pharmaceutical product. 14 June 2024
A New Jersey, USA, federal judge has ruled that five patents covering Israel-based Teva Pharmaceutical Industries-brand asthma inhalers were improperly listed in the Food and Drug Administration’s (FDA) Orange Book, in a win for US drugmaker Amneal Pharmaceuticals. 12 June 2024
Indian generics drugmaker Cadila Pharmaceuticals, together with the Russian investment fund the Russian Direct Investment Fund (RDIF), will invest more than 10 billion roubles ($112 million) in the establishment of a pharmaceutical complex and an injection drug plant in Russia. 11 June 2024
India has become the largest supplier of drugs to the Russian market, overtaking Germany, which had been in the lead for the last two years, reports The Pharma Letter’s Russia correspondent. 4 June 2024
The drug shortage crisis in the USA, intensified by supply chain disruptions and increased demand, presents a significant opportunity for Indian pharmaceutical companies to offer essential support. 28 May 2024
UK-based Alliance Pharma (AIM: APH) has successfully appealed against a Competition and Markets Authority (CMA) ruling that had found the company guilty of breaching competition law. 24 May 2024
Indian biotech major Biocon has signed an exclusive licensing and supply agreement with South Korea’s Handok, for the commercialization of its vertically integrated, complex drug product, synthetic liraglutide. 24 May 2024
On Thursday, the US Food and Drug Administration’s (FDA0 Center for Drug Evaluation and Research published its fiscal year 2023 (FY23) Generic Drug User Fee Amendments (GDUFA) Science and Research Report. 24 May 2024
The Russian government is considering tightening domestic patent legislation, in a move to respond to numerous calls of global drugmakers, which are unhappy with the level of protection of their original drugs in the local market, reports The Pharma Letter’s local correspondent. 22 May 2024
Sign up to receive email updates Join industry leaders for a daily roundup of biotech & pharma news
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.