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
Perrigo soared 17% to $77.90 by late morning on Thursday, having surged as much as 20.4%, after the company revealed it has reached an agreement to divest its Israel Active Pharmaceutical Ingredient business. 11 August 2017
A two-tier manufacturing market and forecast increased acquisitions by Indian companies, along with a notable improvement in the international reputation of Indian made pharmaceuticals have been identified in a new report for CPhI titled: 2017 India Pharma Market Report. 10 August 2017
Netherlands-incorporated Mylan’s (Nasdaq: MYL) shares were down 7.9% at $31.79 in pre-market trading, after the company released second-quarter 2017 financial results which missed expectations, and reduced its full-year guidance. 9 August 2017
Privately-held USA-headquartered generics manufacturer Amneal has launched influenza drug oseltamivir phosphate capsules, USP in three strengths: 30mg, 45mg and 75mg. 9 August 2017
American generics drugmaker Mylan has received tentative approval to distribute its HIV/AIDS treatment TLD in developing countries under the US President's Emergency Plan for AIDS Relief (PEPFAR). 7 August 2017
The Indian government is looking to review the existing drug price control measures in order to make medicines more affordable in the country, and at increasing the number of clinical trials taking place in the country, reports The Pharma Letter’s India correspondent. 5 August 2017
With high volumes of trading, shares in Israeli generics giant Teva Pharmaceutical have fallen almost a fifth in New York this morning, as the company revealed disappointing quarterly results. 3 August 2017
The Cabinet Committee on Economic Affairs of India (CCEA) has decided to block Shanghai Fosun Pharmaceutical’s 8.5 billion yuan ($1.3 billion) takeover of the Indian drugmaker Gland Pharma, according to reports. 3 August 2017
In testimony presented to the U.S. House of Representatives’ Judiciary Committee Subcommittee on Regulatory Reform, Commerical and Antitrust Law, the USA’s Federal Trade Commission described its efforts to stop anticompetitive conduct in the pharmaceutical industry. 31 July 2017
The total number of Abbreviated New Drug Applications (ANDAs) from the US Food and Drug Administration for Indian pharma firms rose to 129 this year, an increase of 45% from the number of 89 for the period of January-July of 2015. 31 July 2017
Netherlands-incorporated generic drugmaker Mylan has received approval from the World Health Organization Prequalification of Medicines Program (WHO PQ) for its application for sofosbuvir tablets, 400mg, a generic version of Gilead Sciences' Sovaldi. 26 July 2017
Bangladesh's Beximco Pharmaceuticals has received approval from the US Food and Drug Administration (FDA) for its generic version of Auxilium Pharmaceuticals' Robaxin (methocarbamol) tablets. 25 July 2017
The executive and the supervisory boards of German generic drugs maker Stada Arzneimittel (SAZ: Xetra) today published their reasoned joint statement on the renewed voluntary public takeover offer by Nidda Healthcare Holding, the acquiring company of Bain Capital and Cinven, for all outstanding shares in Stada. 25 July 2017
Baxter International and Claris Lifesciences Limited have agreed to divest two types of pharmaceutical products to settle Federal Trade Commission charges that Baxter’s proposed $625 million acquisition of Claris Injectables business of the Indian parent company is anticompetitive. 21 July 2017
The European Commission has informed Israeli generics giant Teva Pharmaceutical Industries of its preliminary view that an agreement concluded with Cephalon was in breach of European Union antitrust rules. 18 July 2017
Medicure, a specialty pharma focused on the development and commercialization of therapeutics for the US hospital market, has exercised an option to snap up additional interests in Apicore, the New Jersey-based API developer and manufacturer. 11 July 2017
Bain Capital and Cinven, through their Nidda Healthcare unit, have been cleared by German regulators to submit a renewed binding voluntary public takeover offer for all outstanding shares of Stada Arzneimittel, further to its previous bid failing to gain adequate shareholder support. 11 July 2017
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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.