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
London-listed Hikma Pharmaceuticals today reports its preliminary audited results for the year ended December 31, 2020, that disappointed and saw the firm’s share fall 7.9% to 2,227 pence in early trading. 25 February 2021
Russia needs a total overhaul of its patent regulation system with regard to pharmaceuticals, with the aim to ensure access for the local population to cheaper drugs, according to recent statements by local pharma analysts and some domestic media, reports The Pharma Letter’s local correspondent. 23 February 2021
Viatris, the newly-formed generics power-house resulting from the merger of Mylan and Pfizer’s Upjohn unit, saw its share fall more than 11% to $16.30 pre-market today, after it announced 2021 financial guidance. 22 February 2021
The recent merger of Mylan and Upjohn was one of the biggest in healthcare. But in their rebirth as Viatris (Nasdaq: VTRS), a lesson about the future of the industry may be in rediscovering its humanity, writes Christina Falzano, managing director, Conran Design Group, in an Expert View piece. 19 February 2021
The Russian Ministry of Economy has prepared a draft order that will limit the ability of pharmaceutical companies to patent other forms of already known chemical compounds in Russia, according to recent statements by some senior state officials and local media, reports The Pharma Letter’s local correspondent. 17 February 2021
Sandoz, the generics and biosimilars business of Swiss pharma giant Novartis, has signed an agreement to acquire UK drug major GlaxoSmithKline’s cephalosporin antibiotics business, reinforcing its leading global position in antibiotics. 11 February 2021
Israeli genetics giant Teva Pharmaceutical Industries today reported results for the year and the quarter ended December 31, 2020, which disappointed. 10 February 2021
Russian drugmaker Pharmsynthez has begun production of a remdesivir generic, the drug that was originated by the US biotech Gilead Sciences (Nasdaq: GILD) and marketed under the Veklury brand, reports The Pharma Letter’s local correspondent. 2 February 2021
The US Food and Drug Administration issued a warning letter to Professional Compounding Centers of America (PCCA) for receiving and distributing adulterated and misbranded active pharmaceutical ingredients (APIs). 28 January 2021
In another attack on US medicine pricing, a report published today by the RAND Corporation shows that prescription drug prices in the USA average 2.56 times those seen in 32 other nations. 28 January 2021
The European Investment Bank (EIB) will provide 20 million euros ($24.3 million) to finance the research, development and innovation program of Galenicum, a pharmaceutical company founded in Barcelona, Spain. 27 January 2021
The US Federal Trade Commission (FTC) yesterday filed a new antitrust complaint accusing Endo Pharmaceuticals and Impax Laboratories, as well as the latter’s owner, Amneal Pharmaceuticals, of striking a second deal to stave off competition to the Opana ER (oxymorphone hydrochloride extended release) opioid pain medication even as an earlier FTC enforcement action over the same drug was moving forward. 26 January 2021
Bangladesh's largest drugmaker Beximco Pharmaceuticals has entered into a binding commitment with France’s Sanofi regarding the acquisition of a majority stake in Sanofi Bangladesh. 21 January 2021
German drugmaker Stada Arzneimittel invested more than 600 million euros ($725 million) in expanding its Russian range and modernization of its local production facilities in 2020, according to recent statements by the company. 19 January 2021
Highlighting over-medication as a potential hazard while also flagging the prospect of 'profiteering' by drug companies, India's drug price watchdog the National Pharmaceutical Pricing Authority (NPPA) has expressed concern about the many drug cocktail applications that continue to flood its office as also those that are surreptitiously available in the country, reports The Pharma Letter’s India correspondent. 18 January 2021
French pharma major Sanofi has chosen EUROAPI as the name for the future leading European company dedicated to the development, production and marketing of active pharmaceutical ingredients (API). 12 January 2021
In October 2020, the US Food and Drug Administration issued guidance for industry entitled “Referencing Approved Drug Products in Abbreviated New Drug Application (ANDA) Submissions.” 12 January 2021
On Friday, the US Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) announced the approval of the Office of Generic Drugs’ (OGD) reorganization. 9 January 2021
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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.