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
Express Scripts yesterday announced it will partner with Imprimis Pharmaceuticals to drive access to a low-cost alternative to Daraprim (pyrimethamine), 2 December 2015
Mylan says that it expects to be the first to launch, upon regulatory approval and for developing country markets funded by international donors, TLE400 (tenofovir disoproxyl fumarate 300mg + lamivudine 300mg + efavirenz 400mg) for $99 per patient, per year. 2 December 2015
Shares in India’s Jubilant Life Sciences jumped 10% Tuesday as the company announced the US Food and Drug Administration (FDA) has approved its abbreviated new drug application (ANDA) for antidepressant tablets. 1 December 2015
Israel’s Teva Pharmaceutical Industries and Japan’s largest drugmaker Takeda Pharmaceutical have entered into a definitive agreement to establish an unprecedented partnership in Japan. 30 November 2015
Jordon-based Hikma Pharmaceuticals has officially announced its plans for the building of a manufacturing plant in Almaty, the largest city of Kazakhstan during the next several years, reports The Pharma Letter’s local correspondent. 30 November 2015
Cheaper generic drugs may soon be commonplace in India with the government aiming to sell around 400 medications at lower prices by this December, through its Jan Aushadhi stores. 30 November 2015
Indian drugmaker Dr Reddy’s Laboratories said the US Food and Drug Administration have extended the timeline for replying to the warning letter issued to the company to December 7. 27 November 2015
UCB says it has completed its previously-announced transaction providing for the sale of its US specialty generics subsidiary, Kremers Urban Pharmaceuticals (KU), to Lannett Company. 27 November 2015
China’s Food and Drug Administration (CFDA) recently issued a policy, aiming to shake off its long-term reputation for being extremely slow on new drug approvals, as well as largely improve the quality of Chinese made generics, reports The Pharma Letter’s local correspondent, Wang Fangqing. 24 November 2015
The USA’s Federal Trade Commission has filed an amicus brief in the US Court of Appeals for the Third Circuit urging the court to reverse a district court ruling that an alleged reverse-payment settlement of patent litigation did not violate the antitrust laws, in part, because the FTC did not object to the proposed settlement when the companies submitted it to the agency. 20 November 2015
Beximco has become the first Bangladeshi company to receive US Food and Drug Administration approval for a prescription drug manufactured in the country for export to the USA. 19 November 2015
Following a public comment period, the Federal Trade Commission has approved a final order settling charges that the $8 billion merger between Endo International and privately-held Par Pharmaceuticals would likely be anticompetitive. 19 November 2015
Indian drugmaker Dr Reddy's Laboratories has completed the purchase of worldwide exclusive intellectual property rights for fondaparinux sodium, its generic anti-coagulant drug, from its Australian partner Alchemia. 18 November 2015
The European Generic and Biosimilar Medicines Association (EGA) and the German Generic and Biosimilar Medicines Association (Progenerika) today launched the IGES study in a joint press conference in Berlin. 16 November 2015
German drugmaker Stada Arzneimittel today reported that group sales increased by 3% to 1.53 billion euros ($1.64 billion) in the first nine months of 2015, achieving increases in sales in the firm’s two market regions Central Europe and Asia/Pacific & MENA. 12 November 2015
Dr Reddy’s Laboratories today said that it has been made aware of an order passed by the District Court of Delaware, USA, granting a temporary restraining order (TRO) with immediate effect on sales, delivery, transfer, or other disposition of its generic esomeprazole product in the US market. 10 November 2015
The Off-patent Drugs Bill was debated in the UK Parliament last week, having been proposed for a second reading by Nick Thomas-Symonds MP. 9 November 2015
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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.