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.
Chinese firm Qilu Pharmaceutical has launched Yiruike, a generic version of Iressa (gefitinib), as a first-line treatment for non-small cell lung cancer (NSCLC) in China. 20 February 2017
Stada Arzneimittel has confirmed receipt of another – third - legally non-binding conditional expression of interest regarding a bid for the acquisition of up to 100% of the shares in the company. 20 February 2017
The executive board of German generic drugmaker Stada Arzneimittel has decided unanimously to start open-minded talks with both potential bidders for the acquisition of up to 100% of the shares in the company. 14 February 2017
Prices for drugs under public procurements in Russia may significantly increase in the event of the implementation of the latest initiative of the Russian Ministry of Health. 14 February 2017
Due to market rumors, German generic drugmaker Stada Arzneimittel (SAZ: Xetra) has confirmed that it has received two legally non-binding expressions of interest regarding a bid for the acquisition of up to 100% of the shares in the company. 13 February 2017
India’s pharmaceutical exports have done better than many sectorial exports and are in near double digit growth, according to a government official. 10 February 2017
Ireland-incorporated Allergan today reported its fourth quarter and full year 2016 continuing operations performance that pleased investors. 8 February 2017
Indian drugmaker Dr Reddy's Laboratories says it is continuing the expansion of its commercial operations in Europe with the introduction of its portfolio of generics in France. 8 February 2017
Erez Vigodman is stepping down from his post as chief executive of Teva Pharmaceutical Industries “by mutual agreement,” the Israeli generics giant announced late Monday. 7 February 2017
Switzerland’s Dipharma and USA-based Alvogen have announced the launch of Diterin (sapropterin dihydrochloride 100mg tablets), indicated for the treatment of hyperphenylalaninemia (HPA) due to phenylketonuria (PKU), in the Republic of South Korea. 6 February 2017
The European associations representing manufacturers of medicinal products, parallel distributors, pharmaceutical wholesalers and pharmacists have announced a series of recommendations on the provision of information, designed to help tackle medicines shortages. 3 February 2017
Teva Pharmaceutical Industries says that it is seeking approval to market the generic version of Victoza (liraglutide) injection, in the USA. 2 February 2017
Mylan might have had some share-boosting news with a court victory over a rival on Tuesday, but the shadow of a Federal Trade Commission (FTC) investigation continues to hang over the Netherlands-incorporated company. 31 January 2017
The US District Court for the District of Delaware issued a decision finding all asserted claims of four Orange Book-listed patents relating to the top-selling multiple sclerosis drug Copaxone (glatiramer acetate) 40 mg/mL invalid based on obviousness, according to Netherlands-incorporated Mylan. 31 January 2017
The pharmaceutical sector in India is set to gain rather than be impacted with the new US President Donald Trump's decision to reduce drug prices, given that the country's generic medicines are already affordable. 30 January 2017
On January 26, 2017, Dr Arie Belldegrun resigned as a member of the board of directors of Teva Pharmaceutical Industries, according to a company regulatory filing. 27 January 2017
Hospira, the injectables specialist owned by US pharma giant Pfizer, is voluntarily recalling a batch of its products amid fears of contamination. 26 January 2017
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
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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.