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 Russian drugmaker Geropharm says it plans to launch a generic copy of Danish drugmaker Novo Nordisk’s Wegovy (semaglutide) for the treatment of obesity, reports The Pharma Letter’s local correspondent. 9 April 2024
Canada-based Bausch Health saw its shares rise 3.6% to $10.41 after it revealed that, along with its gastroenterology unt Salix Pharmaceuticals, it has filed a lawsuit today in the US District Court for the District of New Jersey against Amneal Pharmaceuticals and its subsidiaries. 6 April 2024
The Russian government will launch a project aimed at creating generic copies of patented original drugs, according to recent statements made by the deputy head of the Ministry of Industry and Trade, Ekaterina Priezzheva. 4 April 2024
The US Food and Drug Administration (FDA) yesterday published the draft guidance for industry, “Data Integrity for In Vivo Bioavailability and Bioequivalence Studies.” 3 April 2024
India’s Biocon says that it has received approval from the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) for its complex formulation liraglutide (6mg/ml solution for injection in pre-filled pen). 2 April 2024
The Indian pharmaceutical sector is poised for a substantial makeover with the inauguration of 27 greenfield plants dedicated to manufacturing bulk drugs. 2 April 2024
KELIX bio, an emerging markets biopharmaceuticals platform, has been sold to Mubadala Investment Company, an Abu Dhabi investor with over $276 billion in assets under management. 25 March 2024
The US Federal Trade Commission revealed on Friday that it has filed an amicus brief explaining that pharmaceutical maker Teva Pharmaceutical Industries has improperly listed patents in the Orange Book and urged the court to order those listings removed. 25 March 2024
Japanese drugmaker Eisai says it has entered into a settlement agreement with the US units of India’s Sun Pharmaceutical Industries regarding the lawsuit filed against generic drug manufacturers (Sun Pharma and Shilpa Medicare) for infringement of the patents relating to Lenvima (lenvatinib mesylate). 25 March 2024
Members of the European Parliament’s health committee (ENVI) yesterday adopted a compromise position on the EU Pharmaceutical legislation review (comprising of a new Pharmaceutical Directive and Regulation). 20 March 2024
As part of the US Food and Drug Administration’s (FDA) commitment to ensuring current and prospective abbreviated new drug application (ANDA) applicants have the information they need to successfully submit high-quality ANDAs, the agency has finalized the guidance for industry, “Controlled Correspondence Related to Generic Drug Development.” 18 March 2024
Russia plans to speed the replacement of imported drugs by domestic generics with the aim of raising state security in the field of pharmaceutics and drugs assistance, reports The Pharma Letter’s local correspondent. 15 March 2024
In what the company describes as “a significant stride towards making advanced cancer treatment accessible to all,” Indian drugmaker Zydus Lifesciences (NYSE: ZYDUSLIFE) has launched olaparib, a PARP inhibitor marketed by UK pharma major AstraZeneca (LSE: AZN) as Lynparza, under the brand name Ibyra in India. 13 March 2024
Brazil’s Institute of Drug Technology (Farmanguinhos/Fiocruz) has announced a partnership agreement with the Brazilian unit of the German family-owned pharma major Boehringer Ingelheim. 11 March 2024
India has finalized a trade pact with the European Free Trade Association (EFTA), comprising Iceland, Liechtenstein, Norway and Switzerland, marking a significant milestone in international commerce. 11 March 2024
Generic drugmaker Aspire Pharma today announced the successful completion of its acquisition of fellow UK-based Cenoté Pharma, in continuation of its strong organic growth. 11 March 2024
Swiss generics and biosimilars drugmaker Sandoz today announced that its US subsidiaries – Sandoz Inc and Fougera Pharmaceuticals - have entered into a settlement agreement with the class of direct purchaser plaintiffs in the multidistrict litigation entitled In re Generic Pharmaceuticals Pricing Antitrust Litigation in the US District Court for the Eastern District of Pennsylvania. 29 February 2024
The tides are shifting. As multinational entities such as Novartis, AstraZeneca and Sanofi recalibrate their strategies in India, spurred by intensified local competition and patent expiries, domestic pharma players like Cipla, Torrent Pharma, Eris Lifesciences, and JB Chemicals are asserting their prominence. 29 February 2024
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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.