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.
Trade group the Association of the British Pharmaceutical Industry (ABPI) has published an executive summary of its consultation response to the government's proposed changes to the Statutory Scheme for branded medicines. 1 May 2024
UK clinical-stage biotech Barinthus Biotherapeutics, formerly Vaccitech, today announced the appointment of Dr Leon Hooftman as chief medical officer (CMO). 1 May 2024
Shares in USA-based NRx Pharmaceuticals have fallen by around a fifth, after the firm announced disappointing results from a trial of NRX-101. 1 May 2024
UK pharma major GSK today reported first quarter 2024 financial results, showing that total sales were £7.4 billion ($9.26 billion) +10% and +13% ex COVID revenues. 1 May 2024
Californian biotech Enlaza Therapeutics has raised $100 million in a series A financing led by J.P. Morgan Asset Management’s Private Capital division. 1 May 2024
The USA’s Federal Trade Commission yesterday revealed it has expanded its campaign against pharmaceutical manufacturers’ improper or inaccurate listing of patents in the Food and Drug Administration’s (FDA) Orange Book, disputing junk patent listings for diabetes, weight loss, asthma and COPD drugs. 1 May 2024
Japanese biotech PeptiDream edged up 3% to 2,081 yen today, after it announced an expansion of its peptide discovery collaboration with Swiss pharma giant Novartis. 1 May 2024
A new age of innovation in immunology could change medical practice and people’s lives, as long as all parts of the system learn, evolve and work together, writes Anant Murthy, General Manager, argenx EMEA, in an Expert View piece. 1 May 2024
UK-based developer of novel immunoglobulin E (IgE) antibodies to treat cancer, Epsilogen, has appointed Ashley Nagle as chief business officer (CBO) with immediate effect as part of a broader company expansion. 1 May 2024
The level of competition in the Russian market of anti-HIV drugs is tightening, due to the plans of global drugmakers to launch their products and expand their existing portfolios, The Pharma Letter’s local correspondent reports. 1 May 2024
US pharma giant Merck & Co has announced results from STRIDE-10, a Phase III trial of V116, the company’s investigational, adult-specific 21-valent pneumococcal conjugate vaccine (PCV), at the European Society of Clinical Microbiology and Infectious Diseases event in Barcelona, Spain. 30 April 2024
Shares of US developer of rare neurological drugs Harmony Biosciences (Nasdaq: HRMY) rose more than 10% to $32.30 today, after it announced the acquisition of Epygenix Therapeutics. 30 April 2024
US pharma major Eli Lilly today announced its financial results for the first quarter of 2024 and raised it guidance, with the news pushing the firm’s share up 5.6% to $778.19. 30 April 2024
X4 Pharmaceuticals has secured US approval for Xolremdi (mavorixafor), for the treatment of WHIM syndrome (warts, hypogammaglobulinemia, infections and myelokathexis). 30 April 2024
A full cycle of production of a drug for the treatment of Fabry disease will be launched in Russia this year, reports The Pharma Letter’s local correspondent. 30 April 2024
The European Medicines Agency’s (EMA) Emergency Task Force (ETF) has recommended updating COVID-19 vaccines to target the new SARS-CoV-2 variant JN.1 for the 2024/2025 vaccination campaign. 30 April 2024
Swiss generic and biosimilar medicines company Sandoz has reached agreement with US biotech major Amgen to resolve all patent disputes between the two companies relating to the former company’s US Food and Drug Administration (FDA)-approved denosumab biosimilars. 30 April 2024
Trevi Therapeutics has announced significant milestones in its clinical programs for Haduvio (nalbuphine), an investigational therapy aimed at treating chronic cough in idiopathic pulmonary fibrosis (IPF) and refractory chronic cough (RCC). 4 October 2024
Italian pharma major Recordati saw its shares rise more than 5% to 52.00 euros in early trading, as it announced a deal to expand its portfolio of marketed rare disease medicines. 4 October 2024
Paris-based asset manager Kurma Partners has raised 140 million euros ($154 million), successfully completing the first closing of Biofund IV 4 October 2024
The European Medicines Agency’s pharmacovigilance committee, PRAC, has started a review of medicines containing finasteride and dutasteride following concerns regarding suicidal ideation (suicidal thoughts) and behaviors. 4 October 2024
Opioid Use Disorder (OUD) is a chronic neurological disorder that is described as the consequences associated with repeated, compulsive use of opioid drugs and prolonged self-administration of opioid drugs. 4 October 2024
Proposals from the National Health Service (NHS) England have been set out for a phased launch of Eli Lilly’s obesity injection Mounjaro/Zepbound (tirzepatide) at the start of a consultation. 4 October 2024
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
Bristol Myers Squibb has received a new approval from the US Food and Drug Administration for its blockbuster checkpoint blocker, Opdivo (nivolumab). 4 October 2024
Singapore’s Agency for Science, Technology and Research (A*STAR) and US biotech incubator Flagship Pioneering have agree to collaborate on advancing health and sustainability outcomes in Singapore and the broader Asia Pacific region. 4 October 2024
The US Food and Drug Administration (FDA) has removed the partial clinical hold on delpacibart etedesiran (del-desiran/AOC 1001), an investigational treatment designed to address the root cause of myotonic dystrophy type 1 (DM1), under development by US biotech Avidity Biosciences . 4 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. 3 October 2024
The US Food and Drug Administration (FDA) has granted the Gilead Sciences subsidiary Kite a Regenerative Medicine Advanced Therapy Designation (RMAT) for Yescarta (axicabtagene ciloleucel) for adults with newly-diagnosed, high-risk large B-cell lymphoma (LBCL). 3 October 2024
The US Food and Drug Administration (FDA) has determined the shortage of tirzepatide injection, a glucagon-like peptide 1 (GLP-1) medication, has been resolved. 3 October 2024
Israel’s Teva Pharmaceutical Industries and mAbxience, a Fresenius Kabi majority-owned group with partial ownership from Insud Pharma, have announced a global licensing deal for the development of an anti PD-1 oncology biosimilar candidate. 3 October 2024
Caliway Biopharmaceuticals has successfully completed its initial public offering, raising NT$6.4 billion ($206 million), the largest IPO in Taiwan's biotech industry to date. 3 October 2024
Kedrion Biopharma has finalized an agreement with Germany-based Biotest for the long-term commercialization and distribution of Yimmugo (immune globulin) in the USA. 3 October 2024
US clinical-stage biotech Arcus Biosciences has entered into a clinical trial collaboration with AstraZeneca on renal cancer treatments. 3 October 2024
PeptiDream says that its wholly-owned PDRadiopharma subsidiary has entered into a strategic partnership with French nuclear medicines firm Curium. 3 October 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.