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.
As more biologics drugs lose their patent protection, the influx of biosimilars is set to expand, offering cost-effective alternatives and significantly impacting their respective markets. 5 June 2024
US biotech major Gilead Sciences has announced two-year interim results from the ongoing ASSURE study of investigational seladelpar for the treatment of primary biliary cholangitis (PBC), a rare, chronic inflammatory liver disease. 5 June 2024
Italy’s Philogen and Indian drugmaker Sun Pharmaceutical Industries have submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for the approval of Nidlegy (daromun). 5 June 2024
Russian drugmaker Nanolek plans to accelerate its expansion this year by expanding its range and increase of output, paying a particular focus to vaccines, The Pharma Letter’s local correspondent reports. 5 June 2024
Lykos Therapeutics’ hopes of being the first to market with a hallucinogenic medicine suffered a major blow Tuesday during a meeting of the US Food and Drug Administration's (FDA) Psychopharmacologic Drugs Advisory Committee (PDAC). 5 June 2024
Ireland-headquartered fish oil-based heart drug specialist Amarin Corporation announced that it has appointed Aaron Berg, currently Amarin’s executive vice president and president of the US business, as president and chief executive (CEO). 5 June 2024
Shares in California, USA-based autoimmune specialist Annexon soared more than 37% in pre-market trading on Tuesday to $6.32, after it announced positive top-line results from its randomized placebo-controlled pivotal Phase III trial in patients with Guillain-Barré syndrome (GBS). 5 June 2024
San Diego, USA-based biopharma company Viking Therapeutics has announced favorable 52-week results from its Phase IIb VOYAGE study of VK2809. 5 June 2024
Florida, USA-based Summit Therapeutics has managed to beat the leading checkpoint blocker, Keytruda (pembrolizumab), in a head-to-head comparison. 4 June 2024
Treos Bio, a biotech using data science and proprietary biomarkers to develop precision peptide immunotherapies, has presented results from its Phase II OBERTO-301 study. 4 June 2024
The market for branded multiple myeloma drugs is projected to grow to $33 billion by 2030, up from $23.5 billion in 2023, according to Bloomberg Intelligence (BI). 4 June 2024
BridgeBio Pharma’s (Nasdaq: BBIO) shares were up nearly 5% at $30.37 in early trading, after the company announced sustained positive results from PROPEL 2. 4 June 2024
India has become the largest supplier of drugs to the Russian market, overtaking Germany, which had been in the lead for the last two years, reports The Pharma Letter’s Russia correspondent. 4 June 2024
Shares of US biotech Structure Therapeutics shot up as much as 71% yesterday and gained a further 4.6% to $55.17 in pre-market activity on the back of encouraging research results on its oral GLP-1 weight management candidate. 4 June 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.