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.
Swiss pharma giant Roche today released new data from the Phase III OCARINA II study (S31.006) of Ocrevus (ocrelizumab), an investigational twice-yearly, 10-minute subcutaneous (SC) injection. 17 April 2024
The Icelandic-Israeli pairing of Alvotech and Teva Pharmaceutical Industries have announced that the US Food and Drug Administration (FDA) has approved Selarsdi (ustekinumab-aekn) injection for subcutaneous use. 17 April 2024
Ahead of a planned presentation at the American Thoracic Society meeting next month, US biotech major Amgen has released an update regarding the results of the Phase IIa COURSE trial for Tezspire (tezepelumab-ekko) in chronic obstructive pulmonary disease (COPD), 17 April 2024
US privately-held Kumquat Biosciences today announced a strategic and exclusive collaboration with Japan’s Takeda to develop and commercialize a novel immuno-oncology (I-O) small molecule inhibitor as a mono- and/or combination-therapy. 17 April 2024
Novartis has announced data from the ALITHIOS open-label extension study showing sustained efficacy of first-line, continuous Kesimpta (ofatumumab) treatment for up to six years in recently diagnosed treatment-naïve people living with relapsing multiple sclerosis (RMS). 17 April 2024
The Japanese Ministry of Health, Labor, and Welfare (MHLW) has approved Fintepla (fenfluramine) oral solution for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS) as an add-on therapy to other anti-epileptic medicines for patients two years of age and older. 17 April 2024
Medicare beneficiaries in the USA are facing greater access restrictions on their lifesaving medicines, according to a study by the Schaeffer Center at the University of Southern California. 17 April 2024
A change of therapeutic focus, a full rebrand and a major cash injection will shake things up considerably at Massachusetts, USA-based Cullinan Therapeutics. 17 April 2024
North Carolina, USA-based KBI Biopharma has appointed Jean-Baptiste Agnus as chief business officer, joining the company’s executive team. 17 April 2024
The Russian government is considering designing additional measures aimed at creating conditions for the growth of domestic pharmaceutical market during the period of 2024-2025, reports The Pharma Letter’s local correspondent. 17 April 2024
France-based Medincell, a biopharma developing long-acting injectable drugs in many therapeutic areas, has announced a collaboration with US drugmaker AbbVie. 16 April 2024
US clinical-stage cell therapy developer Vittoria Biotherapeutics has announced that Keith Westby has joined the company as its inaugural chief operating officer (COO). 16 April 2024
German family-owned drugmaker Boehringer Ingelheim today announced a strong acceleration of its pipeline in 2023, as pivotal trials in key research areas progressed as planned, along with its full-year 2023 financial results. 16 April 2024
Having recently gained US regulatory approval for its Fabhalta (iptacopan) as the first oral monotherapy for the treatment of adults with paroxysmal nocturnal hemoglobinuria (PNH), Swiss pharma giant Novartis is now arming itself with clinical data for a new indication. 16 April 2024
Germany’s Fresenius - via its operating company Fresenius Kabi - has announced the immediate US availability of Tyenne (tocilizumab-aazg), a biosimilar of Roche’s Actemra (tocilizumab). 16 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.