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.
Japanese drugmaker Astellas expects to book an impairment charge of 70 billion yen ($453 million) in the fourth quarter of Japan’s 2023 fiscal year, which ended last month. 16 April 2024
US biotech Arrowhead Pharmaceuticals recently unveiled final data from its Phase II SHASTA-2 clinical trial for plozasiran, previously recognized as ARO-APOC3. 16 April 2024
USA-based rare seizure specialist Marinus Pharmaceuticals saw its shares crash, falling nearly 83% to $1.36, after it revealed that a trial failed to meet early stopping criteria. 16 April 2024
UK pharma major AstraZeneca has notched up another clinical success for its already blockbuster cancer drug Imfinzi (durvalumab) in biliary tract cancer. 16 April 2024
In a significant stride towards addressing the challenge of meningococcal-B disease, Serum Institute of India (SII) and the University of Oxford, UK, have formalized a technology license agreement negotiated by Oxford University Innovation. 16 April 2024
Italian family-owned drugmaker Chiesi Farmaceutici has appointed Richard Smith as vice president and business unit leader of the US AIR at Chiesi USA. 16 April 2024
Bulgaria’s Supreme Administrative Court has cancelled the mechanism guaranteeing the predictability and sustainability of the National Health Insurance Fund (NHIF) budget for drugs for 2021. 15 April 2024
US immuno-oncology company Portage Biotech has only around a fifth of its stock market value since early Friday, when the firm reported that it is expanding its evaluation of strategic alternatives and implementing additional measures to extend its cash runway. 15 April 2024
The Phase I trial of NMRA-266 has been placed on clinical hold by the US Food and Drug Administration (FDA), said the drug’s developer, Massachusetts, USA-based based brain disease biotech Neumora Therapeutics. 15 April 2024
A US judge has dismissed a legal claim from pharma major Eli Lilly alleging that an online pharmacy illegally sold an unauthorized compounded version of the company's dual GIP and GLP-1 receptor agonist tirzepatide. 15 April 2024
Japanese drugmaker Nxera Pharma has entered into an exclusive supply and distribution agreement with Handok to commercialize Pivlaz (clazosentan sodium) 150mg in South Korea. 15 April 2024
The US Centers for Medicare & Medicaid Services (CMS) has announced proposals to improve access to gene therapies that have recently been approved for use in the USA for the treatment of sickle cell disease (SCD). 15 April 2024
Roche’s CD20xCD3 T-cell engaging bispecific antibody Columvi (glofitamab) has met the primary endpoint of overall survival in relapsed or refractory diffuse large B-cell lymphoma in the Phase III STARGLO study. 15 April 2024
A new modelling analysis by UK pharma major AstraZeneca, IMPACT CKD, forecasts up to 16.5% of the population across eight countries will suffer from chronic kidney disease (CKD) by 2032, including a staggering rise of up to 59.3% in advanced-stage. 15 April 2024
The US Food and Drug Administration’s (FDA) oncology drugs advisory committee (ODAC) voted 12-0 to endorse the use of minimal residual disease (MRD) at 10-5 in complete responders (CR) as an intermediate endpoint for accelerated approval, potentially opening the door to new trial designs for blood cancer drugs. 15 April 2024
How the regions should handle the rising costs of medicine was a central theme at the Danish Regions' summit last week, where it was agreed to work for the re-introduction of a state guarantee scheme to finance medicine subsidies 15 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.