French biotech Step Pharma, which is developing new drugs for oncology and autoimmune diseases, has announced the successful closing of a 35 million euros ($41.5 million) Series B financing. 24 March 2021
Following feedback from the US Food and Drug Administration in a pre-New Drug Application meeting, Odonate Therapeutics has concluded that the clinical data package for tesetaxel is unlikely to support FDA approval. 23 March 2021
Eisai has won Japanese approval for Remitoro (denileukin diftitox) to treat relapsed or refractory peripheral T-cell lymphoma (PTCL) and relapsed or refractory cutaneous T-cell lymphoma (CTCL). 23 March 2021
Late Monday, the US Data and Safety Monitoring Board (DSMB) notified the NIAID, BARDA, and AstraZeneca that it was concerned by information released by AstraZeneca on initial data from its COVID-19 vaccine clinical trial. 23 March 2021
Just in the last seven days, the Russian Direct Investment Fund (RDIF) has announced production contracts with three Indian manufacturers for more than 300 million people doses of Sputnik V a year. 22 March 2021
UK pharma major AstraZeneca yesterday announced the death of José Baselga, executive vice president oncology R&D, and member of its senior executive team. 22 March 2021
Japanese firm Nippon Shinyaku has entered into an exclusive license agreement for the development and commercialization of tagraxofusp in Japan with family-owned Italian drugmaker Menarini. 19 March 2021
Søren Bregenholt will become chief executive officer of Alligator Bioscience from June, with current COO Malin Carlsson taking over as interim CEO to facilitate the transition. 19 March 2021
Nordic Nanovector has appointed Peter Braun, a former Roche executive with three decades of experience at the company, as chief executive officer. 18 March 2021
The European Medicines Agency (EMA) continues to stress that it favors going ahead with the roll-out of COVID-19 Vaccine AstraZeneca despite its distribution being halted in 11 member states due to a number of events of blood clots among vaccinated people. 16 March 2021
Data from a Phase III extension study shows that Tremfya (guselkumab) maintains joint efficacy and complete skin clearance in adults with active psoriatic arthritis (PsA) through two years. 16 March 2021
Takeda Pharmaceutical today announced that Milano Furuta, Takeda’s current global corporate strategy officer and chief of staff, has been appointed as president of the Japan Pharma Business Unit (JPBU) effective April 1, 2021. 15 March 2021
Adding to its European Commission conditional marketing authorization just a day earlier, the World Health Organization (WHO) today listed the COVID-19 vaccine Ad26.COV2.S, developed by Janssen, the prescription pharma unit of US healthcare giant Johnson & Johnson, for emergency use in all countries and for COVAX roll-out. 12 March 2021
Japanese drugmaker Daiichi Sankyo has started manufacturing COVID-19 Vaccine AstraZeneca in the country, under the terms of an outsourcing agreement. 12 March 2021
UK pharma major GlaxoSmithKline has said it will expand its manufacturing capability for cell and gene therapies using the Cell and Gene Therapy Catapult’s large scale manufacturing facility in Stevenage, UK. 11 March 2021
A new partnership between The Coalition for Epidemic Preparedness Innovations (CEPI) and VBI Vaccines will seek to develop vaccine candidates against coronavirus variants. 11 March 2021
The US regulator is proceeding to review a submission for Idorsia’s investigational dual orexin receptor antagonist, daridorexant, for adults with insomnia. 10 March 2021
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