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Biotechnology
British pharma major AstraZeneca is facing challenges in its bid to secure full approval for its anticoagulant reversal therapy, Andexxa (andexanet alfa), in the USA. 22 November 2024
Biotechnology
San Diego-based Kura Oncology and Japan’s Kyowa Kirin have entered into a global strategic collaboration to develop and commercialize ziftomenib. 21 November 2024
Biotechnology
The European Commission (EC) has granted marketing authorization for Hympavzi (marstacimab), from US pharma giant Pfizer. 20 November 2024
Pharmaceutical
Ascentage Pharma will see its investigational BCL-2 selective inhibitor, lisaftoclax, assessed under China’s Priority Review scheme. 20 November 2024
Pharmaceutical
The US Food and Drug Administration (FDA) has approved Syndax Pharmaceuticals’ Revuforj (revumenib). 18 November 2024
Biotechnology
UK drugmaker GSK might be trading lower following Thursday’s nomination of vaccine sceptic Robert F Kennedy Jr as the USA’s next health secretary, but the day brought good news for the group elsewhere in the business. 15 November 2024
Biotechnology
Adaptimmune Therapeutics reported promising data Wednesday from its pivotal Phase II trial of lete-cel in certain solid tumors with few effective treatments. 14 November 2024
Biotechnology
Sanofi has announced that the UK's health technology assessor will conduct a new review of its Sarclisa (isatuximab) combo therapy for relapsed or refractory multiple myeloma. 13 November 2024
Biotechnology
Syndax Pharmaceuticals has announced that its Phase II AUGMENT-101 trial of experimental drug revumenib achieved its primary endpoint. 13 November 2024
Biotechnology
VarmX, a Dutch biotech developing innovative approaches for the bypass of direct oral anticoagulants targeting activated factor Xa (FXa DOACs) and inherited coagulation disorders, has appointed industry veteran John Glasspool (pictured, above) as chief executive. 12 November 2024
Biotechnology
On November 8, the US Food and Drug Administration approved Aucatzyl (obecabtagene autoleucel; obe-cel) from US biopharma Autolus Therapeutics' 11 November 2024
Biotechnology
Geron Corporation, a biopharma company focused on telomerase inhibition therapies, has announced a $375 million financing agreement aimed at supporting the commercial rollout of Rytelo (imetelstat). 11 November 2024
Biotechnology
US healthcare giant Johnson & Johnson today revealed it has submitted applications with the US Food and drug Administration (FDA) and European Medicines Agency (EMA) to expand the approved indications for its Darzalex (daratumumab) subcutaneous (SC) formulation for the treatment of high-risk smouldering multiple myeloma (SMM). 8 November 2024
Biotechnology
UK health technology assessor the National Institute for Health and Care Excellence (NICE) issued final guidance recommending reimbursement of Ayvakyt (avapritinib) from USA-based Blueprint Medicines. 6 November 2024
Biotechnology
French drugmaker Sanofi has revealed the results from the Phase III LUNA 3 trial of rilzabrutinib, an oral bruton tyrosine kinase (BTK) inhibitor, in persistent or chronic immune thrombocytopenia (ITP). 6 November 2024
Biotechnology
Beam Therapeutics will detail new clinical and preclinical data on its sickle cell disease (SCD) therapies at the upcoming American Society of Hematology (ASH) meeting. 6 November 2024
Pharmaceutical
An impressive set of quarterly financial results and an improved outlook for the rest of the year were announced by Bristol Myers Squibb on Thursday. 31 October 2024
Biotechnology
Maryland, USA–based glycobiology specialist GlycoMimetics has entered into an acquisition agreement with Crescent Biopharma, a privately held biotechnology company advancing a pipeline of oncology therapeutics designed to treat solid tumors. 30 October 2024
Pharmaceutical
Novartis late yesterday revealed that Scemblix (asciminib) was granted accelerated approval by the US Food and Drug Administration (FDA) for adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP). 30 October 2024
Biotechnology
Last week Vertex Pharmaceuticals released positive Phase III results for its suzetrigine for moderate-to-severed pain. Belgium’s UCB revealed that Swiss pharma giant Roche was terminating its collaboration on the Alzheimer’s candidate bepranemab. The UK’s health technology assessor the Institute for Health and Clinical Excellence (NICE) declined to recommend a second Alzheimer’s treatment, this time Eli Lilly’s Kisunla. Also of note, Lyell Immunopharma announced its planned acquisition of ImmPACT Bio and reprioritization of its own clinical pipeline. 27 October 2024
Biotechnology
2017 has kicked off with the first multi-billion dollar acquisition deal announced in the biopharma sector, with US biotech firm Ariad Pharmaceuticals (Nasdaq: ARIA) agreeing to a bid from Japan’s largest drugmaker. 9 January 2017
Pharmaceutical
US gene therapy company Spark Therapeutics saw its share rise 10.8% to $59.49 on Wednesday after it announced receipt of an interim payment. 5 January 2017
Biotechnology
The clear-up looks to have begun at Alexion Pharmaceuticals after an alarming few months. 5 January 2017
Biotechnology
Biotech firm Sobi have announced the recruitment of Armin Reininger as senior vice president and head of global medical and scientific affairs. 5 January 2017
Biotechnology
US-based biotech firm Gilead has recruited Alessandro Riva as senior vice president of hematology and oncology. Dr Riva helped develop more than 20 cancer compounds as head of oncology at Swiss giant Novartis, including both targeted and immune-oncology treatments. 4 January 2017
Biotechnology
Sumitomo Dainippon Pharma has made its first venture into the M&A arena this year, with the proposed acquisition of a privately-held cancer-focussed US company. 28 December 2016
Biotechnology
Seattle Genetics has revealed receipt of a notice from the US Food and Drug Administration that a clinical hold or partial clinical hold has been placed on several early stage trials. 28 December 2016
Pharmaceutical
The US Food and Drug Administration has approved Adynovate (antihemophilic Factor [recombinant], PEGylated), an extended circulating half-life recombinant Factor VIII (rFVIII) treatment for hemophilia A, in pediatric patients under 12 years of age. 28 December 2016
Biotechnology
The primary endpoint has been met for the Phase III HAVEN 1 study evaluating emicizumab (ACE910) prophylaxis in people 12 years of age or older with hemophilia A and inhibitors to factor VIII, the drug’s developer announced this morning. 22 December 2016
Biotechnology
The board of directors of US biotech Biogen has approved the spin-off of its hemophilia business, which will be known as Bioverativ Inc. 21 December 2016
Pharmaceutical
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended seven new medicines for marketing authorization at its December 2016 meeting. 17 December 2016
Pharmaceutical
Rather like Kite’s registrational Zuma-1 trial of KTE-C19 in lymphoma, Novartis’ Eliana study has generated a fileable response rate. In the case of the Swiss firm’s rival CAR-T therapy, CTL019, this is in childhood leukemia patients, says EP Vantage, the editorial arm of the Evaluate group. 10 December 2016
Biotechnology
Breakthrough immunotherapy Opdivo (nivolumab) has been approved in the European Union for the treatment of classical Hodgkin lymphoma (cHL), a rare and often-aggressive blood cancer. 7 December 2016
Biotechnology
Janssen Research and Development, a subsidiary of the US health care giant Johnson & Johnson, has presented Phase II data on Imbruvica (ibrutinib) in chronic graft-versus-host-disease (cGVHD), who failed prior systemic therapy. 6 December 2016
Pharmaceutical
Swiss pharma giant Novartis has responded to the growing competition to its off-patent product Gleevec (imatinib mesylate) by presenting the latest findings on its new drug that it wants patients to start taking as a replacement therapy. 6 December 2016
Biotechnology
New data from the Phase III GALLIUM study has been presented at the 58th American Society of Hematology (ASH) annual meeting which suggests that Gazyvaro (obinutuzumab) could be an effective first-line treatment for follicular lymphoma (FL). 5 December 2016
Biotechnology
Data presented at the 58th American Society of Hematology (ASH) Annual Meeting has offered hope that the first new sickle cell-related pain crises (SCPC) option for 20 years could be on its way. 5 December 2016
Biotechnology
US biotech Celgene, the Dana-Farber Cancer Institute and the University of Arkansas for Medical Sciences have announced the creation of the Myeloma Genome Project. 5 December 2016
Pharmaceutical
Denmark’s Novo Nordisk has announced new results on NovoSeven (rFVIIa), a portable room temperature stable recombinant activated factor VIIa, at the 58th American Society of Hematology (ASH) annual meeting. 5 December 2016
Pharmaceutical
In another reversal of a negative cancer drug opinion from the cost-effectiveness watchdog for England and Wales based on the drug manufacturer’s agreement on a price discount, the agency has said that a new drug for the treatment of leukemia can be used routinely on the National Health Service. 25 November 2016
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