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Based on the observed large differences in overall survival in pre-specified subgroups, the US Food and Drug Administration has requested a partial clinical hold of all clinical studies with melflufen, pending further investigation, Swedish biotech Oncopeptides revealed on Thursday, sending the firm’s shares tumbling as much as 23%. 9 July 2021
Biotechnology
Privately-held US biotech Eureka Therapeutics and Memorial Sloan Kettering Cancer Center (MSK) have entered into a license agreement with French pharma major Sanofi for the non-CAR use of a novel, human binding domain targeting GPRC5D (G Protein-Coupled Receptor Family C Group 5 Member D). 7 July 2021
Pharmaceutical
The Russian Ministry of Health wants to sign long-term contracts with global drugmakers on supplies of their drugs against HIV, hepatitis and rare diseases for state needs. As part of state plans, that will allow the achievement of significant savings during public procurements of these drugs, reports The Pharma Letter’s local correspondent. 6 July 2021
Biotechnology
Italian drugmaker Alfasigma has entered into an exclusive licensing agreement with USA-based cardiopulmonary diseases focused company PhaseBio Pharmaceuticals for the commercialization of bentracimab. 5 July 2021
Biotechnology
Ireland-headquartered firm Jazz Pharmaceuticals has won US approval for Rylaze (asparaginase erwinia chrysanthemi-rywn), in combination with chemo, for certain rare forms of blood cancer. 1 July 2021
Biotechnology
Austria-based rare diseases specialist AOP Orphan Pharmaceuticals announced its latest analysis on Besremi (ropeginterferon alfa-2b) in patients with Polycythemia Vera (PV), a rare blood cancer, from its CONTINUATION-PV study presented at the European Hematology Association (EHA) 2021 meeting by Professor Jean-Jacques Kiladjian from the Saint-Louis Hospital & Université de Paris in France. 1 July 2021
Biotechnology
Gilead Sciences’ subsidiary Kite has announced top-line results from the primary analysis of ZUMA-7, a global Phase III study showing superiority of Yescarta (axicabtagene ciloleucel) compared to standard of care (SOC) in second-line relapsed or refractory large B-cell lymphoma (LBCL). 29 June 2021
Biotechnology
UK pharma major GlaxoSmithKline last Wednesday hosted a much-anticipated investor update, where it showcased its sales aims and R&D pipeline, ahead of splitting out its consumer health care business. Dutch gene therapy company uniQure released positive Phase IV data on its hemophilia B candidate etranacogene dezaparvovec. The US Food and Drug Administration issued Breakthrough Therapy designations for two Alzheimer’s disease candidates, first for Biogen and Eisai’s lecanemab and, a day later, Eli Lilly’s donanemab. Meanwhile, US biotech Incyte suffered a setback on Thursday, as an FDA advisory committee voted that further data was required prior to an approval decision on its immuno-oncology drug retifanlimab. 27 June 2021
Generics
Indian drug major Sun Pharmaceutical Industries has settled the patent litigation over a generic version Revlimid (lenalidomide) in the USA. 24 June 2021
Biotechnology
Johnson & Johnson subsidiary Janssen today announced the European Commission (EC) has granted marketing authorization for the expanded use of Darzalex (daratumumab) subcutaneous (SC) formulation in two new indications. 23 June 2021
Biotechnology
Dutch gene therapy specialist uniQure has announced positive 52-week clinical data from the Phase III HOPE-B trial of etranacogene dezaparvovec. 23 June 2021
Biotechnology
The European Commission (EC) has granted full Marketing Authorization for Onureg (azacitidine tablets; CC-486), US pharma major Bristol Myers Squibb announced on Friday. 21 June 2021
Biotechnology
Japan’s Daichi Sankyo last Monday gained approval to market its malignant glioblastoma candidate, Delytact (teserpaturev) on the domestic market. USA-based Novavax released new Phase III data on its COVID-19 vaccine, giving the firm a leg up in the development program. Belgian biotech iTeos Therapeutics signed a collaboration deal for its anti-TIGIT candidate EOS-448 with UK pharma major GlaxoSmithKline, potentially worth more than $2 billion. US biotech Biogen last Monday released disappointing Phase III results for its investigational rare eye disease drug timrepigene emparvovec. Last Wednesday, the US Food and Drug Administration granted approval for Blueprint Medicines’ Ayvakit as a treatment for systemic mastocytosis. 20 June 2021
Biotechnology
The US Food and Drug Administration approved Cambridge, Massachusetts-based Blueprint Medicines’ Ayvakit (avapritinib) for adult patients with advanced systemic mastocytosis (AdvSM). 17 June 2021
Pharmaceutical
US biopharma Global Blood Therapeutics says that the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has granted a Promising Innovative Medicine (PIM) designation for voxelotor for the potential treatment of hemolytic anemia in adults and adolescent patients 12 years of age and older with sickle cell disease (SCD). 14 June 2021
Biotechnology
Positive follow-up results from the pivotal ZUMA-5 trial of Yescarta (axicabtagene ciloleucel) - the first and only CAR T-cell therapy approved in the USA in patients with relapsed or refractory indolent follicular lymphoma (FL) - were presented over the weekend at the 26th Annual Meeting of the European Hematology Association (EHA 2021) now taking place virtually. 14 June 2021
Biotechnology
US biotech Protagonist Therapeutics saw its shares gain 17% to $39.64 on Friday, after it announced updated results from the ongoing Phase II study of rusfertide (PTG-300), an investigational new drug being evaluated for the treatment of polycythemia vera (PV), a type of blood cancer. 12 June 2021
Biotechnology
Sino-American biotech BeiGene’s shares edged up 3% to HK$216.4% on Friday, after it presented results from the interim analysis of the Phase III ALPINE trial comparing its BTK inhibitor Brukinsa (zanubrutinib) to ibrutinib. 12 June 2021
Biotechnology
Swiss pharma giant Roche today announced the latest data from three pivotal Phase III studies of Venclexta/Venclyxto (venetoclax) – CLL14, MURANO and VIALE-A – at the European Hematology Association Virtual Congress, June 9-17 (EHA2021). 11 June 2021
Biotechnology
French pharma major Sanofi is presenting results from Part A of CADENZA, a pivotal Phase III double-blind, placebo-controlled study evaluating the safety and efficacy of sutimlimab in people with cold agglutinin disease (CAD) without a recent history of blood transfusion (within the prior six months), at an oral session of the European Hematology Association (EHA) 2021 Congress now taking place virtually. 11 June 2021
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
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