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Positive results of the Phase III trial of Cablivi (caplacizumab) in adults with acquired thrombotic thrombocytopenic purpura (aTTP) have been published in the New England Journal of Medicine (NEJM). 10 January 2019
Pharmaceutical
USA-headquartered Karyopharm Therapeutics has followed up its US filing with a submission to the European Medicines Agency (EMA) for selinexor in a multiple myeloma (MM) indication. 9 January 2019
Biotechnology
The US Food and Drug Administration has granted crizanlizumab (SEG101) Breakthrough Therapy designation for the prevention of vaso-occlusive crises (VOCs) in patients of all genotypes with sickle cell disease (SCD). 8 January 2019
Pharmaceutical
Hope all our readers have had a wonderful festive season, so now welcome back to our review of important news, this time for the two weeks to January 4. Opening the New Year, was Bristol-Myers Squibb’s surprise announcement that it was to acquire fellow USA-based biotech Celgene in a $74 billion cash and share deal. In a rush of pre-year-end US approvals, the Food and Drug Administration cleared Alexion’s Ultomiris for a rare, life-threatening blood cancer. The FDA granted Breakthrough Therapy designation for Roche and Chugai’s satralizumab for a rare disease, and also approved Acorda’s Inbrija for Parkinson’s disease. 6 January 2019
Pharmaceutical
US pharma major AbbVie has licensed the MALT1 (Mucosa-Associated Lymphoid Tissue Lymphoma Translocation Protein 1) inhibitor program from an Indian drugmaker. 24 December 2018
Biotechnology
US biotech Stemline Therapeutics has been granted US Food and Drug Administration approval of Elzonris (tagraxofusp-erzs; SL-401) for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adult and pediatric patients two years and older, in both treatment-naïve and previously-treated populations. 22 December 2018
Biotechnology
The US Food and Drug Administration today approved Ultomiris (ravulizumab) injection for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH), a rare and life-threatening blood disease. 21 December 2018
Biotechnology
Tokyo-based Chugai Pharmaceutical has won Japanese approval for additional dosing options for Hemlibra (emicizumab), a coagulation factor VIII substitute. 21 December 2018
Pharmaceutical
Orphan Europe, a subsidiary of family-held Italian drugmaker Recordati, has in-licensed a new asset from Swiss oncology specialist Helsinn Pharmaceuticals. 20 December 2018
Biotechnology
Hong Kong’s Innovent Biologics, which has recently completed a $400 million-plus IPO, today said it had entered into a licensing deal for three clinical-stage compound for the Chinese market 17 December 2018
Pharmaceutical
Russian drugmaker Polysan will invest about 4 billion roubles (~$60 million) in the establishment of full-cycle production of a drug from German pharma major Bayer, according to the company, reports The Pharma Letter’s local correspondent. 13 December 2018
Biotechnology
Australia has become the first country anywhere to grant regulatory approval to a cancer drug originally found in a marine microorganism. 11 December 2018
Biotechnology
Following its acceptance in the UK’s Cancer Drug Fund in October, the medicines cost-effectiveness watchdog has now agreed to the regular NHS England funding of Yescarta (axicabtagene ciloleucel). 7 December 2018
Biotechnology
Swedish Orphan Biovitrum and Novimmune have presented positive data from a pivotal Phase II/III study of Gamifant (emapalumab-lzsg) at the annual meeting of the American Society of Hematology. 5 December 2018
Pharmaceutical
Janssen Pharmaceutical, the pharma business of US healthcare company Johnson & Johnson, has announced positive Phase III data for Darzalex (daratumumab) at the annual meeting of the American Society of Hematology. 5 December 2018
Biotechnology
Belgo-Dutch biotech argenx yesterday announced an exclusive, global collaboration and license agreement for cusatuzumab (ARGX-110), adding to its lucrative deal in the summer with AbbVie (NYSE: ABBV), with the news sending its share leaping 13% to 10.90 euros by close of trading on Monday. 4 December 2018
Biotechnology
Swiss pharma giant Roche has presented data from the largest pivotal study to date in children with hemophilia A at the American Society of Hematology Annual Meeting. 4 December 2018
Biotechnology
BeiGene clinical data from the pivotal Phase II trial of its investigational anti-PD-1 antibody, tislelizumab, in Chinese patients with relapsed/refractory (R/R) classical Hodgkin’s lymphoma (cHL), at the Annual Meeting of the American Society of Hematology (ASH) yesterday. 4 December 2018
Pharmaceutical
Daiichi Sankyo yesterday announced positive comprehensive analyses of overall survival from the pivotal QuANTUM-R Phase III study of single agent quizartinib compared to salvage chemotherapy in patients with FLT3-ITD acute myeloid leukemia (AML). 4 December 2018
Pharmaceutical
Basel, Switzerland-based Roche has announced new Phase III data for Venclyxto (venetoclax) at the annual meeting of the American Society of Hematology. 4 December 2018
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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