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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
California, USA-based Lyell Immunopharma (Nasdaq: LYEL) has entered into a definitive agreement to acquire privately-held US CAR-T company ImmPACT Bio. 26 October 2024
Biotechnology
US biotech Curis saw its shares close down almost 10% at $1.01 yesterday, despite its announcement that the US Food and Drug Administration (FDA) has notified the company that it may resume enrollment of additional patients in the monotherapy phase of the TakeAim Leukemia study of emavusertib. 31 August 2022
Biotechnology
The European Commission (EC) has approved Scemblix (asciminib) for the treatment of adult patients with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP), previously treated with two or more tyrosine kinase inhibitors (TKIs). 30 August 2022
Biotechnology
The US Food and Drug Administration (FDA) has accepted for priority review the Biologics License Application (BLA) for efanesoctocog alfa (BIVV001) for the treatment of hemophilia A, a rare and life-threatening bleeding disorder. The target action date for the FDA decision is February 28, 2023. 30 August 2022
Pharmaceutical
On the regulatory front last week, the long-awaited approval of Axsome Therapeutics’ Auvelity from the US Food and Drug Administration finally came through, clearing the drug for the treatment of major depressive disorder (MDD). Also, Foghorn Therapeutics announced that it has received a full clinical hold from the FDA regarding its Phase I trial of leukemia drug candidate FHD-286. And, Swiss drug developer Pharvaris last Monday revealed it had been notified of an FDA clinical hold on its PHA121 trial in hereditary angioedema. In the M&A space, a merger of eye care specialists is forthcoming, with last week’s announcement that Alcon has agreed to acquire Aerie Pharmaceuticals. Also of note, last Thursday Pfizer released positive new data on its respiratory syncytial virus (RSV) candidate RSVpreF. 28 August 2022
Biotechnology
Delaware, USA-based Incyte has announced that the US Food and Drug Administration (FDA) has approved Pemazyre (pemigatinib), a selective fibroblast growth factor receptor (FGFR) inhibitor, to treat adults with relapsed or refractory myeloid/lymphoid neoplasms (MLNs) with FGFR1 rearrangement. 26 August 2022
Biotechnology
Franco-American biopharma Erytech Pharma lost 20% of its market value on Thursday. 26 August 2022
Biotechnology
US biotech BioMarin Pharmaceutical yesterday announced that the European Commission (EC) has granted conditional marketing authorization (CMA) to Roctavian (valoctocogene roxaparvovec) gene therapy for the treatment of severe hemophilia A (congenital Factor VIII deficiency) in adult patients without a history of Factor VIII inhibitors and without detectable antibodies to adeno-associated virus serotype 5 (AAV5). 25 August 2022
Biosimilars
Competition for AstraZeneca’s Soliris (eculizumab) is stepping closer to the market, with developer Amgen, a Californian biotech giant, announcing positive trial results. 24 August 2022
Biotechnology
US healthcare giant Johnson & Johnson subsidiary Janssen today revealed that the European Commission (EC) has granted conditional marketing authorization (CMA) of Tecvayli (teclistamab) as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma (RRMM). 24 August 2022
Biotechnology
US cancer-focused biotech Foghorn Therapeutics saw its shares plummet 25% to $11.00 by close of trading yesterday, after it announced that the US Food and Drug Administration (FDA) has placed a full clinical hold on the Phase I dose escalation study of FHD-286. 24 August 2022
Biotechnology
Japanese drugmaker Chugai Pharmaceutical today announced receipt of approval from the Ministry of Health, Labor and Welfare (MHLW) for the anticancer agent/antimicrotubule binding anti-CD79b monoclonal antibody Polivy intravenous infusion (polatuzumab vedotin (genetical recombination) for an additional indication of treatment of patients with previously untreated diffuse large B-cell lymphoma (DLBCL). 24 August 2022
Biotechnology
Singapore-based Tessa Therapeutics, a Temasek-backed clinical stage biotech company, today announced the appointment of Thomas Willemsen as its president and chief executive, effective October 1, 2022. 22 August 2022
Biotechnology
Swedish blood disease specialist Oncopeptides has won European approval for its multiple myeloma therapy Pepaxti (melphalan flufenamide). 19 August 2022
Biotechnology
Shares of China-based immuno-oncology-focussed biotech I-Mab plunged more than 13% to $6.90 yesterday, after the company revealed in a filing with the Securities and Exchange Commissions that AbbVie has discontinued a Phase I trial of I-Mab's anti-CD47 monoclonal antibody lemzoparlimab, which the US pharma major in-licensed for an upfront $180 million 2020. 18 August 2022
Biotechnology
The US Food and Drug Administration approved Zynteglo (betibeglogene autotemcel), also known as beti-cel, from bluebird bio the first cell-based gene therapy for the treatment of adult and pediatric patients with beta-thalassemia who require regular red blood cell transfusions. 18 August 2022
Biotechnology
Blueprint Medicines has announced positive top-line results from the registrational Part 2 of the PIONEER clinical trial of Ayvakit (avapritinib). 17 August 2022
Biotechnology
UK pharma major GSK announced today that the US Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for momelotinib for the potential treatment of myelofibrosis patients. 17 August 2022
Generics
As generic drugmakers are dragged to court by patent holders and the cost of litigation soars for both generic as well as innovative pharma companies, many are settling patent disputes out of court. Generic companies often agree to delay their entry into the market in exchange for certain benefits, such as licenses to other patents, reports The Pharma Letter’s India correspondent. 16 August 2022
Biotechnology
Swiss pharma giant Roche has announced that the US Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) for Polivy (polatuzumab vedotin-piiq) in combination with Rituxan (rituximab). 16 August 2022
Biotechnology
Terns Pharmaceuticals saw it shares fly up more than 25% to $3.02 on Friday, after it announced a $65 million underwritten public offering, which is expected to close on August 16, 2022, subject to customary closing conditions. 15 August 2022
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