Hematology
Refine Search
Biotechnology
This morning abstracts for the American Society of Hematology (ASH) meeting became available online, showing data from the Phase III luspatercept studies in myelodysplastic syndromes (MDS) and beta-thalassemia that were not previously disclosed in the top-line press releases by Celgene. 1 November 2018
Biotechnology
The European Commission has approved Venclyxto (venetoclax) in combination with MabThera (rituximab) for chronic lymphocytic leukemia (CLL) patients who have received at least one prior therapy. 1 November 2018
Biotechnology
Danish biotech Genmab has announced topline results from the Phase III MAIA study of daratumumab in combination with lenalidomide and dexamethasone (DRd) versus the latter two alone, in front-line multiple myeloma. 30 October 2018
Biotechnology
Ireland-based rare diseases specialist Shire has filed its second submission to the US Food and Drug Administration for its new plasma manufacturing facility near Covington, Georgia. 25 October 2018
Biotechnology
UK-headquartered Hemogenyx is collaborating with US biopharma Orgenesis to rapidly develop and bring to market its human postnatal hemogenic endothelial cell technology (Hu-PHEC). 22 October 2018
Pharmaceutical
Jesper Brandgaard (pictured above) is to retire after 20 years with Danish pharma major Novo Nordisk, vacating the role of executive vice president, Biopharm and Legal Affairs. 15 October 2018
Biotechnology
The USA’s MEI Pharma has lined up with China’s BeiGene on a clinical collaboration to evaluate the safety and efficacy of MEI’s ME-401, an investigational PI3K delta inhibitor, in combination with BeiGene’s zanubrutinib, an investigational BTK inhibitor, for the treatment of patients with B-cell malignancies. 12 October 2018
Biotechnology
A post-hoc analysis of the SUSTAIN study of crizanlizumab, Novartis’ humanized anti-P-selectin monoclonal antibody being investigated for the treatment of sickle cell disease (SCD), have been presented ahead of an expected US filing in 2019. 11 October 2018
Pharmaceutical
US Food and Drug Administration approvals dominated much of the news last week. Among these was the FDA’s approval of Regeneron’s Libtayo, marking the firm’s entry into the immuno-oncology sector. The FDA also cleared for marketing: Pfizer’s Vizimpro for a rare form of lung cancer; Paratek’s antibiotic Nuzyra and acne drug Seysara; and Roche’s hemophilia A drug Hemlibra in a much wider patient population, so boding well for the Swiss pharma giant’s moves to expand out of its core oncology franchise that is facing copycat competition. On the deal-making front, there was the unexpected news that Janssen is pulling out of its agreement with Aduro Biotech on cancer drug candidates. 7 October 2018
Biotechnology
A month after the UK's National Health Service (NHS) agreed a deal to make Novartis’ Kymriah (axicabtagene ciloleucel) available to children and young people with a rare form of leukemia, a deal has been announced to bring another CAR-T therapy to English patients. 5 October 2018
Biotechnology
There was good news for Roche with the coveted wider indication for its hemophilia drug in the USA, so increasing its focus on diseases beyond cancer to help replace revenue from older products that have, or will soon, lost patent exclusivity. 5 October 2018
Biotechnology
Legend Biotech, a subsidiary of reagents services provider Genscript Biotech Corporation, regained some of Thursday’s stock market losses on Friday. 1 October 2018
Biotechnology
With its molecular-targeted radio-therapy Iomab-B showing promise and in a pivotal Phase III for bone marrow transplant, USA-based Actinium Pharmaceuticals has initiated a program to use lower dose (Iomab-ACT) to boost safety and efficacy of the much vaunted CAR-T therapy in blood cancers, comments Dr Chris Redhead, an analyst at Goetzpartners Securities Research. 28 September 2018
Biotechnology
It’s not often that the company announcing an acquisition sees a significant share price spurt, but this was certainly the case on Wednesday for Alexion Pharmaceuticals, which gained over 5.1% to $135.61. 27 September 2018
Biotechnology
The Japanese Ministry of Health, Labor and Welfare (MHLW) has granted marketing approval for Blincyto (blinatumomab) for the treatment of relapsed or refractory B-cell acute lymphoblastic leukemia (ALL). 26 September 2018
Pharmaceutical
In what was clearly an active session for the Japanese Ministry of Health, Labor and Welfare (MHLW), four new drug approvals were announced this morning. 21 September 2018
Pharmaceutical
Following a public comment period, the US Federal Trade Commission has approved a final order that settles charges that Catalan pharma-chemical company Grifols’ $286 million acquisition of USA-based Biotest Pharmaceuticals is anticompetitive and violates federal antitrust law. 19 September 2018
Biotechnology
Approval of the immunotoxin Lumoxiti (moxetumomab pasudotox-tdfk), a first-in-class medicine for hairy cell leukemia, marks first new treatment option for patients in over 20 years 14 September 2018
Pharmaceutical
Japanese drug major Daiichi Sankyosaw its share move up 4.3% to 4,563 yen after it revealed its quizartinib, an investigational FLT3 inhibitor, has been granted Orphan Drug designation by the Japan Ministry of Health, Labor and Welfare (MHLW) for the treatment of FLT3-mutated acute myeloid leukemia (AML). 11 September 2018
Biotechnology
Danish biotech Genmab and its commercialization partner Janssen Biotech promise sales of Darzalex (daratumumab) in the front-line setting will start soon after the European Commission (EC) gave it the green light. 31 August 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
Sign up to receive email updates
Join industry leaders for a daily roundup of biotech & pharma news
Today's issue
Company Spotlight
A US biotech company dedicated to creating oral drugs with an emphasis on indications in virology and immunology.
Copyright © The Pharma Letter 2024 | Headless Content Management with Blaze