Hematology
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Pharmaceutical
The cost of prescription items dispensed in England in 2020/21 was £9.61 billion ($13.6 billion). This was a 3.49% increase of £324 million from £9.28 billion in 2019/20 and a 7.41% increase of £663 million from £8.94 billion in 2014/15. 10 June 2021
Biotechnology
The US Food and Drug Administration has approved Ultomiris (ravulizumab-cwvz) injection to treat patients aged one month and older with FDA backs Ultomiris for pediatric patients with PNH, a rare, life-threatening blood disease, that is marketed by Alexion Pharmaceuticals. 8 June 2021
Biotechnology
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has approved Venclyxto (venetoclax) in combination with a hypomethylating agent for the treatment of newly-diagnosed adults 7 June 2021
Biotechnology
The US Food and Drug Administration on Friday approved Ryplazim (plasminogen, human-tvmh) for the treatment of patients with plasminogen deficiency type 1 (hypoplasminogenia) through Canada-based Liminal BioSciences’ subsidiary Prometic Biotherapeutics, holder of the biological license application (BLA) for Ryplazim. 7 June 2021
Biotechnology
Bristol Myers Squibb has been sued by the former shareholders of Celgene, the company that it acquired in 2019. 4 June 2021
Biotechnology
Shares of US cancer drug maker Constellation Pharmaceuticals closed up a massive 66.7% at $33.74 yesterday on the news that it has agreed to be acquired by Germany’s MorphoSys. 3 June 2021
Pharmaceutical
Specialty UK pharma company Shield Therapeutics, with a focus on addressing iron deficiency with its lead product Feraccru/Accrufer (ferric maltol), today announced that Greg Madison has been appointed as chief executive, with effect from Tuesday, June 1, 2021. 28 May 2021
Biotechnology
The US Food and Drug Administration has accepted the Biologics License Application (BLA) for ublituximab, an investigational glycoengineered anti-CD20 monoclonal antibody, in combination with Ukoniq (umbralisib), TG Therapeutics’ once-daily, oral, inhibitor of PI3K-delta and CK1-epsilon, as a treatment for patients with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). 26 May 2021
Pharmaceutical
The European Commission has approved Venclyxto (venetoclax) in combination with hypomethylating agents, azacitidine and decitabine, for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) who are ineligible for intensive chemotherapy. 26 May 2021
Biotechnology
Positive top-line results have been reported from the Phase III PRINCE study evaluating the efficacy and safety of pegcetacoplan in adults with paroxysmal nocturnal hemoglobinuria (PNH) who are treatment naïve. 25 May 2021
Biotechnology
The Roche unit Chugai has announced the launch of Polivy (polatuzumab vedotin) intravenous infusion 30mg and 140mg for the treatment of relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) in Japan. 19 May 2021
Biotechnology
The US Food and Drug Administration FDA has approved Empaveli (pegcetacoplan) injection to treat adults with paroxysmal nocturnal hemoglobinuria (PNH), a rare, life-threatening blood disease. 18 May 2021
Biotechnology
Last week’s regulatory news included a US Food and Drug advisory committee vote equally for and against approval of ChemoCentryx’ vasculitis treatment candidate avacopan. Also, US vaccine developer Novavax last Monday announced that it is delaying the regulatory filing for its COVID-19 candidate NVX-CoV2373. Research news saw US biotech Curis presenting early-stage data for its CA-4948 for myeloid leukemia and myelodysplastic syndrome, which clearly pleased investors. On the negative side, Biogen released Phase II/III results for its cotoretigene toliparvovec (BIIB112) in a retinal disease that failed to meet its primary endpoint. 16 May 2021
Biotechnology
Netherlands-headquartered uniQure yesterday presented 26-week clinical data from the pivotal, Phase III HOPE-B gene therapy trial of etranacogene dezaparvovec showing clinical benefit in hemophilia B patients with pre-existing neutralizing antibodies (NAbs) to AAV5, and no relationship between AAV5 NAbs and the tolerability of the therapy. 13 May 2021
Biotechnology
Shares of oncology focussed US biotech firm Curis closed up 65.5% at $16.27 yesterday, after it announced that two abstracts for CA-4948, a novel, small molecule IRAK4 inhibitor, have been accepted for oral and poster presentation at the European Hematology Association 2021 Virtual Congress (EHA), which will be held virtually June 9-17, 2021. 13 May 2021
Biotechnology
US health technology assessor the Institute for Clinical and Economic Review (ICER) has released a Final Evidence Report assessing the comparative clinical effectiveness and value of three new treatments targeting the B-cell maturation antigen (BCMA) for heavily pre-treated patients with triple class refractory multiple myeloma (TCRMM) who have cycled through numerous previous lines of therapy: 12 May 2021
Pharmaceutical
Takeda Pharmaceutical has officially launched full-cycle production of its Ninlaro (ixazomib) – a drug for the treatment of multiple myeloma - at its Russian plant in the Yaroslavl region, according to the company. 5 May 2021
Pharmaceutical
Chiesi Global Rare Diseases, a business unit of Chiesi Farmaceutici, announced that the US Food and Drug Administration has approved Ferriprox (deferiprone) for the treatment of patients with transfusional iron overload due to sickle cell disease (or other anemias) in adults and children (age three and older). 4 May 2021
Biotechnology
Legend Biotech, a clinical stage CAR-T immuno-oncology biotech being spun out of Hong Kong-listed GenScript Biotech, revealed on Friday that a Marketing Authorization Application (MAA) has been submitted to the European Medicines Agency (EMA) seeking approval of ciltacabtagene autoleucel (cilta-cel) for the treatment of patients with relapsed and/or refractory multiple myeloma. 1 May 2021
Biotechnology
Samsung Biologics and US biotech TG Therapeutics have announced an expansion of a large-scale contract manufacturing deal for the supply of TG Therapeutics’ ublituximab, an investigational anti-CD20 monoclonal antibody. 27 April 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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