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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
Biotechnology
Danish biotech Genmab and ADC Therapeutics have amended the terms of their agreement for the Swiss company’s continued development and commercialization of camidanlumab tesirine (Cami). 30 October 2020
Biotechnology
Swedish Orphan Biovitrum, also known as Sobi, saw its share price tumble by 5% in Thursday’s trading. 22 October 2020
Biotechnology
Danish biotech Genmab late Wednesday released positive top-line results from the second part of the Phase III CASSIOPEIA (MMY3006) study of cancer drug daratumumab monotherapy as maintenance treatment versus observation (no treatment) for patients with newly-diagnosed multiple myeloma eligible for autologous stem cell transplant (ASCT). 22 October 2020
Biotechnology
The Institute for Clinical and Economic Review (ICER) has released an Evidence Report assessing the comparative clinical effectiveness and value of BioMarin Pharmaceutical’s Roctavian (valoctocogene roxaparvovec) and Roche’s Hemlibra (emicizumab) for the treatment of hemophilia A. 20 October 2020
Biotechnology
US cancer metabolism specialist Agios Pharmaceuticals late Friday announced the withdrawal of its European Marketing Authorization Application (MAA) for Tibsovo (ivosidenib tablets) for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with an isocitrate dehydrogenase-1 (IDH1) mutation. 19 October 2020
Pharmaceutical
UK-based Shield Therapeutics has provided an update on an ongoing patent dispute with Israeli generics giant Teva Pharmaceutical. 19 October 2020
Pharmaceutical
At its October meeting, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended 10 medicines for approval. These now go the European Commission, which usually provides a final decision within two to three months. 16 October 2020
Pharmaceutical
The UK's National Institute for Health and Care Excellence (NICE) has issued a Final Appraisal Determination recommending Sarclisa (isatuximab) alongside the existing treatments of pomalidomide and dexamethasone for adults with relapsed/refractory multiple myeloma who have received three prior lines of treatment and at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on the last treatment. 15 October 2020
Biotechnology
Japanese drugmaker Otsuka and its member company Astex Pharmaceuticals have announced top-line results of the ASTRAL-2 and ASTRAL-3 clinical studies. 15 October 2020
Pharmaceutical
The Phase III study CHRONOS-3 evaluating Aliqopa (copanlisib) in combination with rituximab in indolent non-Hodgkin's lymphoma (iNHL) patients (n=458) who have relapsed after one or more prior lines of rituximab-containing therapy has met its primary endpoint of prolonged progression-free survival (PFS). 15 October 2020
Pharmaceutical
Swiss pharma giant Roche this morning announced that group sales for the first nine months of 2020 ($48.33 billion) increased 1% to 43.98 billion Swiss francs at constant exchange rates and declined 5% in Swiss francs as a result of continued appreciation of the Swiss franc against most currencies 15 October 2020
Pharmaceutical
US healthcare giant Johnson & Johnson made the headlines on Tuesday largely because of the temporary halt to its coronavirus vaccine trial. 13 October 2020
Biosimilars
Halpryza (rituximab injection), a recombinant human/murine chimeric monoclonal antibody drug co-developed by Chinese biopharma firm Innovent Biologics and US pharma major Eli Lilly, has been officially approved by the National Medical Products Administration (NMPA) of China for patients with diffuse large b cell lymphoma (DLBCL), follicular lymphoma (FL), and chronic lymphocytic leukemia (CLL) in China. 9 October 2020
Biotechnology
Health Canada has approved Reblozyl (luspatercept) for the treatment of adult patients with red blood cell (RBC) transfusion-dependent anemia associated with beta(β)-thalassemia. 29 September 2020
Biotechnology
Swedish Orphan Biovitrum, the Nordic biotech company known as Sobi, and specializes on the production of drugs for the treatment of orphan diseases is considering expanding into the Russian market this year, according to Russian media reports. 29 September 2020
Biotechnology
The Russian government will revise plans for the purchase of some of the most expensive drugs for state needs this year due to the lack of funds in the state budget, according to some sources close to the federal government and local media, reports The Pharma Letter’s local correspondent. 29 September 2020
Biotechnology
The US Food and Drug Administration has accepted and granted Priority Review for Bristol Myers Squibb and bluebird bio’s Biologics License Application (BLA) for idecabtagene vicleucel (ide-cel; bb2121). 22 September 2020
Biotechnology
Health Canada has approved Inrebic (fedratinib), a new once-daily oral medication used to treat adults with an enlarged spleen and associated symptoms caused by intermediate-2 or high-risk primary myelofibrosis, post-polycythemia vera myelofibrosis or post-essential thrombocythemia myelofibrosis. 21 September 2020
Pharmaceutical
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended seven new medicines (which included one biosimilar and one generic) for approval at its September 2020 meeting. 19 September 2020
Generics
When US pharma major Bristol Myers Squibb acquired Celgene last year for $74 billion, one of the assets sure to offer an immediate return was Revlimid (lenalidomide). 17 September 2020
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