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Biotechnology
In briefing notes released ahead of a key meeting on Tuesday, scientists at the US Food and Drug Administration describe uncertainty in the risks associated with a new gene editing technology. 30 October 2023
Biotechnology
Swedish Orphan Biovitrum (STO: SOBI), also known as Sobi, saw its shares rise 5.5% to 235.80 Swedish kronor in early trading today, as it released financial results for the third quarter of 2023. 30 October 2023
Biotechnology
American critical care specialist Citius Pharma is to list its oncology subsidiary on the Nasdaq exchange, via merger with a special purpose acquisition company (SPAC). 25 October 2023
Biotechnology
Shanghai-based gene therapy company Belief BioMed (BBM) has out-licensed certain rights for the commercialization of its hemophilia candidate, BBM-H901. 23 October 2023
Biotechnology
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has today authorized a new medicine called, Tepkinly (epcoritamab), as a treatment for diffuse large B-cell lymphoma (a type of blood cancer) in adults. 20 October 2023
Pharmaceutical
Nearly five months have passed since the Annual Meeting of the American Society of Clinical Oncology (ASCO) took place, and cancer-focused drugmakers are ready once again to dump their data to the world’s oncologists, media and more. 19 October 2023
Pharmaceutical
Swiss pharma giant Roche saw its shares fall more than 5% to 254.60 francs this morning, after it posted a cautious forecast for full-year 2023. 19 October 2023
Biotechnology
A first-of-its-kind, made-in-India product catering to advanced cell-and-gene therapies has been developed in the country. 16 October 2023
Pharmaceutical
New York-based SELLAS Life Sciences is on track to complete enrollment for its Phase III REGAL study of galinpepimut-S (GPS). 13 October 2023
Biotechnology
China’s CARsgen Therapeutics has announced the publication of two cases of long-term disease-free survival in the treatment of advanced hepatocellular carcinoma (HCC) with its CAR-GPC3 T-cell therapy. 12 October 2023
Biotechnology
Dutch gene therapy company uniQure saw its shares fall 11.6% to $6.73 yesterday, after it announced a strategic reorganization. 6 October 2023
Biotechnology
Innate Pharma was trading 15% lower by late-activity in Paris Thursday. 5 October 2023
Pharmaceutical
Rare diseases specialist Swedish Orphan Biovitrum, also known as Sobi, today announced that Lydia Abad-Franch has been appointed as senior vice president, head of research, development and medical affairs (RDMA), and chief medical office, a role which she has held on an interim basis since June. 5 October 2023
Pharmaceutical
Despite positive top-line data, Syndax Pharmaceuticals stock has fallen more than a tenth, following an interim analysis from the AUGMENT-101 trial. 3 October 2023
Biotechnology
US pharma major AbbVie (NYSE: ABBV) saw its shares dip 2.1% to $149.06 on Friday after it announced disappointing data from its Phase III CANOVA study evaluating the safety and efficacy of Venclexta (venetoclax). 2 October 2023
Biotechnology
Moving the compound a step closer to regulatory approval, the US Food and Drug Administration (FDA) has accepted for Priority Review the Biologics License Application (BLA) filed by US biotech Regeneron Pharmaceuticals for odronextamab. 29 September 2023
Biotechnology
Gilead Sciences has released a statement confirming it has stopped its ENHANCE-2 study of magrolimab in acute myeloid leukemia (AML). 27 September 2023
Biotechnology
The US Food and Drug Administration has granted a new approval for US pharma giant Pfizer’s hematologic malignancies drug Bosulif (bosutinib). 27 September 2023
Biotechnology
The European Commission (EC) has granted conditional marketing authorization for Tepkinly (epcoritamab) as a monotherapy to treat adults with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy. 25 September 2023
Biotechnology
Having gained US and Taiwan regulatory approval for its hematology drug Altuviiio (efanesoctocog alfa) earlier this year, French pharma major Sanofi has now bagged marketing clearance in Japan. 25 September 2023
Biotechnology
BeOne Medicines - the Sino-American oncology specialist formerly known as BeiGene - has announced that the National Institute for Health and Care Excellence (NICE) has recommended Brukinsa (zanubrutinib) to treat relapsed or refractory mantle cell lymphoma (MCL) after one line of treatment. 10 July 2025
Pharmaceutical
The US Food and Drug Administration (FDA) has accepted the supplemental new drug application (sNDA) for Inqovi (decitabine and cedazuridine) plus venetoclax as a treatment for adults with newly diagnosed acute myeloid leukemia (AML) who are ineligible for intensive induction chemotherapy. 10 July 2025
Biotechnology
The GPRC5D-directed therapies market is witnessing robust growth, driven by high unmet need in relapsed/refractory multiple myeloma, according to a report on the field by DelveInsight. 7 July 2025
Biotechnology
US pharma major AbbVie announced it plan to acquire Capstan Therapeutics, along with its autoimmune disease candidate CPTX2309, for up to $2.1 billion. Organon posted disappointing mid-stage trial results for its investigational endometriosis pain drug, OG-6219. Also of note last week, the US Food and drug Administration (FDA) granted accelerated approval for Regeneron’s multiple myeloma drug Lynozyfic. 6 July 2025
Pharmaceutical
The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA), through the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG), have issued recommendations to address vulnerabilities in the supply chain of anti-D immunoglobulins. 4 July 2025
Biotechnology
The US Food and Drug Administration (FDA) has granted accelerated approval for Regeneron Pharmaceuticals’ Lynozyfic (linvoseltamab-gcpt) to treat adult patients with relapsed or refractory (R/R) multiple myeloma (MM) who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti CD38 monoclonal antibody. 3 July 2025
Biotechnology
The US Food and Drug Administration (FDA) has announced the elimination of the Risk Evaluation and Mitigation Strategies (REMS) for currently approved BCMA- and CD19-directed autologous chimeric antigen receptor CAR-T cell immunotherapies. 30 June 2025
Biotechnology
In a significant showcase for investors, BeOne Medicines announced major advancements to its industry-leading oncology pipeline during an investor R&D Day. 27 June 2025
Biotechnology
US pharm giant Pfizer today announced positive top-line results from the Phase III BASIS study evaluating Hympavzi (marstacimab) for adults and adolescents living with hemophilia A or B with inhibitors. 26 June 2025
Generics
US insurance giant Cigna has taken fresh legal action against Bristol Myers Squibb, accusing the drugmaker of manipulating the patent system to preserve its monopoly on the multiple myeloma treatment Pomalyst (pomalidomide). 26 June 2025
Biotechnology
Japan’s largest drugmaker Takeda presented final results from a Phase II trial evaluating mezagitamab (TAK-079), a potential best-in-class anti-CD38 monoclonal antibody, in patients with persistent or chronic primary immune thrombocytopenia (ITP). 25 June 2025
Biotechnology
US biotech BioMarin Pharmaceutical has presented new five-year data from its pivotal Phase III trial of Roctavian (valoctocogene roxaparvovec), showing sustained bleed control and a stable safety profile for adults with severe hemophilia A. 25 June 2025
Biotechnology
Swiss pharma giant Roche has announced positive Phase I/II data on NXT007 in people with hemophilia A, supporting its progression into Phase III clinical development. 24 June 2025
Biotechnology
Swiss pharma giant Roche has released encouraging results from the Phase III SUNMO study showing Lunsumio (mosunetuzumab) administered subcutaneously in combination with Polivy (polatuzumab vedotin), delivered a seismic update in aggressive lymphoma therapy. 23 June 2025
Pharmaceutical
Danish drugmaker Novo Nordisk has released fresh clinical data on two of its lead investigational assets, seeking to bolster its strong position in obesity while moving to challenge in rare blood disorders. 23 June 2025
Pharmaceutical
The European Medicines Agency’s (EMA) human medicines committee (CHMP) recommended five novel medicines for approval at its June 2025 meeting. 20 June 2025
Pharmaceutical
Spanish plasma-derived medicines specialist Grifols announced that the positive Phase III study data on its fibrinogen concentrate, BT524, has been published in eClinicalMedicine, a peer-reviewed journal published by The Lancet Discovery Science Suite. 20 June 2025
Pharmaceutical
US biopharma Mineralys Therapeutics has announced positive top-line data from its Phase II Explore-CKD trial evaluating the safety and efficacy of 25mg of lorundrostat in subjects with hypertension and comorbid chronic kidney disease (CKD). 18 June 2025
Pharmaceutical
Pharma majors AbbVie and Roche were both trading lower early Tuesday after top-line results were announced from the global Phase III VERONA trial. 17 June 2025
Biotechnology
US healthcare giant Johnson & Johnson’s subsidiary Janssen-Cilag yesterday announced today new results from the Phase II RedirecTT-1 study evaluating the investigational combination of Talvey talquetamab) and Tecvayli teclistamab). 16 June 2025
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