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Biotechnology
US biotech bluebird bio closed 38% lower after Tuesday’s trading. 17 February 2021
Biotechnology
On Friday, the US Food and Drug Administration granted accelerated approval for Ukoniq (umbralisib), a kinase inhibitor including PI3K-delta and casein kinase CK1-epsilon. 8 February 2021
Biotechnology
The China National Medical Products Administration (NMPA) has granted conditional approval to Xospata (gilteritinib) for the treatment of adult patients who have relapsed (disease that has returned) or refractory (resistant to treatment) acute myeloid leukemia (AML) with a FLT3 mutation (FLT3mut+) detected by a fully validated test. 4 February 2021
Biotechnology
Swiss pharma giant Roche this morning announced 2020 financial results, showing that group sales increased 1% to 58.32 billion Swiss francs ($65.43 billion) at constant exchange rates (CER), but a 5% decline in Swiss francs, as a result of continued appreciation of the Swiss franc against most currencies, as well as biosimilars competition. 4 February 2021
Biotechnology
AbbVie, which has recently completed its $63 billion acquisition of Allergan, today announced financial results for the fourth quarter and full year ended December 31, 2020, that beat Wall Street forecasts, and pushing the firm’s shares 1.8% higher to $105.33 by mid-morning. 3 February 2021
Biotechnology
Hypereosinophilic syndrome (HES) refers to a group of rare blood disorders that are characterized by a marked overproduction of eosinophils (white blood cells that lay an important role in immunity). While the exact prevalence of HES is unknown, the World Health Organization reported age-adjusted incidence of about 3-4 people per 10,000,000 between 2001 and 2005. 28 January 2021
Pharmaceutical
Agios Pharmaceuticals has announced positive results from the Phase III ACTIVATE trial of mitapivat. 28 January 2021
Biotechnology
The National Institute for Health and Care Excellence (NICE) has recommended the use of Revlimid (lenalidomide) as maintenance treatment after an autologous stem cell transplant (ASCT) for newly diagnosed multiple myeloma in adults. 27 January 2021
Pharmaceutical
Recordati has announced that the US Food and Drug Administration (FDA) has approved a new indication for Carbaglu (carglumic acid) tablets 200mg. 27 January 2021
Pharmaceutical
US biopharma company Global Blood Therapeutics today announced that the European Medicines Agency has completed the validation of GBT’s Marketing Authorization Application (MAA) for Oxbryta (voxelotor) tablets and started its standard review process. 27 January 2021
Pharmaceutical
Johnson & Johnson was 3% higher after Tuesday morning’s trading in New York. 26 January 2021
Biotechnology
Daiichi Sankyo today announced the Japan Ministry of Health, Labor and Welfare (MHLW) has approved Yescarta (axicabtagene ciloleucel), a chimeric antigen receptor (CAR) T-cell therapy, for the treatment of adult patients with certain relapsed/refractory large B-cell lymphomas. 22 January 2021
Biotechnology
Shares of Swedish Orphan Biovitrum, also known as Sobi, gained more than 2% in early trading, as the company revealed that the European Commission has approved an extension of the indication for Doptelet (avatrombopag) to include the treatment of primary chronic immune thrombocytopenia (ITP) in adult patients who are refractory to other treatments (eg, corticosteroids, immunoglobulins) in all European Union member states. 20 January 2021
Biotechnology
Francesco Marincola will join Kite as senior vice president and global head of cell therapy research, effective February 1, said the biotech firm. 19 January 2021
Biotechnology
US trade group the Pharmaceutical Research and Manufacturers of America (PhRMA) has pointed out the savings that gene therapies can deliver for patients that otherwise require lifelong treatment. 18 January 2021
Biotechnology
US biotech firm BioMarin Pharmaceutical saw its shares close down 9.6% at $81.24 on Monday, after it announced positive top-line results from its ongoing global Phase III GENEr8-1 study of valoctocogene roxaparvovec, an investigational gene therapy for the treatment of adults with severe hemophilia A, which has been issued two brand names – Roctavian and Valrox. 12 January 2021
Biotechnology
The Gilead Sciences subsidiary Kite has agreed to set up a cell therapy research collaboration with UK-based Oxford BioTherapeutics (OBT). 6 January 2021
Biotechnology
Leaps by Bayer has led a $105 million Series B financing round in the gene circuit company, Senti Biosciences. 6 January 2021
Pharmaceutical
Onureg (azacytidine tablets), the Bristol Myers Squibb drug approved in the USA last year for the continued treatment of patients in first complete remission with acute myeloid leukemia (AML), has been given an airing in the New England Journal of Medicine (NEJM). 5 January 2021
Biotechnology
Incyte and Cellenkos have signed a development collaboration to investigate the combination of ruxolitinib (Jakafi) and CK0804. 31 December 2020
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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