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Biotechnology
USA-based cancer specialist Epizyme today announced a collaboration with Chinese biotech Hutchmed to research, develop, manufacture and commercialize Tazverik (tazemetostat) in Greater China, including mainland China, Hong Kong, Macau and Taiwan (the Territory). 9 August 2021
Biotechnology
Roche has announced a successful trial outcome with Polivy (polatuzumab vedotin), an anti-CD79b antibody-drug conjugate (ADC) currently under investigation for the treatment of several types of non-Hodgkin's lymphoma (NHL) that the company is developing using Seagen ADC technology. 9 August 2021
Biotechnology
Shares of Spectrum Pharmaceuticals fell nearly 30% on Friday, after the US oncology specialist revealed yet another delay in the approval process for its lead product candidate Rolontis (eflapegrastim). 9 August 2021
Pharmaceutical
Data and analytics company GlobalData has weighed up the factors for consideration surrounding the prevention of thrombosis in managing COVID-19 patients. 6 August 2021
Biotechnology
The Kite unit of US biotech major Gilead Sciences has signed a collaboration and license agreement with Appia Bio, an early-stage biotech, to research and develop HSC-derived cell therapies directed toward hematological malignancies. 5 August 2021
Pharmaceutical
Patients in the USA with peripheral T-cell lymphoma (PTCL) who have received at least one prior therapy will no longer be given Istodax (romidepsin). 4 August 2021
Biotechnology
Independent French pharma major Servier today announced the global Phase III double blinded placebo controlled AGILE study of Tibsovo (ivosidenib tablets) in combination with the chemotherapy azacitidine in adults with previously untreated IDH1-mutated acute myeloid leukemia (AML) met its primary endpoint of event-free survival (EFS). 3 August 2021
Biotechnology
US drugmaker AbbVie announced financial results for the second quarter of 2021, showing that revenues were up 33.9% on a reported basis at $13.959 billion, beating the expectations of analysts polled by FactSet of $13.63 billion. 30 July 2021
Biotechnology
The US Food and Drug Administration today alerted patients and health care professionals that a clinical trial (OCEAN, Study OP-103) evaluating Pepaxto (melphalan flufenamide) with dexamethasone to treat patients with multiple myeloma showed an increased risk of death. 28 July 2021
Biotechnology
Marking a second licensing deal this month, French drugmaker Ipsen has signed an exclusive worldwide collaboration agreement with US biotech BAKX Therapeutics to research, develop, manufacture and commercialize BKX-001 as a potential treatment for leukemia, lymphoma and solid tumors. 28 July 2021
Biotechnology
Swiss pharma giant Roche posted financial results this morning showing that first-half 2021 net profit rose 2% to 8.22 billion Swiss francs ($8.96 billion) and sales increased by 8% at constant exchange rates to a better-than expected 30.71 billion francs. 22 July 2021
Biotechnology
US clinical-stage biotech Magenta Therapeutics’ shares closed down more than 9% at $8.07 on Wednesday, after the company revealed it has received a clinical hold letter from the US Food and Drug Administration related to its Investigational New Drug Application (IND) filed in June 2021 to initiate a Phase I/II clinical trial of MGTA-117 in patients with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). 22 July 2021
Biotechnology
Venclexta (venetoclax), in combination with azacytidine, has been granted Breakthrough Therapy Designation (BTD) by the US Food and Drug Administration (FDA) for previously untreated intermediate, high- and very high-risk myelodysplastic syndromes (MDS) based on the revised International prognostic scoring system (IPSS-R). 21 July 2021
Pharmaceutical
Spanish plasma specialist Grifols today announced it will establish an intravenous (IV) solutions production plant in Nigeria for Dozie and Dozie’s Pharma Nig Ltd, a leading provider of healthcare products in the country and surrounding region. 19 July 2021
Generics
Sandoz, the generic and biosimilar medicines unit of Swiss pharma giant Novartis, today announced the immediate US availability of generic ferumoxytol, an intravenous medicine used to treat iron deficiency anemia (IDA). 16 July 2021
Biotechnology
Positive top-line results from a Phase III study evaluating the safety and efficacy of Ultomiris (ravulizumab-cwvz) in adults with generalized myasthenia gravis (gMG) were announced yesterday by Alexion Pharmaceuticals, whose shares nevertheless dipped 3.3% to $180.51 by close of trading. 16 July 2021
Biotechnology
The US Food and Drug Administration has lifted a partial clinical hold, previously announced on April 8, 2021, on the first-in-human (FIH) Phase Ib, dose escalation clinical trial of RVU120 (also known as SEL120) in patients with relapsed/refractory (R/R) acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (high-risk MDS), being conducted in the USA, Poland largest biotech Ryvu Therapeutics (WSE: RVU) announced today. 14 July 2021
Biotechnology
The US Food and Drug Administration has approved Darzalex Faspro (daratumumab and hyaluronidase-fihj) in combination with pomalidomide and dexamethasone for adult patients with multiple myeloma who have received at least one prior line of therapy including lenalidomide and a proteasome inhibitor. 13 July 2021
Pharmaceutical
Last Tuesday, Boehringer Ingelheim and Eli Lilly released new Phase III data on their diabetes drug Jardiance in heart failure, which they described as ‘breakthrough.’ Swedish biotech Oncopeptides presented mixed new data on its Pepaxto (melphalan) in multiple myeloma but also revealed a partial clinical hold on the Phase III trial by the US Food and Drug Administration. Biogen, at its own request, has seen the FDA amend the label information on its recently approved Alzheimer’s disease drug Aduhelm. Meantime, tobacco giant Philip Morris made a counter takeover bid for UK inhaled therapies specialist Vectura. 11 July 2021
Biotechnology
The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) held its July meeting this past week, and today reported on safety issues with a leukemia drug and four COVID-19 vaccines. 9 July 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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