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Biotechnology
Roche company Genentech has announced interim results from the Phase III HAVEN 7 study at this year’s American Society of Hematology (ASH) meeting. 12 December 2022
Pharmaceutical
The ASH (American Society of Hematology) Annual Meeting is here once again, ready to round off another year in pharma. 9 December 2022
Biotechnology
Shares of US biotech firm Arcellx roared up almost 26% to $27.24 by mid-morning, on the revelation of lucrative collaboration for its lead late-stage product candidate, CART-ddBCMA. 9 December 2022
Biotechnology
UK biotech Autolus Therapeutics has announced that the pivotal Phase II FELIX trial of obecabtagene autoleucel (obe-cel) in relapsed/refractory (r/r) adult acute lymphoblastic leukemia (ALL) has met its primary endpoint at interim analysis. 9 December 2022
Pharmaceutical
Swiss pharma major Novartis has announced positive results from the Phase III APPOINT-PNH study. 8 December 2022
Biotechnology
Swedish biotech Oncopeptides saw its shares plunge 36% to 12.00 Swedish kronor yesterday, after it revealed that the US Food and Drug Administration (FDA) has requested a withdrawal of the US marketing authorization for its multiple myeloma drug Pepaxto (melphalan flufenamide). 8 December 2022
Biotechnology
The marketing authorization application (MAA) for momelotinib, an investigational oral treatment for myelofibrosis, submitted by UK pharma major GSK, has been accepted by the European Medicines Agency (EMA). 7 December 2022
Biotechnology
Australian biotech CSL Limited today unveiled the future of plasma manufacturing in Australia with the opening of its A$900 million ($608 million) plasma fractionation facility in Victoria, which the company claims is the largest of its kind in the Southern Hemisphere. 7 December 2022
Pharmaceutical
Well ahead of expectations, on December 1, the US Food and Drug Administration (FDA) approved Rezlidhia (olutasidenib) capsules for adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible IDH1 mutation as detected by an FDA-approved test. 2 December 2022
Pharmaceutical
A regulatory approval could come within the next year for X4 Pharmaceuticals’ lead oral CXCR4 antagonist, mavorixafor. 30 November 2022
Pharmaceutical
Australian CSL Limited’s recently-incorporated Swiss business CSL Vifor and its partner Fresenius Kabi today announced that China’s National Medical Products Administration (NMPA) has approved Ferinject (ferric carboxymaltose). 28 November 2022
Biotechnology
Notable news last week including the UK’s GSK on Monday announcing it is withdrawing the US marketing authorization for its multiple myeloma drug Blenrep. The same day, the US Food and Drug Administration (FDA) approved the first one-time hemophilia B treatment, Hemgenix, developed by Dutch firm uniQure and to be marketed in the USA by CSL Behring. Last Wednesday, US biotech Arvinas released data from a Phase III trial of its breast cancer candidate ARV-471. Also of note, BioMarin had some good news, when it revealed that the FDA had done a U-turn on its review of hemophilia A candidate Roctavian, saying it would not after all hold an advisory committee evaluation of the product. 27 November 2022
Biotechnology
California, USA-based BioMarin Pharmaceutical saw its shares leap 10.7% to $98.49 yesterday, after it announced that the US Food and Drug Administration (FDA) review of the Biologics License Application (BLA) of Roctavian (valoctocogene roxaparvovec AAV gene therapy) for adults with severe hemophilia A would not, after all, be submitted for review by the agency’s advisory panel. 24 November 2022
Biotechnology
In a landmark regulatory first, Dutch gene therapy company uniQure (Nasdaq: QURE) has secured US approval for its one-time hemophilia B treatment, Hemgenix (etranacogene dezaparvovec-drlb). 23 November 2022
Biotechnology
UK pharma major GSK has started the process of withdrawing the US marketing authorization for multiple myeloma drug Blenrep (belantamab mafodotin-blmf). 22 November 2022
Biotechnology
Franco-American biopharma Erytech Pharma revealed Monday that the company will no longer be developing its lead candidate Graspa (eryaspase), an l-asparaginase encapsulated inside donor-derived red blood cells (RBCs). 22 November 2022
Biotechnology
Denmark’s Genmab (Nasdaq: GMAB) edged up 1.3% after it announced that the US Food and Drug Administration (FDA) has accepted for priority review the Biologics License Application for epcoritamab (DuoBody-CD3xCD20). 21 November 2022
Biotechnology
Over the past two decades, numerous complex cancer therapies called antibody drug conjugates (ADCs) have been tested in clinical trials and approved for use in patients. 21 November 2022
Biotechnology
French drugmaker Sanofi has added a European approval to those in the USA and Japan for Enjaymo (sutimlimab) to treat hemolytic anemia in adults with cold agglutinin disease (CAD). 18 November 2022
Biotechnology
The European Commission today granted marketing authorization for Sino-American biotech BeiGene’s Brukinsa (zanubrutinib) for the treatment of adult patients with treatment-naïve or relapsed/refractory chronic lymphocytic leukemia (CLL), one of the most common types of leukemia in adults. 17 November 2022
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
California, USA-based Lyell Immunopharma (Nasdaq: LYEL) has entered into a definitive agreement to acquire privately-held US CAR-T company ImmPACT Bio. 26 October 2024
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