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Lilly's Jaypirca hits goals in Phase III CLL/SLL study

Eli Lilly today announced positive top-line results from the Phase III BRUIN CLL-314 clinical trial of Jaypirca (pirtobrutinib), a non-covalent (reversible) Bruton's tyrosine kinase (BTK) inhibitor, versus Imbruvica (ibrutinib), a covalent BTK inhibitor, in patients with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL). 29 July 2025

World Hepatitis Day 2025 spotlights barriers to elimination

World Hepatitis Day, marked each year on July 28, is shining a light on what GlobalData calls an “urgent need” for a renewed push to tackle viral hepatitis as mortality rises worldwide. The disease remains among the deadliest infectious threats, affecting more than 300 million people globally. 28 July 2025

Unlike FDA, EC backs re-approval of GSK’s Blenrep

In an import contrast to events in the USA, UK pharma major GSK late Thursday announced the approval of Blenrep (belantamab mafodotin) by the European Commission. 25 July 2025

Sanofi’s Sarclisa gains new approval in the EU

Following the positive opinion by the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) on June 19, 2025, the European Commission has approved French pharma major Sanofi's (isatuximab) in combination with bortezomib, lenalidomide, and dexamethasone (VRd) for the induction treatment of adult patients with newly diagnosed multiple myeloma (NDMM) who are eligible for autologous stem cell transplant. 25 July 2025

Blenrep saga drags on as PDUFA date put back

The US Food and Drug Administration (FDA) has extended the review period for the Biologics License Application (BLA) for GSK’s Blenrep (belantamab mafodotin-blmf) combinations for the treatment of patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy. 24 July 2025

Roche continues strong momentum in first half of 2025

Swiss pharma giant Roche this morning released financial results for the first half of 2025, showing that sales grew 7% (+4% in Swiss francs) to 30.9 billion francs ($35.1 billion) due to strong demand for pharmaceutical products. Sales were in line with Visible Alpha consensus of 30.80 billion francs. 24 July 2025

J&J blockbusters bag new hematology approvals

US healthcare giant Johnson & Johnson (NYSE: JNJ) has announced that the European Commission (EC) has approved a new indication and an indication extension for Darzalex (daratumumab) and Imbruvica (ibrutinib), respectively. 23 July 2025

ImCheck doubles up on orphan designations for ICT01 in AML

French biotech ImCheck Therapeutics has announced that the European Medicines Agency (EMA) has granted Orphan Drug Designation (ODD) to its lead program, ICT01, a humanized anti-butyrophilin 3A (BTN3A) monoclonal antibody designed to selectively activate γ9δ2 T cells, in acute myeloid leukemia (AML). 22 July 2025

Replimune rocked by CRL for lead candidate

Shares in Replimune Group, a US biotech developing novel oncolytic immunotherapies, went in freefall Tuesday, as the company announced a major setback. 22 July 2025

Phase III trial for Reblozyl misses endpoint

US pharma major Bristol Myers Squibb’s shares remained steady, despite the company reporting disappointing results from its Phase III INDEPENDENCE trial evaluating Reblozyl (luspatercept-aamt) with concomitant janus kinase inhibitor (JAKi) therapy in adult patients with myelofibrosis-associated anemia receiving red blood cell (RBC) transfusions. 19 July 2025

GSK shares slide on FDA’s Blenrep concerns

The US Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee has voted against two proposed combination regimens containing GSK’s Blenrep (belantamab mafodotin), sending shares in the UK drugmaker tumbling by 5% Friday. 18 July 2025

Grifols to invest 160M euros in new manufacturing site

Spanish plasma-derived medicines specialist Grifols saw its share close up 7% yesterday, after it revealed that it will invest 160 million euros ($185.6 million) in a new facility in Lliçà de Vall (Barcelona), expanding its industrial footprint in Spain and doubling its plasma fractionation capacity in Europe. 17 July 2025

UK approval for Roche combination

Swiss pharma giant Roche has won approval from the UK’s Medicines and Healthcare Regulatory Agency (MHRA) for its combination treatment of Columvi (glofitamab) alongside gemcitabine and oxaliplatin (GemOx) for adults with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) not otherwise specified who are ineligible for autologous stem cell transplant. 17 July 2025

J&J jumps on improved outlook

Shares in US healthcare conglomerate Johnson & Johnson rose by 6% during Wednesday morning’s trading after the presentation of its second-quarter financial results and latest guidance for 2025. 16 July 2025

FDA probes ocular toxicity of Blenrep as GSK seeks new indications

UK pharma major GSK is seeking US approval for Blenrep (belantamab mafodotin) in two multiple myeloma indications. 16 July 2025

Medicaid to offer outcomes-based deal for sickle cell gene therapies

The US regulator has launched a new national initiative to help Medicaid programs fund gene therapies for sickle cell disease, under an agreement aimed at broadening access while linking payments to real-world treatment results. 16 July 2025

Ascentage wins NMPA approval of first China-developed Bcl-2 inhibitor

Sino-American biopharma Ascentage Pharma announced that its proprietary novel Bcl-2 selective inhibitor lisaftoclax (APG-2575) has been approved by China’s National Medical Products Administration (NMPA). 11 July 2025

NICE moves fast on Brukinsa in MCL

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

FDA accepts Taiho’s sNDA for Inqovi

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

Multiple myeloma need driving growth in GPRC5D-directed therapies market

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

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Roctavian first hemophilia gene therapy to gain federal price in Germany

California, USA-based biotech firm BioMarin Pharmaceutical (Nasdaq: BMRN) has announced an agreement with the German National Association of Statutory Health Insurance Funds (GKV-SV) on the reimbursement amount for Roctavian (valoctocogene roxaparvovec-rvox) for people with severe hemophilia A. 29 November 2023

Hemogenyx shares jump on platform's promise in cancer

Shares in UK-based biopharma Hemogenyx Pharmaceuticals closed 18% higher on Monday. 27 November 2023

First-in-class blood cancer med could soon face regulatory test

It has been a challenging week for Germany's MorphoSys, with the firm’s share price falling as much as 40% in the last five days. 22 November 2023

FDA delays review of sBLA for Abecma for earlier use

Shares of US pharma major Bristol Myers Squibb fell more than 4% pre-market and partner 2seventy bio was down 17.6% at $1.76 on Monday, after the companies said the US Food and Drug Administration would miss its target date for potential approval of earlier use of a cancer therapy Abecma (idecabtagene vicleucel). 21 November 2023

Acrotech urged to hurry up with confirmatory trial

Aurobindo Pharma subsidiary Acrotech Biopharma has been urged to work with the US Food and Drug Administration (FDA) to swiftly advance a confirmatory trial of the cancer drugs Folotyn (pralatrexate) and Beleodaq (belinostat). 20 November 2023

BeiGene notches up fourth EC approval for Brukinsa

The European Commission (EC) has granted marketing authorization for China-headquartered biotech BeiGene’s Brukinsa (zanubrutinib) in combination with obinutuzumab for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma. 17 November 2023

Kite punts millions more into Arcellx partnership

Adding to the collaboration agreed last December, Gilead Sciences’ subsidiary Kite has today announced it is expanding it collaboration with US biotech Arcellx. 15 November 2023

Hemogenyx lentivirus re-manufacturing completed

London-listed blood disease specialist Hemogenyx Pharmaceuticals has announced the successful completion of the re-manufacturing of an improved lentivirus (LVV) devoid of splice variants. 15 November 2023

Vanflyta scores a first with EU approval

Following US approval in the same indication earlier this year, Japanese drugmaker Daiichi Sankyo’s Vanflyta (quizartinib) has now also been approved in the European Union (EU). 13 November 2023

November 2023 batch of EMA/CHMP recommendations

The European Medicines Agency’s (EMA) human medicines committee (CHMP) recommended four novel medicines and two biosimilars for approval at its November 2023 meeting. 11 November 2023

FDA approves first drug for rare inherited blood clotting disorder

The US Food and Drug Administration yesterday approved Japanese pharma major Takeda’s Adzynma (ADAMTS13, recombinant-krhn; TAK-755), adding to the approval a day earlier of the firm’s bowel cancer drug Fruzaqla (fruquintinib). 10 November 2023

Another ADC foray for Bristol Myers Squibb

In another antibody-drug conjugate (ADC) deal for the US pharma major, Bristol Myers Squibb has acquired USA and South Korea-based Orum Therapeutics’ ORM-6151 program. 6 November 2023

Roquefort boasts of NK cells activation in multiple cancer types

UK-based biotech Roquefort Therapeutics has announced that its mesodermal killer (MK) cell program has reached a significant milestone. 6 November 2023

Pierre Fabre to acquire wider license for Ebvallo

Independent French drugmaker Pierre Fabre has expanded a global partnership for Ebvallo (tabelecleucel) with US biotech Atara Biotherapeutics. 3 November 2023

FDA AdCom largely supports safety of Vertex/CRISPR's exa-cel

The US Food and Drug Administration’s (FDA) Cellular, Tissue and Gene Therapies Committee concluded that Vertex Pharmaceutical and Swiss gene editing specialist CRISPR Therapeutics’ exagamglogene autotemcel (exa-cel) is generally safe for clinical use. 1 November 2023

Amgen reports 3rd-qtr sales in line with expectations, EPS beats

US biotech giant Amgen saw its shares fall by 4.4% to $251.44 on Tuesday, after it announced financial results for the third quarter of 2023. 1 November 2023

Pfizer's pandemic windfall well and truly over, results show

US pharma giant Pfizer was trading more than 1% lower during Tuesday morning’s trading in New York, following the release of financial results. 31 October 2023

Safety of sickle cell disease therapy may not be certain, say FDA scientists

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

Sobi rises on strong 3rd-qtr 2023 revenue and solid performance

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

Citius to spin off oncology division into separate public company

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

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