Hematology
Refine Search
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
Pharmaceutical
Sanofi reported 15.7% sales growth for the third quarter of the year, reaching 13.4 billion euros ($14.2 billion), with adjusted earnings per share (EPS) rising by 12.2% to 2.86 euros, surpassing many forecasts. 25 October 2024
Biotechnology
Johnson & Johnson has secured European approval for an expanded indication of Darzalex (daratumumab) in a subcutaneous formulation. 24 October 2024
Biotechnology
Swedish Orphan Biovitrum, the Nordic biotech company also known as Sobi, today announced significantly improved financial results for the third quarter of 2024, sending the firm’s shares up 2.5% to 333.60 kronor in early trading. 24 October 2024
Biotechnology
US clinical-stage biotech AvenCell Therapeutics announced that it has raised $112 million in Series B financing, which was led by global life sciences investor Novo Holdings. 23 October 2024
Pharmaceutical
Swiss pharma giant Roche this morning reported that, in the first nine months of 2024 group sales increased by 6% at CER (2% in francs) to 45.0 billion francs ($52.0 billion). 23 October 2024
Pharmaceutical
UK pharma major AstraZeneca’s Alexion Rare Disease unit has received a positive recommendation for Voydeya (danicopan), from the UK’s National Institute for Health and Care Excellence (NICE). 22 October 2024
Biotechnology
The European Medicines Agency’s (EMA) human health committee, CHMP, announced six positive opinions of novel medicines, as well as two biosimilars, following its October meeting. 18 October 2024
Biotechnology
The US Food and Drug Administration (FDA) on Friday approved US pharma giant Pfizer’s Hympavzi (marstacimab-hncq). 14 October 2024
Biotechnology
US healthcare giant Johnson & Johnson’s Tecvayli (teclistamab) has been recommended by the National Institute for Health and Care Excellence (NICE) as a first-line option to treat myeloma in England and Wales. 10 October 2024
Biotechnology
The US Food and Drug Administration (FDA) has granted the Gilead Sciences subsidiary Kite a Regenerative Medicine Advanced Therapy Designation (RMAT) for Yescarta (axicabtagene ciloleucel) for adults with newly-diagnosed, high-risk large B-cell lymphoma (LBCL). 3 October 2024
Pharmaceutical
AstraZeneca’s supplemental New Drug Application (sNDA) for Calquence (acalabrutinib) has been accepted and granted Priority Review in the USA for the treatment of adults with previously untreated mantle cell lymphoma (MCL). 3 October 2024
Biotechnology
Dutch biotech VarmX has been awarded up to 17.5 million ($20.4million) from the European Innovation Council (EIC) Accelerator, subject to negotiation, to upscale and accelerate cost effective manufacturing of its lead compound, VMX-C001. 21 October 2021
Biotechnology
Shares of Omeros Corporation plummeted nearly 27% to $5.67 by close of trading Monday, as the US biotech revealed another setback in its development of narsoplimab. 19 October 2021
Biotechnology
One of the latest developments in medicine is the advent of cell and gene therapies (CGTs). Cell therapies include cellular immunotherapies, cancer vaccines, and stem cells. Gene therapies are designed to modify the expression of specific genes or alter the biological properties of cells for the treatment of diseases. 18 October 2021
Biotechnology
Following its meetings over October 11-14, the European Medicines Agency’s human medicines committee, the CHMP, today recommended five novel medicines and one generic for approval. 15 October 2021
Biotechnology
London-listed blood disease specialist Hemogenyx Pharmaceuticals has signed a license agreement with US pharma major Eli Lilly. 13 October 2021
Pharmaceutical
Protagonist Therapeutics saw its share leap nearly 100% to $35 after the company revealed that the US Food and Drug Administration has lifted the full clinical hold on its rusfertide clinical studies, announced on September 17, 2021. 13 October 2021
Biotechnology
Shares of US drug develop Sutro Biopharma gained around 3% to $19.21 in early trading today, as the company announced an option agreement for Chinese firm BioNova Pharmaceuticals to develop and commercialize STRO-001, a CD74-targeting antibody-drug conjugate (ADC), for patients with hematologic cancers, in Greater China, including mainland China, Hong Kong, Macau and Taiwan. 12 October 2021
Biotechnology
Ahead of the potential takeover of Swedish Orphan Biovitrum by private equity firm Advent International and Singapore wealth fund GIC, the Stockholm-based firm has provided details of its financial position. 12 October 2021
Pharmaceutical
Spanish plasma specialist Grifols says it has closed its issuance of senior unsecured notes for the equivalent of 2 billion euros ($2.32 billion) to finance its investment in Biotest AG.
The issuance, launched on September 6 October 2021
Biotechnology
For the first time in 20 years, a new therapy for sickle cell disease is to be made available on the UK's National Health Service (NHS). 5 October 2021
Biotechnology
US biotech Xencor saw its shares gain 5.5% by close of trading and a further 2% to $36.23 after hours, following its revelation of a second deal with US health care giant Johnson & Johnson. 5 October 2021
Biotechnology
Seattle, USA-based biotech Omeros Corporation saw its shares plummet 38% to $8.54 on Friday, as it revealed that the US Food and Drug Administration notified the company that its marketing application for narsoplimab could not be approved. 4 October 2021
Biotechnology
The US Food and Drug Administration has granted approval for Tecartus (brexucabtagene autoleucel) for the treatment of adult patients (18 years and older) with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL), scoring a first for Kite. 2 October 2021
Pharmaceutical
High-risk MDS, often referred to as preleukemia, is a chronic form of blood cancer with a significant level of unmet medical need. While no new therapies have been approved in over a decade, that may be about to change, with multiple drugmakers making significant progress. 1 October 2021
Biotechnology
Spanish plasma-derived medicines company Grifols has announced that Tavlesse (fostamatinib), used to treat chronic immune thrombocytopenia (ITP) in adult patients refractory to other treatments, is now available in France, Italy and Spain and reimbursable from their respective health systems. 29 September 2021
Biotechnology
US hematopoietic cell transplant therapies biotech Jasper Therapeutics says it has completed its business combination with Amplitude Healthcare Acquisition Corporation, a special purpose acquisition company (SPAC) sponsored by affiliates of Avego Management and Metalmark Capital. 27 September 2021
Biotechnology
US epigenetic therapies company Epizyme has presented new data on its approved product, Tazverik (tazemetostat), at the European Society for Medical Oncology (ESMO) Congress 2021. 20 September 2021
Biotechnology
Last week’s significant news included AbbVie and Regenxbio entering into a potential $1.75 billion collaboration on an ophthalmic gene therapy RGX-314. The UK government terminated a supply agreement for French vaccine maker Valneva’s COVID-19 vaccine VLA2001 that could have been worth $1.66 billion, claiming breach of contract by the company. Meantime, US biotech Regeneron Pharmaceuticals was awarded another US government contract for the COVID-19 cocktail treatment REGEN-COV developed and marketed with Swiss pharma giant Roche worth $2.94 billion. Also, Spain’s Grifols said it will acquire German rival Biotest to enhance its stake in the plasma product sector. 19 September 2021
Pharmaceutical
Spanish plasma specialist Grifols today proposed a 1.6 billion-euro ($1.9 billion) takeover of its German rival Biotest, in a move to consolidate the plasma-based drug industry. , 17 September 2021
Biosimilars
The European Medicines Agency ’s human medicines committee (CHMP) recommended five novel medicines and two biosimilars for approval at its September 2021 meeting. 17 September 2021
Sign up to receive email updates
Join industry leaders for a daily roundup of biotech & pharma news
Today's issue
Company Spotlight
A US biotech company dedicated to creating oral drugs with an emphasis on indications in virology and immunology.
Copyright © The Pharma Letter 2024 | Headless Content Management with Blaze