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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
Pharmaceutical
The German Institute for Quality and Efficiency in Health Care (IQWiG) examined in an early benefit of AbbVie and Roche’s Venclexta/Venclexto (venetoclax) in combination with a hypomethylating agent (HMA) offers an added benefit over the appropriate comparator therapy for patients with newly diagnosed acute myeloid leukemia (AML) who are ineligible for intensive chemotherapy. 17 September 2021
Biotechnology
The US Food and Drug Administration has granted accelerated approval for Brukinsa (zanubrutinib) for the treatment of adult patients with relapsed or refractory (R/R) marginal zone lymphoma (MZL) who have received at least one anti-CD20-based regimen. 16 September 2021
Biotechnology
Following the transformational merger with DCprime in December 2020, Swedish biotech Immunicum now aims to become a global leader in off-the-shelf, allogeneic cell therapies, using its expertise in dendritic cell (DC) biology, comment analysts at Edison Investment Research. 15 September 2021
Biotechnology
The Center for Drug Evaluation of China’s National Medical Products Administration (NMPA) has granted Breakthrough Therapy designation (BTD) to amdizalisib (HMPL-689), a highly selective and potent PI3Kδ inhibitor, for the treatment of relapsed or refractory follicular lymphoma (FL), a subtype of non-Hodgkin’s lymphoma (NHL). 13 September 2021
Biotechnology
Shares of Centessa Pharmaceuticals were up 17.6% at $24.76 in early trading today after, together with subsidiary ApcinteX, it announced positive top-line results from the Phase IIa part of AP-0101, the six-month repeat dose portion of its ongoing first-in-human proof-of-concept study evaluating SerpinPC in severe hemophilia A and B patients. 9 September 2021
Biotechnology
Global Blood Therapeutics has announced that the US Food and Drug Administration (FDA) has accepted for filing and review two submissions relating to Oxbryta (voxelotor). 7 September 2021
Biotechnology
As part of its advice on safety-related aspects to other European Medicines Agency committees, the Pharmacovigilance Risk Assessment Committee (PRAC) last week discussed a direct healthcare professional communication (DHPC) containing important safety information for Imbruvica (ibrutinib). 6 September 2021
Biotechnology
Significant clinical trial news last week included AC Immune and Roche subsidiary Genentech reporting encouraging Phase II data on their Alzheimer’s disease candidate semorinemab, while Japan’s Takeda presented Phase III results for its myeloid leukemia hopeful pevonedistat that failed to meet study endpoints. Among regulatory news, Chinese biotech BeiGene received a second US Food and Drug Administration approval for Brukinsa, this time for the treatment of Waldenström’s macroglobulinemia. Also, the FDA finally released its much-anticipated review of JAK inhibitors, with damaging warnings on the safety of drugs, such as Pfizer’s Xeljanz, AbbVie’s Rinvoq and Eli Lilly’s Olumiant. 5 September 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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