Hematology
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Pharmaceutical
The US Food and Drug Administration (FDA) has granted breakthrough therapy designation to a drug in Phase III development for relapsed/refractory FLT3-ITD AML, a very aggressive form of the disease associated with poor prognosis and no approved targeted treatments. 1 August 2018
Pharmaceutical
The US Food and Drug Administration approved Mulpleta (lusutrombopag) for thrombocytopenia in adults with chronic liver disease who are scheduled to undergo a medical or dental procedure. 1 August 2018
Biotechnology
China’s BeiGene says that its investigational BTK inhibitor zanubrutinib has been granted Fast Track designation by the US Food and Drug Administration for the treatment of patients with Waldenström macroglobulinemia (WM). 24 July 2018
Pharmaceutical
Swedish Orphan Biovitrum today announced financial results for the second quarter 2018 that beat analysts’ expectations. 18 July 2018
Pharmaceutical
Janssen has been on a good run of form recently. 16 July 2018
Pharmaceutical
Takeda announced on Wednesday that Ninlaro (ixazomib) achieved its primary endpoint in the Phase III TOURMALINE-MM3 trial oriented toward multiple myeloma treatment. 11 July 2018
Biotechnology
Results from a Phase III, randomized, double-blind, multi-center clinical study (BELIEVE) showed that luspatercept achieved a highly statistically-significant improvement in the primary endpoint of erythroid response, adding to earlier positive data a couple of weeks ago. 10 July 2018
Biotechnology
NHS England has approved the reimbursement of Hemlibra (emicizumab) for the prevention of bleeding episodes in adults and children with hemophilia A who have factor VIII inhibitors, according to the drug’s marketers. 7 July 2018
Biotechnology
There was good news for US pharma major Bristol-Myers Squibb yesterday, with an expanded approval for its already blockbuster blood cancer drug Sprycel (dasatinib) in Europe. 6 July 2018
Biotechnology
Celgene yesterday announced promising results from the OPTIMISMM study, a Phase III, randomized, open-label, international clinical trial of the investigational combination regimen of pomalidomide, bortezomib and dexamethasone in patients with relapsed or refractory multiple myeloma (RRMM) who had received at least one prior treatment including lenalidomide 4 July 2018
Biotechnology
Dutch biotech company VarmX, which focuses on the development of therapies in the field of hemostasis and thrombosis, today announced the closing of a Series A financing round of 7.5 million euros ($8.8 million). 2 July 2018
Biotechnology
Results from a Phase III, randomized, double-blind, multi-center clinical study (MEDALIST) showed that luspatercept achieved a highly statistically-significant improvement in the primary endpoint of red blood cell (RBC) transfusion independence of at least 8 consecutive weeks during the first 24 weeks compared to placebo. 29 June 2018
Pharmaceutical
US firms Akebia Therapeutics and Keryx Biopharmaceuticals have announced a definitive merger agreement under which the companies will combine in an all-stock merger. 29 June 2018
Pharmaceutical
Singapore-based Menarini Asia-Pacific Holdings and Japanese pharma major Daiichi Sankyo (TYO: 4568) have signed a multi-year exclusive licensing agreement for the former to assume the sales, marketing and distribution of the oral, once-daily, direct factor Xa inhibitor anticoagulant Lixiana (edoxaban) in the Philippines, Malaysia and Singapore, following respective regulatory approvals in those countries. 29 June 2018
Pharmaceutical
A revamped drug that can withstand extreme heat and stay effective for 1,000 days could "revolutionise the ability" to keep new mothers alive, the World Health Organization (WHO) says. 28 June 2018
Biotechnology
US biotech Global Blood Therapeutics is pretty confident that it will have important regulatory news on its sickle cell disease (SCD) candidate voxelotor by Christmas. 28 June 2018
Biotechnology
At its 2018 Investor and Analyst Event, Incyte's (Nasdaq: INCY) recent suffering continued with the announcement that it planned to scrap one of its clinical trials. 21 June 2018
Biotechnology
US development stage company TG Therapeutics and privately-held Swiss firm Novimmune have entered into an exclusive global agreement to collaborate on the development and commercialization of Novimmune’s novel first-in-class anti-CD47/anti-CD19 bispecific antibody known as TG-1801 (previously NI-1701). 20 June 2018
Biotechnology
Less than a week after setting up two new companies with a $35 million investment, life sciences trust Syncona is making more waves in gene therapy by contributing £85 million ($112 million) to Freeline Therapeutics' Series B funding campaign. 20 June 2018
Biotechnology
US biotech major Amgen yesterday announced that the European Commission (EC) has granted a full marketing authorization for Blincyto (blinatumomab) based on the overall survival (OS) data from the Phase III TOWER study. 20 June 2018
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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