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
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
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
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
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
Syndax Pharmaceuticals has announced that its Phase II AUGMENT-101 trial of experimental drug revumenib achieved its primary endpoint. 13 November 2024
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
On November 8, the US Food and Drug Administration approved Aucatzyl (obecabtagene autoleucel; obe-cel) from US biopharma Autolus Therapeutics' 11 November 2024
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
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
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
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
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
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
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
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
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
AstraZeneca and its hematology subsidiary Acerta Pharma have presented new, long-term follow-up results for Calquence (acalabrutinib) at the annual meeting of the American Society of Hematology. 4 December 2018
The Novartis drug Promacta (eltrombopag) improved outcomes for immune thrombocytopenia (ITP) patients compared to other second-line therapies. 3 December 2018
US biotech firm Seattle Genetics’ shares gained 2.75% to $64.3-in pre-market trading today, after it highlighted data from the ECHELON-1 Phase III clinical trial evaluating Adcetris (brentuximab vedotin) at the ASH meeting. 3 December 2018
China’s BeiGene on Saturday announced clinical data from two ongoing trials of its investigational Bruton’s tyrosine kinase (BTK) inhibitor, zanubrutinib, in patients with mantle cell lymphoma (MCL), at the 60th Annual Meeting of the American Society of Hematology (ASH), taking place December 1-4, 2018 in San Diego, USA. 3 December 2018
Gilead Sciences company Kite Pharma released positive two-year efficacy and safety data from the pivotal ZUMA-1 trial of Yescarta (axicabtagene ciloleucel) in patients with refractory large B-cell lymphoma. 3 December 2018
The US Food and Drug Administration on Wednesday approved Xospata (gilteritinib) tablets for the treatment of adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation as detected by an FDA-approved test. 29 November 2018
US gene therapy company Rocket Pharmaceuticals yesterday announced that the US Food and Drug Administration has granted Regenerative Medicine Advanced Therapy (RMAT) and fast track designations to RP-L102, the company’s lentiviral vector (LVV)-based gene therapy for the treatment of Fanconi anemia (FA). 28 November 2018
The US Food and Drug Administration Wednesday approved Daurismo (glasdegib) tablets to be used in combination with low-dose cytarabine (LDAC), a type of chemotherapy, for the treatment of newly-diagnosed acute myeloid leukemia (AML). 22 November 2018
Promacta (eltrombopag), a drug from Swiss pharma giant Novartis that is marketed as Revolade in most countries outside the USA, has had its label expanded by the US Food and Drug Administration (FDA). 19 November 2018
Shares in Netherlands-based gene therapy company uniQure jumped over a third in trading on Thursday, after the firm announced positive data from a Phase IIb dose-confirmation study of AMT-061. 16 November 2018
The UK’s National Health Service (NHS) will pay for eligible English children and young people with pediatric acute lymphoblastic lymphoma (ALL) to be treated with Novartis’ CAR-T therapy Kymriah (tisagenlecleucel). 16 November 2018
After a number of setbacks on the path to market, US pharma giant Pfizer has announced the introduction of Retacrit (epoetin alfa-epbx) injection in the USA. 15 November 2018
The global market for drugs to treat myeloproliferative disorders is expected to be valued at $9.26 billion by 2023, expanding at a compound annual growth rate (CAGR) of 3.4% during the forecast period. 13 November 2018
Ireland-based drugmaker Jazz Pharmaceuticals has had its Vyxeos (daunorubicin and cytarabine) product for adults with specific types of secondary acute myeloid leukemia (AML) recommended for public funding in England and Wales. 8 November 2018