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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
Biosimilars
USA-based Hospira, a leading provider of generic injectable drugs and infusion technologies, announced that its biosimilar epoetin, Retacrit (epoetin zeta), was effective in the management of chemotherapy-induced anemia in patients with solid tumors, lymphoma and myeloma. 24 July 2014
Pharmaceutical
German family-owned drug major Boehringer Ingelheim has been accused of withholding ‘important analyses’ from regulators regarding its anticoagulant Pradaxa (dabigatran). 24 July 2014
Generics
In a second acquisition this month, India’s Strides Arcolab has entered into an agreement with Bafna Pharmaceuticals to acquire majority (74%) stake of its India Branded Generics Business for a cash consideration of 481 million rupees (about $8 million). 22 July 2014
Pharmaceutical
US pharma giant Pfizer today released positive results of a Phase III study comparing a prophylaxis regimen of BeneFIX Coagulation Factor IX (recombinant) 100 IU/kg once-weekly to on-demand treatment in people with moderately severe to severe hemophilia B. 16 July 2014
Pharmaceutical
German drug major Bayer is just one of the latest companies to be facing lawsuits over its anticoagulants, according to Reuters. 16 July 2014
Pharmaceutical
Four elderly French people who had taken Praxada to present strokes died of hemorrhages last year, although studies from the Agency for the Safety of Health Products (ANSM) and the National Health Insurance Fund for Employees (CNAMTS) has concluded that modern oral anticoagulants are not more dangerous than older treatments like vitamin K antagonists. 15 July 2014
Pharmaceutical
German family-owned drug major Boehringer Ingelheim says that Pradaxa (dabigatran etexilate) will be commercially available in the UK from today for the treatment and prevention of deep vein thrombosis (DVT) and pulmonary embolism (PE). 15 July 2014
Pharmaceutical
The European Committee for Orphan Medicinal Products (COMP) gave a positive opinion recommending the approval of US drugmaker OPKO Health’s orphan drug designation for OPKO's long-acting version of clotting Factor VIIa (Factor VIIa-CTP) for the treatment of bleeding episodes in patients with hemophilia A or B, with inhibitors to Factor VIII or Factor IX and congenital Factor VII deficiency. 10 July 2014
Biotechnology
US drugmaker Baxter International said yesterday that it has acquired AesRx, a private US biopharmaceutical company focused on orphan drug targets, including the development and commercialization of Aes-103, an investigational prophylactic treatment for sickle cell disease (SCD). 10 July 2014
Pharmaceutical
Danish diabetes care giant Novo Nordisk’s hemophilia treatment NovoSeven RT (coagulation factor VIIa [recombinant]) has received approval for an additional indication in the USA. 9 July 2014
Pharmaceutical
Bone marrow transplants can reverse severe sickle cell disease in adults, according to new data published in the Journal of the American Medical Association. 3 July 2014
Biotechnology
USA-based venture capital;-backed biotech Dimension Therapeutics has entered into a collaboration with German drug major Bayer for the development and commercialization of a novel gene therapy for the treatment of hemophilia A. 22 June 2014
Pharmaceutical
UK pharma major GlaxoSmithKline announced the results from the Phase III PETIT2 study evaluating the efficacy of eltrombopag versus placebo in pediatric patients with chronic immune (idiopathic) thrombocytopenic purpura (cITP) at the European Haematology Association annual congress in Milan, Italy. 16 June 2014
Pharmaceutical
Janssen-Cilag International, a subsidiary of US health care giant Johnson & Johnson, announced Phase III study data of investigational use of a Velcade (bortezomib)-based combination in the treatment of patients with mantle cell lymphoma (MCL) who were newly-diagnosed and unsuitable, or not considered, for a stem-cell transplant, at the European Hematology Association annual congress in Milan, Italy. 16 June 2014
Pharmaceutical
Among companies presenting results from across the board at the European Hematology Association annual congress in Milan, Italy, was US biotech company Celgene Corp. 16 June 2014
Biotechnology
US biotech Geron Corp's shares jumped around 27% to $3.31 in early afternoon trading yesterday after the company revealed that the US Food and Drug Administration has removed the partial clinical hold on the investigator-sponsored clinical trial of imetelstat in myelofibrosis, a rare form of blood cancer (Myelofibrosis IST). 13 June 2014
Biotechnology
Dutch/Belgian preclinical stage biotech company arGEN-X, has entered into a partnership with The Leukemia & Lymphoma Society, the world's largest voluntary health agency dedicated to blood cancer, which is headquartered in the USA. 10 June 2014
Biotechnology
The US Food and Drug Administration on Friday approved US biotech firm Biogen Idec’s Eloctate, antihemophilic factor (Recombinant), Fc fusion protein, for use in adults and children who have hemophilia A. The company’s shares edged 1% higher in after hours trading to $320.70. 9 June 2014
Pharmaceutical
Hematologists in China estimate that Glivec (imatinib) from Swiss drug major Novartis will lose nearly half of its patient share for treatment of chronic myeloid leukemia (CML) in the next three years due to the market entry of generic imatinib, according to research by Decision Resources Group. 3 June 2014
Pharmaceutical
Vifor Pharma, a part of Switzerland-based Galenica Group which develops pharmaceutical products for the treatment of iron deficiency, has published results of its FIND-CKD study demonstrating that compared to oral iron, Ferinject (intravenous ferric carboxymaltose) quickly maintains Hb levels and reduces the need for other anemia management. 3 June 2014
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