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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
Pharmaceutical
Swiss oncology specialist Helsinn and Danish anemia drugmaker Pharmacosmos have entered into an agreement to exclusively commercialize Monofer (iron isomaltoside 1000) in the USA. 8 January 2015
Pharmaceutical
Independent UK pharma company Shield Therapeutics has received acceptance for review of the Marketing Authorization Application for Ferracru (ST10, ferric maltol) by the European Medicines Agency. 7 January 2015
Pharmaceutical
The global plasma fractionation market is witnessing continuous growth. The rise in aging population worldwide is an important factor for this market, mainly because the risk of complications of hemophilia, such as inhibitor development, intracranial hemorrhage, and joint diseases, increases along with the age of a person. 6 January 2015
Pharmaceutical
Japanese drug major Daiichi Sankyo has received approval in Japan for the manufacture and marketing of the methemoglobinemia treatment, Methylene Blue Injection 50mg (methylthioninium chloride hydrate) for toxic methemoglobinemia. 5 January 2015
Pharmaceutical
Japan’s largest drugmaker Takeda Pharmaceutical has entered into an agreement with US drugmaker AMAG Pharmaceuticals to mutually terminate the March 2010 license, development and commercialization agreement for ferumoxytol in ex-USA territories 30 December 2014
Pharmaceutical
USA-based CSL Behring, a unit of Australia’s CSL Ltd, has submitted a biologics license application (BLA) to the US Food and Drug Administration for the marketing authorization of its long-acting fusion protein linking recombinant coagulation factor IX with recombinant albumin (rIX-FP). 18 December 2014
Biotechnology
US biotech major Gilead Sciences has appointed Philippe Bishop as senior vice president of hematology and oncology therapeutics. 15 December 2014
Biotechnology
US gene therapy start up Spark Therapeutics has entered into a global collaboration with pharma giant Pfizer for the development and potential commercialization of SPK-FIX, a development program advancing proprietary, bio-engineered adeno-associated virus (AAV) vectors for the potential treatment of hemophilia B. 10 December 2014
Pharmaceutical
Danish diabetes major Novo Nordisk yesterday presented a new analysis of Phase III data demonstrating that people with hemophilia A who had the highest annualized bleeding rate (ABR) during initial treatment with NovoEight (turoctocog alfa) showed the largest reduction in bleeding over the duration of treatment 8 December 2014
Pharmaceutical
German pharma major Bayer has filed an application for marketing authorization to the European Medicines Agency for BAY 81-8973, a recombinant Factor VIII (rFVIII) compound, for the treatment of hemophilia A in children and adults. 6 December 2014
Pharmaceutical
German pharma major Bayer gave a spirited presentation of its pipeline candidates in both pharma and crop sciences at a “Perspective on Innovation 2014” meeting with journalists yesterday at its Leverkusen headquarters. 3 December 2014
Pharmaceutical
Nordic biotech firm Swedish Orphan Biovitrum will exercise its opt-in right to take over final development and commercialization of Elocta (rFVIIIFc) for the territory composed of Europe, North Africa, Russia and most Middle Eastern markets. 21 November 2014
Pharmaceutical
The US subsidiary of German family-owned pharma major Boehringer Ingelheim has presented Phase I study sub-analyses showing that its investigational antidote idarucizumab reverses the effects of Pradaxa (dabigatran etexilate mesylate), on fibrin formation in healthy volunteers. 19 November 2014
Biotechnology
Onxeo, created by a merger between French company BioAlliance Pharma, and Danish biopharmaceutical company Topotarget, confirmed receipt of $25 million related to the approval of Beleodaq (belinostat). 14 November 2014
Biotechnology
Geron Corp has entered into an exclusive worldwide license and collaboration agreement with Janssen Biotech, a subsidiary of US health care giant Johnson & Johnson, to develop and commercialize, imetelstat. 14 November 2014
Pharmaceutical
Generic and branded specialty pharma company Par Pharmaceuticals has received approval for its New Drug Application for Vasostrict (vasopressin injection, USP) from the US Food and Drug Administration. 13 November 2014
Pharmaceutical
German family-owned drug major Boehringer Ingelheim has initiated a global Phase III study on idarucizumab, in clinical settings where Pradaxa (dabigatran etexilate mesylate) patients may require emergency intervention or experience an uncontrolled or life-threatening bleed. 12 November 2014
Pharmaceutical
At its meeting last week, the European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) made recommendations on products that contain Factor VIII and discussed a fatality in a patient treated with Tecfidera. 9 November 2014
Pharmaceutical
A study carried out by the US Food and Drug Administration on Pradaxa (dabigatran etexilate mesylate) has found that the drug was associated with significantly reduced risks of ischemic stroke, intracranial hemorrhage and death, and a significantly increased risk of major gastrointestinal hemorrhage, compared with warfarin in patients with non-valvular atrial fibrillation. 3 November 2014
Biotechnology
Biotechnology companies Biogen Idec of the USA and Swedish Orphan Biovitrum said on Friday that the European Medicines Agency has validated the Marketing Authorization Application (MAA) of Elocta (rFVIIIFc), for the treatment of hemophilia A. 1 November 2014
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