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Biotechnology
Arsia Therapeutics, a Cambridge, USA-based start-up company, today announced a major collaboration with biotech giant Biogen. 16 December 2015
Pharmaceutical
Akebia Therapeutics and Japan’s Mitsubishi Tanabe Pharma have entered into a development and commercialization agreement for vadadustat (formerly AKB-6548). 14 December 2015
Biotechnology
Syncona and UCL Business (UCLB), the wholly-owned technology transfer company of University College London, have created the biopharmaceutical company, Freeline Therapeutics, to develop and commercialize gene therapies for bleeding and other debilitating disorders. 14 December 2015
Pharmaceutical
Bayer and its development partner Janssen Pharmaceuticals today presented results from two real world studies – the non-interventional XALIA study in patients with deep vein thrombosis (DVT) and a study looking at patients with cancer-associated thrombosis (CAT). 10 December 2015
Biotechnology
The US Food and Drug Administration late Tuesday announced it has approved Vonvendi, (von Willebrand factor [Recombinant]), for use in adults 18 years of age and older who have von Willebrand disease (VWD). 9 December 2015
Biotechnology
Biotherapeutics company CSL Behring says it is expanding its geographic reach by opening operations in Russia. This is particularly significant in Russia where the health care system has some unmet needs for state-of-the-art biotherapies and blood plasma products, the company said. 8 December 2015
Biotechnology
US biotech major Amgen said new data from mid-stage trials for Blincyto (blinatumomab) to treat lymphoblastic leukemia (ALL) support the efficacy and safety of the drug 8 December 2015
Biotechnology
The US Food and Drug Administration has granted Breakthrough Therapy designation status to California-headquartered oncology biopharma specialist Kite Pharma’s lead product candidate, KTE-C19. 7 December 2015
Biotechnology
US biotech major Celgene Corp and Anglo-Swedish pharma firm AstraZeneca have initiated the FUSION clinical development program of durvalumab (MEDI4736), an investigational human monoclonal antibody directed against programmed cell death ligand 1 (PD-L1) in hematologic disorders. 7 December 2015
Biotechnology
bluebird bio has presented new data from the ongoing HGB-205 and HGB-206 clinical studies evaluating its LentiGlobin BB305 product candidate in patients with beta-thalassemia major and severe sickle cell disease. 7 December 2015
Pharmaceutical
The European Commission has granted marketing authorization for Praxbind (idarucizumab), a treatment to rapidly and specifically reverse the anticoagulant effects of Pradaxa (dabigatran etexilate) in cases of emergency surgery/urgent procedures or in situations of life-threatening or uncontrolled bleeding. 27 November 2015
Biotechnology
The European Commission has approved Elocta (rFVIIIFc) for the treatment of hemophilia A in all 28 European Union member states, as well as Iceland, Liechtenstein and Norway. 24 November 2015
Generics
Beximco has become the first Bangladeshi company to receive US Food and Drug Administration approval for a prescription drug manufactured in the country for export to the USA. 19 November 2015
Generics
Indian drugmaker Dr Reddy's Laboratories has completed the purchase of worldwide exclusive intellectual property rights for fondaparinux sodium, its generic anti-coagulant drug, from its Australian partner Alchemia. 18 November 2015
Biosimilars
The US Food and Drug Administration has accepted the regulatory submission by Sandoz, the generics division of Novartis, for its biosimilar pegfilgrastim. 18 November 2015
Biotechnology
US biotech firm Baxalta said on Friday that the US Food and Drug Administration has approved Adynovate [antihemophilic Factor (recombinant), PEGylated], an extended circulating half-life recombinant Factor VIII (rFVIII) treatment for hemophilia A. 14 November 2015
Pharmaceutical
US drug developer Portola Pharmaceuticals has updated on its development of its investigational antidote to the anticoagulant effects of FXa inhibitors, noting results of the Phase III ANNEXA study have been published online in the New England Journal of Medicine. 12 November 2015
Pharmaceutical
Swiss pharma giant Novartis’ development of the FLT3 inhibitor midostaurin could at long last be nearing the finish line, courtesy of a large, investigator-sponsored acute myeloid leukemia study whose results have been given pride of place at the American Society of Hematology (ASH) meeting’s plenary session due to take place next month, comment analysts at EP Vantage, the editorial arm of Evaluate. 10 November 2015
Pharmaceutical
Boehringer Ingelheim yesterday presented results from two new analyses evaluating idarucizumab, recently approved under the Accelerated Approval pathway and marketed in the USA as Praxbind, a specific reversal agent for its blockbuster anticoagulant Pradaxa (dabigatran etexilate mesylate) at the American Heart Association (AHA) Scientific Sessions 2015 in Orlando. 10 November 2015
Biotechnology
US biotech firm Baxalta, currently the subject of a $30.6 billion hostile takeover approach form Shire, today reported strong third quarter financial results, exceeding its previously-issued sales and earnings guidance. 29 October 2015
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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