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Biotechnology
The US Food and Drug Administration on Friday approved Mylotarg (gemtuzumab ozogamicin) for adults with newly-diagnosed CD33-positive acute myeloid leukemia (AML), and adults and children two years and older with relapsed or refractory CD33-positive AML. 2 September 2017
Pharmaceutical
News on chimeric antigen receptor T-cell (CAR-T) therapies in the last week has added to the immediacy of a question that has been hanging over these individually-tailored cancer treatments as they have edged closer to market – how on earth are health systems going to afford them? 1 September 2017
Pharmaceutical
At its late August meeting, the European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) has recommended that modified- or prolonged-release paracetamol products (designed to release paracetamol slowly over a longer period than the usual immediate-release products) should be removed from the market. 1 September 2017
Biotechnology
The US Food and Drug Administration (FDA) has accepted for review a supplemental New Drug Application (sNDA) based on data demonstrating that Kyprolis (carfilzomib) and dexamethasone reduced the risk of death and increased overall survival versus Velcade (bortezomib) and dexamethasone in patients with relapsed or refractory multiple myeloma. 31 August 2017
Generics
Following a public comment period, the Federal Trade Commission (FTC) has approved a final order designed to remedy the anticompetitive effects resulting from Baxter International’s proposed $625 million acquisition of India-based Claris Lifesciences’ injectable drugs business. 31 August 2017
Pharmaceutical
The Australian government is listing almost half a billion dollars’ worth of new medicines, providing sufferers of both common and rare diseases access to life-changing drugs for as little as A$6.30 ($5.00) per script. 30 August 2017
Biotechnology
CSL Behring, a subsidiary of Australia’s CSL Limited, has agreed to acquire Calimmune, a US biotechnology company focused on the development of ex vivo hematopoietic stem cell (HSC) gene therapy with R&D facilities in Pasadena, California, and Sydney, Australia. 29 August 2017
Biotechnology
Swiss pharma giant Roche’s regulatory application for emicizumab in hemophilia A has been given priority review status by the US Food and Drug Administration. 24 August 2017
Biotechnology
The European Commission today approved the extension of the indication for USA-based Alexion Pharmaceuticals’ Soliris (eculizumab) to include the treatment of refractory generalized myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor (AChR) antibody-positive. 21 August 2017
Biotechnology
Hours after US pharma giant Pfizer announced the news of regulatory approval for its drug Besponsa (inotuzumab ozogamicin) in the USA, the company suffered a setback with its attempts to sell the drug in the UK. 18 August 2017
Biotechnology
In timely fashion, US pharma giant Pfizer has received US Food and Drug Administration (FDA) approval for Besponsa (inotuzumab ozogamicin) for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). 18 August 2017
Pharmaceutical
A new coagulation reversal agen, Praxbind (idarucizumab) from German family-owned pharmaceutical company Boehringer Ingelheim, is now being used in Brazil, following marketing clearance earlier this year. 17 August 2017
Biotechnology
Australian biotech firm CSL Limited today announced a net profit after tax (NPAT) of $1,337 million (all figures US dollars) for the 12 months ended June 30, 2017. 16 August 2017
Pharmaceutical
Galena Biopharma and Sellas Life Sciences Group, a privately-held Swiss/Greek oncology-focused company, have entered into an all stock definitive merger agreement. 14 August 2017
Biotechnology
The Institute for Clinical and Economic Review (ICER) will develop a report assessing the comparative clinical effectiveness and value of emicizumab, from Swiss pharma giant Roche. 14 August 2017
Pharmaceutical
US specialty biopharmaceutical firm Mallinckrodt is to acquire InfaCare Pharmaceutical in a deal that could add up to $425 million. 4 August 2017
Pharmaceutical
The US Food and Drug Administration has approved Vyxeos (daunorubicin and cytarabine) liposome for injection for the treatment of adults with two types of acute myeloid leukemia (AML), a rapidly progressing and life-threatening blood cancer. 4 August 2017
Biotechnology
For the second time in two days, Anglo-Swedish pharma company AstraZeneca announced that the US Food and Drug Administration (FDA) had given Breakthrough Therapy Designation to one of its oncology medicines. 1 August 2017
Biotechnology
Chugai Pharmaceutical says it has filed a new drug application for its anti-coagulation factor IXa/X humanized bispecific monoclonal antibody emicizumab to the Ministry of Health, Labor and Welfare (MHLW). 24 July 2017
Pharmaceutical
Swiss pharma group Vifor Pharma has received European marketing authorization for Veltassa a sodium-free potassium binder for the treatment of hyperkalemia in adult patients. The company filed for approval in April 2016. 21 July 2017
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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