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Biotechnology
Shares in US biotech Portola Pharmaceuticals closed 3% up on Friday following news that the European Commission (EC) has granted conditional Marketing Authorization for Ondexxya (andexanet alfa). 29 April 2019
Pharmaceutical
Back on full form since its move to Amsterdam, the European Medicines Agency’s Committee for Medicinal Products for Human Use committee (CHMP) recommended nine novel medicines for approval at its April 2019 meeting. 27 April 2019
Pharmaceutical
Japanese drugmaker Astellas and US biotech Amgen have agreed to pay a total of $124.75 million to the Department of Justice (DoJ) in the USA over alleged kickbacks. 26 April 2019
Biotechnology
The USA’s Centers for Medicare & Medicaid Services (CMS) has proposed a rule that focuses the agency’s efforts on a singular objective: transforming the healthcare delivery system through competition and innovation to provide patients with better value and results. 25 April 2019
Biotechnology
Russia’s Research Institute of Highly Pure Biopreparations, a St Petersburg-based producer of active ingredients and drugs, plans to invest up to $20 million in the launch of production of certain drugs against anemia, as well as some active ingredients, with the aim of their further exports, according to the company, reports The Pharma Letter’s local correspondent. 24 April 2019
Biotechnology
Researchers at the University of Southern California (USC) claim that they have tweaked an immunotherapy molecule and created a cancer treatment with none of the severe side effects typically seen. 23 April 2019
Pharmaceutical
Japan’s largest drugmaker Takeda has officially launched the production of Advate (octocog alfa) - a drug for the treatment of patients with hemophilia A - at the facilities of its Russian partner, the Moscow-based Biocad plant. 16 April 2019
Biotechnology
Janssen has added the first two first data centers to a Europe-wide program to gain better real-world evidence (RWE) on blood cancers. 11 April 2019
Biotechnology
US biotech XOMA Corporation has agreed to acquire the rights to potential royalties and a portion of any milestone payments associated with five hematology assets from antithrombotic drugs specialist Aronora. 9 April 2019
Biotechnology
China’s biopharma start up Ascentage Pharma has entered into a strategic collaboration with Shanghai Junshi Biosciences to explore the synergies of Ascentage's inhibitor of apoptosis proteins (IAP) inhibitor APG-1387, and Junshi Biosciences' anti-PD-1 therapy toripalimab in clinical trials in solid and hematological tumors in China. 9 April 2019
Biotechnology
The research phase of the RNAi therapeutics collaboration between Sanofi and Alnylam Pharmaceuticals is over, the companies have announced. 8 April 2019
Biotechnology
US biotech major Celgene and Acceleron Pharma today announced that Celgene has submitted a Biologics License Application (BLA) for luspatercept, 8 April 2019
Biotechnology
The US Food and Drug Administration (FDA) has extended the review period for Daiichi Sankyo’s (TYO: 4568) quizartinib. 5 April 2019
Pharmaceutical
AstraZeneca’s approved asthma therapy Fasenra (benralizumab) looks likely to provide a much-needed treatment for a group of rare, potentially fatal disorders. 5 April 2019
Pharmaceutical
Sickle cell disease (SCD) is the most common inherited blood disorder in the USA, afflicting nearly 100,000 Americans. 3 April 2019
Biosimilars
Novartis’ USA-based generics division Sandoz has resubmitted a US application for a biosimilar version of pegfilgrastim. 3 April 2019
Biotechnology
Results of the Phase III ADMIRAL clinical trial comparing Xospata (gilteritinib) to salvage chemotherapy in adult patients with relapsed or refractory (resistant to treatment) acute myeloid leukemia (AML) with a FLT3 mutation were presented at the American Association for Cancer Research (AACR) Annual Meeting, which suggest the drug is even better than it seemed when it secured accelerated US approval last November. 2 April 2019
Biotechnology
A broker’s report on Alexion Pharmaceuticals has found that the popular perception of the US pharma as the 'Soliris (eculizumab) company' does not do justice to its pipeline. 28 March 2019
Biotechnology
Japan’s Ministry of Health, Labor and Welfare (MHLW) has approved Kymriah (tisagenlecleucel) for the treatment of two distinct indications – CD19-positive relapsed or refractory (r/r) B-cell acute lymphoblastic leukemia (ALL) and CD19-positive r/r diffuse large B-cell lymphoma (DLBCL). 26 March 2019
Pharmaceutical
Among regulatory news last week, Spectrum Pharmaceuticals suffered a setback when, following a US Food and Drug Administration request for further information, it withdrew its Biological License Application (BLA) for its neutropenia drug Rolontis. There was good news for Sage Therapeutics with FDA approval for its Zulresso, making it the first new drug to be cleared for the treatment of post-partum depression. Disappointing clinical trials featured strongly in last week’s news, most notably Biogen and Eisai’s decision to drop the development of their late-stage Alzheimer’s disease candidate aducanumab. Also, Germany’s Merck KGaA and Pfizer have ditched a Phase III trial of ovarian cancer drug Bavencio. 24 March 2019
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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