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Last week’s research news included French pharma major Sanofi releasing mixed Phase III results for it tolebrutinib in progressive multiple sclerosis. Also of note, US vaccine developer Vaxcyte announced strong early-stage trial results for its VAX-31 in pneumococcal disease. On the regulatory front, US drugmaker Travere Therapeutics gained full approval from the US Food and Drug Administration (FDA) for its kidney disease drug Filspari. US cancer drug developer IN8bio announced a prioritization of its R&D pipeline to focus on INB-100 in acute myeloid leukemia, along with a workforce cutback. 8 September 2024
Biotechnology
Shares of US gamma-delta T cell therapies for cancer developer IN8bio closed down more than 7% yesterday and fell a further 3.2% to $0.465 pre-market, after it announced a major reshuffle. 5 September 2024
Biotechnology
Cambridge, UK-based clinical-stage biotech CellCentric has appointed Andy Fergus as chief development officer. 5 September 2024
Biotechnology
Rigel Pharmaceutical’s shares dipped 4.4% to $12 .85 by late morning, despite announcing what could be a lucrative deal for the company. 3 September 2024
Biotechnology
The treatment landscape for paroxysmal nocturnal hemoglobinuria (PNH) continues to evolve with the introduction of new therapies. 3 September 2024
Biotechnology
Marseille-based ImCheck Therapeutics has received 20.2 million euros ($22.4 million) in non-dilutive funding as part of the i-Démo call for projects under the France 2030 Plan operated by Bpifrance on behalf of the French government. 29 August 2024
Biotechnology
The European Commission has approved PiaSky (crovalimab), a novel recycling monoclonal antibody that inhibits the complement protein C5, from Swiss pharma giant Roche. 27 August 2024
Pharmaceutical
Last week’s research news featured a new study from Eli Lilly, showing tirzepatide – the active ingredient of its diabetes drug Mounjaro and obesity treatment Zepbound – can delay the onset of diabetes. On the financial reporting front, Denmark’s Lundbeck released strong first-half results and raised its full year guidance. A new company – Borealis Biosciences – emerged from stealth last week, with funding from Novartis and Versant Ventures. Also of note, US biotech major Regeneron had a setback, when the Food and Drug Administration (FDA) issued a complete response letter (CRL) regarding the biologics license application (BLA) for its multiple myeloma candidate linvoseltamab. 25 August 2024
Pharmaceutical
The Institute for Clinical and Economic Review (ICER) has published its final evidence report evaluating the clinical effectiveness and value of Rytelo (imetelstat), raising concerns about the drug's net health benefits and its high cost. 23 August 2024
Pharmaceutical
Russia plans to create conditions for a significant increase of domestic production of anti-Rhesus immunoglobulin drugs after a sharp decrease of their imports to the local market this year, reports The Pharma Letter’s local correspondent. 22 August 2024
Biotechnology
The US Food and Drug Administration (FDA) has issued a complete response letter (CRL) for the biologics license application (BLA) for linvoseltamab.. 21 August 2024
Biotechnology
US gene therapy company bluebird bio closed Wednesday’s trading 23% lower. 15 August 2024
Biotechnology
US oncology focused biotech Syros Pharmaceuticals announced that it will discontinue enrollment in the SELECT-AML-1 Phase II clinical trial. 14 August 2024
Biotechnology
CRISPR genome-editing biopharma company Caribou Biosciences has announced the appointment of Tina Albertson as chief medical officer (CMO). 13 August 2024
Biotechnology
Octapharma announced the results from the Phase III (LEX-209) study on the efficacy and safety of Balfaxar (prothrombin complex concentrate, human-lans) have been published by the American peer-reviewed journal JAMA Network Open. 13 August 2024
Biotechnology
Australian biotech CSL Limited today reported revenue of A$14.8 billion (US$9.7 billion) for the 12 months ended June 30, 2024. 13 August 2024
Biotechnology
US pharma giant Merck & Co is to buy CN201, an investigational clinical-stage bispecific antibody for the treatment of B-cell associated diseases, from privately-held Chinese biotech Curon Biopharmaceutical. 9 August 2024
Biotechnology
Citius Pharmaceuticals has won US Food and Drug Administration (FDA) approval for Lymphir (denileukin diftitox-cxdl), a novel immunotherapy for the treatment of relapsed or refractory (r/r) cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy. 9 August 2024
Biotechnology
Finland-based Faron Pharmaceuticals, a biopharma reprogramming myeloid cells to activate anti-tumor immunity in hematological and solid tumor microenvironments, has announced that its chief executive Markku Jalkanen is to retire. 7 August 2024
Pharmaceutical
Plenty of companies in the pharmaceutical industry talk the talk when it comes to focusing on patients. 6 August 2024
Biotechnology
An Expert View from Tomislav Kamenski, Senior Director, Therapy Area Market Access Leader, Hematology, Johnson & Johnson. 25 March 2024
Biotechnology
The European Medicines Agency’s (EMA) human medicines committee (CHMP) recommended six novel medicines for approval at its March 2024 meeting. 22 March 2024
Pharmaceutical
This year could be a crucial one for Maat Pharma, a French microbiome company with a focus on cancer. 22 March 2024
Biotechnology
The European Commission (EC) has granted expanded approval for the cell therapy Abecma (idecabtagene vicleucel; ide-cel). 21 March 2024
Pharmaceutical
The US Food and Drug Administration (FDA) has granted accelerated approved the supplemental new drug application (sNDA) for Iclusig (ponatinib). 20 March 2024
Biotechnology
The US Food and Drug Administration (FDA) has accepted the resubmission of US critical care specialist Citius Pharmaceuticals’ Biologics License Application (BLA) for Lymphir (denileukin diftitox). 19 March 2024
Biotechnology
Among research news last week, Swiss clinical-stage biotech MoonLake Immunotherapies held an R&D day, when it presented new data on its pipeline, emphasizing the success of its sonelokimab in psoriatic arthritis. Also, US pharma giant Pfizer released Phase III data on its Adcetris for the treatment of B-cell lymphoma. On the regulatory front, the US Food and Drug Administration (FDA) last week approved Mirum Pharmaceuticals’ Livmarli for the new indication of intrahepatic cholestasis (PFIC). Also of note, US pharma major ELI Lilly linked up with Amazon Pharmacy to make its products, including the new obesity drug Zepbound, available to patients. And the UK’s AstraZeneca announced a takeover bid for USA-based Amolyt Pharma for up to $1.05 billion. 17 March 2024
Biotechnology
Two meeting of the US Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) held on Friday resulted in recommendations for approval of two cell therapies – Abecma (idecabtagene vicleucel) and Carvykti (ciltacabtagene autoleucel. 16 March 2024
Biotechnology
The US Food and Drug Administration (FDA) has granted accelerated approval for a new indication of Breyanzi (lisocabtagene maraleucel; liso-cel), a CD19-directed chimeric antigen receptor (CAR) T cell therapy from US pharma major Bristol Myers Squibb (NYSE: BMY). 16 March 2024
Pharmaceutical
A US Food and Drug Administration (FDA) advisory panel has voted in favor of the clinical benefit/risk profile of imetelstat for transfusion-dependent (TD) anemia in adults with low-to-intermediate-1 risk myelodysplastic syndromes (LR-MDS) who have not responded to or have lost response to or are ineligible for erythropoiesis-stimulating agents (ESAs). 15 March 2024
Biotechnology
Britain’s health technology assessor (HTA) is moving to recommend against funding Casgevy (exagamglogene autotemcel), the second such blow for people with sickle cell disease (SCD) in the country. 15 March 2024
Biotechnology
Sweden-headquartered contract development and manufacturing organization (CDMO) Recipharm says that its ReciBioPharm unit has entered a collaboration agreement with GeneVentiv Therapeutics, a pre-clinical US gene therapy company 13 March 2024
Biotechnology
US pharma giant Pfizer today announced further positive data for its recently acquired Adcetris (brentuximab vedotin). 12 March 2024
Biotechnology
Shanghai-based CARsgen Therapeutics has announced that zevorcabtagene autoleucel (CT053), or zevor-cel, its autologous CAR T-cell developed for multiple myeloma, has been approved by China’s National Medical Products Administration (NMPA). 11 March 2024
Biotechnology
The US Food and Drug Administration granted accelerated approval for Brukinsa (zanubrutinib) with obinutuzumab for relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy. 8 March 2024
Biotechnology
The US Food and Drug Administration (FDA) late yesterday approved Pfizer’s antibody drug conjugate Besponsa (inotuzumab ozogamicin) to include patients one year of age and older with relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia (B-ALL). 7 March 2024
Biotechnology
UK pharma major GSK today announced positive headline results from an interim analysis of the DREAMM-8 Phase III head-to-head trial evaluating Blenrep (belantamab mafodotin). 7 March 2024
Biotechnology
China-headquartered oncology specialist BeiGene has announced a new matching adjusted indirect comparison (MAIC) of the efficacy of Brukinsa (zanubrutinib) versus acalabrutinib in relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL) based on data from the Phase III ALPINE and Phase III ASCEND trials. 1 March 2024
Biotechnology
There is a ray of hope for sickle cell disease (SCD) patients in the UK, after the British health technology assessor re-opened its review into Oxbryta (voxelotor). 1 March 2024
Pharmaceutical
Shares of biotech FibroGen leapt 14.6% to $2.12 by close of trading Tuesday, after it announced a deal with UK pharma major AstraZeneca for roxadustat would be terminated. 28 February 2024
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