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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
Biotechnology
California, USA-based Lyell Immunopharma (Nasdaq: LYEL) has entered into a definitive agreement to acquire privately-held US CAR-T company ImmPACT Bio. 26 October 2024
Pharmaceutical
Sanofi reported 15.7% sales growth for the third quarter of the year, reaching 13.4 billion euros ($14.2 billion), with adjusted earnings per share (EPS) rising by 12.2% to 2.86 euros, surpassing many forecasts. 25 October 2024
Biotechnology
Johnson & Johnson has secured European approval for an expanded indication of Darzalex (daratumumab) in a subcutaneous formulation. 24 October 2024
Biotechnology
Swedish Orphan Biovitrum, the Nordic biotech company also known as Sobi, today announced significantly improved financial results for the third quarter of 2024, sending the firm’s shares up 2.5% to 333.60 kronor in early trading. 24 October 2024
Biotechnology
US clinical-stage biotech AvenCell Therapeutics announced that it has raised $112 million in Series B financing, which was led by global life sciences investor Novo Holdings. 23 October 2024
Pharmaceutical
Swiss pharma giant Roche this morning reported that, in the first nine months of 2024 group sales increased by 6% at CER (2% in francs) to 45.0 billion francs ($52.0 billion). 23 October 2024
Pharmaceutical
UK pharma major AstraZeneca’s Alexion Rare Disease unit has received a positive recommendation for Voydeya (danicopan), from the UK’s National Institute for Health and Care Excellence (NICE). 22 October 2024
Biotechnology
The European Medicines Agency’s (EMA) human health committee, CHMP, announced six positive opinions of novel medicines, as well as two biosimilars, following its October meeting. 18 October 2024
Biotechnology
The US Food and Drug Administration (FDA) on Friday approved US pharma giant Pfizer’s Hympavzi (marstacimab-hncq). 14 October 2024
Biotechnology
US healthcare giant Johnson & Johnson’s Tecvayli (teclistamab) has been recommended by the National Institute for Health and Care Excellence (NICE) as a first-line option to treat myeloma in England and Wales. 10 October 2024
Biotechnology
The US Food and Drug Administration (FDA) has granted the Gilead Sciences subsidiary Kite a Regenerative Medicine Advanced Therapy Designation (RMAT) for Yescarta (axicabtagene ciloleucel) for adults with newly-diagnosed, high-risk large B-cell lymphoma (LBCL). 3 October 2024
Pharmaceutical
AstraZeneca’s supplemental New Drug Application (sNDA) for Calquence (acalabrutinib) has been accepted and granted Priority Review in the USA for the treatment of adults with previously untreated mantle cell lymphoma (MCL). 3 October 2024
Generics
PSK Pharma, a Russian drugmaker that is part of the local Rus Biopharm Group, is looking to become one of the leading pharmaceutical companies in Russia in the coming years to come, achieving this by a significant increase of its output and expansion of its range, reports The Pharma Letter’s local correspondent. 10 January 2023
Biotechnology
Boston, USA-based Ensoma, a genomic medicines company developing one-time in vivo treatments that precisely engineer any cell of the hematopoietic system, has announced the completion of an $85 million financing. 9 January 2023
Biotechnology
Among featured research news last week, US pharma giant Pfizer impressed when it released positive Phase III data on its hemophilia B gene therapy fidanacogene elaparvovec. Italian drugmaker Newron Pharmaceuticals last Monday released what it called “compelling” trial results for its antipsychotic candidate evenamide. Also, Deciphera Pharmaceuticals last Tuesday touted the benefits of its gastrointestinal stromal tumor (GIST) drug Qinlock. Kicking off the 2023 M&A season, US mRNA specialist Moderna last Wednesday announced its first ever full acquisition, that of Japanese firm OriCiro Genomics for $85 million. Fate Therapeutics has terminated its deal with Johnson & Johnson subsidiary Janssen to develop CAR-T cell therapies for cancer targets. 8 January 2023
Biotechnology
Armed with promising new data from the Phase III interim analysis, Japan’s largest drugmaker Takeda says it aims to seek marketing authorization for TAK-755 as the first recombinant ADAMTS13 (rADAMTS13) for a disorder with considerable unmet patient need. 6 January 2023
Biotechnology
The US Food and Drug Administration (FDA) yesterday accepted Biologics License Applications (BLAs) from Swiss pharma giant Roche and Belgium’s UCB, and granted them accelerated review. 6 January 2023
Biotechnology
It has been a long road for Geron’s telomerase blocker, but the company is now finally planning a commercial launch for imetelstat in 2024. 5 January 2023
Biotechnology
Switzerland-based biotech ADC Therapeutics today announced the appointment of Dr Mohamed Zaki as chief medical officer, bringing over 20 years of experience in hematology and oncology drug development to his role. 4 January 2023
Biotechnology
USA-based Legend Biotech Corporation has announced that China’s National Medical Products Administration (NMPA) has formally accepted its New Drug Application (NDA) for ciltacabtagene autoleucel (cilta-cel). 3 January 2023
Biotechnology
A marketing authorization submission for talquetamab - an immunotherapy with the potential to shake up the multiple myeloma market - is now sat on regulators’ desks at the European Medicines Agency. 3 January 2023
Biotechnology
Slightly earlier than expected, US pharma giant Pfizer last week announced positive top-line results from the Phase III BENEGENE-2 study evaluating fidanacogene elaparvovec, an investigational gene therapy, for the treatment of adult males with moderately severe to severe hemophilia B. 3 January 2023
Biotechnology
The Indian pharma market is increasing at an annual growth rate of 15%, twice the world market growth rate, and has become one of the most expansive sectors in India. While the pharma industry is expected to grow to $130 billion by 2030, there are deep seated challenges posed at this industry when it comes to rare disease management. 30 December 2022
Biotechnology
Japan’s Ministry of Health, Labor and Welfare (MHLW) has approved anti-cancer agent/humanized anti-CD20 monoclonal antibody Gazyva (obinutuzumab [genetical recombination]) intravenous infusion for an additional indication of CD20-positive chronic lymphocytic leukemia (including small lymphocytic lymphoma). 27 December 2022
Biotechnology
The market position of Bristol Myers-Squibb’s Abecma (idecabtagene vicleucel; ide-cel) for the treatment of relapsed or refractory multiple myeloma (RRMM), is facing a serious threat from a relatively novel class of drugs known as bispecific T-cell engagers (BiTEs), as they leverage clinical advantages such as improved duration of response to therapy and quicker administration. 27 December 2022
Biotechnology
US health technology assessor the Institute for Clinical and Economic Review (ICER) today released a Final Evidence Report assessing the comparative clinical effectiveness and value of two gene therapies intended for the treatment of hemophilia A and B. 22 December 2022
Biotechnology
Bayer subsidiary Asklepios BioPharmaceutical (AskBio) has drawn attention to the role of its own adeno-associated virus technology in all US Food and Drug Administration-approved gene therapies of this type. 22 December 2022
Biotechnology
The European Commission (EC) has granted conditional marketing authorization for the use of Zynlonta (loncastuximab tesirine) for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL), Swedish Orphan Biovitrum, also known as Sobi, and Switzerland’s ADC Therapeutics announced today. 21 December 2022
Pharmaceutical
Japan’s Daiichi Sankyo today announced it has launched Ezharmia (valemetostat tosilate), a first-in-class dual inhibitor of EZH1 and EZH2, in Japan for the treatment of patients with relapsed or refractory adult T-cell leukemia-lymphoma (ATLL). 20 December 2022
Biotechnology
Clinical-stage US biotech Mustang Biotech, which is focused on cell and gene therapies for hematologic cancers, solid tumors and rare genetic diseases, today provided updates on its CAR-T portfolio and 2023 anticipated milestones. 19 December 2022
Pharmaceutical
UK specialty pharma firm Shield Therapeutics has entered into an exclusive, multi-year agreement with US generics major Viatris to co-commercialize Accrufer (ferric maltol), a novel, oral iron therapy differentiated from other conventional irons by its efficacy, well-tolerated formulation, and broad indication, in the USA. 17 December 2022
Biotechnology
The European Medicines Agency’s human medicines committee (CHMP) recommended four novel medicines for approval at its December 2022 meeting. A final approval decision from the European Commission can be expected within the next two or three months. 16 December 2022
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