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Biotechnology
28 November 2024 Johnson & Johnson has made significant strides in multiple myeloma treatment, with breakthroughs in targeted therapies like CAR-T and bispecific antibodies. At the 2024 ASH meeting, J&J aims to showcase progress, with a goal of achieving a functional cure for multiple myeloma.
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Biotechnology
Positive new data from the PREVENT trial evaluating the efficacy and safety of Cosentyx (secukinumab) in patients with nr-axSpA (non-radiographic axial spondyloarthritis) have been released by Swiss pharma giant Novartis. 17 September 2019
Biotechnology
While there are several commonly-cited reasons for the present pre-eminence of the Cambridge-Boston biotech cluster, it's clear that the hub is greater than the sum of its parts. 16 September 2019
Biotechnology
The US Food and Drug Administration (FDA) has been asked to approve Tremfya (guselkumab) in a second indication. 16 September 2019
Biotechnology
The world’s largest biotech firm Amgen on Friday announced positive Phase III CANDOR study results evaluating its Kyprolis (carfilzomib) in combination with dexamethasone and Johnson & Johnson’s Darzalex (daratumumab) (KdD) compared to Kyprolis and dexamethasone alone (Kd) for the treatment of multiple myeloma. 16 September 2019
Biotechnology
Danish CNS specialist Lundbeck saw its share rise by 5.7% to 249.90 Danish kroner after it revealed plans to acquire a significant migraine asset with the takeover of US drug developer Alder BioPharmaceuticals. 16 September 2019
Biotechnology
US biotech major Biogen] has completed registration of Spinraza (nusinersen), one of the world’s most expensive drugs, for the treatment of spinal muscular atrophy (SMA) in Russia, according to the Russian Ministry of Health, reports The Pharma Letter’s local correspondent. 16 September 2019
Biotechnology
A US Food and Drug Administration advisory panel on Friday voted in favor of recommending approval of the first peanut allergy treatment. 16 September 2019
Biotechnology
On Friday, the US Food and Drug Administration issued a safety warning on three already-marketed drugs used to treat some patients with advanced breast cancers, saying they may cause rare but severe inflammation of the lungs. 16 September 2019
Biotechnology
Castle Creek Pharmaceutical has reached an agreement to acquire Fibrocell Science, a cell and gene therapy company focused on transformational autologous cell-based therapies for skin and connective tissue diseases. 13 September 2019
Biotechnology
The US Food and Drug Administration has approved Nucala (mepolizumab) for use in children as young as six years old who are living with severe eosinophilic asthma. 13 September 2019
Biotechnology
As World Alzheimer’s Day 2019 approaches (September 21), with the aim this year of raising global awareness and understanding of the stigma, stereotypes and myths that surround a dementia diagnosis; Alessio Brunello, pharma analyst at GlobalData, comments: ‘‘Its timely to reflect that no new drug for Alzheimer’s disease AD) has been approved in the past 17 years, despite more than 400 clinical trials and billions of dollars being spent in an attempt to tackle the disease and address unmet needs.’’ 13 September 2019
Biotechnology
US clinical stage gene therapy company Tocagen saw its market cap decimated yesterday after posting negative late-stage results with its lead brain cancer candidate. 13 September 2019
Biotechnology
Roche today presented full pivotal Phase III study results for satralizumab as a monotherapy for neuromyelitis optica spectrum disorder (NMOSD), a rare, debilitating central nervous system disease. 12 September 2019
Biotechnology
Johnson & Johnson subsidiary has announced positive results from the Phase III OPTIMUM study for ponesimod, an investigational selective S1P1 receptor modulator, showing superior efficacy on the primary endpoint and most secondary endpoints compared to Sanofi’s Aubagio (teriflunomide) 14mg in adults with relapsing multiple sclerosis (MS). 12 September 2019
Biotechnology
A survey from industry analyst Spherix Global Insights suggests that more people may be using anti-calcitonin gene-related peptide (CGRP) therapies for episodic migraines than had been reported. 11 September 2019
Biotechnology
Cambridge, USA-based biotech Biogen has presented 10-year data on Tecfidera (dimethyl fumarate), demonstrating the long-term benefits for people with multiple sclerosis (MS). 11 September 2019
Biotechnology
German pain management specialist Grünenthal and Australia’s Mesoblast (ASX: MSB) today announced a strategic partnership to develop and commercialize MPC-06-ID. 10 September 2019
Biotechnology
Ireland-incorporated Horizon Therapeutics has announced that the US Food and Drug Administration has accepted the Biologics License Application (BLA) for teprotumumab, an investigational medicine for the treatment of active thyroid eye disease (TED), and granted it Priority Review designation. 10 September 2019
Biotechnology
Detailed results from the Phase III CASPIAN trial show that the checkpoint inhibitor Imfinzi (durvalumab) performed well as a first-line option for people with extensive-stage small cell lung cancer (SCLC). 9 September 2019
Biotechnology
Privately-held Israeli biotechnology company KAHR Medical today announced a new clinical collaboration with Swiss pharma giant Roche. 9 September 2019
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Biotechnology
AstraZeneca and Daiichi Sankyo’s breast cancer med Enhertu (trastuzumab deruxtecan) will be included in China’s state-run health insurance scheme from next year, boosting availability at the cost of reduced pricing. 29 November 2024
Biotechnology
Minghui Pharmaceutical has reported encouraging results from a Phase III trial of MH004 (tofacitinib etocomil) in mild to moderate atopic dermatitis (AD). 29 November 2024
Biotechnology
Allink Biotherapeutics, a Chinese start-up focused on bispecific antibody and antibody-drug conjugates (ADC), has raised $42 million in a financing round led by Lanchi Ventures. 29 November 2024
Biotechnology
China’s Innovent Biologics has announced that the updated 2024 National Reimbursement Drug List (NRDL) now includes Sintbilo (tafolecimab) injection, an anti-PCSK9 monoclonal antibody for the first time. The updated NRDL will be officially effective from January 1, 2025. 29 November 2024
Biotechnology
Zug-based Galderma has published positive results from the Phase III OLYMPIA 1 trial in JAMA Dermatology, as the company’s newly-minted shares change hands in record volumes. 29 November 2024
Biotechnology
Indian drugmaker Dr Reddy’s Laboratories has launched its toripalimab in the domestic market, sending the firm’s share up 2%. Toripalimab is a New Biological Entity (NBE), the company noted. 29 November 2024
Biotechnology
French pharma major Sanofi has added a new plant in Singapore to make vaccines and other medicines, as the company seeks to bolster preparedness for emergencies, including potential pandemics, according to Bloomberg and other media reports. 29 November 2024
Biotechnology
During the Belgian Economic Mission to Brazil, a historic Memorandum of Understanding (MoU) was signed between the Brazilian Oswaldo Cruz Foundation (Fiocruz) through its Institute of Technology on Immunobiologicals (Bio-Manguinhos), and the Belgian companies Quantoom Biosciences and Univercells. 29 November 2024
Biotechnology
PTC Therapeutics is to sell its rare pediatric disease priority review voucher (PRV) for $150 million. 28 November 2024
Biotechnology
A report from industry analyst DelveInsight highlights progress in the myotonic dystrophy treatment landscape, with more than 20 companies developing over 22 innovative treatments. 28 November 2024
Biotechnology
The UK subsidiary of Dutch drugmaker argenx confirmed today that its investigational therapy, subcutaneous efgartigimod alfa has been granted Promising Innovative Medicine (PIM) designation by the UK Medicines and Healthcare products Regulatory Agency (MHRA) for the treatment of adults with chronic inflammatory demyelinating polyneuropathy (CIDP). 28 November 2024
Biotechnology
Privately-held French drugmaker Servier has announced the inauguration of its first unit dedicated to the production of biological medicines from its R&D pipeline. 28 November 2024
Biotechnology
The US Food and Drug Administration has received new reports of hematologic malignancies, including life-threatening cases of myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML), following treatment of early, active cerebral adrenoleukodystrophy (CALD) patients with Skysona (elivaldogene autotemcel). 28 November 2024
Biotechnology
San Diago, USA-based Acadia Pharmaceuticals yesterday announced it has entered into an exclusive worldwide license agreement with Denmark’s Saniona for the development and commercialization of SAN711, a first-in-class, highly selective GABAA-α3 positive allosteric modulator. 28 November 2024
Biotechnology
Kronos Bio, a biotech with a presence on the east and west coasts of the USA, has unveiled a major restructuring plan. 28 November 2024
Biotechnology
Johnson & Johnson has made significant strides in multiple myeloma treatment, with breakthroughs in targeted therapies like CAR-T and bispecific antibodies. At the 2024 ASH meeting, J&J aims to showcase progress, with a goal of achieving a functional cure for multiple myeloma. 28 November 2024
Biotechnology
The European medicines regulator has approved a combo therapy starring PD-1 inhibitor Tevimbra (tislelizumab), from cancer firm BeiGene. 27 November 2024
Biotechnology
After trading closed yesterday, Exelixis revealed that the US Food and Drug Administration (FDA) has notified the company that the supplemental New Drug Application (sNDA) for cabozantinib (Cabometyx) for the treatment of adults with previously treated advanced pancreatic neuroendocrine tumors (pNET) and advanced extra-pancreatic NET (epNET) will be discussed at an Oncologic Drugs Advisory Committee (ODAC) meeting in March 2025. 27 November 2024
Biotechnology
Chengdu-based Kelun-Biotech has received marketing authorization in China for sacituzumab tirumotecan (sac-TMT), a Trop2-directed antibody-drug conjugate (ADC). 27 November 2024
Biotechnology
AI-powered protein engineering company Cradle has raised $73 million in a Series B funding. The European firm, which has now raised more than $100 million in total, calls itself the leading platform for AI-powered protein engineering. 27 November 2024
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