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.
The cost-effectiveness watchdog for England and Wales has ruled that Novartis’ anti-CGRP migraine therapy is too expensive at its current price to be provided on the National Health Service (NHS). 26 September 2019
US Venture capital-backed biotech Blade Therapeutics, which is focused on novel anti-fibrotic therapies, today announced the acquisition of ATXCo Inc, including its core asset, PAT-409, a Phase I-ready autotaxin inhibitor for patients with fibrotic diseases. 26 September 2019
US biotech Omeros Corp has announced study results showing that inhibition of mannan-binding lectin-associated serine protease-2 (MASP-2) protects against renal injury caused by proteinuria (ie, high levels of plasma proteins in the urine) and inflammation. 26 September 2019
The New England Journal of Medicine (NEJM) on Thursday will publish important results online from the VARSITY study, the first head-to-head clinical trial in ulcerative colitis. 25 September 2019
Swiss pharma giant Novartis has responded to the US Food and Drug Administration’s (FDA) issuing of a Form 483 relating to allegations of data manipulation on Zolgensma (onasemnogene abeparvovec-xioi). 25 September 2019
The US Food and Drug Administration yesterday announced the approval of Jynneos smallpox and monkeypox vaccine, live, on-replicating, for the prevention of smallpox and monkeypox disease in adults 18 years of age and older determined to be at high risk for smallpox or monkeypox infection. 25 September 2019
Urovant Sciences has reported positive Phase III results for its investigational drug candidate vibegron, a next-generation, once‐daily oral beta‐three adrenergic agonist in development for the treatment of overactive bladder. 25 September 2019
The Cell and Gene Therapy (CGT) Catapult, a UK government-backed agency, has doubled the capacity of its manufacturing center in Stevenage, Hertfordshire. 24 September 2019
Shares of clinical-stage US biotech Provention Bio rose 6% in pre-market trading in reaction to reiteration of its registration plan for its Breakthrough Therapy-designated teplizumab (PRV-031) for the prevention or delay of clinical type 1 diabetes in at-risk people 24 September 2019
In Cambridge, USA, just around the corner from fellow gene therapy specialist bluebird bio, a less well-known biotech startup could be about to shake up the market for certain rare disease therapies. 24 September 2019
UK-headquartered DNA Damage Response (DDR) company Artios Pharma today announces the appointment of Tania Dimitrova as chief business officer and its expanded presence in the USA. 24 September 2019
French biotech Deinove saw its shares rise more than 5% to 0.79 euros by mid-morning, as the company said it has expanded its technology platform with an advanced genetic too, the CRISSPR-cas9 system, to enhance its ability to optimize various microorganisms. 24 September 2019
Swiss cancer giant Roche has outlined the data it intends to present at the upcoming annual meeting of the European Society for Medical Oncology (ESMO). 23 September 2019
In a surprise change of leadership at Akcea Therapeutics, Paula Soteropoulos, chief executive, Sarah Boyce, president, and Jeff Goldberg, chief operating officer, have all resigned with immediate effect. 23 September 2019
China-based biotech CARsgen Therapeutics has been granted PRIority MEdicines (PRIME) eligibility to its investigational CAR-T cell therapy fully human anti-BCMA (B Cell Maturation Antigen) autologous chimeric antigen receptor (CAR) T Cells (ct053) for the treatment of relapsed or refractory multiple myeloma, by the European Medicines Agency 23 September 2019
As well as recommending approval of four novel medicines and three generic medicines at its September 2019 meetings, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) announced positive opinions for a number of label extensions, as follows: 23 September 2019
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
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
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
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
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
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
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
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
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
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
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
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
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
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
The European medicines regulator has approved a combo therapy starring PD-1 inhibitor Tevimbra (tislelizumab), from cancer firm BeiGene. 27 November 2024
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
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
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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Acadia Pharmaceuticals (Nasdaq: ACAD) is a leading pharmaceutical company with a focus on bringing life-changing therapies to patients suffering from CNS diseases.