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.
Japanese drugmaker JCR Pharmaceuticals has withdrawn its application with the Ministry of Health, Labor and Welfare of Japan (MHLW) for additional marketing approval of Temcell HS Inj, allogeneic bone marrow-derived mesenchymal stem cells, for the indication of epidermolysis bullosa (EB) (development code: JR-031EB). 20 September 2019
On Thursday, US House of Representatives Speaker Nancy Pelosi unveiled drastic proposals that would allow Medicare to negotiate lower prices on as many as 250 drugs and apply those discounts to private health plans. 19 September 2019
The full results of Strongbridge Biopharma’s Phase III SONICS study of the use of Recorlev (levoketoconazole) in endogenous Cushing’s syndrome have been published online in The Lancet Diabetes & Endocrinology. 19 September 2019
Bristol-Myers Squibb has outlined the data it will present at this year’s annual meeting of the European Society for Medical Oncology (ESMO), in Barcelona. 19 September 2019
New research examining the impact of antibiotics suggests that fluoroquinolones could create an elevated risk of developing aortic and mitral regurgitation, serious heart problems. 19 September 2019
A new report from industry analyst GlobalData finds that the market for hidradenitis suppurativa (HS) therapies is expected to grow from $898 million in 2018 to $1.81 billion in 2028, across the major markets. 19 September 2019
Privately-held oncology specialist Rgenix says that Robert Wasserman, has joined the Rgenix management team as its new chief medical officer. 19 September 2019
,veXis today announced that new interim data from the Phase III SPR1NT trial in pre-symptomatic patients as well as interim data from the ongoing Phase III STR1VE clinical program for Zolgensma (onasemnogene abeparvovec-xioi) showed positive outcomes, demonstrating age appropriate major milestone gain with pre symptomatic treatment and prolonged event-free survival* in patients with spinal muscular atrophy (SMA) Type 1. 19 September 2019
The US Food and Drug Administration has approved Erleada (apalutamide), from Johnson & Johnson subsidiary Janssen Biotech, for patients with metastatic castration-sensitive prostate cancer (mCSPC). 18 September 2019
Data presented in a symposium session at the annual meeting of the European Association for the Study of Diabetes (EASD) provide insights into imeglimin, an investigational type 2 diabetes medicine. 18 September 2019
Shares of Alexion Pharmaceuticals dipped 1.3% to $106.44 in after-hours trading on Tuesday, after the US biotech company announced plans for the transition of executive vice president and chief financial officer Paul Clancy later this year. 18 September 2019
The US Food and Drug Administration has granted Breakthrough Therapy designation (BTD) to Gazyva (obinutuzumab), a drug from Swiss pharma giant Roche, for adults with lupus nephritis. 18 September 2019
US pharma giant Merck & Co has had its Biologics License Application (BLA) for an Ebola vaccine accepted by the Food and Drug Administration (FDA). 17 September 2019
A Phase II trial flop for rare disease candidate ACE-083 has prompted Acceleron Pharma to abandon development of the program in facioscapulohumeral muscular dystrophy (FSHD). 17 September 2019
The US Food and Drug Administration has accepted the Biologics License Application (BLA) for the investigational agent enfortumab vedotin and granted Priority Review for the treatment of patients with locally advanced or metastatic urothelial (bladder) cancer. 17 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.