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.
Nantes, France-based biotech OSE Immunotherapeutics has agreed a deal with immuno-oncology diagnostic firm HalioDx, to conduct a translational investigation of immune biomarkers. 28 November 2019
The US Food and Drug Administration has accepted for Priority Review the New Drug Application (NDA) for pemigatinib, a selective fibroblast growth factor receptor (FGFR) inhibitor, as a treatment for patients with previously treated, locally-advanced or metastatic cholangiocarcinoma with FGFR2 fusions or rearrangements. 28 November 2019
Researchers from Queen Mary University of London and Zhengzhou University, China, have developed a personalized vaccine system that could ultimately delay the onset of pancreatic cancer, they believe. 27 November 2019
Singapore-based TauRx has announced the publication of unexpected results of its drug hydromethylthionine, or LMTM, in patients with mild-to-moderate Alzheimer's disease. 27 November 2019
US drugmaker AbbVie frequently comes under fire for the money – well in excess of $100 billion – that it has earned from its mega blockbuster arthritis drug Humira (adalimumab). 27 November 2019
The Roche majority-owned Chugai has launched the 840mg intravenous infusion of Tecentriq (atezollizumab) in Japan for the treatment of PD-L1-positive triple-negative breast cancer (TNBC). 27 November 2019
Switzerland-based companies Lonza and DiNAQOR, a global gene therapy platform firm, have announced a strategic collaboration to advance the latter’s pre-clinical programs for the treatment of cardiac myosin-binding protein-C (MYBPC3) cardiomyopathies, a genetic condition that can result in heart failure. 27 November 2019
US biotech firm Evofem Biosciences announced the resubmission of its New Drug Application to the US Food and Drug Administration for its lead candidate Amphora (L-lactic acid, citric acid and potassium bitartrate) for the prevention of pregnancy. 26 November 2019
Shares in CymaBay Therapeutics closed 76% down on Monday after the company announced it was terminating its Phase IIb study of seladelpar in non-alcoholic steatohepatitis (NASH) and its recently initiated Phase II study of seladelpar in primary sclerosing cholangitis (PSC). 26 November 2019
The US Food and Drug Administration (FDA) has granted accelerated approval to Oxbryta (voxelotor) tablets for the treatment of sickle cell disease (SCD) in adults and children 12 years of age and older. 26 November 2019
Canadian immuno-oncology specialist Medicenna Therapeutics has presented positive data from its Phase IIb trial of MDNA55 in people with recurrent glioblastoma (rGBM). 26 November 2019
Privately-held Swiss drugmaker Ferring Pharmaceuticals has launched a new gene therapy company, FerGene, together with Blackstone Life Sciences. 25 November 2019
The respiratory syncytial virus (RSV) market is expected to grow at a compound annual growth rate (CAGR) of 44.7% from $36.88 million in 2018 to $1.48 billion by 2028 across the five growth markets (5GM; Australia, India, Japan, South Korea and urban China) in the Asia-Pacific (APAC) region. 25 November 2019
Full results from ERYTECH Pharma’s Phase IIb trial evaluating eryaspase in metastatic pancreatic cancer have now been published in the European Journal of Cancer. 25 November 2019
As is often the case, though not always, comments last week from ‘sources close to the negotiations’ have proved correct in the likely takeover by the Swiss pharma giant Novartis of USA-based The Medicines Company and its key novel siRNA candidate inclisiran, a biennial cholesterol-lowering drug now in Phase III testing. 25 November 2019
Japan’s largest drugmaker Takeda Pharmaceutical presented updated data from the Phase III ALTA-1L trial, which evaluated Alunbrig (brigatinib) versus crizotinib (Pfizer’s [NYSE: PFE] Xalkori) in adults with advanced anaplastic lymphoma kinase-positive (ALK+) non-small cell lung cancer (NSCLC) who had not received a prior ALK inhibitor. 23 November 2019
USA-based drugmaker Biogen has announced positive Phase III data for next-gen multiple sclerosis (MS) therapy Vumerity (diroximel fumarate). 22 November 2019
US House of Representatives Speaker Nancy Pelosi's Lower Drug Costs Now Act of 2019, HR3, could result in at least 56 fewer new medicines for patients over 10 years, according to a new analysis from economic consulting firm Vital Transformation. 22 November 2019
Californian biotech BioMarin Pharmaceutical has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for its gene therapy, valoctocogene roxaparvovec, for adults with severe hemophilia A. 22 November 2019
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
US clinical stage biotech Alector saw its shares tumble 35% to $2.57 by close of trading yesterday, as it announced disappointing results from the INVOKE-2 Phase II clinical trial evaluating the safety and efficacy of AL002 in slowing disease progression in individuals with early Alzheimer’s disease (AD). 27 November 2024
PTC Therapeutics has announced that its Phase II trial for utreloxastat, aimed at treating amyotrophic lateral sclerosis (ALS), failed to meet its primary endpoint. 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.