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.
Dutch antibody-drug conjugate (ADC) specialist Synaffix and Shanghai Miracogen have expanded an existing collaboration with an agreement to develop and commercialize a second product candidate. 7 January 2020
A subsidiary of Japanese group Kyorin Holdings has acquired an exclusive license to develop and commercialize a candidate for interstitial lung diseases in Japan from California’s aTyr Pharma. 7 January 2020
US clinical-stage biopharma firm Pulmatrix today announced that it has entered into a research collaboration with fellow USA-based Nocion Therapeutics to explore new technologies to enable and improve inhaled drug delivery. 6 January 2020
There was good news for Germany’s Merck KGaA and US partner Pfizer today as they announced the Phase III JAVELIN Bladder 100 study with their PD-L1 antibody Bavencio (avelumab) met its primary endpoint of overall survival (OS) at the planned interim analysis. 6 January 2020
The National Institute of Health and Care Excellence (NICE) has issued draft guidance not recommending Waylivra (volanesorsen) as a treatment for familial chylomicronaemia syndrome (FCS) on the National Health Service (NHS) in England. 3 January 2020
US drugmaker Incyte Corporation looked set to open Friday’s trading more than 11% down after taking an after-hours pummelling in the stock market. 3 January 2020
Californian biotech Durect Corporation lost almost a third of its value in the stock market on Thursday after the company announced disappointing results from its study of DUR-928 in mild to moderate plaque psoriasis. 3 January 2020
Pulmatrix has entered into a licensing and development agreement with the Lung Cancer Initiative at US healthcare giant Johnson & Johnson. 3 January 2020
Israel’s RedHill Biopharma today revealed that it has provided Salix Pharmaceuticals with a notice of termination of their 2014 license agreement and has regained the worldwide exclusive rights to RHB-106, a proprietary encapsulated formulation for bowel preparation, currently under development. 2 January 2020
Antabio, which is focused on developing a broad pipeline of antibacterial treatments against life threatening WHO critical priority pathogens, has been awarded up to $4.4 million in a second tranche funding from CARB-X, the global non-profit partnership dedicated to tackling the global rising threat of drug-resistant bacteria. 2 January 2020
The Roche majority-owned subsidiary Chugai has won Japanese approval of a diagnostic that it calls the FoundationOne CDx Cancer Genomic Profile. 2 January 2020
Ranging from big pharma to small biotech, there was a great deal of global merger and acquisition (M&A) activity in 2019. The Pharma Letter’s annual tally of such deals in the biopharma sector, which excludes diagnostics and devices, saw a total of 108 announced, marginally down from the 111 in 2018. 1 January 2020
Bouncing back from a Complete Response Letter (CRL) received at the start of 2019, Immunomedics has announced the US regulator will review a new filing for accelerated approval of sacituzumab govitecan. 31 December 2019
Urovant Sciences says it has submitted a New Drug Application (NDA) to the US Food and Drug Administration seeking approval of once-daily 75mg vibegron for the treatment of patients with overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency. 31 December 2019
Israel-based biotech Sol-Gel Technologies saw its share price rocket nearly 93% to $17.80 during Monday morning’s trading after the company presented positive data from two Phase III trials. 30 December 2019
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
Clinical-stage US CAR-T therapies developer Poseida Therapeutics saw its shares skyrocket 227% to $9.36 pre-market today, on the news of a proposed takeover by Swiss pharma giant Roche. 26 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.