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.
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 BeOne Medicines, formerly 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
The ADAURA Phase III trial for Tagrisso (osimertinib) in the adjuvant treatment of patients with Stage IB, II and IIIA epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) with complete tumor resection will be unblinded early following a recommendation from an Independent Data Monitoring Committee (IDMC) based on its determination of overwhelming efficacy. 12 April 2020
The Food and Drug Administration has approved a supplemental New Drug Application (sNDA) for Braftovi (encorafenib) from Array BioPharma, which was acquired last July by Pfizer in an $11.4 billion deal. 10 April 2020
Privately-held US T cell-focused biotech NeoImmuneTech (NIT) has entered into a clinical collaboration agreement with Bristol-Myers Squibb to evaluate the combination of NeoImmuneTech’s NT-I7 (also known as Hyleukin-7), a long-acting interleukin (IL)-7, and the US pharma major’s Opdivo (nivolumab), a PD-1 blocking antibody. 10 April 2020
German immunotherapeutics specialist BioNTech and US pharma giant Pfizer today disclosed details of their collaboration to advance candidates from BioNTech’s mRNA vaccine program, previously announced on March 17, 2020. 9 April 2020
New Jersey, USA-based cell therapy specialist Celularity is expanding an existing collaborative license agreement with Lung Biotechnology, a United Therapeutics company. 9 April 2020
Germany’s Merck KGaA and US pharma giant Pfizer today announced completion of the submission of a supplemental Biologics License Application (sBLA) to the US Food and Drug Administration for Bavencio (avelumab) for first-line maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma (UC). 9 April 2020
Shares in Novavax jumped 15% on Wednesday, after the biotech firm announced it has identified a coronavirus vaccine candidate, NVX-CoV2373, and was moving towards a first-in-human trial in mid-May. 9 April 2020
A new project to develop a treatment for COVID-19 has been initiated between CSL Behring, a unit of Australia’s CSL Limited, and antibody specialist SAB Biotherapeutics (SAB). 9 April 2020
London-based cell therapy specialist Quell Therapeutics has kicked off a new collaboration with the Hannover Medical School, aimed at the discovery and validation of multiple Chimeric Antigen Receptor (CAR)-Treg cell therapies. 8 April 2020
Announcing its first partnership, US biotech start-up Arrakis Therapeutics says it has entered a strategic collaboration and license agreement with Swiss pharma giant Roche for the discovery of RNA-targeted small molecule (rSM) drugs against a broad set of targets across all of Roche’s research and development areas. 8 April 2020
The highly-respected, peer-reviewed journal The Lancet has published comprehensive data from the Phase III trials, DISCOVER-1 and -2, evaluating the safety and efficacy of Tremfya (guselkumab) for the treatment of adults with active psoriatic arthritis (PsA). 8 April 2020
Swiss oncology giant Roche has announced an extension to the US review of its risdiplam New Drug Application (NDA) in spinal muscular atrophy (SMA). 8 April 2020
Privately-held, clinical-stage US biotech company Tarveda Therapeutics says that the proposed merger agreement with Organovo Holdings has been terminated following the emergence of unanticipated, late opposition to the proposed transaction by major Organovo stockholders. 8 April 2020
Privately-held US biotech EpiVax yesterday announced its partnership with GAIA Vaccine Foundation (GVF) to crowd-source funds for the COVID-19 project and its pledge to make a free license available to developing countries who qualify, in the context of this partnership. 8 April 2020
Germany’s Biotest and Swiss firm Octapharma have joined an alliance formed by CSL Behring, a unit of Australia’s CSL Limited, and Japan’s Takeda Pharmaceutical to develop a potential plasma-derived therapy for treating COVID-19. 7 April 2020
US RNAi therapeutics company Alnylam Pharmaceuticals has announced the completion of the rolling submission of a New Drug Application (NDA) to the US Food and Drug Administration for lumasiran, an investigational RNAi therapeutic targeting glycolate oxidase (GO), in development for the treatment of primary hyperoxaluria type 1 (PH1). 7 April 2020
US biopharma company Millendo Therapeutics yesterday announced that it is discontinuing the development of livoletide as a potential treatment for Prader-Willi syndrome (PWS), a rare genetic condition. 7 April 2020
Bristol, UK-based Imophoron plans to begin pre-clinical tests on multiple COVID-19 vaccine candidates, together with the University of Bristol's COVID-19 Emergency Research (UNCOVER) Group. 7 April 2020
UK drug major GlaxoSmithKline is the latest to announce a link-up with Vir Biotechnology in search of coronavirus solutions, sending the latter’s share price up by nearly 20% during Monday morning. 6 April 2020
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Company Spotlight
Acadia Pharmaceuticals (Nasdaq: ACAD) is a leading pharmaceutical company with a focus on bringing life-changing therapies to patients suffering from CNS diseases.