27 November 2024 The strain of opioid use disorder (OUD), a chronic neurological disorder characterized by the compulsive, repeated use of opioid drugs, has weighed heavily on many countries in recent years, especially the USA.
Oral peptide specialist Chiasma has announced positive data from the Phase III CHIASMA OPTIMAL open-label extension (OLE) study of Mycapssa (octreotide). 28 July 2020
The US Department of Health and Human Services has reserved the available advanced manufacturing capability and capacities of the Center for Innovation in Advanced Development and Manufacturing (CIADM) at the Texas A&M University System for use in manufacturing COVID-19 vaccines. 28 July 2020
BioNTech and Pfizer have revealed the start of a global (except for China) Phase II/III safety and efficacy clinical study to evaluate a single nucleoside-modified messenger RNA (modRNA) candidate from their BNT162 mRNA-based vaccine program, against SARS-CoV-2. 28 July 2020
Swiss giant Roche has exercised an option to increase the scope and value of a research project with UK-based immunodiagnostics firm Oncimmune Holdings. 27 July 2020
Japanese drugmaker Daiichi Sankyo (TYO: 4568) saw its shares rise more than 4% to 8.712 yen, after it revealed another multi-billion licensing deal, potentially worth $6 billion. 27 July 2020
The US Food and Drug Administration has granted accelerated approval to Tecartus (brexucabtagene autoleucel, formerly KTE-X19), the first and only approved chimeric antigen receptor (CAR) T cell therapy for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL). 27 July 2020
mRNA therapeutics and vaccines specialist Moderna Therapeutics has secured an additional $472 million from the US authorities for late-stage development of mRNA-1273. 27 July 2020
North Carolina, USA-based oncology specialist G1 Therapeutics has signed a license agreement for lerociclib to EQRx, a biopharmaceutical company focused on making innovative medicines at dramatically lower prices for the benefit of people and society. 24 July 2020
Chinese publication Science and Technology Daily has analyzed the progress of the AstraZeneca and University of Oxford coronavirus vaccine alongside a competitor from China. 24 July 2020
UCB today announced positive results from the Phase IIIb BE RADIANT study, a direct comparison of the investigational interleukin (IL)-17A and IL-17F inhibitor, bimekizumab, to the IL-17A inhibitor, Novartis’ (NOVN: VX) Cosentyx (secukinumab) in the treatment of adult patients with moderate-to-severe plaque psoriasis. 24 July 2020
After a run of positive announcements on the clinical side, mRNA therapeutics and vaccines developer Moderna Therapeutics has been struck with a patent blow, knocking 10% off its share price. 24 July 2020
Shares in CymaBay Therapeutics have been lifted by a quarter after the liver disease specialist announced multiple clinical holds for seladelpar had been lifted. 24 July 2020
Incyte Corporation has announced that the Phase III trial of Jakafi (ruxolitinib) in steroid-refractory or steroid dependent chronic graft-versus-host disease (GVHD) met its primary endpoint of superior overall response rate (ORR) at week 24, compared to best available therapy (BAT). 23 July 2020
The transthyretin amyloidosis (ATTR) market is expected to grow from $585 million in 2019 to $14.1 billion in 2029 across the seven major markets, according to GlobalData. 23 July 2020
Dutch biotech firm Synaffix today announced that Swiss oncology-focused drug discovery firm ADC Therapeutics has expanded its existing collaboration to explore additional applications, including DAR1, of Synaffix’ site-specific conjugation technologies. 23 July 2020
The UK’s capability to manufacture vaccines has received a substantial boost today, as the government announces an additional £100 million ($127 million) to ensure that any successful COVID-19 vaccine can be produced at scale in the UK. 23 July 2020
Swiss pharma giant Roche has presented detailed results from the Phase III Archway study of its investigational Port Delivery System (PDS). 23 July 2020
Putting the final nail in the coffin for its non-alcoholic steatohepatitis (NASH) drug candidate, French metabolic specialist Genfit today announced the discontinuation of the RESOLVE-IT Phase III clinical trial of elafibranor in adults with NASH and fibrosis. 23 July 2020
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
Replimune, a clinical-stage biotech focused on oncolytic immunotherapies, has announced plans to raise $125 million through a public offering. 26 November 2024
Chinese gene therapy firm Kanglin Biotechnology has completed a $20 million series A financing round, with the money earmarked for KL003, an innovative treatment for blood disorders. 26 November 2024
BRL Medicine, a Shanghai-based biotechnology company specializing in cell and gene therapies, has raised nearly 200 million yuan ($27 million) in a series B+ round led by CSPC Fund. 26 November 2024
Italian oncology focused biotech Nerviano Medical Sciences yesterday announced that it has successfully negotiated with Germany’s Merck KGaA to buy back the full world-wide rights of NMS 293 (also known as NMS-03305293). 26 November 2024