24 September 2024 Japan’s Daiichi Sankyo and Anglo-Swedish pharma major AstraZeneca were trading lower on Tuesday after announcing topline results from the TROPION-Breast01 study.
Italian biotech Genespire—which is developing off-the-shelf gene therapies for pediatric patients affected by genetic diseases—has announced the closing of a 46.6 million euros ($52 million) Series B financing. 25 September 2024
US biotech 2seventy bio and partner Bristol Myers Squibb today revealed that they will discontinue enrollment in its ongoing Phase III KarMMa-9 study. 25 September 2024
Amgen yesterday revealed that Tepezza (teprotumumab [genetical recombination]) has been approved for the treatment of active or high clinical activity score (CAS) thyroid eye disease (TED) in Japan. 25 September 2024
Eli Lilly's Kisunla has been approved in Japan for early symptomatic Alzheimer's disease, following its US approval in July 2024. Administered via IV infusion, it targets patients with mild cognitive impairment and dementia linked to amyloid pathology. Kisunla aims to slow cognitive and functional decline in AD patients 25 September 2024
Belgian drugmaker UCB (Euronext: UCB) has announced the presentation of new four-year data in patients with moderate to severe plaque psoriasis treated with bimekizumab, the company’s IL-17A and IL-17F inhibitor that is marketed as Bimzelx. 25 September 2024
Healthcare plan provider Centivo has raised $75 million in equity and debt financing to support its goal of offering affordable care to employees and their families. 25 September 2024
President Biden has said the USA will commit at least $500 million to support African countries in battling the ongoing mpox outbreak in Central and Eastern Africa. 25 September 2024
People affected Niemann-Pick disease, a rare and fatal genetic disorder, have waited a lifetime for an effective medicine. Now, in the space of a week, the US regulator has approved two. 25 September 2024
Rare disease firm bluebird bio has announced a company-wide restructuring aimed at cutting costs by 20% and achieving quarterly cash flow break-even by the second half of 2025. 25 September 2024
Wave Life Sciences has announced positive interim data from the ongoing Phase II FORWARD-53 study of WVE-N531, which is an exon skipping oligonucleotide being investigated in boys with Duchenne muscular dystrophy (DMD) who are amenable to exon 53 skipping. 25 September 2024
USA-based Generate:Biomedicines (Generate) today announced a multi-target collaboration with Swiss pharm giant Novartis to discover and develop protein therapeutics across multiple disease areas. 24 September 2024
The Japanese Ministry of Health, Labor, and Welfare (MHLW) has approved Otsuka’s (TYO: 4578) Lupkynis (voclosporin) for the treatment of lupus nephritis (LN), an inflammation of the kidneys caused by systemic lupus erythematosus (SLE), an autoimmune disease 24 September 2024
CSL Vifor today announced that Japan’s Ministry of Health and Labor Welfare (MHLW) has granted its partner, Zeria Pharmaceutical marketing authorization approval for Veltassa (patiromer). 24 September 2024
The Pharmaceutical Research and Manufacturers of America (PhRMA) is continuing its legal challenge against the US government’s drug pricing reforms. 24 September 2024
BioAtla has granted an exclusive global license to Context Therapeutics for BA3362, a T cell-engaging antibody targeting solid tumors. 24 September 2024
Japan’s Daiichi Sankyo and Anglo-Swedish pharma major AstraZeneca were trading lower on Tuesday after announcing topline results from the TROPION-Breast01 study. 24 September 2024
The European Medicines Agency (EMA) has recommended granting a marketing authorization for COVID-19 Vaccine (inactivated, adjuvanted) Valneva, developed by developed by French company Valneva, for use in the primary vaccination of people from 18 to 50 years of age. 23 June 2022
Detailed results from the positive FoCus Phase III trial in Wilson disease showed that ALXN1840, an investigational once-daily, oral medicine, met its primary endpoint demonstrating three-times greater copper mobilization from tissues compared to the standard of care (SoC) arm (Least Square Mean Difference [LSM Diff] 2.18 µmol/L; p< 0.0001), including in patients who had been treated previously for an average of 10 years. 23 June 2022
Shares in Athira Pharma, a US biopharma focused on developing small molecules to restore neuronal health and slow neurodegeneration, closed nearly 70% lower on Wednesday. 23 June 2022
Swiss pharma giant Novartis has received an Accelerated Approval in the USA for its combination BRAF/MEK inhibitor therapy, for certain biomarker-defined tumors. 23 June 2022
Swiss pharma giant Novartis today announced that the European Commission (EC) approved Tabrecta (capmatinib) as a monotherapy for the treatment of adults with advanced non-small cell lung cancer (NSCLC) harboring alterations leading to mesenchymal-epithelial-transition factor gene (MET) exon 14 (METex14) skipping who require systemic therapy following prior treatment with immunotherapy and/or platinum-based chemotherapy. 23 June 2022
invoX Pharma, a wholly-owned subsidiary of Sino Biopharmaceutical that is focused on research and development (R&D) and business development activities outside of China, today announced that it has entered into a definitive agreement to acquire all of the issued and outstanding shares of F-star Therapeutics’ common stock. 23 June 2022
US biotech Moderna announced new clinical data on its bivalent (Omicron) COVID-19 booster candidate, mRNA-1273.214, leading the company’s share price to close 5% higher on Wednesday. 23 June 2022
US pharma giant Merck & Co has announced that Chirfi Guindo will lead Human Health Marketing as chief marketing officer for Merck Human Health, and will join Merck’s executive team, effective July 1, 2022. 23 June 2022
When Sierra Oncology announced positive top-line results from the MOMENTUM trial earlier this year, certain execs at Gilead Sciences may have had a sinking feeling. 23 June 2022
Despite tremendous political-economic challenges that Egypt faced in last two decades, Egypt still remains the largest producer and consumer of pharmaceuticals in the entire Middle East and Africa region with a market value of EGP 56.6billion (US$2.9 billion) in 2022 for pharmaceutical sales. 23 June 2022
Emerging US biopharma firm Mycovia Pharmaceuticals has shared top-line results from evaluating Vivjoa (oteseconazole) capsules in patients suffering from recurrent vulvovaginal candidiasis (RVVC). 23 June 2022
Serum Institute of India’s (SII) Cervavac - a quadrivalent human papillomavirus (qHPV) vaccine - is likely to be the first indigenous qHPV vaccine to be approved in India. 23 June 2022
The US Centers for Disease Control and Prevention’s (CDC’s) Advisory Committee on Immunization Practices (ACIP) unanimously voted to include Vaxneuvance (pneumococcal 15-valent conjugate vaccine) as a recommended option for vaccination in infants and children, including routine use in children under two years of age, US pharma giant Merck & Co announced yesterday. 23 June 2022
Just three months after Nutcracker Therapeutics’ announcement of receiving $167 million in Series C funding, three new leadership positions have been filled alongside the release of its oncology and disease-focused pipeline. 22 June 2022
UK-based biotech Roquefort Therapeutics is to acquire Oncogeni in an all-share transaction which sources value at around £4 million ($4.9 million). 22 June 2022
Swiss independent dermatology specialist Galderma today announced the phase III OLYMPIA 2 trial met all primary and key secondary endpoints, showing nemolizumab as monotherapy significantly improved skin lesions and pruritus (itch) compared with placebo in adult patients with moderate to severe prurigo nodularis. 22 June 2022
The 32nd edition of EY’s Beyond borders report found that despite global upheavals, including geopolitical complexities and the COVID-19 pandemic, the US and European biotechnology industries have not only stayed on course, but thrived on innovation. 22 June 2022
One of the most important coronavirus vaccine developers and a pioneer in mRNA technologies, Moderna, is to launch a major manufacturing and R&D hub in the UK. 22 June 2022
Belgian biotech company Galapagos (Euronext: GLPG) announced that it will acquire Dutch cell therapy company CellPoint and AboundBio to boost access to next-generation cell therapies, for around $250 million. 22 June 2022
The stock markets took a liking to Precision BioSciences, a gene editing company developing ARCUS-based ex vivo allogeneic CAR T and in vivo gene editing therapies, on Tuesday and Wednesday. 22 June 2022
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Company Spotlight
Capricor Therapeutics is a clinical-stage biotechnology company focused on the discovery, development, and commercialization of first-in-class biological therapeutics for the treatment of rare disorders.