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.
Asklepios BioPharmaceutical (AskBio), a gene therapy company wholly-owned and independently operated as a subsidiary of Bayer, has announced a new strategic collaboration with Belief BioMed (BBM) to explore the potential for new gene therapies. 25 September 2024
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
Today, California, USA-based Ultima Genomics emerged from stealth mode with a new high-throughput, low-cost sequencing platform that delivers the $100 genome. 31 May 2022
US clinical-stage biotech Eledon Pharmaceuticals saw its share gain 8% to $3.92 pre-market, after it announced positive top-line results from a Phase IIa clinical trial of tegoprubart (formerly AT-1501) in patients with amyotrophic lateral sclerosis (ALS). 31 May 2022
Pherecydes Pharma has been granted AAC Early Access Program approval by France’s Agence Nationale de Sécurité du Médicament et des produits de santé (ANSM) for its anti-Staphylococcus aureus (S. aureus) phages. 31 May 2022
US mRNA biotech Moderna and Japan’s largest drugmaker Takeda have announced the transfer of the marketing authorization in Japan for Moderna’s COVID-19 vaccine Spikevax (mRNA-1273) from Takeda to Moderna as of August 1, 2022. 31 May 2022
“We need to make sure that cancer care gets back on top of the priority list for societies. Cancer is a disease that every second person will face, and many people still die of. It deserves our full attention. It needs to be back on the political agenda so that, collaboratively, we can change that trajectory.” 31 May 2022
Spain’s Minoryx Therapeutics, a Phase III stage biotech company focused on the development of treatments for orphan central nervous system (CNS) disorders, today announced it has closed a 51 million-euro ($55 million) financing, including Series C equity financing and complementary bank debt. 31 May 2022
The US Food and Drug Administration (FDA) has accepted for priority review the supplemental Biologics License Application (sBLA) for Dupixent (dupilumab) to treat adults with prurigo nodularis, a chronic inflammatory skin disease that causes extreme itch and skin lesions. 31 May 2022
Two new approvals for Opdivo (nivolumab)-based regimens in esophageal squamous cell carcinoma (ESCC) will bring meaningful competition for the leading checkpoint blocker, Keytruda (pembrolizumab). 31 May 2022
A US label extension for oral spinal muscular atrophy (SMA) drug Evrysdi (risdiplam) will help its developers make further inroads in what is an increasingly competitive therapeutic area. 31 May 2022
Having already shot up dramatically on the disclosure of previous orders, shares of Denmark’s Bavarian Nordic (OMX: BAVA) rose a further 6.2% to 217.00 kroner on Monday, after it announced the signing of a number of supply contracts with undisclosed countries for the company’s smallpox vaccine with the aim to ensure sufficient supply to meet the requirements for vaccinating individuals at risk for monkeypox in the short to medium term. 31 May 2022
The UK Medical Research Council (MRC) and its Laboratory of Molecular Biology (LMB) have agreed to an additional $4millon (~£3.2million) funding to extend the Blue Sky collaboration with UK pharma major AstraZeneca beyond 2022. 31 May 2022
As Januvia/Janumet (sitagliptin), a Merck & Co drug, nears patent expiry, India's drug price regulator National Pharmaceutical Pricing Authority (NPPA) has fixed the prices of fixed-dose combinations of several anti-diabetic drugs with a 50% reduction on the patented component in a move set to increase the price war in India's $2.3 billion anti-diabetic drugs market. Howls of protest have followed the move, reports The Pharma Letter’s India correspondent. 30 May 2022
New pivotal data is to be presented on Roche’s CD20xCD3 T-cell engaging bispecific antibody, glofitamab at this week’s 2022 American Society of Clinical Oncology (ASCO) Annual Meeting and the European Hematology Association (EHA) 2022 Congress. 30 May 2022
NRG Therapeutics, a privately-held UK-based neuroscience company targeting mitochondrial dysfunction, has received a Biomedical Catalyst (BMC) award from the UK government. 30 May 2022
ALTURiX - a rapidly-growing British pharmaceutical company - has acquired the exclusive rights to liothyronine for the UK following the finalization of an agreement with HELM AG, based in Hamburg, Germany. 30 May 2022
Taiwanese biotech firm AcadeMab has broken new ground in the development of immunotherapies through the development of a potentially life-saving monoclonal antibodies (MAbs) for COVID-19 patients using single B cell technology, shows the best neutralization ability (IC50 = 11.4 and 4.3 ng/ml) in both Omicron variants BA.1 and BA.2 respectively. 30 May 2022
At the 2022 annual meeting of the American Society of Clinical Oncology (ASCO 22), Shanghai-based cancer company I-Mab is presenting new Phase I data for uliledlimab. 30 May 2022
German biotech Evotec today announced the signing of a definitive agreement to acquire 100% of the capital of Rigenerand Srl, an Italian cell technology company. 30 May 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.