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
Bavarian Nordic has announced that its respiratory syncytial virus (RSV) vaccine candidate for the prevention of RSV in older adults has been granted PRIME eligibility by the European Medicines Agency (EMA). 28 June 2022
Japanese pharma major Astellas Pharma today announced a worldwide, strategic collaboration and licensing agreement with USA-based drug developer Sutro Biopharma, focused on the discovery and development of novel immunostimulatory antibody-drug conjugates (iADCs). 28 June 2022
In a filing with the US Securities and Exchange Commission (SEC), central nervous system specialist Axsome Therapeutics reveals proposed labeling has been received for its depression candidate AXS-05 (bupropion/dextromethorphan). 28 June 2022
The European Commission (EC) has approved Sanofi’s Xenpozyme (olipudase alfa) as the first and only enzyme replacement therapy to treat non-central nervous system (CNS) manifestations of acid sphingomyelinase deficiency (ASMD) in pediatric and adult patients with ASMD type A/B or ASMD type B. 28 June 2022
The US Food and Drug Administration (FDA) has placed a partial clinical hold on US biotech firm Nuvation Bio’s Phase I dose escalation study of NUV-422 in solid tumors, including high grade glioma, HR+/HER2- advanced breast cancer and metastatic castration resistant prostate cancer. 28 June 2022
The European Commission (EC) has approved its CAR-T cell therapy Yescarta (axicabtagene ciloleucel) for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after three or more lines of systemic therapy. 28 June 2022
Japanese drugmaker Ono Pharmaceutical and US biotech Fate Therapeutics have boosted their collaboration, adding the discovery of CAR-NK cell therapies to an existing agreement. 28 June 2022
The European Medicines Agency’s (EMA) human medicines committee (CHMP) has started a review of data to extend the use of the smallpox vaccine Imvanex to include protecting people from monkeypox disease. 28 June 2022
Russia is reducing procurements of expensive Western original drugs for the treatment of HIV, switching to cheaper medicines, due to the lack of funds and the ever-growing number of patients with HIV in the country, reports The Pharma Letter’s local correspondent. 28 June 2022
The European Commission has granted marketing authorization for Nexviadyme (avalglucosidase alfa), an enzyme replacement therapy (ERT) for the long-term treatment of both late-onset and infantile-onset Pompe disease, a rare, progressive and debilitating muscle disorder, from French pharma major Sanofi. 28 June 2022
Shares of Swiss biotech Basilea Pharmaceutica gained more than 3% to 38.45 francs yesterday, after it announced an update on the progress made in the implementation of its strategic focus on anti-infectives. 28 June 2022
Russia plans to begin a second stage of clinical trials of an innovative drug for the treatment of Parkinson's disease and which was developed by scientists from Novosibirsk and Tomsk. According to scientists, this is the world’s first drug that can stop the development of the disease. 28 June 2022
National Health Service England and Improvement (NHSE/I) has announced the launch of the Innovative Medicines Fund (IMF), aimed at providing earlier access to certain promising new drugs while additional evidence is generated about their use. 27 June 2022
The US Food and Drug Administration (FDA) has placed a clinical hold on the FORTIS PhI/II trial following a serious adverse event (SAE) of peripheral sensory neuropathy in one of the trial participants. 27 June 2022
With strong results from its SURPASS program for gastric inhibitory peptide/glucagon-like peptide-1 receptor (GIP/GLP-1) dual agonist Mounjaro (tirzepatide) for the treatment of type 2 diabetes (T2D), US pharma major Eli Lilly’s can expect Mounjaro to gain a significant share of the GLP-1 and wider T2D and obesity markets. 27 June 2022
Family-owned Italian drugmaker Menarini Group and USA-based Radius Health have announced that Menarini, with support from Radius, has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for elacestrant in patients with ER+/HER2- advanced or metastatic breast cancer. 27 June 2022
Danish firm Lundbeck and Japan’s Otsuka Pharmaceutical brought some rare good news in a challenging disease as they announced positive results from a Phase III trial of brexpiprazole in the treatment of agitation in patients with Alzheimer's-type dementia. 27 June 2022
Novartis presented new data at the European Academy of Neurology (EAN) Congress demonstrating treatment with Kesimpta (ofatumumab) significantly increased the odds of achieving no evidence of disease activity (NEDA-3, defined as having no MS relapses, no disability worsening and no MRI activity) versus switching from teriflunomide in people living with relapsing multiple sclerosis (RMS). 27 June 2022
Leading PARP blocker Lynparza (olaparib) looks set to secure a new marketing authorization in Europe, after a positive scientific opinion. 27 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.