Just weeks after two unexpected cases of blood cancer landed trials of its investigational gene therapies for sickle cell disease (SCD) and beta-thalassemia on FDA-issued clinical holds, Bluebird Bio Inc. said it's talking to regulators about their resumption after what RBC analyst Luca Issi called a "partial exoneration" of the BB-305 lentiviral vector shared between the medicines. Read More
Following an interim futility analysis, Affimed NV has decided to continue enrolling its phase II, registration-directed study of AFM-13, a tetravalent, bispecific innate cell engager, as a monotherapy for treating relapsed or refractory CD30-positive peripheral T-cell lymphoma. Read More
Chinese eye disease specialist Arctic Vision Biotechnology Co. Ltd. raised more than $100 million in a series B financing round. The clinical-stage company will use the funds to initiate a phase III trial for its core asset, ARVN-001 (triamcinolone acetonide suprachoroidal injectable suspension), for uveitic macular edema in China this year. Read More
DUBLIN – Agomab Therapeutics NV raised $74 million in a series B round that attracted two heavyweight U.S. crossover investors, Redmile Group, which led the financing, and Cormorant Asset Management. Read More
With the prevalence of central nervous system disorders such as Alzheimer’s disease, multiple sclerosis, epilepsy, Parkinson’s disease and stroke increasing annually, the need for novel therapeutics to treat neurologic and psychiatric disorders has never been greater. Unfortunately, even though there is a significant unmet medical need, because of the high risk and low approval rates of drugs targeting those devastating diseases, in the past decade big pharma companies have been dramatically reducing their R&D spending on CNS disorders, noted Naheed Kurji, president and CEO of Toronto-based Cyclica Inc. Read More
Curing HIV remains a dream for now, but it is clearly not a pipe dream. One of the challenges for developing a vaccine is that there is no natural immune response to model such a vaccine on. Over time, an untreated HIV infection will almost certainly kill its host. However, there is a group of elite controllers – people who, although they cannot eliminate the virus, manage to keep it in check. Read More
With COVID-19 vaccine manufacturing still scaling up and the scarcity of some supplies, most of the vaccine doses available so far have been distributed in 75 countries while 115 countries are still waiting, World Trade Organization (WTO) Director-General Ngozi Okonjo-Iweala said at the March 9 Global C19 Vaccine Supply Chain and Manufacturing Summit. Read More
New hires and promotions in the biopharma industry, including: Abbvie Brazil, Atyr, Chimeron, Enterome, Ermium, Etherna, Intercept, Penrose, Tryp. Read More
Biopharmas raising money in public or private financings, including: Bavarian Nordic, Cybrexa, Gain, Jounce, Neurelis, Nurix, Santhera, Valo, Xenon. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Adicet, Affimed, Alar, Aligos, Beigene, Eli Lilly, Genentech, Gilead, Impact, VBI, Vertex, Viiv, Viriom. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Adaptive Phage, Amgen, Circ, Demerx, Idorsia, Kiromic, Lannett, Linnaeus, RDIF, Tarus, Vertex. Read More
