Ensoma Inc., a gene therapy startup working to drastically simplify the production and delivery of genomic medicines, announced itself Feb. 11 with a $70 million series A financing plus a strategic collaboration with Takeda Pharmaceutical Co. Ltd., which licensed vectors from the company for up to five rare disease targets in a deal that could deliver as much as $1.25 billion in potential payouts. Ensoma's co-founder and seed investor, 5AM Ventures, led the financing. Takeda took a $10 million equity stake as part of the round. Read More
Molecular Templates Inc., of Austin, Texas, has signed an R&D collaboration with Bristol Myers Squibb Co. (BMS) worth $70 million up front and potential development, regulatory and sales milestone payments of up to $1.3 billion. Molecular Templates will work on therapies designed for unnamed oncology targets to kill targeted cells by forcing receptor internalization, delivering payloads and enzymatically inactivating ribosomes. Read More
Nearly five months after its tau-directed antibody, semorinemab, failed to demonstrate efficacy in a phase II trial in Alzheimer’s disease, AC Immune SA is back with positive data on a different approach with its anti-phospho-tau vaccine candidate, ACI-35.030. Read More
PERTH, Australia – After hitting a few setbacks in recent months, regenerative medicine company Mesoblast Ltd. believes it finally has a path to market with its allogeneic mesenchymal precursor cell therapy, rexlemestrocel-L, in chronic low back pain. Read More
As it waits on initial data from its two lead programs, in sensorineural hearing loss and multiple sclerosis, Pipeline Therapeutics Inc. raised $80 million in a series C crossover round to progress its pipeline of small-molecule drugs for neuroregeneration and to position it for a potential IPO. Read More
Regeneron Pharmaceuticals Inc.’s angiopoietin-like 3 (ANGPTL3)-targeting antibody, Evkeeza (evinacumab), won FDA approval for use in reducing LDL cholesterol in patients with homozygous familial hypercholesterolemia. Read More
Twenty years to the month after the completion of the draft sequence of the human genome, the Human Genome Project and follow-on projects like The Cancer Genome Atlas are underpinning advances in precision medicine. Read More
LONDON – The EMA has requested all COVID-19 vaccine developers to investigate if their products offer protection against new variants of SARS-CoV-2 and to submit the relevant data. Read More
LONDON – After a number of equivocal small studies, the U.K. Recovery trial has applied its heft to turn in statistically significant evidence that the rheumatoid arthritis treatment Roactemra (tocilizumab) reduces mortality in hospitalized COVID-19 patients. Read More
Limited manufacturing capacity, supply chain disruptions and a dearth of personnel with specialized skills are all challenges vaccine makers are facing as they race to produce contracted quotas of COVID-19 vaccines that were developed and authorized in record time. Read More
The latest global regulatory news, changes and updates affecting biopharma, including: Fed Circuit agrees Amgen patents lack enablement; HC nudging along with regulatory modernization plan; EMA: No Sputnik application yet. Read More
New hires and promotions in the biopharma industry, including: Antios, Biodelivery Sciences, Contrafect, Kromatid, Recro, Retrotope, Sophia Genetics, Surface Oncology, Tryp. Read More
New and updated preclinical and clinical data presented by biopharma firms at the American Society of Clinical Oncology Genitourinary Cancers Symposium, including: Aveo, Cardiff, Clovis, Essa, Infinity, Noxopharm. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: AC Immune, Acer, Actinium, Almirall, Artios, Athenex, Benevolentai, Kite, Mesoblast, Olatec, Outlook, Urovant. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Atyr, Celltrion, China SXT, Dnatrix, Dyno, Exscientia, Gain, GSK, Incyte, M6P, Macrogenics, Mindmed, Mindshift, Nuvation, Olix, Panacea, Portage, Protalix, Renji, Rentschler, Repertoire, Sandoz, Sarcomed, Vyne. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Clinuvel, Genmab, Moderna, Oryzon, Polaryx, Seagen. Read More
