LONDON – The U.K. will become the first country to stage a human challenge trial in which volunteers are deliberately infected with SARS-CoV-2, as a fast route to assessing the effectiveness of COVID-19 vaccines, and to build understanding of what an effective immune response looks like. The contract research organization Open Orphan plc said it is in advanced negotiations with the U.K. government and other partners for the studies, which are expected to be formally announced next week. Read More
Deals by Bayer AG’s “impact investment unit” called Leaps that build upon each other let the Leverkusen, Germany-based firm “basically renew [the company’s] technology platform” by tapping fresh sources, said Leaps head Jurgen Eckhardt. And the unit is casting nets widely. Read More
The aging portfolios of drug companies and the emergence of China as it moves to develop more innovative therapies are two signposts from an industry in flux, according to the newly released 2020 Centre for Medicines Research (CMR) International Pharmaceutical R&D Factbook. Read More
DUBLIN – Afimmune Ltd. is starting a phase IIb trial of a bioactive lipid, epeleuton, in patients with high triglycerides and type 2 diabetes, in an effort to confirm prospective observations already seen in a phase IIa study. Read More
PERTH, Australia – Melbourne-based Telix Pharmaceuticals Ltd. has submitted its first new drug application to the FDA for TLX591-CDx, a radiopharmaceutical targeting prostate-specific membrane antigen (PSMA) for imaging prostate cancer using positron emission tomography (PET). Read More
HONG KONG – Seongnam-Si, South Korea-based ABL Bio Inc. hopes to file IND applications for two solid tumor-focused bispecific antibodies (BsAb), CEO Sang-hoon Lee, told the 2020 Bioplus Interphex Korea conference. Read More
The latest global regulatory news, changes and updates affecting biopharma, including: FDA stands by plasma EUA; Benzodiazepines to get added warnings; EMA posts draft guidance for registry-based studies; SEC finalizes whistleblower changes; Gilead to pay $97M; Plandai, CEO settle with SEC. Read More
BioWorld looks at translational medicine, including: Buyer beware for SARS-CoV-2 antibody detection; Statins help pancreatic tumors go from bad to worse. Read More
Biopharmas raising money in public or private financings, including: 4basebio, ADC, Alsa, Eagle, Gilead, Immunome, Immunomedics, Lexicon, Monte Rosa, PMV, Taysha, Titan, Zogenix. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Aerie, Akero, Axsome, Biomarin, Calithera, Cortexyme, Inmed, Medicinova, Millendo, Neomatrix, Oncimmune, Theralase, Verrica, Vifor. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Algenex, Alligator, CNS, Dexcom, Dynavax, Hoth, Ideaya, Image Analysis, Innoplexus, Kanaph, Kyan, Lumen, Mindmed, Pfizer, Samsung, Taiho, Trisalus, Vir. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Advaxis, Amicus, Anokion, Applied Therapeutics, Ascendis, Innova, Leap, Mereo, Telix. Read More
