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Home » Newsletters » BioWorld

BioWorld

Sep. 24, 2020

View Archived Issues
Vaccination

Researchers support U.K. plans for first human challenge trial for COVID-19 vaccine

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

Biopharm America: Bayer investing advances by Leaps and no boundaries

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
Drug research illustration

The U.S. remains strong in first-in-world launches but Asia is becoming an innovator

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

Afimmune follows Amarin playbook with next-generation omega-3 fatty acid drug

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
Illumet

Australia’s Telix Pharmaceuticals submits NDA for prostate cancer companion diagnostic

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

ABL reveals logic behind partnerships, hopes to advance bispecific antibodies

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

Trump questions need for EUA vaccine guidance

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
Brain circuits

Popular opinion correct on fear, anxiety

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

Appointments and advancements for Sept. 24, 2020

New hires and promotions in the biopharma industry, including: Diffusion, Evgen, Novadiscovery, Novan, Scancell. Read More

Financings for Sept. 24, 2020

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

In the clinic for Sept. 24, 2020

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

Other news to note for Sept. 24, 2020

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 actions for Sept. 24, 2020

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

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