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Home » Newsletters » BioWorld

BioWorld

Nov. 16, 2020

View Archived Issues
COVID-19 mRNA vaccine vials, syringe

Dynamic stability: Moderna flies high with storage-friendly COVID-19 vaccine bid

Moderna Inc.’s phase III win with its COVID-19 vaccine candidate, mRNA-1273, lifted spirits while validating the Cambridge, Mass.-based firm’s platform, as Wall Street buzzed with comparisons between the prospects that have yielded late-stage data thus far. Read More
J&J COVID-19 vaccine candidate

J&J targets U.K. for second study, as early data start flowing from COVID-19 vaccine trials

LONDON – A second phase III trial of Johnson & Johnson’s adenoviral-vectored COVID-19 vaccine is starting in the U.K. this week, amid concerns the positive news from the Pfizer Inc./Biontech SE vaccine study will deter volunteers from coming forward to take part. Read More
IPO money

Olema files to raise $170M to advance targeted cancer therapy

Olema Pharmaceuticals Inc., a company looking to improve on current endocrine therapies with an oral estrogen receptor antagonist and degrader of its own, has filed for a $170 million IPO on Nasdaq. The offering follows an $87.4 million series C round, closed in September and a $54 million series B financing closed not long before in July. Read More

Canada focuses on innovations in therapeutic radiopharmaceuticals

There has been a recent renaissance in the interest in radiopharmaceuticals used for diagnostic and therapeutic applications, as well as their combined use (theranostics). A recent Canadian partnership between Admare Bioinnovations and the Centre for Probe Development and Commercialization (CPDC) aims to take advantage of the country’s expertise in the field and leverage promising radiopharmaceutical innovations into potential commercial opportunities. Read More
cardio red blood cells artery

A CRL for sutimlimab is Sanofi’s Friday 13th bad luck charm

The FDA has issued Sanofi SA a complete response letter (CRL) regarding its complement pathway inhibitor sutimlimab, citing deficiencies found during a pre-license inspection of a third-party manufacturing facility. Read More
Startup key, rocket icon

Newly launched Myricx tackling sought-after cancer target Myc

LONDON – Myricx Pharma Ltd. has launched with £4.5 million (US$5.9 million) seed funding to advance a new approach to targeting Myc, an oncogene that has defied long years of effort to drug it. The company will take a synthetic lethal approach, developing small-molecule inhibitors of N-myristoyltransferase to perturb pathways that Myc drives, causing cancer cell death. Read More

Skeptical OIG issues fraud alert about speaker programs

If the Office of Inspector General (OIG) for the U.S. Department of Health and Human Services has its way, one of the casualties of the COVID-19 pandemic would be the in-person speaker programs many drug and device companies sponsor. The OIG issued a special fraud alert Nov. 16 questioning the need for such events in which health care professionals are often paid a hefty honorarium or fee to provide colleagues with information that’s readily available online and in the labeling of a drug or device. Read More

Vaccine, diagnostic developers targeted by cyberattacks

The latest global regulatory news, changes and updates affecting biopharma, including: Lawmakers protest latest 340B scheme; Groups make case for extending sequester moratorium; More $$ needed for global vaccine effort; Russia extends COVID-19 drug, device program. Read More
DNA-testing.png

Late events dog gene therapy

BioWorld looks at translational medicine. Read More
ICYMI illustration

ICYMI: Week in review, Nov. 9-13, 2020

A quick look back at top stories. Read More

Appointments and advancements for Nov. 16, 2020

New hires and promotions in the biopharma industry, including: Arch, Athersys, Crinetics, Gossamer, Melinta, Monte Rosa, Q-State, Silo, Spark, Terns, Ziopharm. Read More

Conference data for Nov. 16, 2020: AASLD

New and updated preclinical and clinical data presented by biopharma firms at The Liver Meeting of the American Association for the Study of Liver Diseases Nov. 13-16, including: Arbutus, Can-Fite, Dicerna, Gilead, Mallinckrodt, Mirum, Novo, Seal Rock, Theratechnologies, Twoxar Read More

Conference data for Nov. 16, 2020: AHA

New and updated preclinical and clinical data presented by biopharma firms at the 2020 American Heart Association Scientific Sessions Nov. 13-17, including: Acceleron, Astrazeneca, Cytokinetics, Daiichi, Myokardia, Silence. Read More

Financings for Nov. 16, 2020

Biopharmas raising money in public or private financings, including: Bioatla, Compass, Intervenn, Kinnate, Moberg, Nereid, Oncozenge, Sigilon, Stat Codon. Read More

In the clinic for Nov. 16, 2020

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Adverum, Akebia, Alligator, Aptevo, Atara, Beyondspring, Bioaegis, Biological E., Calypso, Cerevance, Dynavax, Genenta, Intravacc, Karyopharm, Kodiak, Moderna, Medexus, Obseva, Precigen, PTC, Rapt, Redhill, Revelation, Rhovac. Read More

Other news to note for Nov. 16, 2020

Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: 9 Meters, Abpro, Aeterna, Agbiome, AIkido Amag, Assembly, Biohaven, Bone, Catalent, Covis, Dicerna, Door, Elevatebio, IEH, Innocan, Johnson & Johnson, Kala, Lead, Lifeedit, Lilly, Merck & Co., Minoryx, Mylan, Pfizer, Pharvaris, Prime, PTC, Receptor, Roche, Synthetic Biologics, Vertex, Viatris, Vivus, Xoma, Xortx. Read More

Regulatory actions for Nov. 16, 2020

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: 3D, Agilent, Alphamab, Amylyx, Artelo, Aruvant, Boehringer, Cytodyn, Dicerna, Eisai, Exegi, Innovation, Insmed, Kiniksa, Jounce, Lilly, Lupin, Merck, Mindmed, Neoimmunetech, Neuronasal, Sanofi, Tracon. Read More

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