The large-scale failure of a handful of drugs repurposed for COVID-19 hasn’t slowed efforts to find existing – and new – therapies as well as vaccines that can fight the pandemic, with research updates continuing to roll out. Read More
At its October meeting, the EMA’s Committee for Human Medicinal Products (CHMP) voted in favor of 11 new therapies, two of them for treating cancers and two for treating HIV-1. The European Commission will review the recommendations and make its decisions by the end of 2020. Read More
While the number of FDA approvals in 2020 are lockstep in line with last year, despite disruptions from the COVID-19 pandemic, the amount of regulatory news this year tracked by BioWorld has risen by 43% over 2019. Compared with 2018, it is 52% higher. Read More
Once upon a time in an age before the Internet, all things digital and even Hatch-Waxman, the FDA worked in its corner of the government approving drugs and therapeutic equivalents with little fanfare or transparency. Its decisions were duly recorded on paper and filed away. With the files located only at the agency, pharmacies across the country were left to wonder about which drugs could be substituted for another. Their recourse was to pick up the phone and pay for a long-distance call to the FDA every time a question arose. To reduce the number of phone calls it was getting, the FDA printed out a list of approved drugs with their equivalents and sent it to the pharmacies. The year was 1980, and the month was October. Going with the season, the FDA slapped an orange paper cover on the listing, giving birth to the Orange Book. Read More
In July a major initiative of the International Federation of Pharmaceutical Manufacturers and Associations, designed to combat the rising tide of antimicrobial resistance and accelerate the pace at which new antibiotics are discovered and brought to market, was announced. The $1 billion AMR Action Fund, supported by 23 pharma companies, was created “because there was a clear realization that we have no time to spare to address the lack of innovation in this area,” said Martin Bott, interim general manager of the fund, who described the progress being made with the fund in a fireside chat at this week’s virtual BIO Investor Forum. Read More
Investigators at the ECOG-ACRIN Cancer Research Group and the National Cancer Institute reported a roughly 40% match rate of patients to molecularly targeted therapies in its NCI-Molecular Analysis for Therapy Choice (NCI-MATCH) trial, ultimately leading to molecularly targeted treatments for almost 20% of trial participants. Read More
Biopharmas raising money in public or private financings, including: Aligos, Cellectis, FSD, Guardant, Intelgenx, Kiromic, Opthea, Praxis, Tarsus. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Adaptimmune, Amarin, Amylyx, Arch, Avalyn, Faron, Galapagos, Imara, Lipella, Pharmamar, Respira, Rocket, Y-mabs, Zynerba. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Abbvie, Anges, Aslan, Beyond Air, Er-kim, ICER, Macrogenics, Omeros, Takeda. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aimmune, Akero, Alnylam, BMS, Eisai, Kite, Gilead, Janssen, Medicenna, Nestle, Novartis, Oramed, Orchard, Recce, Regeneron, Sanofi, Valneva, Viiv, Zogenix. Read More
