Interim data from the Solidarity Therapeutics Trial coordinated by the World Health Organization show that remdesivir, hydroxychloroquine, lopinavir plus ritonavir, and interferon regimens apparently “have little or no effect” on 28-day mortality or the in-hospital course of COVID-19 among patients admitted. Amid the disappointing outcome, efforts continue to identify existing – or new – therapies as well as vaccines to fight the pandemic. Faron Pharmaceuticals Oy, Pfizer Inc., and Pharmamar SA offered updates on their programs.

Cancer and HIV top CHMP’s October recommendations

At its October meeting, the EMA’s Committee for Human Medicinal Products (CHMP) voted in favor of 11 new drugs, two of them for treating cancers and two for treating HIV-1. Both Bristol Myers Squibb Co.’s Opdivo (nivolumab) for adults with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma after prior fluoropyrimidine- and platinum-based combination chemotherapy and Kite Pharma Inc.’s CAR T-cell therapy for treating adults with relapsed or refractory mantle cell lymphoma received CHMP’s positive opinion Oct. 16. For treating HIV-1, the committee offered positive opinions on Viiv Healthcare Ltd.’s Vocabria (cabotegravir injection) and Johnson and Johnson’s Rekambys (rilpivirine injection). Both HIV treatments are combination therapies.

Busy year with regulatory news tracking 43% higher than 2019

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. The numbers show that since January, there have been 1,883 global regulatory news items and 162 approvals of drugs and biologics by the FDA. This compares with 1,312 items and 161 FDA approvals by this point last year.

FDA’s Orange Book turns 40

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.

No time to lose to curb rising tide of antimicrobial resistance

In July this year a major initiative of the International Federation of Pharmaceutical Manufacturers and Associations, designed to combat the rising tide of antimicrobial resistance (AMR) 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.

NCI-MATCH data give insights into late-stage tumors

Investigators from the Eastern Cooperative Oncology Group, the American College of Radiology Imaging Network, and the National Cancer Institute (NCI) 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. Some individual arms of the trial, a basket trial testing 30 drugs that were either approved or in late-stage clinical trials at the time the NCI-MATCH trial began, have read out. But the new publication is “the first molecular analysis of the [whole] trial population,” Keith Flaherty told BioWorld.

Bench Press: BioWorld looks at translational medicine

Natural killer cells dabble in adaptive immunity; PDAC subtypes point to targeting strategies; Lactose tolerance may be Red Herring

Also in the news

Adaptimmune, Aimmune, Akero, Aligos, Allovir, Alnylam, Amarin, Amylyx, Anges, Arch, Aslan, Avalyn, Beyond Air, Bristol Myers Squibb, Calyxt, Cellectis, Eisai, Er-Kim, Faron, FSD, Galapagos, Gilead, Guardant, Imara, Intelgenx, Janssen, Kiromic, Lipella, Macrogenics, Medicenna, Novartis, Omeros, Oramed, Orchard, Pharmamar, Praxis, Recce, Respira, Rocket, Sanofi, Servier, Tarsus, Valneva, Viiv, Y-mabs, Zogenix, Zynerba