Gilead's remdesivir is first drug fully approved by FDA to treat COVID-19. Roche and Atea team up on an investigational direct acting antiviral while Moderna reaches the 30,000-patient enrollment target for its Phase III COVE study of the company's investigational mRNA vaccine. 

From efficacy endpoints to patient warehousing, US FDA advisors weigh in on vaccine development and regulatory review.

Pfizer's COVID-19 vaccine is sure to dominate the third quarter results call, with everything from data to widescale distribution and the potential financial reward on the minds of investors and the public.

With the impact of pandemic-prompted disturbances waning, analysts forecast better Q2 numbers for Indian pharma firms, with some including Glenmark and Cipla seen emerging winners. But after doing well in the quarter, Gilead’s licensees might see remdesivir demand tapering somewhat in Q3 post the WHO finding the antiviral ineffective in COVID-19 treatment.

Early in 2020, company guidance was that pandemic-related effects would have dissipated in the third quarter. Issues specific to J&J and Roche leave this broad conclusion still up in the air.

The UK backs the world's first COVID-19 human challenge studies to accelerate research – though the first results will not be ready until mid-2021.

The head of global vaccine and plasma segments, bioprocessing, at German multinational Merck discusses key aspects around evolving vaccine manufacturing to improve the efficiency and speed of response during a pandemic. Pre-existing manufacturing platforms, the executive says, could compress process development work and fast-track scale-up.

Join us for a brief audio roundup of the major developments in the international biopharma industry over the past week, as covered by Scrip's global team.

Pfizer CEO says that an EUA request for its COVID-19 vaccine is unlikely before late November. Analyst calls Pfizer’s development pace an encouraging sign it could be a more nimble company.

Plus Sanofi and Translate Bio release preclinical data from their COVID-19 vaccine candidate, another entrant to the now crowded mRNA vaccine field.

The Swiss major's old guard of oncology products continue to falter but Roche's new wave of treatments is helping to keep the financials fairly healthy.

With a candidate COVID-19 therapy in clinical development, the UK’s Synairgen has raised $101m on the UK’s AIM to support clinical studies and manufacturing plans.

Roche Pharma CEO Bill Anderson is excited about the prospects for REGN-COV2 but with the company and Regeneron possibly producing two million doses per year by the end of Q1 2021, meeting demand worldwide will be an impossible task.

Join the Asia content team for a wide-ranging overview and analysis of developments and trends in the region, including coronavirus vaccines in China, Korean developments in NASH, digital health shifts, Indian corporate performance and Japanese deal trends. 

Analysts are confident that Pfizer/BioNTech’s mRNA vaccine will prove its safety and efficacy – but waiting a little longer for more robust data could be for the best.

Although top-line efficacy results from a small study in critically ill patients with COVID-19 suggest there are therapeutic benefits associated with Relief Therapeutics/NeuroRx’s RLF-100 (aviptadil), further data are awaited from the results of a randomized clinical trial, expected later this year.