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Despite administering a total of 2.2 billion COVID-19 shots, China as the first country to experience the coronavirus outbreak has yet to open its borders, while more effective mRNA vaccines are still nowhere to be found amid apparent delays for the licensed-in lead candidate.
The foundation is donating to help supply Merck/Ridgeback’s antiviral to low-income nations; also Pfizer got one step closer to full approval for booster shots of Comirnaty, while the FDA authorized Moderna and J&J boosters, and Daiichi Sankyo made progress on its own mRNA vaccine candidate. Shionogi's once-daily oral antiviral is also moving forward.
Ronapreve and Actemra for COVID-19 indications padded the top-line. Roche raised its financial outlook for the year to mid-single digit growth.
An attempt to show efficacy even in younger people with mild COVID-19 symptoms has fallen flat in Phase II, and AT-527 will now lag behind rivals Merck and Pfizer.
Results from a large Swedish study provide further evidence that mixing different COVID-19 vaccines boosts effectiveness. Meanwhile, Japan plans new funding to support the home-grown development of coronavirus and other vaccines.
The company is currently providing its COVID-19 vaccine on a not-for-profit basis but expects that will change as the pandemic phase of the crisis abates.
EyeGene R&D head talks to Scrip at CPhI Korea about the development of its COVID-19 vaccine candidate EG-COVID, potential challenges in clinical trials and positioning and the over-riding importance of validating a viable mRNA platform.
Immunogenicity data from Valneva’s COV-COMPARE study are encouraging, but the inactivated vaccine will need proper efficacy data to gain a toehold in a crowded market.
From the latest COVID-19 advances to the emergence of a game changer for heart failure, Scrip’s editor in chief Eleanor Malone reviews the big stories of the past three months. Safety issues around JAK inhibitors and AAV vector-based gene therapy were also to the fore, while biopharma financing continued apace.
With the latest Delta variant wave in the rear-view mirror, vaccine and antiviral sales, and their impact on full-year guidance, are likely to remain the big swing factors in third-quarter earnings season.
EuBiologics CEO Yeong Ok Baik sat down with Scrip at CPhI Korea to talk about why he wants to develop vaccines for global public health needs and what plans are in store for its late-stage recombinant protein candidate for COVID-19.
While Bharat Biotech is close to an accelerated approval of Covaxin in two to 18-year-olds, Zydus Cadila is yet to roll out its COVID-19 vaccine in India. As they head to a face-off in pediatric vaccines, the former faces manufacturing constraints and the latter hesitance over a first of its kind DNA vaccine. Experts speak to Scrip on which one stands a better chance of winning.
Chinese venture Brii seeks US emergency authorization for its antibody combo, as Chugai aims for wider use of its antibody cocktail in Japan and two other Chinese firms link up on an oral antiviral.
The UK major is delighted with the German biotech's decision to throw in the regulatory towel with CVnCoV and concentrate on the firms' collaboration to development a second-generation COVID-19 vaccine. However, GSK is insisting that the partners look at both modified as well as unmodified mRNA approaches, a significant change of strategy for CureVac.
Two Indian firms want to terminate specific Phase III trials for molnupiravir, the Merck/ Ridgeback Biotherapeutics’ antiviral in the spotlight as a treatment for mild-to-moderate COVID-19. Should much be read into these plans or is it merely an “administrative closure” that is being sought?
AstraZeneca Shrugs Off COVID Antibody’s Inferiority In Therapy Setting, Sees Prevention As Main Role
AstraZeneca’s anti-SARS-CoV-2 antibody product is unlikely to rival Regeneron or Vir/GSK’s offerings in mild-to-moderate patients, where Merck’s newly-submitted oral molnupiravir will also change treatment.
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