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COVID-19

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Pfizer Reveals Secret Digital Sauce To Cut Trial Duration, MLR Review Times

How do you send 90,000 employees home and still bring a COVID-19 vaccine to market in record time? Pfizer showed the way and at a recent virtual event, senior vice-president Robert Brown revealed how the "secret sauce" of digitalization continues to help cut medical legal review times, crunch clinical trial duration and reduce service interruptions.

China's Ongoing 'COVID Zero' Policies To Prompt More Domestic Deals?

China biotechs appear increasingly interested in partnering with domestic counterparts amid signs the Chinese government's restrictive "COVID Zero" policies are likely to stay until well into 2023.

Quick Listen: Scrip's Five Must-Know Things

In this week's podcast edition of Five Must-Know Things: a big US approval for BMS; Roche touts its diverse R&D pipeline; Lumakras’s mixed Phase III results in lung cancer; Japan controversy over a COVID-19 antiviral; and GSK's vaccine strategy in India.

COVID-19 DNA Vaccine Halt Another Blow To AnGes

AnGes has terminated R&D work on a DNA vaccine for COVID-19 and will now look at intranasal candidates with a US partner. Although the original project received funding from the Japanese government, a spike in related costs caused the Japanese firm's net loss to triple last year, and the decision represents the latest in a string of pipeline setbacks.

Can Moderna Pull Off More Disruptive Innovation? Flu And RSV Shots Are Next Test

Moderna needs to develop new mRNA-based therapies beyond COVID-19, and flu and RSV will be the big readouts in 2023.

China Approves World’s First Inhaled COVID-19 Vaccine

China has cleared for sale the world's first inhaled vaccine for COVID-19, as China continues to face challenges to its strict "COVID Zero" policies, including a new extended lockdown in a major city, ahead of the upcoming high-stakes National Congress. 

Japan Physician Groups' Controversial Push For Xocova Backfires

A controversial letter from two Japanese doctors' associations seemingly pressing regulators to approve Shionogi’s oral COVID-19 drug prompts a backlash from other physicians. 

Bharat Biotech Debuts World’s First Exclusively Intranasal COVID-19 Vaccine

With the world’s first exclusively intranasal COVID-19 vaccine against COVID-19 getting restricted use approval in India, Bharat Biotech/Washington University St. Louis offer an easy-to-use immunization option. But is it too little too late?

AZ’s Evusheld Receives World-First Approval As COVID-19 Treatment, In Japan

Japan has approved Evusheld for both the prevention of infection in people who have not been exposed to the virus and, for the first time globally, as a treatment. The country's government will purchase 300,000 units from AZ amid global supplies that have been limited due to the surging need for the drug.

New Front-Runner Emerges In China mRNA Booster Race

China's CSPC Pharmaceutical Group surprises by announcing investigator-initiated trial results for SYS6006, its mRNA COVID-19 vaccine candidate against the Omicron variant.

Coronavirus Update: Pfizer/BioNTech, Moderna Submit Omicron EUAs For Fall Season

Under FDA guidance, the companies submitted clinical data for BA.1-targeting bivalent vaccines together with BA.4/BA.5 preclinical data. Novavax got a nod for its COVID-19 vaccine in adolescents, but its own Omicron development efforts remain behind the two mRNA heavyweights.

Moderna Wins Bivalent COVID-19 Vaccine Booster Race With First Approval

Moderna takes the next step in the in the development of COVID-19 vaccines, with the first approval of the first bivalent vaccine that can produce a broader immune response to new SARS-CoV-2 variants.

Anger Over Access To AstraZeneca's Evusheld Peaks In UK

News that the UK government will not procur any doses of AstraZeneca’s Evusheld for the prevention of COVID-19 infections in immunocompromised people has been greeted with dismay and the move will hurt the combo's already-limited sales growth.

Valneva Confirms Step Back From COVID-19 Vaccine Development

The French firm has suspended the manufacturing of its COVID-19 vaccine, instead emphasizing its hopes in advanced Lyme disease and Chikungunya.

Frontier Bets $52m On Potential Rival To Gilead's Veklury

Frontier Biotechnologies is seeking to enroll roughly 1,200 hospitalized COVID patients in an international Phase II/III clinical trial to evaluate its bofutrelvir (FB2001) in competition with Gilead’s Veklury.

Lost In Translation? New Zoonotic Virus Naming Gets China's Largest Physician Platform In Trouble

China's largest physician portal DXY has been banned from posting on a major social media platform after naming a new zoonotic virus after the place where it originated.

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