COVID-19 Update

Exscientia has entered into a four-year agreement with the Bill & Melinda Gates Foundation for the development of small-molecule therapeutics that can tackle coronavirus and other viruses with pandemic potential.

Low- and middle-income countries are at the greatest risk of receiving substandard and falsified COVID-19 vaccines.

The COVID-19 pandemic has further impacted ongoing drug shortage issues; essential action is needed to avoid repeating previous mistakes.

The White House announced a nearly $3 billion program to ramp up production of vaccines and their components.

Alternative materials, as well as supply-chain planning, are essential to ensure a reliable supply for parenteral drug packaging.

The intranasal route of administration is showing clinical promise, particularly for COVID-19, but there are multiple hurdles to overcome to ensure successful formulation.

Despite the market challenges caused by COVID-19, M&A activity in the life sciences sector is recovering well.

SK and GSK announce the initiation of a Phase III clinical study of SK’s COVID-19 vaccine candidate, GBP510, in combination with GSK’s pandemic adjuvant.

Merck and Ridgeback Biotherapeutics announced the initiation of the Phase III clinical trial to evaluate an investigational oral antiviral therapeutic for the prevention of COVID-19 infection.

Two of FDA’s vaccine regulators will be leaving in the fall of 2021, which has the potential to impact COVID-19 vaccine recommendations for both children under the age of 12 and booster shots.

After receiving the COVID-19 vaccine from a batch of Moderna vaccines that were suspected to have contaminants, two people in Japan died. Meanwhile, another one million doses have been temporarily suspended in Japan.

FDA’s full approval of the Pfizer-BioNTech COVID-19 vaccine raises hopes that this action will help overcome vaccine hesitancy.

HHS Public Health and a team of medical experts recommend that COVID-19 vaccine booster shots will soon be necessary.

FDA approved the Pfizer-BioNTech COVID-19 vaccine, which will be marketed as Comirnaty.

MHRA has approved Moderna’s COVID-19 vaccine for use in 12–17-year-olds.

EMA has started evaluating RoActemra (tocilizumab), an anti-inflammatory medicine, as a potential treatment for hospitalized adult patients with severe COVID-19.

WHO’s solidarity plus trial will enroll hospitalized patients to test artesunate, imatinib, and infliximab in hospitalized COVID-19 patients.

Eli Lilly and Company and Incyte have announced promising results that patients with COVID-19 on mechanical ventilation saw a reduction in deaths with the addition of baricitinib treatment.

The agency has amended the emergency use authorizations for the Pfizer-BioNTech and Moderna vaccines to allow certain immunocompromised people to receive an additional dose of the vaccine.

A research team at the Keck Graduate Institute will work to adapt its decade-long low-cost vaccine R&D for developing countries into a COVID-19 vaccine.

A collaboration between Aldevron and Ginkgo Bioworks has resulted in a manufacturing enhancement that can improve production of an enzyme used for mRNA therapeutics.

Moderna will build an mRNA vaccine manufacturing facility in Canada to provide access to domestically manufactured vaccines against respiratory viruses.

The agency’s Pharmacovigilance Risk Assessment Committee recommended updating the product information for Janssen’s COVID-19 vaccine to list immune thrombocytopenia as an adverse reaction.

EMA’s Pharmacovigilance Risk Assessment Committee has requested more data for its evaluation of reports of Guillain-Barré syndrome after vaccination.

BMG Pharma's clinical trial has demonstrated positive results in the efficacy of BMG0705 Nasal Spray and BMG0703A Mouth Rinse as treatments for asymptomatic COVID-19 patients.

EMA’s CHMP has approved the increased manufacturing capacity and supply of Moderna’s COVID-19 vaccine active substance in its US manufacturing site.

A global safety database analysis has demonstrated no increased incidence of thrombosis with TTS after the second dose of Vaxzevria.

Glenmark Pharmaceuticals has partnered with SaNOtize to manufacture, market, and distribute NONS to India, Singapore, Malaysia, Hong Kong, and more.

The European Commission has entered into a supply agreement with GlaxoSmithKline and Vir Biotechnology for up to 220,000 doses of sotrovimab, an investigational mAb for treating COVID-19.

The expanded authorization from FDA enables the use of Regeneron Pharmaceuticals’ REGEN-COV antibody cocktail therapy for post-exposure prophylaxis in certain people exposed to SARS-CoV-2.