COVID-19 Update

Combatting Future Viral Threats with Vaccine Advances

The COVID-19 pandemic has led to many changes in how pharmaceutical companies develop vaccines.

What’s Next for COVID-19 Vaccines and Variants?

More technologies and treatments are emerging for COVID-19—along with new variants.

Key Elements for Assay Transfer Success

Partnerships formed during the COVID-19 pandemic have provided a platform for change in assay development and transfers.

Moderna Plans to Build mRNA Vaccine Manufacturing Facility in Canada

August 12, 2021

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

EMA Recommends Including Adverse Reaction Warning to Janssen COVID-19 Vaccine

August 09, 2021

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 PRAC Requests Additional Data on Guillain-Barré Syndrome in COVID-19 Vaccine

August 09, 2021

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

Nasal Spray and Mouth Rinse Demonstrate Efficiency in Preventing COVID-19 and Other Infections

August 05, 2021

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.

CHMP Approves Manufacturing Scale-Up for Spikevax

August 04, 2021

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

Analysis Demonstrates No Increased Incidence of Thrombosis with TTS After Vaxzevria Second Dose

August 04, 2021

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

Nitric Oxide Nasal Spray for COVID-19 to Be Distributed to India and Other Asia Markets

August 04, 2021

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

EC Makes Supply Agreement with GSK and Vir Biotechnology for mAb COVID-19 Treatment

August 03, 2021

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.

Regeneron Receives Expanded Authorized Use from FDA for Antibody COVID-19 Treatment

August 02, 2021

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.

CMOs and CDMOs Adjust to Pandemic Response and Beyond

August 02, 2021

Investments, biologics, and the impact of COVID-19 will continue to shape the bio/pharmaceutical outsourcing industry for the near term.