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Coronavirus Notebook: 35 Generic Firms To Produce Pfizer’s Paxlovid, AZ’s Evusheld Gains UK & Australian Approval

 
• By Ian Schofield

Finland’s Rokote expects to begin clinical trials with its intranasal vaccine after the summer, while Australia’s ENA Respiratory has dosed the first patients in a Phase IIa study of its antiviral nasal spray.

Coronavirus Disease 2019 or Covid-19 information map showing infection risk area - Concept of medical big data science analytic
Companies across the world will be able to produce Pfizer's COVID-19 therapy • Source: Alamy

A total of 95 low- and middle-income countries (LMICs) will be able to get access to generic versions of Pfizer Inc.’s new COVID-19 treatment, Paxlovid (nirmatrelvir with low-dose ritonavir), after 35 companies signed non-exclusive sublicenses with the Medicines Patent Pool.

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More from International

Global Pharma Guidance Tracker March 2025

 
• By Vibha Sharma and Anabel Costa-Ferreira

Stay up to date on regulatory guidelines from around the world with the Pink Sheet’s Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.

Industry Benefits As EU CTIS Hits Global Data Sharing Milestone

 
• By Neena Brizmohun

The EU Clinical Trials Information System has achieved primary registry designation in the International Clinical Trials Registry Platform in a move that is expected to reduce regulatory burden for companies and help them lower compliance costs by aligning with publication requirements in medical journals.

Gene Therapy ‘Survival Of The Fittest’ – Why Companies Need To Understand Health Systems

 
• By Eliza Slawther

Cell and gene therapy manufacturers must consider the practicalities of their product within the context of a health care system before it comes onto the market to be successful, experts from Novartis, AstraZeneca and England’s National Health Service say.

Global Pilot Reduces Drug Manufacturing Inspections With Hybrid Approach

 
• By Vibha Sharma

A global collaborative inspections pilot reduced the number of individual inspections for participating manufacturing facilities, demonstrating that multiple regulatory authorities can carry out joint inspections using a mix of on-site and remote approaches.

More from Geography

FDA Special Assistant Høeg’s Vaccine Concerns On Display At ACIP

 
• By Sue Sutter

Tracy Beth Høeg, who is reportedly re-examining Novavax’s COVID vaccine application, is the FDA rep at the CDC panel’s first meeting under the Trump Administration. She raised concerns about routine use of Jynneos for adolescents at risk of mpox and questioned how Moderna assessed efficacy of its COVID vaccines.

US FDA’s Advanced Manufacturing Designation Lifts Off With Cellares Cell Shuttle

 
• By Bridget Silverman

Cellares’ fully automated cell therapy manufacturing platform is the first system to receive an Advanced Manufacturing Technology designation from US FDA

HRA To Revisit Simplified Consent Provisions Under New UK Clinical Trials Law

 
• By Vibha Sharma

Study sponsors looking for guidance on how the simplified informed consent provisions will be implemented under the new UK clinical trials legislation will have to wait longer. The Health Research Authority is looking at what safeguards are needed to address the “range of concerns” stakeholders had regarding its initial proposal.