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Policy & Regulation

New National Security Checks Could Hinder Investment, Warns UK Biotech Sector

Life science SMEs and their investors need to comply with new UK government checks on their dealmaking.

Companies Commercial Regulation

Novo Nordisk On The Pluses And Minuses Of The UK Post-Brexit R&D Environment

Post-Brexit Britain offers a fertile R&D ecosystem, but it needs to improve uptake in novel medicines there and strike a lasting deal with the EU over batch testing, Novo Nordisk’s UK general manager Pinder Sahota tells Scrip.

Brexit Clinical Trials Companies

Policy

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Latest From Policy

BIO Notebook: Going Fast And Being Precise

News and views from day three of the BIO Digital annual meeting include Amgen’s CEO on speedy development and NIH’s chief on bringing personalized medicine to COVID vaccines.

Clinical Trials Drug Safety

BIO 2021 Notebook: Looking Past The Pandemic

News and views from day one of the BIO Digital annual meeting include debate about when FDA will go back to the offices, industry's role in pandemic-related policy discussions and how to prepare for the next pandemic. 

Coronavirus COVID-19 FDA

Coronavirus Update: Brazil Opens Up Vaccine Imports

Brazil is permitting imports of additional coronavirus vaccines, while in India, Serum Institute will manufacture Sputnik V, the government is unifying vaccine sourcing, and emergency use approval has been granted to Lilly's anti-COVID-19 antibodies. 

Commercial Policy

Will Decentralized Trials Continue Growing After COVID-19 Pandemic Ends?

Some of the changes from the pandemic are here to stay, but so are some of the concerns that kept them from taking root.

Clinical Trials Policy

Pandemic Perspectives: 20-Plus Vaccines In Development As India Tackles COVID-19 Surge

From mRNA to subunit vaccines, Indian companies have 20 COVID-19 vaccine candidates, while three have already been approved. An August nod for Biological E could not just cut down time to immunize the country's population but also allow exports to resume.

India Coronavirus COVID-19

Pressure Mounts On EU To Follow US In Backing COVID-19 Vaccine IP Waiver

The pharmaceutical industry in Europe has attacked the US decision to come out in support of a relaxation of IP rights that is designed to boost global production of COVID-19 vaccines. But the move by the Biden administration could well cause other countries to rethink their opposition to the move.

Coronavirus COVID-19 Intellectual Property
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Regulation

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Latest From Regulation

BIO 2021 Notebook: Biogen CEO On Corporate Responsibility

News and views from day four of the BIO Digital annual meeting include the FDA's plans to use carrots not sticks to improve diversity and reflections on how the pandemic has strengthened biopharmaceutical supply chains. 

Clinical Trials Companies

BIO Notebook: Going Fast And Being Precise

News and views from day three of the BIO Digital annual meeting include Amgen’s CEO on speedy development and NIH’s chief on bringing personalized medicine to COVID vaccines.

Clinical Trials Drug Safety

BIO 2021 Notebook: A Breakthrough Year For Emerging Companies?

News and views from day two of the BIO Digital annual meeting include the increasing number of small companies driving US product approvals, the US FDA's Patrizia Cavazzoni on science vs. emotion at advisory committees and Merck & Co.'s Julie Gerberding on the need for continued HIV/AIDS research.

Advisory Committees Real-World Evidence

GSK/Vir’s Covid Antibody Gains EU Clearance, But Demand May Have Peaked

The green light for the COVID-19 antibody therapy is welcome news for the partners, but rising vaccination rates plus three other competitors in Europe will limit revenues.

Coronavirus COVID-19 Commercial

Quick Listen: The Story Behind The Pharmaprojects’ Pharma R&D Annual Review 2021

In this one-off podcast, hear in the inside story of how the Pharmaprojects’ Pharma R&D Annual Review 2021 is put together, its history and the trends it has revealed in R&D over the years.

Research & Development Companies

Humanigen Raises Chances of Lenzilumab EUA With Severe COVID-19 Data

Data on medRxiv showed a 90% improvement in likelihood of need for mechanical ventilation in the intent-to-treat population. The company plans a filing in Q2.

Coronavirus COVID-19 Clinical Trials
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