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Policy & Regulation

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 Infectious Diseases

Swiss Biotechs May Get SPAC Listing Option Soon

Although 2020 was the best year ever for Swiss biotech financing activities, no domestic IPOs were launched by the sector. But introducing the SPAC might change that.

Switzerland Companies Financing

Policy

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Latest From Policy

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

US COVID Vaccine Patent Waiver Is Big, Symbolic Blow For Pharma, But The Fight Is Just Beginning

Drug manufacturers still have a variety of ways to limit the impact of the Biden administration’s historic decision. Whether the huge political loss for industry translates into more than just headline-risk or faster global COVID vaccination remains to be seen. It is also not clear whether it is an ominous sign for other industry battles in the US, including the drug pricing debate.

Intellectual Property Coronavirus COVID-19

Do R&D Spending And Approvals Really Measure Innovation?

A lot of new drugs aren’t really all that innovative, which complicates the view that lower profitability will mean less biopharma innovation.

Innovation Policy

Pharma Gets Warm Spotlight At White House Event Showcasing J&J-Merck Collaboration

Biden Administration seeks to put its stamp on a new phase of the US government’s collaboration with the pharma industry against COVID-19.

Coronavirus COVID-19 Politics

ACIP Shies Away From COVID-19 Vaccine Comparative Efficacy And Safety Evaluations

The CDC panel’s mandate is to make recommendations for each specific vaccine brought forward, not ‘comparing two, three or four vaccines, and coming up with specific recommendations for each one independent of the other,’ chairman Jose Romero says as ACIP recommends use of Janssen’s COVID-19 vaccine under EUA.

Vaccines Coronavirus COVID-19

Scrip Asks…What Does 2021 Hold For Biopharma? Part 5: Business Environment And Strategy

A strong year is predicted for biopharma business with investment and deal making set to continue apace. Executives across industry share their forecasts for the year ahead.

Artificial Intelligence Brexit
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Regulation

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Latest From Regulation

Roche Warns On Anti-Trust Zeal While Posting Painful Q1

Biosimilar erosion and slack drugs sales caused by the pandemic depressed Roche’s first quarter pharma revenue while its diagnostics unit saw sales soar on COVID testing.

Sales & Earnings Commercial

Stock Watch: The Two Sides Of A Complete Response Letter

The FDA’s rejection of Acadia’s label expansion into a broader patient population for its only approved drug resulted in an aggrieved reaction. Better disclosure from both sides would have helped.

Complete Response Letters Companies

Regulators Reassure On AZ Vaccine Safety After Rare Side Effect Deemed Plausible

The EMA and MHRA issue parallel safety updates on the vaccine, with the UK offering an alternative of the Pfizer/BioNTech or Moderna vaccines to the under 30s.

Companies Coronavirus COVID-19

Roxadustat CKD Doubts Fanned By FibroGen Data Blunder

AstraZeneca's partner FibroGen stunned investors and regulators by announcing that previously disclosed cardiovascular safety data for CKD candidate roxadustat included changes made post hoc, rather than as pre-specified with the US FDA.

Clinical Trials Companies

Servier Guilty Of ‘Involuntary Manslaughter’ in Mediator Safety Affair

The long-running Mediator saga reached a conclusion of sorts on 29 March when fines and sentences were handed out to those involved in delaying the withdrawal of a fenfluramine derivative that is thought to have caused many thousands of serious cardiac side-effects.

Commercial Companies

AbbVie’s Rinvoq Delay By US FDA Could Foreshadow More Trouble For JAKs

The expansion of upadacitinib for a new indication in psoriatic arthritis has been pushed out three months to late in the second quarter.

Drug Safety Immune Disorders
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