Scrip is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

Stockwatch: Lax Approval Requirements Yield Blockbusters That Don’t Work

How Sarepta And Biogen Are Following The Actimmune Playbook

Executive Summary

With the backdrop of Biogen’s BLA filing, and the FDA’s expected response for aducanumab in Alzheimer’s disease in 2020, the link between efficacy and approval seems to have broken. Conditional FDA approvals can’t help when the conditions are ignored.

You may also be interested in...



Sarepta's Eteplirsen Approved After Contentious Internal FDA Debate

CDER Director Woodcock grants accelerated approval after FDA Commissioner Califf refuses to overturn her finding that the drug's effect on dystrophin is reasonably likely to predict clinical benefit in Duchenne muscular dystrophy.

Stock Watch: Moderna Shares Soar While Pfizer Slides

The stock price performances of the top two coronavirus vaccine producers are inversely correlated to their sales and pipelines. There seems to be an expectation of declining coronavirus vaccine sales for some, but not for others.

Stock Watch: How The Pandemic Impact On Pharma’s Value Chain Is Mutating

From clinical trials to in-person sales calls, the pharmaceutical value chain has been tested by the COVID-19 pandemic, but has held up. Nevertheless, recent friction within this chain may be more than a passing irritation.

Topics

Related Companies

UsernamePublicRestriction

Register

SC141755

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Thank you for submitting your question. We will respond to you within 2 business days. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel