Please login to the form below

Not currently logged in
Email:
Password:

FDA`

This page shows the latest FDA` news and features for those working in and with pharma, biotech and healthcare.

FDA’s Gottlieb lambasts industry’s biosimilar-blocking tactics

FDA’s Gottlieb lambasts industry’s biosimilar-blocking tactics

FDA’ s Gottlieb lambasts industry’ s biosimilar-blocking tactics. Speech coincides with Biosimilars Action Plan. ... FDA Commissioner Scott Gottlieb has taken a swipe at biologics developers who use unwarranted delaying tactics to block the launch of

Latest news

  • US approval for first ever cannabis-based medicine US approval for first ever cannabis-based medicine

    Epidiolex is the first medicine based on highly-purified, plant-derived cannabidiol (CBD), which lacks the high associated with marijuana, and is the first in a new category of anti-epileptic ... GW Pharma has already filed with the FDA for a second

  • The year of the blockbuster The year of the blockbuster

    shown in that setting based  on which the US FDA granted Hemlibra breakthrough therapy designation in April. ... It is expected to become the first FDA-approved RNAi therapeutic following Alnylam’s completion of its new drug application (NDA)

  • Daily Brief: Gottlieb sets out cell and gene pathway, NICE says no to Chiesi ultra-rare treatment and more Daily Brief: Gottlieb sets out cell and gene pathway, NICE says no to Chiesi ultra-rare treatment and more

    A new era in haemophilia approaches. Yesterday’s big news came from two rival developing gene therapies which could represent a cure for haemophilia – Spark Therapeutics and BioMarin. ... pharmaceuticals. He also envisages a far greater need for

  • Sage surges after depression drug gets rapid path to approval Sage surges after depression drug gets rapid path to approval

    The FDA has given its blessing to an expedited development route for Sage Therapeutics’depression pill SAGE-217, upgrading its ongoing study to a pivotal trial. ... The move - which ties in with FDA Commissioner Scott Gottlieb ’s stated ambition to

  • AbbVie, Roche get FDA OK for broader use of Venclexta AbbVie, Roche get FDA OK for broader use of Venclexta

    AbbVie, Roche get FDA OK for broader use of Venclexta. The drug is tipped to become a $2.5bn product by 2024. ... Venclexta was approved by the FDA as a second-line therapy for CLL patients with a chromosomal abnormality known as 17p deletion in 2016,

More from news
Approximately 31 fully matching, plus 851 partially matching documents found.

Latest Intelligence

  • 30 women leaders in UK healthcare (part 3) 30 women leaders in UK healthcare (part 3)

    2004. Fifteen years on, the company’s lead product candidate, Lynovex, for the treatment of acute pulmonary exacerbations in Cystic Fibrosis, was recently granted FDA Fast Track Designation. ... I am focused most on how to make the average person

  • Significant figures Significant figures

    US regulators at the FDA have recognised the treatment’s potential, handing it breakthrough and fast-track status. ... Offering an on-label treatment. The current standard of care for treating patients with NTM lung disease consists of a triple

  • The good, the bad and the ugly The good, the bad and the ugly

    The main drivers of revenue for Roche are well-established, standard-of-care blockbuster oncology drugs including Rituxan, Herceptin and Avastin. ... The data this article was based on is available in full online: pmlive.com/top_pharma_list.

  • The gold standard of scientific evidence The gold standard of scientific evidence

    The gold standard of scientific evidence. Will randomised controlled trials become a thing of the past? ... The FDA uses RWE to monitor drug safety as part of the Sentinel project.

  • Europe vs the US: New drug product approvals Europe vs the US: New drug product approvals

    During 2016 the FDA issued 14 CRLs, compared to just two in 2015. ... We expect the strong overall trend for more orphan drugs submitted to and approved by the FDA and the EMA to continue.

More from intelligence
Approximately 0 fully matching, plus 22 partially matching documents found.

Latest appointments

More from appointments
Approximately 6 fully matching, plus 42 partially matching documents found.

Latest from PMHub

More from PMHub
Approximately 0 fully matching, plus 36 partially matching documents found.

Featured jobs

Subscribe to our email news alerts

PMHub

Add my company
VCCP Health

We’re the challenger agency for challenger brands. Brands with a point to prove. Rx, OTC and wellness brands run by...

Latest intelligence

Developing advocacy in the pharmaceutical industry.
The importance of advocacy programmes...
GDPR and events. What does the pharma industry need to know?
Many people in the pharma industry still aren’t following the rules set out by the GDPR when it comes to running events and attending tradeshows. But with eye-watering fines for...
Digital trends in B2B sales - how far behind is Pharma?
The modern approach to B2B sales is data-driven, and enabled by digital tools....

Infographics