Register for our free email digests:
Policy and Regulation
Regulation Explore this Topic
Are you sure you'd like to remove this alert? You will no longer receive email updates about this topic.
US Generics Approvals Will Decline
With the pre-GDUFA backlog largely acted upon, the FDA expects ANDA approvals to decrease, but supplement actions to increase in FY 2020 and FY 2021.
Harmonization Needed For Complex And Value-Added Drugs
Complex generics and value added medicines share common challenges on harmonization of regulation, lack of incentives and clarity of guidelines, heard delegates to Medicines for Europe’s Regulatory & Scientific Affairs conference.
Regulatory Measures Could Mitigate EU Coronavirus Risks
As part of its response to the coronavirus outbreak, Medicines for Europe has set out a series of policy recommendations that it says could help to mitigate the risks of COVID-19.
Pricing Strategies; Reimbursement Explore this Topic
Are you sure you'd like to remove this alert? You will no longer receive email updates about this topic.
Beximco And Mylan Strike Biosimilars Deal
Bangladesh’s Beximco will market Mylan’s biosimilars in its domestic market, under a deal that has just been struck between the two companies. The Ogivri trastuzumab biosimilar, co-developed by Mylan and Biocon, will be the first product launched as part of the collaboration.
Upsher-Smith Launches Three New Generics
Upsher-Smith has strengthened its US generics portfolio with three new launches that will compete in a combined market worth nearly $102.5m.
US Generics Approvals Will Decline
With the pre-GDUFA backlog largely acted upon, the FDA expects ANDA approvals to decrease, but supplement actions to increase in FY 2020 and FY 2021.
Intellectual Property Explore this Topic
Are you sure you'd like to remove this alert? You will no longer receive email updates about this topic.
Beximco And Mylan Strike Biosimilars Deal
Bangladesh’s Beximco will market Mylan’s biosimilars in its domestic market, under a deal that has just been struck between the two companies. The Ogivri trastuzumab biosimilar, co-developed by Mylan and Biocon, will be the first product launched as part of the collaboration.
Upsher-Smith Launches Three New Generics
Upsher-Smith has strengthened its US generics portfolio with three new launches that will compete in a combined market worth nearly $102.5m.
US Generics Approvals Will Decline
With the pre-GDUFA backlog largely acted upon, the FDA expects ANDA approvals to decrease, but supplement actions to increase in FY 2020 and FY 2021.
Market Intelligence Explore this Topic
Are you sure you'd like to remove this alert? You will no longer receive email updates about this topic.
Beximco And Mylan Strike Biosimilars Deal
Bangladesh’s Beximco will market Mylan’s biosimilars in its domestic market, under a deal that has just been struck between the two companies. The Ogivri trastuzumab biosimilar, co-developed by Mylan and Biocon, will be the first product launched as part of the collaboration.
Upsher-Smith Launches Three New Generics
Upsher-Smith has strengthened its US generics portfolio with three new launches that will compete in a combined market worth nearly $102.5m.
US Generics Approvals Will Decline
With the pre-GDUFA backlog largely acted upon, the FDA expects ANDA approvals to decrease, but supplement actions to increase in FY 2020 and FY 2021.
You must sign in to use this functionality
Authentication.SignIn.HeadSignInHeader
Email Article
All set! This article has been sent to my@email.address.
All fields are required. For multiple recipients, separate email addresses with a semicolon.
Please Note: Only individuals with an active subscription will be able to access the full article. All other readers will be directed to the abstract and would need to subscribe.