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EU CHMP Opinions And MAA Updates
This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the...
Pink Sheet - April 29, 2024
EU & South Korea Sign Deal On Exchange Of Confidential Information
The EU and Korean authorities say the agreement will allow them to further develop moves towards mutual recognition and regulatory...
Pink Sheet - April 29, 2024
Pipeline Watch: Eighteen Approvals And Six Phase III Trial Updates
Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies...
Scrip - April 29, 2024
Stick, Twist Or Split? Generics Industry’s Big Three Place Their Bets
With Teva and Viatris recently under new management and Sandoz having last year split from former parent company Novartis, the...
Generics Bulletin - April 29, 2024
Sunshine Subsidiary Nora Pharma Secures Canadian Approval For Neulasta Biosimilar
The approval brings another biosimilar to Amgen’s Neulasta, stepping up competition in an already heated market that has seen major...
Generics Bulletin - April 29, 2024
Recent And Upcoming FDA Advisory Committee Meetings
Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered. 
Pink Sheet - April 29, 2024
Bolar Exemption India Files: Roche Blocks Alleged Infringer Of Evrysdi Patent
More legal action in India that has the Bolar exception provision at its crux with Roche, in this instance, warding...
Scrip - April 29, 2024

Pipeline Watch: Eighteen Approvals And Six Phase III Trial Updates
Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies...
Scrip - April 29, 2024
Bolar Exemption India Files: Roche Blocks Alleged Infringer Of Evrysdi Patent
More legal action in India that has the Bolar exception provision at its crux with Roche, in this instance, warding...
Scrip - April 29, 2024

EU CHMP Opinions And MAA Updates
This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the...
Pink Sheet - April 29, 2024
EU & South Korea Sign Deal On Exchange Of Confidential Information
The EU and Korean authorities say the agreement will allow them to further develop moves towards mutual recognition and regulatory...
Pink Sheet - April 29, 2024
Recent And Upcoming FDA Advisory Committee Meetings
Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered. 
Pink Sheet - April 29, 2024

News We're Watching: LDT Final Rule Near Publication, Zimmer ROSA Used In Shoulder Surgery, $60M For Menopause Clinic
This week, the US FDA's proposed final rule on lab-developed tests cleared another hurdle on the path to release; Zimmer...
Medtech Insight - April 26, 2024
Epitel Gets 510(k) Clearance On Remote EEG Technology
The REMI Remote EEG monitoring system and REMI Vigilenz AI could help patients with infrequent seizures get a quicker diagnosis.
Medtech Insight - April 26, 2024
Valuable Health Data Sources For Medtech Industry Come A Step Closer In The EU
The only step that remains now before the  European Health Data Space Regulation is approved is sign off by the...
Medtech Insight - April 26, 2024

Partisan Politics Returns To US FDA Congressional Oversight
The US FDA has stood out as an agency that tends to draw broad bipartisan support amid a generally rancorous...
HBW Insight - April 28, 2024
The Aspirin Test For AI?
US FDA Commissioner Robert Califf tells Congress that regulators don’t have to know how artificial intelligence works in medicine, but...
HBW Insight - April 28, 2024

Stick, Twist Or Split? Generics Industry’s Big Three Place Their Bets
With Teva and Viatris recently under new management and Sandoz having last year split from former parent company Novartis, the...
Generics Bulletin - April 29, 2024
Sunshine Subsidiary Nora Pharma Secures Canadian Approval For Neulasta Biosimilar
The approval brings another biosimilar to Amgen’s Neulasta, stepping up competition in an already heated market that has seen major...
Generics Bulletin - April 29, 2024

Human Cell-Secreted Proteins Offer A Wellspring Of Potential Therapeutics
CEO Hanadie Yousef leads Juvena Therapeutics in utilizing an AI-based platform that analyzes cell-secreted proteins to identify potential therapeutics. One...
In Vivo - April 24, 2024
Fujifilm Demonstrates Health Specialism With European HealthTech Spinout
From X-ray film in 1936 to the world’s first digital X-ray system in 1983, Fujifilm has a long heritage in...
In Vivo - April 24, 2024
Financing Quarterly Statistics, Q1 2024
During Q1, biopharmas brought in an aggregate $30.1bn in financing and device company fundraising totaled $2.8bn; while in vitro diagnostic...
In Vivo - April 24, 2024
Helping Organizations Deliver On KPIs And Giving Staff A Voice
ImproveWell has won awards for its software technology that allows health care staff at the sharp end of patient care...
In Vivo - April 24, 2024