LifeSciVC

APRIL 2, 2024

We are confident that there is room for improvement over existing cystic fibrosis (CF) therapies because we have not yet achieved fully normalized function of the cystic fibrosis transmembrane conductance regulator (CFTR) protein. The last takeaway is just how much the experience around us made a difference.

Science 67

Science Small Molecule International Clinical Development 67

The Pharma Data

DECEMBER 12, 2020

AstraZeneca , with Alexion ‘s R&D team, will work to build on Alexion ‘s pipeline of 11 molecules across more than 20 clinical-development programmes across the spectrum of indications, in rare diseases and beyond. Any failure to comply with this restriction may constitute a violation of such laws or regulations.

Regulations 75

Regulations International Disease Small Molecule 75

The Pharma Data

JULY 6, 2021

Adjusted operating margins are expected to improve from the current mid-20s level to over 30% by 2026. The £33 billion sales ambition is before any significant revenue contribution from early-stage pipeline assets or any contribution from business development. Cash generated from operations is expected to exceed £10 billion by 2026.

Government 52

Government Vaccine Production Science 52

Agency IQ

AUGUST 18, 2023

A deep dive into MDR and IVDR implementation: Where we are and where we’re going Late last summer, AgencyIQ took a close look at how the European Commission had been meeting its goals in implementing the medical device and IVD regulations (MDR and IVDR, respectively). regulators. reference laboratories. reference laboratories.

Science 40

Science Regulations Laboratories Production 40

Agency IQ

APRIL 8, 2024

FDA updates set the stage for broader use of harmonized standards for safety reporting Though long considered a top priority by regulators, the process to standardize and harmonize the submission of individual case safety reports (ICSRs) has been slow. Periodic Benefit-Risk Evaluation Reports ).

FDA 40

FDA Production Regulations Vaccine 40