The Pharma Data

JANUARY 20, 2021

Drug Industry Daily (DID) the premier online resource for savvy pharmaceutical professionals whose jobs depend on accurate knowledge about the daily activities of Congress, the FDA, other key regulators … and what their competitors are up to.

Drug Trials 52

Drug Trials Drugs Trials Compliance 52

Drug Discovery World

NOVEMBER 3, 2023

First spaceflight mission for drug development lab Redwire will launch its in-space pharmaceutical manufacturing platform, PIL-BOX, onboard SpaceX’s 29th cargo resupply services mission (SpaceX-29) for NASA to the International Space Station (ISS).

Drugs 52

Drugs Gene Therapy Clinical Trials Clinical Trials 52

Advarra

MARCH 21, 2023

Regulations for research involving devices, in vitro diagnostics (IVDs), and digital therapeutics differ from those governing pharmaceutical development. Interpreting evolving regulations for these devices is often a unique challenge for emerging biotech companies. In other words, what are the risks and benefits of the product?

Clinical Trials 52

Clinical Trials Clinical Trials Trials Production 52

pharmaphorum

AUGUST 4, 2020

Germany had the highest approval rate of orphan drugs at 98% – however most of these recommendations (73%) were awarded a ‘non-quantifiable benefit’ rating, the automatic rating for an orphan drug, which shows the regulator did not see any benefit compared to comparator products (see graph 1).

Drugs 101

Drugs Manufacturing Marketing Regulation 101

Delveinsight

AUGUST 12, 2021

LQTT has a portfolio of in-licensed compounds from Sanofi that prohibit serum/glucocorticoid-regulated kinase 1, or SGK1. That kinase plays a role in inappropriate sodium regulation, a hallmark of arrhythmias like Long QT Syndrome. Takeda also received the rights to follow-on products in IBD.

Trials 97

Trials Clinical Trials Clinical Trials Regulation 97

FDA Law Blog

MAY 3, 2021

The “responsible party” is the sponsor or principal investigator of the trial. An “applicable clinical trial” is generally defined to mean any clinical trial (other than a device feasibility trial or a phase I drug trial) to collect data to support an FDA premarket submission, such as a New Drug Application or 510(k) premarket notification.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Regulation 52

FDA Law Blog

MAY 3, 2021

The “responsible party” is the sponsor or principal investigator of the trial. An “applicable clinical trial” is generally defined to mean any clinical trial (other than a device feasibility trial or a phase I drug trial) to collect data to support an FDA premarket submission, such as a New Drug Application or 510(k) premarket notification.

Clinical Trials 40

Clinical Trials Clinical Trials Trials Regulation 40