Patients will be able to participate in clinical ophthalmology trials from home thanks to a groundbreaking digital app developed by Novartis. The FocalView app, which will enable patients with mobility issues to take part in clinical trials, means researchers can…
Shire considers Takeda’s revised £46bn takeover offer
Shire’s board said that it is willing to recommend Takeda Pharmaceutical’s revised acquisition offer of £46bn to its shareholders. As per the revised proposal, Takeda offers to pay nearly £49 per each share of Shire in the form of £21.75…
Glenmark closes Indian trial site over fraud
As regulatory authorities in India move to tighten up oversight of the country’s fast-growing clinical research sector, local company Glenmark Pharmaceuticals has announced the closure of a clinical trial site in Jamnagar, Gujarat state, citing fraudulent activities. Glenmark started using…
Pfizer biosimilar of Roche’s cancer drug fails to get FDA approval
The US Food and Drug Administration (FDA) has declined to approve Pfizer’s proposed biosimilar of Roche’s breast cancer drug Herceptin (trastuzumab) and asked for more technical information. Pfizer said that the additional requested information asked in the Complete Response Letter…
Leading CROs Form New Industry Standards Group to Improve Collaboration with Sponsors
NEW YORK — March 27, 2018 — Six leading contract research organizations (CROs) and Veeva Systems(NYSE:VEEV) today introduced Align Clinical CRO, a new industry standards group dedicated to making it easier for sponsors and CROs to work together during clinical trials. Founding members, with input…
