Verily Life Sciences LLC, a division of Alphabet Inc., took its first major step to fulfill its goal of transforming clinical trials with the announcement of an agreement to buy Signalpath LLC for an undisclosed sum. The deal is Verily’s first major acquisition since the company spun out of Google Inc. in 2015. It’s likely not the last deal for the company in the short-term, however, as it raised $700 million in December 2020 to fund its aggressive expansion plans.
LONDON – More than six years after the technical specification was agreed, the EMA clinical trial information system (CTIS) has cleared the final hurdle and can go live in January 2022, after notice of approval was published in the EU Official Journal on Saturday July 31. The approval, following an independent audit of the system, was the spur for the EMA to intensify the training program it is putting in place for trial sponsors and national regulators, to ensure CTIS’ successful implementation.
The FDA’s device center has a mantra of sorts when it comes to the details, or lack thereof, in guidance, which is “talk to us early and often.” For device makers eyeing the brain-computer interface (BCI) device space, this mantra has been applied to the question of pivotal study enrollment numbers, suggesting that some sponsors will find their pivotal studies come with a case of sticker shock sufficient to force them to rethink their research and developmental plans.
LONDON – The U.K. Medicines and Healthcare products Agency (MHRA) has embarked on wide-ranging reforms that are designed to make the most of post-Brexit regulatory flexibility while capitalizing on the ‘spirit of the pandemic,’ which has seen it rise to the occasion in supporting rapid set up of large-scale randomized clinical trials and approvals of COVID-19 vaccines.
Regardless of the controversy swirling around the FDA’s accelerated approval of Biogen Inc.’s Alzheimer’s drug, Aduhelm, that U.S. approval is expected to open the door to more opportunities for Alzheimer’s treatments and diagnostics.
Regardless of the controversy swirling around the FDA’s accelerated approval of Biogen Inc.’s Alzheimer’s drug, Aduhelm, that U.S. approval is expected to open the door to more opportunities for Alzheimer’s treatments and diagnostics.
LONDON – Moves to expand the legal remit of the European Medicines Agency (EMA) and give it more powers to deal with the COVID-19 pandemic and future health emergencies are moving to fruition, after the European Parliament and national health ministers in the European Council separately voted through the proposal.
Accelerated approval based on a phase II single-arm trial doesn’t appear to be in the cards for Incyte Corp.’s retifanlimab as a second-line treatment for advanced or metastatic squamous cell anal cancer (SCAC). Following the lead of FDA reviewers June 24, the agency’s Oncologic Drugs Advisory Committee (ODAC) voted 13-4 to recommend that the agency defer its approval decision until more data are available from POD1UM-303, a confirmatory trial in platinum-naïve advanced SCAC.
Recognizing that people with cancer want to know what symptoms they may experience and how a particular therapy may affect their quality of life, the FDA is issuing a draft guidance advising sponsors on incorporating a core set of patient-reported outcomes (PROs) into cancer clinical trials.
Early feasibility studies for cardiology devices were a massive problem for the FDA and industry in times gone by, a problem that was believed to drive device flight from the U.S. That problem has been largely solved, according to the FDA’s Andrew Farb, but Farb noted that neurological devices are the next target for improved early feasibility study (EFS) development in the U.S., which suggests that the path to pivotal studies for devices in this space will soon be much less cumbersome.