Last week, the Trump administration announced it was evaluating proposals to allow consumers to buy drugs legally from Canada. HHS Secretary Alex Azar said that the Trump administration will consider new rules that would allow states, pharmacies and other parties…
Daiichi Sankyo’s Turalio Approved for Rare, Non-Cancerous Tumor
The U.S. Food and Drug Administration (FDA) approved Daiichi Sankyo’s Turalio (pexidartinib) for adults with symptomatic tenosynovial giant cell tumor (TGCT). TGCT is a rare, non-malignant tumor that can be aggressive locally. It affects the synovium-lined joints, bursae and tendon…
Sosei Heptares and Takeda Ink $1.2 Billion+ Deal to Develop GPCR Targets
Sosei Group Corporation inked a strategic multi-target partnership with Takeda Pharmaceutical to find, develop and commercialize small molecules and biologics that modulate G protein-coupled receptor (GPCR) targets. The initial focus will be on gastrointestinal targets. Under the terms of the…
Amicus Therapeutics’ Gene Therapy for Rare, Fatal Childhood Disease Shows Promise in Early Clinical Trial
Amicus Therapeutics, based in Cranbury, New Jersey, announced positive interim results from its CLN6 Batten disease gene therapy program. The Abigail Wexner Research Institute (AWRI) at Nationwide Children’s Hospital is running the ongoing Phase I/II clinical trial of a one-time…
Mylan’s Merger with Pfizer’s Off-Patent Drug Unit Will Create ‘New Champion for Global Health’
This morning, Pfizer announced that its off-patent medicines company, Upjohn, will merge with generic drugmaker Mylan to form a new pharmaceutical company with projected 2020 revenues of up to $20 billion. The potential merger of the companies has been teased…
Simple on the Surface, Complex Underneath: Lessons from a Real-World Trial
Trying to make a real-world data study as easy as possible for practitioners and participants requires a great deal of work behind the scenes, experts say, but careful planning pays off. Representatives of GlaxoSmith Kline’s Salford Lung Study (SLS) say…
Global Regulatory & Consumer Insights (GRCIS) is going Global
On completion of three years of operations, Global Regulatory & Consumer Insights (GRCIS) has opened it’s first overseas office in Ontario, Canada. The team is excited to face a new challenges and a new landscape. Canada is widely regarded as…
Will Google and Apple Compete for Clinical Trial Dominance?
Google officially entered the clinical space with the launch of their Verily Study Watch last month. One of their driving goals with this device is to help researchers passively capture human health data. Among other things, Verily will use the…
Elon Musk Sees His Neuralink Merging Your Brain With A.I.
Elon Musk said startup Neuralink, which aims to build a scalable implant to connect human brains with computers, has already implanted chips in rats and plans to test its brain-machine interface in humans within two years, with a long-term goal…
Novotech CRO Partners Skin Research Institute
Novotech, an Asia-Pacific CRO, has further strengthened its presence in the region through a Partnership with the Skin Research Institute of Singapore (SRIS). With this partnership, the two groups will be working together to promote combined capabilities in skin research…