The pharmacy company's Wegovy (semaglutide) is the first therapy designated for chronic weight management that the agency has granted approval since 2014.
The online pharma event will address the COVID-19 pandemic’s impact on the industry (and vice versa) and innovation in the face of formidable challenges.
The therapeutic has been approved as an adjuvant treatment for varieties of esophageal cancers in patients who have received neoadjuvant chemoradiotherapy.
A robust research and innovation ecosystem makes Italy an attractive life sciences hotspot, according to a post from an Italian trade delegation at Bio Digital 2021.
June 2021 marks the 40th anniversary of the publication of the first reported cases of AIDS in the US. A session at BIO Digital – featuring Dr. Anthony Fauci, Director of NIAID at the NIH – will focus on four decades of innovation as well as the critical...
Acting FDA commissioner Janet Woodcock explains how government, researchers, doctors and patients can contribute to improving the clinical research system.
The medical device tech firm is poised to assist manufacturers in navigating the new European Medical Device Regulation, which goes into effect this week.
This month’s roundup of new equipment, technology partnerships, and other news includes items from Ajinomoto, Elligo, Syneos, ACD/Labs and other companies.
In this third part of a series on the state of clinical research, the acting FDA commissioner talks about possible pathways to improving the infrastructure.
The company reportedly will utilize the investment funding to expand its research platform, and to advance six of its preclinical therapeutic programs.
The newly formed company (valued at $1.05b USD) will center on funding the firm’s decentralized trial technology platform and exploring new opportunities,
This month’s roundup of new hires, investment funding, partnerships, and other industry news includes key firms such as Clinical Ink, Medable, CPhI, and Sterling Pharma.
In the face of increasing demand for decentralized clinical trials and remote technology, the company has received funding to enable its further expansion.
The US agency continues to keep a watchful eye over the nation’s pandemic response, issuing advice to professionals and taking action where appropriate.
The chairman, president and CEO of Thermo Fisher says the acquisition stands to benefit clinical trial and drug development clients in a long list of ways.
ImmunoScape plans to use the investor funds to grow its Asia presence, expand into the US, and to further develop its Deep Immunomics platform technology.
This month’s roundup of new equipment, materials, digital solutions and other news includes items from Lonza, Waters, Eversana, Clinical Ink, and more.
The science service and technologies firm plans to bring the CRO under its Laboratory Products and Services Segment umbrella after the deal is completed.
The collaboration centers on development of precision cancer treatments, through discovery and validation of next-generation DNA damage response targets.
An expert from FourKites shares impacts of the February storm that hit Texas and other parts of North America, and lessons can be learned from the event.
The clinical research tech specialists, which had held 60% of Q2 Diagnostics, will now wholly own the comprehensive clinical laboratory services company.
This month’s hires, promotions, acquisitions and other notable news includes Ajinomoto, Medable, Charles River, Immunai, AstraZeneca and other top firms.
A couple of new developments to report in relation to Merck, known as MSD outside the US and Canada: the first being the rejection by the US FDA of the company’s application to use its anti-PD-1 therapy, Keytruda, in certain breast cancer patients.
According to a Veeva Systems survey, contract research organizations are working to ensure clinical trials keep going during the COVID-19 era and beyond.
A survey by the Pistoia Alliance indicates most professionals believe the tech can accelerate R&D, but companies are stymied by a skills gap and data bias.
A US court’s recent decision to find in favor of Sanofi and invalidate Amgen's broad antibody patent claims has biotech manufacturers concerned about how to preserve their IP.
A new report from the organization forecasts a wave of pharma innovation over the next four years could lead to 75 FDA drug approvals annually by 2025.
As the vaccine goes into the arms of more people around the country, the US agency keeps on top of issues around the virus, offering resources and guidance.
The development technology firm plans to use the funds, sourced from a wide range of investors, to expand its dev-ops platform and expand its global reach.
The companies announcing acquisitions, new hires, promotions and other news this month include Syneos, Elligo, PCI Pharma Services, I Holland and more.
Immunai has secured a total of $80m in funding to develop and promote its efforts to harness machine learning to fuel advancement of novel immunotherapies.
The federal agency continues to keep researchers, pharma firms and citizens apprised of current happenings and research related to the virus and pandemic.
The company’s medical imaging technology and other eClinical solutions reportedly played a part in half of the treatments to receive the FDA designation.
As the COVID-19 vaccines continue the early stages of circulation in the US, the agency keeps an eye on industry actions and offers advice to key players.
While the change signifies the life-sciences solutions firm’s commitment to help customers and patients, day-to-day functions will remain much the same.
A leader from the supply-chain specialist explains vulnerabilities and challenges unique to pharma, and how professionals can safeguard and streamline.
Formerly Parexel Informatics, the renamed clinical research technology company has broken off and will operate as an independent company going forward.
A leader from the anti-counterfeit solutions firm says that while packaging-level efforts may have an effect, on-dose technology is worth a closer look.
