A joint study conducted by analysts from Medable and the Center for the Study of Drug Development points toward shorter cycle times, cost savings, and more.
Bridging the Gap for Clinical Trials is a free competition designed to employ artistic expression to dispel misinformation start positive conversations.
The gathering, convened by patient advocacy group Fight Colorectal Cancer, responded to President Biden’s call to improve screening and treatment options.
The Foundation for Sarcoidosis Research hosted more than 50 agency leaders in a session that addressed patient concerns in research, care, and diagnosis.
This month’s announcements of launches, appointments, and partnerships includes Saama, COTA, Yourway, Eversana, Kindeva, and other notable industry companies.
Merck (MSD outside the US and Canada) is welcoming applications from early-stage biomedical start-ups for its newly launched Merck Digital Sciences Studio (MDSS): which seeks to support technologies for drug discovery and development.
Biotech supply chains face an uncertain future in 2022 and beyond: up against myriad challenges ranging from future pandemic outbreaks to geopolitical tensions – and, indeed, unforeseen threats. Communication and collaboration between policymakers and...
In this first of a two-part series, an expert discusses various factors behind the DCT format’s rapid rise and likely longevity in the drug development arena.
The past two years have been full of shifts and shakes in the drug development field, but the change at Outsourcing-Pharma is easy and one for the better.
The 32nd iteration of the company’s Beyond Borders report offers an in-depth look at the state of the current market landscape, and what’s on the horizon.
The company reports it has met the enrollment target for a trial of its sonic beam therapy, one step closer to submitting for FDA approval of the product.
If new restrictions are placed on the FDA’s Accelerated Approval pathway, as many as two thirds of the treatments that use this pathway would never reach patients, according to research released at the BIO International Convention last week.
The Biotechnology Innovation Organization elected the fresh slate of leaders during the BIO International Convention, taking place in San Diego this week.
Unveiled at the 2022 BIO International Convention, the group's third annual diversity, equity, and inclusion report spotlights improvements both made and needed.
During BIO International, US leaders shared lessons learned from COVID-19, and how government and industry are collaborating to avoid future supply chain crises.
A leader from the site management organization, which already has expanded since opening in 2019, is planning on adding sites and talent to its roster.
This year’s DIA Global Annual Meeting (taking place June 19-23 in Chicago) reunites professionals for face-to-face learning and networking opportunities.
Coming back to the real world June 13-16, the industry event will offer face-to-face learning, networking opportunities, and fun, star-studded opportunities.
Efanesoctocog alfa is an investigational factor III therapy designed to prevent bleeds and bleeding episodes in patients diagnosed with the rare disorder.
This month’s announcements of awards, investments, executive appointment, and expansions include Javara, Thread, uMotif, Lonza, and other notable companies.
Michelle Keefe, formerly the president of medical affairs and commercial solutions, joined the company in 2017; she also had spent 20 years working for Pfizer
Northway Biotech, a contract development and manufacturing organization (CDMO) based out of Vilnius, Lithuania, is set to open a facility in Boston, US.
The digital medicine solutions developer has received $300m in a Series D investment round, which will be used to help scale up its virtual care offerings.
The approval is the first that the Food and Drug Administration has granted for a drug intended to treat eosinophilic esophagitis, a chronic immune disorder.
With Veeva Link for Key People, LEO Pharma is looking to deepen its efforts to engage with knowledgeable medical professionals in the dermatology community.
The two companies are forming a European Medical Advisory Committee to better connect patients and physicians, inviting other trial professionals to join in.
The US agency has approved Enhertu for patients diagnosed with HER2-positive metastatic breast cancer previously treated with an anti-HER2-based regimen.
This month’s news on partnerships, appointments, expansions, and investment includes Javara, ACG, Phastar, Elligo Health Research, and other notable companies.
A leader from the organizer of the pharmaceutical event discusses what’s in store for the upcoming conference, and for the drug development industry itself.
CPhI North America 2022 host city Philadelphia is set to become one of the world’s biggest cell and gene therapy manufacturing hubs. But it’s just one of many centers of innovation that are helping drive the US pharma and biopharma industry.
Introduced by two Republican Congressmen, the American Made Medicine Act is intended to boost domestic drug manufacturing and create jobs in the sector.
The agency has approved an expanded indication for Qelbree extended-release capsules to treat attention deficit hyperactivity disorder in younger patients.
The US agency has expanded its approval of Veklury to include use in pediatric patients 28 days and older who have tested positive for the COVID-19 virus.
The US Food and Drug Administration has approved a move to make the oral lead-in period for ViiV Healthcare’s once-every-other-month drug Cabenuva optional.
The CDMO has been awarded funding from the US government to work on treatments for sarin and other substances used frequently employed in chemical attacks.
The US agency’s latest draft document lays out guidelines to help increase involvement of underrepresented ethnic and racial populations in clinical research.
This month’s news includes hiring, promotions, expansions, and acquisitions at H Clinical, Charles River, DHL Supply Chain, X-Chem, and other key companies.
The US Department of Health and Human Service’s Office of Research Integrity has uncovered evidence that Toni Brand committed fraud in a number of reports.
The Australian biotechnology company has been granted ODD status from the agency for Veyonda, a therapy intended for the treatment of soft-tissue sarcoma.
An executive from Rephine Catena discusses how pharmaceutical companies dealing with supply chain challenges could draw lessons from the food industry.
Working with numerous partners, DiMe has introduced the 3Ps of Digital Endpoint Value to help inclusion of digital endpoints in drug reimbursement decisions.
A renowned university researcher explains the path that laid the foundation and what the novel diagnostic and treatment means for prostate cancer patients.
A leader from the healthcare technology company discusses the conflict’s impact on the region and beyond and the need to better guard against interruptions.
The agency's requested funding for FY 2023, nearly 34% higher than for FY 2022, calls for investments in public health modernization and pandemic preparation.
The drug has received the agency’s seal of approval to treat seizures associated with difficult-to-treat seizures associated with Lennox-Gastaut syndrome.
The company’s analysis of clinical research activity in the region shows the conflict will have long-lasting effects that reach beyond the country’s borders.
