The agency has removed the hold placed on the pharmaceutical company’s IND for injectable lenacapavir, which is intended for HIV treatment and prevention.
The two companies are forming a European Medical Advisory Committee to better connect patients and physicians, inviting other trial professionals to join in.
Leaders from the biotech company share advice on how such organizations can make the most of often limited resources via smart strategy and collaboration.
The US agency has approved Enhertu for patients diagnosed with HER2-positive metastatic breast cancer previously treated with an anti-HER2-based regimen.
The US FDA released new draft guidance yesterday discussing, among other challenges, how unresolved product quality issues might be addressed in the context of regulatory decision-making.
The pharmaceutical firm and university have launched T-REX, a multi-year partnership focused on increasing health outcomes for underrepresented populations.
The thin-film freezing specialist reports positive safety and pharmacokinetic data coming out of the Phase I trial of its niclosamide inhalation powder.
An expert from the organization discusses ahead of his CPhI North America presentation how tomorrow’s drugs can’t all be formulated with yesterday’s excipients.
An expert from Pharmatech Associates offers a glimpse into the evolution of CM and previews a lively discussion during the upcoming CPhI North America event.
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.
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 company’s Precision Olfactory Delivery technology, currently combined with its Trudhesa migraine treatment, reportedly facilitates high absorption rates.
The 2022 edition of the Highly Potent Active Pharmaceutical Ingredients Summit (June 28 to 30 in Boston) will take on a range of topics, including safety.
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 pharma manufacturing specialist is increasing capacity at its development and manufacturing labs to meet growing global demand for highly potent APIs.
An expert from the health tech company explains how AI, natural language processing, and other tools can improve pharmaceutical product safety reporting.
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.
An expert from trial tech specialist Komodo Health talks about how real-world evidence use could elevate study design, conserve costs, and improve recruitment.
The partnership among three research and data specialists is aimed at creating a global database to support faster development of novel cancer treatments.
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 union of the active pharmaceutical ingredient supplier and contract development and manufacturing organization will create a global services company.
Experts from the Decentralized Trials and Research Alliance and Rafael Pharmaceuticals discuss progress and possibilities during Clinical Development Advances.
Leaders from some of the industry’s most notable companies are working together to streamline and automate IDMP workflow and come up with various standards.
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.
An expert from the clinical technology solutions provider discusses some of the top challenges associated with technology adoption, and how to tackle them.
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.
The agency has approved Lynparza for use in the US as an adjuvant treatment for patients with germline BRCA-mutated HER2-negative high-risk early breast cancer.
While strides have been made recruiting more representative patient populations, more can and should be done, according to an Oracle Health Sciences leader.
A leader from the trial platform company discusses how patient experience can be enhanced when the clinical trial team shares a background with the subjects.
Cloud-based Clarify Trials is real-world evidence-based software intended to improve recruitment of clinical study patients from underrepresented communities.
According to findings from Press Ganey, physicians and pharmaceutical company sites are the top resources patients turn to for information about medicines.
During Outsourcing-Pharma’s March 23 webinar, Clinical Development Advances, leaders from different areas will share innovative technology and practices.
An executive from the AI specialist discusses how recent advances have provided opportunities for industry professionals to champion new ways of thinking.
The pharma company is evaluating its Paxlovid oral treatment, intended for high-risk patients who have tested positive for the virus, in pediatric subjects.
Changing to DCT is more than merely flipping a switch; two leaders from the Thermo Fisher Scientific business offer advice for implementing the format.
Returning to an in-person format March 21-24, the industry event is bringing a range of networking, educational, and social programming to New York City.
Experts from the clinical tech firm talk data challenges and how monitoring technology can enable sites and sponsors to better manage audit trail reviews.
The recent Outsourcing-Pharma webinar hosted a trio of industry experts highlighting challenges, opportunities, and innovations in the rare disease realm.
Ergomed, a global contract research organization, is partnering with Trialbee to improve patient recruitment at its new Rare Disease Innovation Center.
