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.
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.
The latest news on software, manufacturing solutions, partnerships, and more includes IQVIA, TFF Pharmaceuticals, Quotient Sciences and other key companies.
According to findings from Press Ganey, physicians and pharmaceutical company sites are the top resources patients turn to for information about medicines.
The business tech company’s Pharmaceutical Supply Chain Vision Study gauges pharma and patient perceptions, including key concerns and areas for improvement.
This month’s announcements include hiring, expansion, and acquisition news from companies like DFE Pharma, ClinOne, Novartis, LEGO, Benchling, and more.
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.
A representative from the HIV-centered pharmaceutical company shares thoughts and perspective on the every-two-month treatment and how it might help patients.
The company’s analysis of trials conducted around the world last year shows cancers took four of the top five positions, with COVID-19 in second place.
The HIV-focused pharma company announced the agency has approved Cabenuva for administration as few as six times a year for adults living with the virus.
This month’s announcements include new hires, promotions, acquisitions, and other events from Saama, Javara, Firma, GlaxoSmithKline, and other companies.
A representative from IQVIA discusses the particulars of the US agency’s new draft document and shares what it might mean for clinical trial data evaluation.
The upcoming industry event offers attendees (in-person and virtual) a range of opportunities to learn, connect, and innovate, according to an organizer.
The agency has given the go-ahead on an IND application for a study evaluating Ananda Scientific’s Nantheia ATL5, a candidate for treating opioid use disorder.
Experts from global professional services outfit Alvarez and Marsal outline challenges created or exacerbated by COVID-19 and insights into potential solutions.
This month’s list of new technology, partnerships, and other announcements includes items from ObvioHealth, Datavant, HumanFirst, and other industry players.
The Medicines and Healthcare Products Regulatory Agency has released proposals to bolster trials legislation, asking citizens for input on the suggestions.
