A WHO report states that more than 6,000 people become infected with viral hepatitis each day worldwide, and greater progress is needed to combat the disease. Report authors found that viral hepatitis deaths rose from 1.1 million in 2019 to 1.3 million in 2022, and while new cases saw a decline during that period, the organization's goals of reducing new infections by 90% and deaths by 65% in the next six years still may not be met. Hepatitis is the second leading cause of death by communicable disease, excluding SARS-CoV-2.

Novartis' chimeric antigen receptor T-cell therapy Kymriah, or tisagenlecleucel, was recommended by the UK's National Institute for Health and Care Excellence as a treatment for children and young adults up to 25 years old diagnosed with B-cell acute lymphoblastic leukemia. The CAR-T therapy is recommended for patients with treatment-resistant B-cell ALL whose disease has recurred after undergoing a stem-cell transplant or have relapsed twice or more times.

AstraZeneca disclosed positive data based on three years of survival follow-up for its immunotherapy Imfinzi, or durvalumab, combined with chemotherapy, consisting of gemcitabine plus cisplatin, tested as a first-line treatment on adults with advanced biliary tract cancer. Results found that the Imfinzi combination lowered mortality risk by 26% compared to chemotherapy plus placebo, and "(t)he latest data from TOPAZ-1 shows that twice as many patients with advanced BTC were still alive at three years with Imfinzi and chemotherapy, an especially meaningful advance in a setting where historically the prognosis has been poor," according to Do-Youn Oh, the trial's principal investigator.

Takeda announced that its drug Takhzyro, or lanadelumab, was approved by the UK's Medicines and Healthcare products Regulatory Agency as a preventive treatment for recurrent attacks of hereditary angioedema in pediatric patients ages 2 to 12 years old. Takhzyro is already approved for patients ages 12 years and older.

Japan's Nxera Pharma, formerly Sosei Group, has struck an exclusive deal with Handok to supply and distribute PIVLAZ in South Korea. The agreement entails Nxera providing the drug to Handok, who will handle promotion and sales, aiming to bring the cerebral vasospasm treatment to Korean patients by early 2025.

A partnership between Apertus Pharmaceuticals, the API Innovation Center and the Glioblastoma Foundation will produce generic lomustine in Missouri as an initial step toward reducing shortages of cancer drugs in the US. The facility will employ continuous manufacturing technology, and expansion into an oncology production suite is part of the partnership's long-term plan.

GSK announced on Tuesday that the FDA has accepted its five-in-one meningococcal vaccine candidate for review. A decision regarding the application is set for Feb. 14, 2025.

Africa needs pharmacogenetic research tailored to its populations to prevent side effects for drugs like efavirenz, an HIV/AIDS drug that was used successfully in the US but had side effects in Africans who carry a variant of the CYP2B6 gene, write pharmacogenetic researchers with the Ersilia Open Source Initiative and the Holistic Drug Discovery and Development Centre. AI offers a potential solution to accelerate pharmacogenetic research, but more genomics data is needed, along with investments in infrastructure and training for African scientists in AI and pharmacogenetics, the researchers write.

Tom and Emily Whitehead
Witness firsthand the incredible journey of Emily Whitehead, the pioneering pediatric patient who defied the odds and became the first in the world to undergo CAR T-cell therapy. Tom and Emily will share their invaluable insights into the transformative power of CAR-T therapy, offering a unique perspective that promises to captivate and inspire.

Dean Kamen
Join visionary inventor Dean Kamen as he delves into the future of regenerative therapies and the pivotal role of public-private partnerships in driving innovation forward. With a track record of groundbreaking technologies, Dean will illuminate the path toward revolutionary advancements in life sciences.

These navigators, alongside our lineup of expert speakers from regulatory bodies, industry leaders, patient advocacy groups, academia, and more will converge to explore the latest trends, challenges, and opportunities shaping the life sciences landscape. See how you can customize your own agenda at DIA 2024.

Industry Track: Regulatory
- Biostatistics Industry and Regulatory Conference | May 2-3, 2024 | Fairfax, VA
- DIA 2024 | June 16-20, 2024 | San Diego, CA

Industry Track: Medical Affairs and Scientific Communications
- DIA 2024 | June 16-20, 2024 | San Diego, CA

Industry Track: Clinical Safety and Clinical Operations
- Biostatistics Industry and Regulatory Conference | May 2-3, 2024 | Fairfax, VA
- DIA 2024 | June 16-20, 2024 | San Diego, CA

See our full list of upcoming conferences, forums, workshops, and more.

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"In the intricate world of life sciences, where patient safety and regulatory compliance are paramount, pharmacovigilance (PV) stands as the guardian. To understand this dynamic landscape, a survey was recently conducted with a diverse pool of 100 PV professionals across the US and Europe. The findings unveiled a tapestry of compelling insights, spanning diverse themes encompassing PV team strategies, technology maturity, and the emergence of GenAI, etc. Notably, the survey (see details below) spotlighted intriguing statistics around the acceleration of automation, the embrace of AI/ML technologies, and the strategic evolution toward smart outsourcing, painting a vivid picture of the industry's current trajectory…" Read more.

"Over the past decade, the importance of patient engagement (PE) has surged, reflecting a move towards integrating patient experiences and insights into research processes. This evolution aims not just to involve patients but to empower them as research partners. Concurrently, there's a burgeoning urgency to incorporate diversity, equity, and inclusion (DEI) principles into the drug development process, though largely as a separate and distinct effort…" Read more.