In today’s Pharmaceutical Executive Daily, the FDA grants breakthrough therapy designation to baxdrostat for uncontrolled hypertension, a wave of leadership departures leaves the FDA facing renewed uncertainty at the top of the agency, and Regeneron enters a multibillion-dollar collaboration with Parabilis Medicines to develop new therapeutic candidates.
FDA undergoes leadership upheaval, leaving key drug and biologics divisions under interim control and raising concerns over regulatory continuity amid turnover at the agency’s highest levels.
FDA approved Baxfendy for adults with uncontrolled hypertension, introducing a new drug class in a large and competitive market.
Regeneron and Parabilis Medicines partner to discover and develop antibody-Helicon conjugates, aiming to create a new class of therapies capable of targeting historically “undruggable” intracellular proteins.
FDA expanded Enhertu (trastuzumab deruxtecan) use in early HER2-positive breast cancer based on phase 3 neoadjuvant and adjuvant trial data.
Toragen’s partnership with the Bill & Melinda Gates Foundation highlights how global health priorities and commercial biotech strategy can align around one of the world’s deadliest HPV-driven cancers.
Dr. Richard Graham explains how FDA’s new program allows for the usage of real-time data during clinical trials.
Author Jeremy Levin discusses how various factors are impacting the biotech industry in a negative way by pushing investment and politics over science.
David Crean, chief business officer at MedicNova, discusses changes at FDA causing variability and unpredictability in regulatory approvals.
In today's Pharmaceutical Executive Daily, FDA approves AstraZeneca's Fasenra as a new treatment for hypereosinophilic syndrome in patients 12 years and older, the FDA places a full clinical hold on Aardvark Therapeutics' ARD-101 program, and BeOne Medicines co-founder and CEO John Oyler touches on building an oncology powerhouse from a disruptive idea and playing the long game on speed, science, and scale.
BeOne Medicines’ John Oyler on building an oncology pharma power from a disruptive idea — and playing the long game on speed, science and scale.
FDA places full clinical hold on Aardvark’s ARD-101 in Prader-Willi syndrome after heart-related adverse events, pausing late-stage studies and raising new questions around safety in appetite-regulation therapies
FDA approved AstraZeneca’s Fasenra for hypereosinophilic syndrome in patients aged 12 and older, expanding the IL-5 receptor-targeting therapy into a third eosinophil-driven disease with limited treatment options.
Dr. Jeremy Levin discusses the mismatch between capital markets and biotech and how the industry doesn’t provide the results that investors are often looking for.
Toragen CEO, Sandra Coufal, MD, says women’s health remains structurally underfunded, arguing that outdated market assumptions continue to undervalue the true commercial opportunity in HPV-driven cancers.
In today's Pharmaceutical Executive Daily, the FDA grants accelerated approval to BeOne Medicines' Beqalzi as the first and only BCL2 inhibitor for relapsed or refractory mantle cell lymphoma, while also approving Taiho Oncology's Inqovi in combination with venetoclax for newly diagnosed acute myeloid leukemia, Pharmaceutical Executive reports on the Doceree Makers Summit, and Dean Erhardt argues that AI-enabled workflow automation offers a practical path to fixing the prior authorization system's chronic failures.
Trialynx’s CEO discusses the benefits of using AI for trial design and how to find the AI companies doing the most promising work.
At the Doceree Makers Summit, leaders from Sanofi, Bristol Myers Squibb, Eli Lilly, and others backed a new pharma marketing operating model to replace fragmented legacy softwares.
How existing technologies and approaches such as targeted AI deployment can help make prior authorization workflows more efficient.
FDA has approved BeOne Medicines’ Beqalzi for relapsed or refractory mantle cell lymphoma and Taiho Oncology’s Inqovi plus venetoclax for newly diagnosed acute myeloid leukemia, expanding treatment options for patients with difficult-to-treat blood cancers.
Why future oncology leaders will be defined by ecosystem orchestration.
Tris Pharma’s founder and CEO discusses his company’s history and how’s he’s adjusted his strategies over the decades.
Dr. Jeremy Levin explains how the current media environment allows for misinformation spread, and the impact it has on trust in medicine.
Toragen CEO Sandra Coufal, MD, explains why the overlooked HPV E5 protein may represent a breakthrough therapeutic target after decades of failed attempts against traditional viral pathways.
In today's Pharmaceutical Executive Daily, Rigel Pharmaceuticals enters an exclusive global licensing agreement with Arvinas and Pfizer for Veppanu, Eli Lilly releases data from two late-phase trials showing patients maintained meaningful weight loss after transitioning from higher-dose injectable GLP-1 therapies, and Hope Mueller argues that true pharmaceutical expertise is defined not just by having answers but by recognizing when you need a reset.
Agentic AI is reshaping pharma market entry by enabling real-time, data-driven insights that allow companies to ask more complex strategic questions and act faster — with greater precision.
It’s also about knowing when you’re stuck and need a reset.
Eli Lilly reported late-stage data showing patients with obesity were able to maintain long-term weight loss after transitioning from higher-dose injectable incretin therapies to lower-dose Zepbound or the company’s oral GLP-1 candidate Foundayo.
Rigel Pharmaceuticals has licensed Veppanu, positioning the company to expand into protein degradation-based oncology treatments for ESR1-mutated metastatic breast cancer.
Ketan Mehta provides examples of how he’s developed new therapies that address both regulatory concerns and patient needs.
