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Eli Lilly acquires Engage Biologics in up to $202 million deal to strengthen its genetic medicines portfolio with a non-viral DNA delivery platform designed to improve durability, tolerability, and re-dosing potential.

Toragen CEO Sandra Coufal, MD, discusses why the company is targeting HPV’s overlooked E5 protein, positioning its small-molecule therapy as a potential complement to checkpoint inhibitors like Keytruda across HPV-driven cancers.

Bristol Myers Squibb and Incyte expand AI capabilities through major collaborations aimed at embedding agentic and molecular AI directly into drug discovery, development, and enterprise operations.

Sandra Coufal, MD, CEO of Toragen, says the company is positioning its HPV E5 inhibitor TGN-S15 not as a competitor to Merck’s Keytruda, but as a combination partner designed to enhance checkpoint inhibition.

MedicNova’s chief business officer David Crean explains how well-intentioned but poorly executed programs at FDA are causing tension between the agency and the industry.

Dr. Richard Graham discusses the distinction between real-time data and real-time oversite and how one option may present better results than the other.

In today’s Pharmaceutical Executive Daily, the Trump administration expands TrumpRx to include more than 600 generic medicines, industry leaders rethink pharma’s traditional go-to-market model, and a biotech funding roundup highlights continued investment in early-stage therapeutics and radiopharmaceutical development.

Sandra Coufal, MD, CEO of Toragen, explains how the company’s Scientific Advisory Board was built to provide highly specialized expertise around HPV biology, immuno-oncology, and clinical development as TGN-S15 advances through trials.

The Trump administration has expanded TrumpRx to include more than 600 generic medications and integrated price comparison tools with partners including Amazon Pharmacy, Cost Plus Drugs, and GoodRx, broadening the platform beyond its original focus.

Seed, Series C, and Series D rounds announced by Violet Therapeutics, Full-Life Technologies, and Accro Bioscience highlight continued appetite for differentiated science tied to high unmet-need indications and platform scalability.

Dr. Richard Graham details how real-time data review may reduce timelines but also allow for bad data or outcomes.

Investors seeking predictability are adjusting their strategies in the current regulatory environment.

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.