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In today’s Pharmaceutical Executive Daily, the FDA approves a new LDL-lowering therapy, Sanofi announces two strategic deals spanning Alzheimer’s disease and B-cell depletion, and the agency issues a national priority voucher tied to Tecvayli in multiple myeloma.

A pair of deal announcements underscore continued strategic reshuffling in biopharma, with Harbour BioMed striking a potentially billion-dollar collaboration with Bristol Myers Squibb to advance next-generation multispecific antibodies, while VYNE Therapeutics agreed to merge with Yarrow Bioscience to create a well-capitalized company focused on developing a first-in-class TSHR antibody for Graves’ disease and thyroid eye disease.

Pfizer’s shares slid after the company outlined its 2026 revenue and EPS guidance, reflecting investor unease over declining Covid-19 sales, looming patent expirations, and a capital allocation strategy that prioritizes pipeline investment over buybacks during a pivotal post-LOE transition period.

The approval is supported by Phase III SWIFT-1 and SWIFT-2 trial data showing that twice-yearly dosing of Exdensur significantly reduced annualized asthma exacerbation rates compared with placebo when added to standard of care.

The agreement grants Sanofi with development and commercialization rights for ADEL-Y0, a potential first-in-class antibody therapy for Alzheimer's disease, and related backup compounds.

In today’s Pharmaceutical Executive Daily, new analysis highlights access gaps in the TrumpRx framework, the FDA awards a national priority voucher tied to Tecvayli in multiple myeloma, and Sobi announces a $1.5 billion agreement to acquire a gout therapy.

Lunit’s new collaboration with Daiichi Sankyo integrates AI-driven digital pathology tools into oncology translational research, aiming to accelerate biomarker discovery, refine patient stratification, and improve the efficiency of clinical development

The approval is based on Phase III DESTINY-Breast09 data showing the Enhertu–Perjeta combination significantly improved progression-free survival compared with the current taxane-based standard of care in previously untreated metastatic disease.

In today’s Pharmaceutical Executive Daily, Eli Lilly reports positive topline Phase III results for retatrutide, the FDA expands Amgen’s Uplizna label into generalized myasthenia gravis subtypes, and a new analysis explores whether pharmaceutical manufacturing is truly moving back onshore.

The 16th addition to the FDA Commissioner’s National Priority Voucher pilot program follows Phase III MajesTEC-3 trial data showing significant survival benefits for the Tecvayli-based regimen compared with standard of care in treating relapsed or refractory multiple myeloma.

Sobi’s $1.5 billion acquisition of Arthrosi Therapeutics positions the company for long-term growth and strengthens its gout treatment portfolio.

Inside Brent Saunders’ return run as CEO of Bausch + Lomb—and setting the storied eye care pharma on a bold path of reinvention.

The FDA’s approval of Uplizna for antibody-positive generalized myasthenia gravis introduces a twice-yearly CD19-targeted therapy option for the rare autoimmune condition.

Ascension of agonist class touching all parts of the market—from science to strategy.

TrumpRx’s promised drug-price cuts expose a deeper systemic flaw, positioning direct-to-patient clinical pathways as the infrastructure pharma must build to turn political headlines into real access and outcomes.

In the third and final part of her conversation with Pharmaceutical Executive, discusses the ways that regulatory agencies in major global markets are acting in similar ways to have a positive impact on the biosimilars market.

Experts weigh in on FDA’s new accelerated review program, revealing what companies stand to benefit the most from the initiative.

With patent cliffs fast approaching, asset differentiation will be king.

Amid the US reshoring push, drugmakers navigate geopolitical and supply chain risks.

In today’s Pharmaceutical Executive Daily, new analysis outlines what it may truly cost to fix the biopharma ecosystem, the FDA approves Waskyra for patients with Wiskott-Aldrich syndrome, and OTR Therapeutics enters a strategic collaboration with Zealand to develop novel metabolic disease therapies.

Why the new wave of direct-to-consumer access represents more than a passing trend.

Lilly’s first Phase III results for retatrutide show unprecedented weight loss and marked reductions in osteoarthritis pain, underscoring the potential of its triple-agonist therapy to reshape treatment for obesity and related metabolic conditions.

Will the politically fueled reforms and mandates around drug pricing reduce the complexity of the system?

The deal will provide Zealand with access to OTR’s proprietary R&D platform.

In the second part of her conversation with Pharmaceutical Executive, Gillian Woollett, VP and head of regulatory strategy at Samsung Bioepis, explains the direct impact changes at FDA have on the biosimilar space.

Outlining the big questions and considerations for pharma companies in determining their readiness for this transformation—and achieving true “AI Advanced” status.

Waskyra’s FDA approval marks a milestone for rare disease care and for Fondazione Telethon, establishing the first nonprofit-led ex vivo gene therapy to reach market after decades of research.

With prescription care changing, it’s up to benefits providers to reinforce the value of human connection in a complex system.