R&D/Clinical Trials

FDA has accepted Roche's NDA for giredestrant under Priority Review, moving the investigational oral SERD closer to potential approval .

As FDA complete response letters continue to impact nearly half of cell and gene therapy submissions, manufacturing strategy and process design are emerging as the industry’s most persistent regulatory vulnerabilities.

Research published this week highlights tirzepatide outperforming other GLP-1 therapies in early type 2 diabetes treatment while separate studies identified autoantibodies as a likely biological driver behind persistent neurological symptoms in some long Covid patients.

The Lupus Research Alliance’s CEO and president discusses how recent treatment breakthroughs are changing the patient experience in Lupus treatment.

A fragmented approach to drug discovery created structural inefficiencies that drive up R&D costs.

The Deloitte Consulting partner discusses how GLP-1s are becoming key value drivers and driving R&D focus during a period of market concentration.

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.

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.

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

Toragen CEO, Sandra Coufal, MD, says women’s health remains structurally underfunded, arguing that outdated market assumptions continue to undervalue the true commercial opportunity in HPV-driven cancers.

Trialynx’s CEO discusses the benefits of using AI for trial design and how to find the AI companies doing the most promising work.

Why future oncology leaders will be defined by ecosystem orchestration.

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.

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.

Bristol Myers Squibb and Hengrui Pharma launch a multibillion-dollar collaboration spanning 13 oncology, hematology, and immunology programs to expand global drug development pipelines and accelerate early-stage clinical innovation.

FDA extended its review of Leqembi’s once-weekly subcutaneous starting dose for early Alzheimer’s disease by three months after requesting additional information from Eisai and Biogen.

Radiopharmaceutical logistics is fundamentally different from traditional pharmaceutical supply chains.

Incyte reports sustained 24-week efficacy and consistent safety data for Opzelura cream in moderate atopic dermatitis, supporting interest in nonsteroidal topical therapies for long-term disease control.

In today's Pharmaceutical Executive Daily, Bayer agrees to acquire Perfuse Therapeutics for up to $2.45 billion and Madrigal obtains an exclusive global license for a precision siRNA therapy targeting a key genetic driver of MASH, Zentalis Pharmaceuticals announces the first patient dosed in a Phase III trial and Brooke Ervin argues that translating real-world evidence into commercial and clinical impact in urology requires more than access to data.

Zentails announced the first dosage of Azenosertib administered in its phase III Aspenova trial to test azenosertib vs chemotherapy in Cyclin E1-positive platinum-resistant ovarian cancer.

Getting from insight to impact requires more than access to information.

FDA clears Cellenkos’ IND for CK0802, enabling a mid-stage trial in steroid-refractory GVHD.

UCB enters agreement to acquire Candid Therapeutics in a deal worth up to $2.2 billion, adding BCMA-targeting T-cell engager cizutamig to expand its immunology pipeline.