R&D/Clinical Trials

Results from the COCOON study showed that Rybrevant plus Lacluze reduced grade 2 or higher dermatologic events by 50% compared to standard care in patients with epidermal growth factor receptor-mutated non-small cell lung cancer.

Results from multiple clinical trials showed that Tagrisso demonstrated survival benefits in EGFR-mutated non-small cell lung cancer, both as monotherapy and in combination therapies.

Research also showed that the test has a very low false positive rate.

The investment, which is a 25% increase from previous years, will support three new advanced manufacturing facilities, expansions at existing sites, and R&D efforts.

Results from the STEER and STRENGTH studies showed that OAV101 IT led to a 2.39-point improvement in motor function in patients with spinal muscular atrophy.

In the Phase III STOP-HS1 and STOP-HS2 trials, results show that patients treated with povorcitinib for hidradenitis suppurativa experienced a ≥50% reduction in the total abscess and inflammatory nodule count.

Company executives provide updates on cancer treatment pelareorep and other elements of the company’s pipeline.

In the Phase III CALYPSO trial, eneboparatide demonstrated statistical significance in achieving albumin-adjusted serum calcium normalization while eliminating the need for active vitamin D and oral calcium therapy in chronic hypoparathyroidism.

Data from the Phase III MINT trial found that Uplizna demonstrated a greater reduction in Myasthenia Gravis Activities of Daily Living score compared to placebo at week 26.

New real-world and implementation study data highlight the efficacy of ViiV’s long-acting injectables for HIV prevention and treatment, with Apretude showing zero HIV acquisitions and Cabenuva maintaining high viral suppression rates.

Immunotherapy pioneer Mark Frohlich, MD, CEO of Indapta Therapeutics, discusses the promise of harnessing natural killer cells to reshape treatment for cancer and autoimmune disease.

Topline results from the Phase III VERITAC-2 trial found that vepdegestrant provided a statistically significant and clinically meaningful improvement in progression-free survival in patients with ER+/HER2- advanced or metastatic breast cancer.

Results from multiple Phase III trials of Icotrokinra in moderate-to-severe plaque psoriasis and a Phase IIb trial in ulcerative colitis successfully met all primary endpoints.

What biopharma companies need to know about this evolving regulatory pathway.

Five-year data from Phase III trials demonstrated that 67.7% of patients moderate-to-severe plaque psoriasis treated with UCB’s Bimzelx achieved complete skin clearance.

Clinical trial results found that a majority of patients with atopic dermatitis who were treated with Ebgylss achieved complete or near complete skin clearance at three years on a single monthly maintenance dose.

Jonathon Whitton, AuD, PhD, VP, auditory global program head, Regeneron, discusses the promising results of DB-OTO in the CHORD trial for children with otoferlin-related hearing loss.

The recent shift in Health Economics and Outcomes Research functions across major pharmaceutical companies highlights a lack of understanding of its value.

Dr. Hernan Bazan, CEO of South Rampart Pharma, discusses his company’s current pipeline.

Aliya Omer, VP, US franchise head, breast cancer, AstraZeneca, discusses how results of the trial compare with other treatments for gBRCAm HER2-negative high-risk early breast cancer.

Under terms of the deal, Gubra will receive an initial $350 million payment and could earn up to $1.875 billion more in development and sales milestones for the potential weight loss drug.

FP008 is designed for patients with solid tumors that have not responded to existing immunotherapies targeting PD-1.

The Alpha Cognition executive discusses recent developments that positively impact the upcoming launch for ZUNVEYL.

Results from a Phase III registrational study suggest that ecopipam has potential as a first-in-class dopamine-1 receptor antagonist for patients with Tourette syndrome.

The Phase III SERENA-6 trial is the first global trial to use a circulating tumor DNA-guided approach to detect endocrine resistance before disease progression in HR-positive, HER2-negative advanced breast cancer.

Daniel Vitt, CEO, Immunic Therapeutics, discusses how the company is positioning itself to lead in the area of gastrointestinal diseases.

Daniel Vitt, CEO, Immunic Therapeutics, discusses how the safety and tolerabilities results from Phase I trials for IMU-856 influences further studies for gastrointestinal diseases moving forward.

These therapies may provide more stable treatments than stem cell therapies.

Daniel Vitt, CEO, Immunic Therapeutics, discusses how IMU-856 could support the challenges of gluten-free diets and cross-contamination risks for celiac disease.

The CEO discusses his company’s platform that helps reformulate oral solid dose medications to liquid forms.