Clinical Trials & CROs

SHERIDAN, WYOMING – July 8, 2025 – KalVista Pharmaceuticals has received U.S. FDA approval for its oral treatment Ekterly (sebetralstat), marking a major milestone as the first and only on-demand tablet therapy for hereditary angioedema (HAE) in patients aged 12 and older.

The company confirmed that the drug will be available in the U.S. “immediately” under the brand name Ekterly. According to KalVista’s press release, it is “the first and so far only oral and on-demand treatment for hereditary angioedema (HAE).”

SHERIDAN, WYOMING – July 8, 2025 – The TIGIT immunotherapy landscape has thinned dramatically amid a string of late-stage failures and corporate exits, yet several biopharma players remain committed to unlocking its clinical promise—driven by differentiated approaches and early signals of efficacy. AstraZeneca, Gilead, Agenus, and Mereo BioPharma are now at the forefront of this once-promising immuno-oncology frontier, recalibrating strategies in a space shaped by volatility and unmet potential.

AstraZeneca Bets Big on Dual Checkpoint Innovation

SHERIDAN, WYOMING – July 8, 2025 – A confluence of artificial intelligence and genomics is creating a critical inflection point for the pharmaceutical industry—offering a long-awaited opportunity to reduce adverse drug reactions, improve clinical outcomes, and restore public trust in a sector burdened by scrutiny and skepticism.

SHERIDAN, WYOMING – July 1, 2025 – Neurogene has reached alignment with the FDA regarding the design of a registrational study for the investigational gene therapy NGN-401 for Rett Syndrome, enabling the company to convert its current Phase I/II study into a pivotal trial—a milestone that analysts describe as the “best-case scenario.”

SHERIDAN, WYOMING – July 1, 2025 – Protagonist Therapeutics has stepped into the fiercely competitive obesity treatment landscape by nominating PN-477, an innovative triple agonist therapy, aiming to deliver flexibility in dosing and a differentiated profile among next-generation anti-obesity drugs.

SHERIDAN, WYOMING – July 1, 2025 – Pfizer has announced the termination of its Phase II trial evaluating the investigational CD47-targeting fusion protein maplirpacept in diffuse large B-cell lymphoma (DLBCL), citing persistent recruitment difficulties that prevented the study from meeting enrollment targets.

SHERIDAN, WYOMING – July 1, 2025 – A late surge of acquisitions in June has reenergized pharmaceutical M&A activity, with six major deals announced that propelled first-half 2025 totals to 32 transactions across the industry. This burst of dealmaking, highlighted by BioNTech’s $1.25 billion acquisition of CureVac and Eli Lilly’s $1.3 billion buyout of Verve Therapeutics, has analysts optimistic that the sector’s cautious stance may finally be easing.

Resilient M&A Amid Regulatory Uncertainty

SHERIDAN, WYOMING – July 1, 2025 – A wave of pivotal FDA decisions in June 2025 is reshaping key segments of the pharmaceutical landscape, with new approvals spanning respiratory syncytial virus (RSV) vaccines, advanced cancer treatments, and the first-ever antiviral for acute hepatitis C. These regulatory moves not only expand therapeutic options for patients but also set the stage for intensified competition in critical markets, underscoring strategic opportunities for companies across the biopharmaceutical sector.

SHERIDAN, WYOMING – June 16, 2025 – Roche has unveiled promising Phase III results for its immunotherapy Tecentriq® (atezolizumab) combined with lurbinectedin (Zepzelca®) in the treatment of extensive-stage small cell lung cancer (ES-SCLC), offering new hope for a patient population with few effective treatment options and historically poor survival outcomes.

SHERIDAN, WYOMING – June 12, 2025 – Genentech, a biotechnology powerhouse and subsidiary of Roche, has confirmed the layoff of 143 employees at its South San Francisco headquarters, marking the latest phase in a year-long operational reshaping. The company disclosed the reduction via a Worker Adjustment and Retraining Notification (WARN), with job terminations set to take effect on July 14.