Clinical Trials

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

Roche is taking a more hard-nosed approach to portfolio prioritization, and said in its Q2 call that it believes it can move faster with a more slimmed down R&D pipeline.

For Sage, the mid-stage failure of SAGE-324 in essential tremor is its second setback in a year full of clinical trial readouts. For Biogen, it highlights a lack of later-stage pipeline prospects.

The company’s giroctocogene fitelparvovec, partnered with Sangamo, could compete with BioMarin’s hemophilia A gene therapy Roctavian, but longer-term data may be needed.

 Phase IIb/III trial testing Merck’s prophylactic monoclonal antibody clesrovimab met the primary safety and efficacy endpoints to protect infants from RSV, but the market is competitive. 

Ionis plans to initiate a Phase III trial for ION582 in the first half of 2025, positioning it just behind Ultragenyx in the race to bring a treatment to market for the rare neurologic condition.

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

A report from Accenture, based on interviews with 75 R&D execs from large biopharma companies, found adopting the technology could cut costs by up to 45%.

Having relaunched Susvimo for wet AMD, Roche now has the ocular implant under FDA review for approval in two diabetic ophthalmic indications and presented two-year data in those settings.

With sales of its big sellers Jardiance and Ofev to start shrinking in the next few years, the German group is teeing up a suite of new drugs.

The two biotechs each hope to offer an Eylea-sparing regimen to wet age-related macular degeneration patients with gene therapies that induce natural production of aflibercept.

The Phase III study success is good news, but not the surprise upside that Bayer needs to lift investor sentiment.

That is, if very early data in a handful of patients are borne out in later, larger studies.

Jeeva’s founder and CEO talks to Scrip about how the firm’s clinical trial management platform does away with the need for numerous point solutions and vendors, enabling sponsors to undertake trials more effectively including in the complex and competitive oncology space.

The company could be first to bring a multi-RAS inhibitor to market, and has NSCLC as well as pancreatic cancer in its sights.

The German biotech has unveiled a $150m series D financing round to support a “broad Phase IIb development program for visugromab” and explore its potential to induce cancer remission depth and durability across multiple solid tumor indications.