Clinical Trials
Multi-blockbuster falls short in a giant cell arteritis study.
Once hailed as a potential game changer, OG-6219 gets the axe after failing in a Phase II endometriosis-related pain trial.
4D Molecular Therapeutics has fast-tracked its Phase III trials for 4D-150 in wet AMD, with top-line data from one now expected in H1 2027 and another underway ahead of schedule. The company is also cutting a quarter of its staff as it focuses on its late-stage pipeline and to help fund the trials.
The psychedelic therapy firms pass a key condition for their planned merger after the antidepressant BPL-003 meets the main endpoints of a Phase IIb trial.
The merger with a fellow Norwegian biotech comes a few months after its lead asset, bemcentinib, bit the dust.
Data from a second pivotal trial support a filing in the US for Opus Genetics’ phentolamine ophthalmic solution, to treat presbyopia.
BlissBio is to single-handedly move BB-1701, its eribulin-containing, HER2-targeting antibody-drug conjugate, into a global pivotal Phase II/III program for HER2-expressing, Enhertu-resistant breast cancer.
From a letter of intent with BIRAC sealed at BIO 2025 to supporting Immuneel’s CAR-T efforts and a study for point-of-care manufactured anti-CD19 CAR-T cell therapy, Miltenyi Biotec is moving on multiple fronts in India. The German group also expects to advance its own CAR-T candidates.
A new study by Tufts CSDD performed a deep dive into use of decentralized clinical trial techniques, but one of the study’s authors said DCTs have been dialed back.
Deal Snapshot: The French drugmaker has been shifting its investments away from cancer to focus on immunology and inflammation but it continues to seek out interesting early-stage oncology assets.
With positive relative efficacy data for its mRNA seasonal flu shot, Moderna hopes to file mRNA-1010 for US approval and refile a COVID-19/flu combo shot that it withdrew in May.
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.
Altimmune’s stock price did not recover on June 27, after a 57% dip the day before, despite efforts to position pemvidutide as both resolving MASH and offering weight loss.
Fresh from having sold Anthos to Novartis, the new CEO is expected to update the oncology and dermatology-focused firm's strategy.
Green light follows a recent rejection by the US FDA to partner Regeneron's request for an extension to the dosing interval.
The late-stage biotech posted results from the maintenance extension portion of its Phase IIb QUALITY trial in which enobosarm reduced weight regain and helped preserve lean mass in patients who discontinued their semaglutide weight-loss treatment.
GSK tells Scrip about timelines for data expected from two Phase II trials for its Bharat Biotech-partnered shigella vaccine candidate, which puts it ahead of Limmatech/Valneva. Meanwhile, a global-first malaria vaccine, also partnered with Bharat, sees an over 50% price cut
The drugmaker announced positive topline results for the drug in hemophilia A and B patients with inhibitors, on top of the existing approval for patients without inhibitors.
The biotech had been looking at options to survive since May.
Biogen hopes to move directly from Phase I to Phase III with salanersen, a higher-potency therapy that uses the same mechanism of action as Spinraza.