Clinical Trials
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Moonlake Aims To Defy The Single-Product Risk
The group is pushing sonelokimab into pivotal trials in two indications and starting from scratch in three more. What comes after that?
Pipeline Watch: Six Approvals And 26 Phase III Trial Updates
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.
US Tevimbra Approval Validates BeiGene’s Asia-Heavy Global Trial Approach
BeiGene's first US approval for Tevimbra (tislelizumab), based on an Asia-heavy global study, is expected to pave the way for the biopharma to win two more approvals within 2024.
Quick Listen: Scrip's Five Must-Know Things
In this week's podcast edition of Five Must-Know Things: Galderma prepares to take on Dupixent; Pfizer’s plans for Adcetris in DLBCL; Lilly’s donanemab approval delayed again; the psychedelic R&D pipeline; and an interview with BMS’s CDTO Greg Meyers.
Bangers In MASH: How Rezdiffra's Rivals Stack Up
A look at the depth of clinical responses seen with various MASH therapies suggests that Madrigal could eventually face serious competition.
Cybin High On Psychedelic-Based CYB003 For MDD
The company will initiate a Phase III program in mid-2024, testing the deuterated psilocybin analog as an adjunctive treatment for depression on top of SSRIs.
Tubulis Touts Transatlantic Plans As Cash Rolls In
The German biotech is benefitting from the heat in the antibody-drug conjugate space and has concluded an upsized series B2 financing for €128m.
Takeda Charges Into Diversification With ITP Win
The company announced positive topline results from a Phase II study of mezagitamab and expects to have five programs in Phase III development this fiscal year.
Ionis Could Be A Factor In MASH With Positive Phase II Data
Ionis’s DGAT2 inhibitor showed potential to improve disease activity score and resolve metabolic-associated steatohepatitis in a Phase II study, but analysts point to fibrosis-reduction data as competitively intriguing.
Silence Open To A Partner But Ready To Go It Alone On Lp(a) Drug
The company said it has the financing to move forward with a Phase III program for zerlasiran in patients with high lipoprotein(a) at high risk of atherosclerotic cardiovascular disease.
Korean Biotech Roundup: String Of Positive R&D Developments Outweighs Some Setbacks
The South Korean biotech space has been marked by multiple positive R&D developments and pipeline and partnering progress in recent months, more than outweighing some other setbacks for the rapidly developing sector.
In Competitive DLBCL Setting, Pfizer Goes Old School With Adcetris
The ECHELON-3 trial in third-line diffuse large B-cell lymphoma showed positive topline results regardless of CD30 expression, and the drug maker intends to take the data to the FDA.
Roche Looks To Defy The Odds In Parkinson’s Study
Others have tried and failed to target α-synuclein in Parkinson’s disease, but Roche hopes a Phase II study could deliver success later this year.
Sernova Seeks Cash And A Partner To Move Type 1 Diabetes Cell Therapy Forward
The company’s CEO Cynthia Pussinen joined the company last year and talked to Scrip about her plans to advance a cell therapy for type 1 diabetes.
Acadia's Nuplazid Expansion Bid Bites The Dust
Nuplazid is a decent earner for the US biotech in psychosis caused by Parkinson’s disease but following previous failures in Alzheimer's and dementia, the drug has now proved a dud for treating the negative symptoms of schizophrenia.
Acelyrin PsA Data Are Positive, But Is Its IL-17 Blocker Competitive?
Troubled since a miss in hidradenitis suppurativa last fall, Acelyrin’s izokibep succeeded in a psoriatic arthritis trial, but will the drug compete well against other IL-17 inhibitors?
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