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Research & Development

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TIL The CARs Come Home: How Cell Therapy’s Solid Tumor Future Is Shaping Up

Iovance’s Amtagvi won FDA accelerated approval in February, and Adaptimmune’s afami-cel may not be far behind, but cell therapies for solid tumors come with some extra challenges.

CAR-T Cancer

Pipeline Watch: 12 Approvals And 18 Phase III Readouts

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.

Pipeline Watch Approvals

Gilead’s Twice-Annual Sunlenca Posts Zero Infection Rate In PrEP Trial

Lenacapavir is halfway to the pivotal data needed to file for twice-annual administration in PrEP, after demonstrating superiority against both background incidence of HIV infections and Truvada.

Clinical Trials Business Strategies

Anti-TROP2 ADCs Lung Cancer Futures Likely Lie In Earlier-Stage Disease

The discussant at ASCO’s NSCLC session said the field would need to “manage expectations” as the drugs do not appear to beat chemotherapy in all-comers. 

ASCO Clinical Trials

Jazz’s Suvecaltamide Fails In Tremor Trial, But Parkinson’s Study Continues

A Phase IIb trial evaluating suvecaltamide failed to show a statistically significant benefit versus placebo on an assessment scale for essential tremor.

Clinical Trials Neurology

Roche Adds Ascidian’s RNA-Writing To Its Neurology Push

A first big pharma partnership for Ascidian, headed up by ex-Biogen research head Michael Ehlers, as the Swiss firm expands its gene editing and neuroscience efforts.

Deals StartUps and SMEs

Parexel On Reimbursement Support, Federated Data Sharing, Diversity Through Communities

Parexel’s chief strategy officer, clinical EVP and India head share thoughts on a winner’s mindset for artificial intelligence, benefits of a “federated approach” to clinical data sharing, support for reimbursement and a cascading impact of obesity treatments, in a two-part interview with Scrip.

Research & Development Business Strategies

Truqap Proves False For AstraZeneca

The company’s attempt to move the ALT inhibitor into first-line triple-negative breast cancer proves a dud with the failure of the CAPItello-290 Phase III trial.

Clinical Trials Cancer

Cagrisema Leads The Charge For 2025

2030 sales forecasts for Novo’s obesity hope are an order of magnitude larger than its closest rival among 2025’s expected debutantes.

Launches Companies

ASCO 2024 Wrap-Up Podcast

Scrip reporter Alaric DeArment is joined by the Datamonitor Healthcare oncology analysts to review key highlights from the recent American Society of Clinical Oncology annual meeting. 

ASCO Cancer

Japan Academia Progresses Novel Melanoma Drug Despite Pharma 'Reluctance'

Academia-developed novel oral PAI-1 inhibitor in combination with Opdivo showed a strong response rate in PD-1 treated melanoma patients with certain disease characteristics and could represent a new breakthrough for a class with no clinical stage competitors. 

Japan Rare Diseases

Intra-Cellular Poised To Add MDD To Caplyta’s Label

Caplyta succeeded in a second Phase III study as adjunctive therapy for major depression, putting the schizophrenia/bipolar disorder drug on track for sNDA filing later in 2024.

Clinical Trials Business Strategies

Aerovate Tanks On Trial Catastrophe

A disastrous Phase II miss for the pulmonary arterial hypertension candidate AV-101 leaves Aerovate drifting. Could Gossamer stand to benefit?

Clinical Trials Companies

China Phase III Results Boost Global Prospects For HUTCHMED ITP Drug

The Phase III ESLIM-01 study with HUTCHMED’s Syk inhibitor sovleplenib met its primary endpoint, demonstrating a 48.4% durable response rate for chronic immune thrombocytopenia, significantly higher than placebo. Global development appears to be accelerating and a multinational dose-finding Phase Ib study has also been initiated.

China Clinical Trials

Marinus Considers Its Options After Mixed Phase III Data

Ganaxolone met one of two endpoints in its Phase III refractory status epilepticus trial, but next steps are uncertain. Analysts say the firm should focus on a more promising trial, but Marinus thinks conditional approval is possible.

Clinical Trials Drug Approval Standards

Takeda’s Soticlestat Fails In Seizure Trials

Two Phase III studies testing soticlestat, licensed from Ovid, in Dravet and Lennox-Gastaut syndromes failed to meet their primary endpoints on improvement in seizure frequency.

Clinical Trials Neurology