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Clinical Trials

Set Alert for Clinical Trials

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

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

Takeda Options Potential Iclusig Successor In Ascentage Deal

Takeda has signed an option deal for Ascentage's olverembatinib, being investigated in two global Phase III trials in the same leukemia indications as those for the Japanese firm's existing drug Iclusig. Olverembatinib has also shown potential to overcome resistance to Iclusig and global competitor Novartis's Scemblix.

China Deals

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

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

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

AstraZeneca Looks To Take On GSK And Merck In Endometrial Cancer With Imfinzi Nod

The FDA has approved the UK firm's checkpoint inhibitor to treat patients whose cancer is mismatch repair deficient (dMMR). The next challenge is to have a treatment for the remaining 70-80% of endometrial cancer patients with mismatch repair proficient (pMMR) disease.

ImmunoOncology Approvals

Nurix’s BTK Protein Degrader Shows Early Promise In Lymphoma

The protein-degrader company has updated results in heavily pre-treated CLL and NHL patients, keeping it competitive with rival BeiGene.

Clinical Trials Cancer

Quick Listen: Scrip's Five Must-Know Things

In this week's podcast edition of Five Must-Know Things: Boehringer best in MASH?; biopharma funding on an upswing?; Moderna’s combo jab; clinical trial recover from pandemic; and Astellas’s US commercial head speaks. 

Financing Vaccines
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