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Clinical Trials

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Pipeline Watch: Japan Dominates 25 New Approvals, Plus Six Phase III 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.

Pipeline Watch Approvals

Quick Listen: Scrip's Five Must-Know Things

In this week's podcast edition of Five Must-Know Things: landmark results for lecanemab in Alzheimer’s; other Alzheimer’s players rise after the lecanemab results; Leqvio’s importance to Novartis; Pfizer’s secret sauce for digitalization; and Amgen’s clinical trial diversity efforts.

Clinical Trials Neurology

Intercept Not Changing NDA Refiling Plans After OCA Misses NASH Cirrhosis Endpoint

Obeticholic acid failed to separate from placebo in a Phase III study of non-alcoholic steatohepatitis patients with cirrhosis, but Intercept said it still plans to refile an NDA for pre-cirrhotic NASH by year’s end.

Clinical Trials Business Strategies

Galecto Validates LOXL2 Targeting With Interim Myelofibrosis Phase II Success

The US biotech’s LOXL2 inhibitor candidate has reduced collagen fibrosis of the bone marrow in a small number of Phase II patients, helping validate a historically tricky approach attempted by few.

Clinical Trials Companies

Axcella Hopes Interim NASH Data Can Help Extend Its Financial Runway

Axcella’s AXA1125, a therapeutic combination of amino acids, shows liver stiffness, liver enzyme and fat reduction benefits in Phase IIb interim look, but the firm lacks the cash to complete the trial.

Clinical Trials Liver & Hepatic

Biohaven’s Non-Migraine Portfolio Takes Another Hit As Verdiperstat Fails In ALS

Pfizer is buying Biohaven's migraine portfolio, but the rest of the pipeline is poised to be spun out and there have been two development setbacks. Despite verdiperstat's failure in ALS, the field had a same-day win with Amylyx's Relyvrio approval. 

Neurology Clinical Trials

Sarepta Files DMD Gene Therapy, Seeking An Accelerated Path To Market

The company is seeking FDA accelerated approval of the closely watched gene therapy based on a surrogate marker and has proposed its fully enrolled Phase III trial to serve as a confirmatory study.

Gene Therapy Rare Diseases

CTI’s Vonjo Shows Potential In Anemic Myelofibrosis Patients, Promising Further Market Growth

New data from anemic myelofibrosis patients showed the drug reduced transfusion dependence, which that could unlock a more sizeable portion of the market for CTI BioPharma.

Clinical Trials Cancer

Rising Tide Lifts Many Ships In Wake Of Eisai/Biogen’s Lecanemab Readout

Eisai and Biogen had double-digit stock price gains based on the positive Phase III readout for lecanemab. The good news also lifted competitors Lilly and Roche as well as earlier-stage Alzheimer’s drug developers.

Clinical Trials Neurology

Pharming’s Leniolisib On Track To Become First Disease-Modifying APDS Drug

The Dutch firm’s US filing for its first-in-class PI3K inhibitor has been accepted under priority review, bringing the asset closer to becoming the first disease-modifying option for a rare, genetic disorder.

Drug Review Companies

Pheon Hopes To Stir Up ADC Space With First-In-Class Compound

The UK firm with a presence in Boston has just emerged but Pheon’s CEO Bertrand Damour tells Scrip that big pharma is already showing interest in its next-generation antibody-drug conjugate.

Financing Cancer

A Banner Moment For Alzheimer's Positions Eisai/Biogen At The Head Of The Pack

Eisai and Biogen, who have an accelerated approval decision pending in the US, said they will seek traditional approvals for lecanemab by Q1 2023 based on positive results from the Phase III Clarity AD trial.

Clinical Trials Strategy
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