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Research & Development

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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

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

China Closes In On Top 10 In Global Innovation Ranking

China is knocking on the door of the world’s top 10 most innovative economies, helped by sustained investment.

China Innovation

Global First Approval For Daiichi’s EZH1/2 Inhibitor Valemetostat In Japan

Japan has granted to the first approval worldwide to Daiichi Sankyo’s dual EZH1/2 inhibitor valemetostat, for the treatment of adult T-cell leukemia/lymphoma. Taisho’s trivalent anti-TNFα nanobody ozoralizumab also received its global first approval, as part a large new batch of regulatory nods in the country.

Japan Approvals

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

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

Why Tessera Believes Its Gene Writing Platform Can Go Way Beyond CRISPR

As the first CRISPR-based therapies draw closer to approval, the Flagship-backed biotech believes its gene writing tech is the ‘definitive’ genetic medicine platform.

Gene Therapy Research & Development

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

Peptilogics’ AI Peptide Platform Could Help Address Orthopedic Unmet Need

Emerging Company Profile: US firm Peptilogics is advancing through the clinic with its lead orthopedic anti-infective drug candidate based on an AI platform that utilizes algorithms to improve peptide design.

Emerging Company Profile Orthopedics

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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