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Immunology

Set Alert for Immunology

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

New Pure Play Novartis Vows To Up Its Game – With Help From In-House Challenger Ronny Gal

Having finally confirmed the Sandoz spin-off, Novartis will become a 'pure play' pharma company and focus on picking bigger blockbuster winners from both internal and external pipelines. CEO Vas Narasimhan talked details at an investor day in Basel.

Companies Research & Development

Dazodalibep Expands Horizons With Phase II Sjögren’s Syndrome Data

A Phase II trial of the anti-CD40 drug, which Horizon Therapeutics acquired in early 2021, met its primary endpoint in Sj

Inflammation Biologics

Novartis’s Cosentyx Secures Qualified Win In Hidradenitis Suppurativa

The Swiss major’s Cosentyx has succeeded in two trials for the debilitating skin condition but there are concerns that the data may not be sufficient to shift AbbVie’s Humira off the top spot for treatment.

Clinical Trials Strategy

BMS Aims To Unseat Otezla In Psoriasis With US FDA-Approved Sotyktu

Chief commercialization officer Chris Boerner said BMS plans to replace Otezla as the oral standard of care for moderate-to-severe psoriasis with Sotyktu (deucravacitinib); its list price is about 40% higher than Amgen’s product.

Launches Dermatology

Arcutis Eyes Atopic Dermatitis Opportunity With Ducentis Buy

Arcutis's CEO believes that with "a modest investment," the company can generate proof-of-concept data "against a de-risked target in a high-value indication,” Ducentis's preclinical atopic dermatits drug DS-234.

Commercial Deals

Equillium Buys Metacrine For Its Cash, Will Outsource Lead Drug Candidate

Deal Snapshot: Equillium will gain $33m, extending its cash runway into 2024 and past several upcoming milestones, but it will seek a strategic partner for Metacrine’s stalled FXR agonist MET642.

Deals M & A

Boehringer’s Spesolimab Wins First Approval In Rare Skin Condition

The German firm’s monoclonal antibody has received a US thumbs-up for a severe skin disease with high unmet need but it must address diagnostic and educational hurdles.

Approvals Inflammation

Amgen Played Waiting Game Before Agreeing $3.7bn ChemoCentryx Deal

Amgen’s latest deal shows the biotech major’s need to replenish its portfolios and also the cool heads required when negotiations get heated.

M & A Deals

Abivax Secures Cash For Ulcerative Colitis Drug But Much More Needed

The French biotech is pleased to have raised nearly €50m considering the "currently very challenging financing environment," but it will need to find €150m more to complete last-stage trials of obefazimod in ulcerative colitis.

Financing Clinical Trials

Novartis Changing Of The Guard Continues As R&D Chief Bradner Exits

A smooth handover hints at an amicable departure for Jay Bradner, but also gives CEO Vas Narasimhan the chance to refresh strategy with a new team.

Immune Disorders Cancer

Generate Biomedicines Picks First Targets To Test Its AI-Based Drug Discovery Revolution

Built with an audacious goal to use AI to unlock the secrets of protein structure and function, Generate Biomedicines believes it is now on the cusp of a drug discovery revolution.

Commercial Companies
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