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Research & Development

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Novartis Excited About Iptacopan But Downcast After Huntington’s Blow

The Swiss major is close to its first submission for ‘pipeline in a pill’ iptacopan but has conceded defeat with branaplam as a potential treatment for Huntington’s disease.

Neurology Clinical Trials

Continuity Or Change? Roche’s New CEO And Pharma Leader Take On Big Strategy Question

Roche will suffer a hangover from its COVID-19 successes this year as revenues stagnate and its future strategy is yet to be laid out by incoming CEO Thomas Schinecker.

Sales & Earnings Strategy

Label Woes For GSK’s Jesduvroq Dampen US Anemic Kidney Disease Approval

The UK major’s Jesduvroq has become the first drug of its class to win US approval for anemic kidney disease but significant label restrictions have left some analysts lukewarm on its sales potential.

Approvals Commercial

From Science To Commercialization: How Genexine Is Making The Shift

Genexine CEO Neil Warma talks to Scrip in this audio interview about a wide range of topics, including key strategy changes, ambitions to become a leading global biopharma, as well as challenges he has faced since joining the Korean biotech.

South Korea ImmunoOncology

Evelo Forges Ahead In Psoriasis As Atopic Dermatitis Pathway Narrows

The company said the first three cohorts of its Phase II atopic dermatitis study failed, while another trial with a faster-release formulation of EDP1815 continues, along with a Phase III study in psoriasis.

Clinical Trials Dermatology

Novo’s Wegovy Back On Track In Q4 But Broader Supply Issues Remain

Now that US supply of the Danish firm’s blockbuster obesity product is back in full swing, Novo is focusing on diversifying its pipeline to reduce dependence on its GLP-1 franchise.

Sales & Earnings Commercial

GSK Exceeded Expectations In 2022, Now Looking For Edge Over Pfizer In RSV Battle

Having outperformed in 2022, GSK is gearing up for key regulatory and market access decisions on its RSV vaccine, but is confident it holds superior data compared with rival Pfizer.

Infectious Diseases Business Strategies

Vera Pins Hopes On Per-Protocol Analysis To Revive Phase II IgAN Asset

The US firm is shifting its focus to IgAN after a promising new prespecified analysis of its Phase II trial of atacicept lifted hopes for the product’s prospects as compared with a key rival candidate.

Clinical Trials Renal

Boost For Oral SERDs As Menarini/Radius’ Orserdu Becomes First Approved For Breast Cancer

The firms’ Orserdu has won a US thumbs up for the treatment of ESR1-mutated advanced or metastatic breast cancer, marking a positive breakthrough for the challenging SERD drug class.

Approvals Cancer

Pipeline Watch: Five Approvals And 15 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

'Pivotal Time For CROs': ICON CEO Cutler On Changing APAC Trial Trends

The CEO of one the global top-five CROs points out a larger opportunity in decentralized trials that might be a “game changer” in the global pharma industry over the next five years. He also refers to the need to accept new technologies by both clinical trial sites and regulators.

Asia Pacific Clinical Trials

J&J/Legend’s Carvykti Data Show Earlier-Line Efficacy As Commercial Headwinds Remain

The companies unblinded data from CARTITUDE-4, which met its primary endpoint, but analysts citing KOLs said they continue to face issues with limited manufacturing slots and out-of-spec product.

ImmunoOncology Cancer
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