Research & Development

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.