Therapy Areas
Alimentary/Metabolic
In its Q2 update, Viking reported that Phase III trials of subcutaneous VK2735 are under way, and that it expects Phase II data for an oral formulation before year’s end.
In this series of articles, we look at different mechanisms of actions beyond GLP-1s that could determine the obesity drug landscape in the coming years. First on our list – amylin receptor agonists, which analysts expect to grow into a $50bn market opportunity.
The go-ahead to resume a trial for its only drug candidate, zetomipzomib, in hepatitis could give Kezar a glimmer of hope of reviving another halted study in lupus nephritis.
With China’s Hengrui reporting successful Phase III data for its dual GLP-1/GIP agonist, licensee Kailera is readying plans to demonstrate better efficacy than current obesity drugs.
Anti-infective
Yeytuo will have remaining challenges to PrEP to overcome, while Kisunla’s label reflects dosing titration data from a Phase IIIb study to mitigate ARIA-E.
Pointing to data that show a benefit in reducing viral load and the histological signs of the infection, Memo says its drug, potravitug, could become the first therapy to treat BK polyomavirus in kidney transplant recipients.
The approval for young children, consistent with the FDA’s new COVID-19 vaccine policy, restricts Spikevax to those with conditions putting them at higher risk.
Four Chinese companies have won approvals in China, the first anywhere, for novel drugs for diffuse large B-cell lymphoma, certain types of non-small cell lung cancer and influenza A.
Anticancer
With a US approval any time soon now looking unlikely, analysts are revising Blenrep’s peak sales guidance downwards.
The privately held German pharma firm is hoping to bring a new generation of pulmonary fibrosis and cancer drugs to market but their commercial success is not yet a certainty.
With $216m in initial funding, the newly launched company is aiming to develop a cell therapy-based universal immuno-oncology option for solid tumor indications.
The Austrian firm is delisting from the NASDAQ and closing down.
Antiparasitic
Coartem Baby to be rolled out in eight African countries in the autumn.
The Swiss major’s global health chief Lutz Hegemann tells Scrip on a trip to Rwanda that being a profitable enterprise while helping to improve access to new and older therapies for those who need it most is the real measure of a successful business.
Lotilaner, the active ingredient in Tarsus’s Demodex blepharitis drug Xdemvy, showed significant ability to kill ticks in a small Phase IIa study. Analysts call the Lyme program a likely out-licensing opportunity for Tarsus.
Gains from its COVID-19 vaccine made Serum Institute’s founder the world’s richest healthcare billionaire. But the demand for boosters hasn’t materialized as expected, leading to a deal with Biocon being tweaked. Meanwhile, gains from India’s first indigenously-developed HPV vaccine and Oxford-partnered malaria vaccine seem imminent.
Blood and Clotting
Analysts see the new strategy as a way to address pressure from the Trump administration’s most favored nation drug pricing proposals.
CMS said that 33 US states plus the District of Columbia and Puerto Rico had joined a program whereby the agency negotiates outcomes-based contracts on their behalf.
Roctavian shows durable bleed control and safety over five years, but high costs and access hurdles limit its commercial outlook.
The drugmaker announced positive topline results for the drug in hemophilia A and B patients with inhibitors, on top of the existing approval for patients without inhibitors.
Cardiovascular
The privately held German pharma firm is hoping to bring a new generation of pulmonary fibrosis and cancer drugs to market but their commercial success is not yet a certainty.
Swiss major confident that new oncology drugs will fill revenue gap.
Anselamimab was expected to complement Alexion's portfolio of amyloid therapies, but regulators will have to be convinced of its benefits to a patient subgroup in the CARES trial.
New US approval in heart failure with preserved or mildly reduced ejection fraction should add to Kerendia’s earning power on top of chronic kidney disease indication.