Therapy Areas

The company announced positive topline results for the oral GLP-1 drug in type 2 diabetes that beat expectations.

With the FDA asking for another Phase III trial, the short bowel syndrome drug apraglutide could be years away from market, while the Linzess patent expiry and near-term debt loom.

The company discontinued development of its oral GLP-1 receptor agonist for weight management due to a safety signal.

The end of semaglutide and tirzepatide shortages means large-scale compounding is declining, ICER noted. But compounded versions – and the demand for them – are likely here to stay.

The US FDA approved Blujepa for the treatment of uncomplicated urinary tract infections, marking the first new mechanism of action for the infection in more than 30 years.

Professor Anil Koul shares vignettes of his life and career trajectory, a captivating mix of hope, science and destiny that took him to the lab of eminent cancer biologist Alex Ullrich at the Max Planck Institute and also saw him contribute to the development of breakthrough TB drug bedaquiline. He also talks about Medicine 3.0 and the intersection of science and spirituality.

The company is developing doravirine and islatravir together as an alternative to therapies containing integrase inhibitors, like Biktarvy, especially as HIV patients age.

The two companies were among those presenting data at CROI that highlighted the next frontiers of competition in the HIV space.

BriaCell announced its cell therapy Bria-IMT plus checkpoint inhibitors bested Gilead’s Trodelvy in a Phase II trial in HR+ breast cancer; a Phase III trial is enrolling.

The company is planning to start a registrational program on its home turf in Australia and is planning to bring the therapy to the US as well.

The bispecific is the first in its class to record a Phase III survival win in small-cell lung cancer, although antibody-drug conjugates and other rivals could challenge in the coming years.

The Oxford group has linked up with the NHS Cancer Vaccine Launch Pad.

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.

Immix collaborates with Israeli research institutions on BCMA-targeted CAR-T therapy. NeoImmuneTech/NIAID alliance could pave way for “animal rule” approval in acute radiation syndrome.

The small interference RNA therapeutic can be used by patients regardless of inhibitor status.

Taiwan-based PharmaEssentia hopes to add essential thrombocytopenia to the label for its pegylated interferon product, already approved to treat polycythemia vera.

With successful Phase II data versus active comparators for both REGN7508 and REGN9933, Regeneron hopes to position the candidates to compete against existing factor X products.

Hematologists’ concerns about hepatoxicity with hemophilia A gene therapies may limit use, but Phase III data for Pfizer’s candidate at ASH show a lower rate of ALT increases than seen with BioMarin’s Roctavian.

BMS’s Phase III ODYSSEY-HCM study did not show statistical significance for either of its two primary endpoints.

The end of the American College of Cardiology conference was a prelude to a volatile trading week for most stocks. Even before Liberation Day, reactions to the conference announcements were not encouraging.

The company posted positive initial results from the Heart-2 trial in HeFH and CAD, with strong LDL cholesterol lowering and a clean safety profile.

The German firm’s chairman, Hubertus von Baumbach, is adopting a ‘wait-and-see’ approach to the threat of pharma tariffs.