Therapy Areas

The blockbuster GLP-1 analog demonstrated a capability for fibrosis reduction and disease resolution in the Phase III ESSENCE study. The firm plans to file for approval in 2025.

Panels at the recent BioFuture conference focused on the next breakthroughs in areas such as oncology and neurodegenerative diseases, continuing challenges to GLP-1 agonists, financing and how use of AI is taking shape.

The UK group began more clinical trials last year than any other company, a new report from Citeline has found.

Lanreotide supply challenges could impact Cipla’s US revenues in the coming quarter, while the firm hopes it can seize emerging opportunities in the GLP-I segment in India, where Novo Nordisk and Eli Lilly are progressing filings for their blockbuster products.

The US FDA approved Orlynvah for uncomplicated urinary tract infections among adult women, despite some concerns about the potential for off-label use and resistance.

Pfizer beat GSK with a new indication for its RSV vaccine in high-risk individuals aged 18-59.

Gilead presented 48-week data for the combination of weekly oral lenacapavir/islatravir, showing results consistent with 24-week data. A Phase III program will soon begin.

Full data from Merck & Co’s Phase IIb/III trial of its novel RSV antibody suggest that it will have to fight hard against Sanofi/AstraZeneca’s leader.

Emerging Company Profile: Volastra is testing two KIF18A inhibitors in early clinical trials in ovarian cancer, backed by investors like Polaris Partners and ARCH Ventures.

Panels at the recent BioFuture conference focused on the next breakthroughs in areas such as oncology and neurodegenerative diseases, continuing challenges to GLP-1 agonists, financing and how use of AI is taking shape.

The UK group began more clinical trials last year than any other company, a new report from Citeline has found.

Troubled GlycoMimetics will merge with Crescent, bringing its PD-1- and VEGF-targeting bispecific CR-001 and gaining a public listing. Crescent also will raise $200m to help position itself against PD-1xVEGF leaders Akeso/Summit and BioNTech.

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 US FDA approved the drug for hemophilia A and B, and while it may struggle to compete in hemophilia A against Roche’s Hemlibra, it has a big convenience advantage in hemophilia B.

Once the deal with Sanofi closes, the rare disease drug will become one of Recordati’s fastest forecast sellers.  

The withdrawal amid concerns about the risk-benefit ratio reduces treatment options for sickle cell disease, but it is not expected to have much effect on the SCD market, including the gene therapies.

US FDA approval of Niktimvo for third-line chronic GVHD, a competitor to Sanofi’s Rezurock, came less than two months ahead of anticipated approval of Syndax’s leukemia drug revumenib.

A mild benefit in the CV outcomes trial of Rybelsus means a likely label expansion in diabetes patients, but probably not vastly increased sales.

The $100m upfront deal help AZ to fill out its cardiovascular, renal and metabolism portfolio, now joining Lilly in seeking to develop an oral Lp(a)-targeting therapy.

CEO Chris Cargill talks to Scrip about Sosei Heptares’ new identity as Nxera, the ups and downs of being big pharma’s go-to small-molecule drug hunter and its move into commercialization in Japan.

At an investor meeting in London, the Swiss company sets out plans for more disciplined decision-making to help it launch a new wave of blockbuster drugs.