Therapy Areas

In the head-to-head Phase III HARMONY trial in metformin-failed type 2 diabetes, HighTide's HTD1801 yielded a mean 1.12% reduction in HbA1c from baseline at 24 weeks, versus 0.93% for AstraZeneca’s Farxiga.

New Phase II data in type 2 diabetes for Novo Nordisk’s GLP-1/amylin agonist amycretin shows significant weight loss and HbA1c-lowering potential. A Phase III trial is planned.

Madrigal, Wave Therapeutics and Kailera are in the next wave of cardiometabolic therapy companies, and at Jefferies talked about how US and China-derived innovation can help reach more patients in the US and the rest of the world.

The company announced positive Phase II results for tradipitant among patients taking Wegovy, enabling them to move more quickly to a therapeutic dose, when patients normally need to titrate.

Still betting on its vaccines portfolio, Moderna is also hoping to deliver on its ambitions in oncology with a Phase III candidate partnered with Merck, while cutting pipeline programs and seeking manufacturing efficiencies.

Cidara’s long-acting antibody candidate could help protect millions of immunocompromised patients against flu – and could work around growing vaccine hesitancy in the US.

Merck & Co. is looking to bolster its respiratory portfolio with Cidara’s Phase III antiviral conjugate CD388, previously owned by Janssen. Phase III data are expected in 2027.

The company is discontinuing congenital CMV development for its mRNA-1647 vaccine but still running a Phase II trial in bone marrow transplant patients.

Janux wowed last year with first data from its ‘masked’ T-cell engager, JANX007, but investors have been spooked by newly updated results for the product. Analysts, however, still think it can compete with rivals from Amgen and J&J.

The company plans to take IGV-001 to the FDA after the mid-stage trial showed a more than six-month improvement in overall survival compared with placebo.

Akeso’s first-in-class PD-1/VEG-F bispecific ivonescimab is a landmark achievement for China’s biotech sector, but the firm is already expanding its ambitions in oncology and beyond, including a challenge to Roche in Alzheimer’s.

With Gilead reporting that both of its approved CAR-Ts saw sales declines as other products saw growth, a mixture of different competitive headwinds seems to be behind the disparities.

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.

The Phase III portion of the Phase II/III RISE UP study in sickle cell disease met the hemoglobin response primary endpoint, but not the sickle cell pain crisis reduction co-primary endpoint nor a secondary endpoint on reducing fatigue.

The company said in its third quarter earnings that it would focus on areas that better foster growth for the company as the hemophilia A treatment only brought in $3m in Q3.

Deal Snapshot: CSL secures exclusive option to acquire VarmX, depending on results for a Phase III trial for its lead compound, VMX-C001, a reversal agent for Factor Xa inhibitors.

The drugmaker reported a negative Phase III study for inclacumab, after a partial clinical hold for osivelotor and pulling Oxbryta from the market.

With the help of a purchased priority review voucher, the drug looks likely to become the first aldosterone synthase inhibitor to receive regulatory authorization, ahead of Mineralys' lorundrostat.

Successful stroke data on the oral Factor XIa inhibitor represents the first Phase III success for the class and is a major boost for Bayer’s cardiovascular franchise.

Redemplo is Arrowhead’s first commercial product, and the drug will enter a competitive market. Arrowhead and Ionis have taken different pricing paths, however.

A Phase II trial testing Winrevair in patients with a type of hypertension caused by heart failure met the primary endpoint and could represent a big growth opportunity.