Therapy Areas

Boston Pharma may be rising in the FGF21 space, while Viking could be formidable competition for Madrigal in the THRβ agonist class. Akero will soon report potentially groundbreaking data in cirrhotic NASH.

The firm revealed that an analysis of its Phase III ESSENCE trial combining fibrosis reduction and NASH resolution showed a higher effect over placebo than in Madrigal’s pivotal trial.

Following Phase III safety and cash problems, Inventiva has its eye on lanifibranor becoming the second oral agent approved in NASH. Former Intercept CEO Mark Pruzanski is advising the effort.

Indian firms Lupin and Aurobindo lay out global plans for GLP-1 agonists, as Aurobindo also updates on its biosimilar ambitions as they report results for fiscal Q2.

Recent data put Vir and Bluejay ahead of the pack, but it is hard to know exactly how well their products work.

The drug maker said in its third quarter earnings report that competition from other therapeutic classes, particularly bispecifics, resulted in a slight decline of sales for the CAR-T.

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.

Billion dollar-plus global deal with Japanese partner gives Kura's lead asset development impetus while adding to Kyowa Kirin's ambitions in hematological malignancies.

The agency granted accelerated approval to zanidatamab in HER2-positive biliary tract cancer, though the company is eyeing larger indications for the drug.

Asia-Pacific continues to solidify its position as a key location for clinical trials, with China in particular dominating such activity in the region, and increasingly globally, a new Citeline White Paper shows.

The new formulation is expected to play a role in helping Merck maintain its multibillion-dollar cancer franchise after Keytruda loses exclusivity in 2028.

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.

The company announced results of the TANDEM study combining the CETP inhibitor with ezetimibe, following successful monotherapy trial data announced in July

The drug maker’s muvalaplin is only in Phase II – behind candidates from Amgen and Novartis – but an analyst said it has “mega-blockbuster” potential, assuming it has the right biological activity.

Among the major topics at the conference this week will be the impact on global biopharma of the upcoming Trump administration, frenetic activity in the obesity field, and hopes of increased funding for UK biotech companies.

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