Therapy Areas
Alimentary/Metabolic
Semaglutide 7.2mg bests placebo for weight loss at 72 weeks, but with efficacy lower than seen with Novo Nordisk’s CagriSema or Lilly’s Zepbound.
The company is moving quickly to bring its antibody oligonucleotide conjugates to patients in three separate muscular dystrophy diseases, causing unease for its rivals.
The company believes its WVE-007 can improve on GLP-1 agonists by preserving muscle mass while also not interfering with the pleasure of eating. Promising mouse data are still to be confirmed in humans, however.
The companies announced Phase II data showing a 22.8% mean weight reduction, but with no plateau, suggesting potentially further weight loss as time goes on.
Anti-infective
At J.P. Morgan, GSK, Sanofi and Pfizer said they are prepared to address questions about vaccines under a new US administration, while former FDA commissioner Gottlieb warned of threats to public safety.
Former Roche CEO Bill Burns reflects on transforming Roche into a global leader in specialty care and oncology. Now, as he spearheads efforts to combat antibiotic resistance, Burns shares insights on industry evolution, the power of cultural change, and the urgent need for a new business model in antibiotics development.
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.
Anticancer
The Pierre Fabre-partnered allogeneic T-cell immunotherapy is already available in Europe but hopes of a US approval have been hit by a complete response letter citing problems at a third-party manufacturing facility.
Acepodia’s dual-payload antibody-drug conjugates can link multiple tumor-killing agents without antibody modification. Apart from a GPC3-targeting candidate, the Taiwan-US biotech is also working on a bispecific antibody ADC with two different payloads, its CEO tells Scrip in an interview.
Scrip spoke with Lilly chief medical officer David Hyman at J.P. Morgan about the company’s oncology dealmaking strategy and plans for Scorpion’s selective PI3Kα-targeting asset.
After setbacks and a withdrawn filing, Dato-DXd is back on track for a potential second-line approval later this year in EGFR-mutant lung cancer. The partners are still counting on success in first line lung cancer and breast cancer treatment
Antiparasitic
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.
Blood and Clotting
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.
Takeda will pay $200m up front for rights to Phase II elritercept for anemia in patients with MDS and myelofibrosis, allowing Keros to extend its cash runway to 2028.
Cardiovascular
While quieter than some recent years, 2024 did produce several clinical trial readouts destined to have an impact on their respective markets. Here, in roughly chronological order, Scrip takes a look at the 10 clinical stories that got readers clicking the most over the past 12 months.
The Swiss group has had an up and down year and it is not ending well, as the proposed sale of its recently-approved antihypertensive Tryvio has been delayed.
Presenting data or announcing a licensing transaction at an appropriately themed conference would normally be expected to be viewed favorably by investors. This is not always the case, however.
Both companies are seeking to license their products as they try to stretch their dwindling cash.