Therapy Areas

Two pharmaceutical companies reporting bumper sales in the hot areas of diabetes and obesity may have helped a thaw in sector sentiment.

Having built its portfolio from university collaborations and targeted in-licensing, the UK firm now hopes to validate its business model with Phase II readouts in 2025.

Patient demand for compounded versions of FDA-approved obesity drugs is unlikely to dissipate, even if semaglutide’s “shortage” status is resolved. The issue likely will continue to be a high-profile concern for the brand industry.

Large headcount reduction and ending preclinical programs may give Inventiva runway to report Phase III data for lanifibranor that are expected during the second half of 2026.

The FDA approved Vimkunya on 14 February as the first vaccine for preventing chikungunya in adolescents as well as adults.

Kostaive is the first self-amplifying mRNA COVID-19 vaccine to receive approval from the European Commission and could provide serious competition to Pfizer/BioNTech's Comirnaty and Moderna's Spikevax.

Pfizer has been unable to take a big slice of the meningococcal vaccine market with Penbraya and now GSK looks set to consolidate its lead with its new 5-in-1 vaccine.

Scrip surveys some of the more interesting Phase III clinical trial readouts expected this year.

Novartis president, development and chief medical officer talks about the pivotal role of the development India hub in progressing breakthrough drugs, how AI is delivering gains in the trials arena, driving focus in the R&D engine and the Swiss group’s approach in the obesity space.

Big pharma once again fails to dominate the top 20 expected best sellers from products due for launch this year. Small-to-medium pharma account for nearly half the list, while Vertex has two products in the top five.

With new Phase I/Ib results in kidney cancer, the HIF-2a inhibitor outshines Merck’s Welireg, but longtime Arcus partner Gilead decided not to exercise its option for casdatifan.

The Swedish biotech has held positive talks with US regulators about the Phase III design for its pancreatic cancer candidate, mitazalimab. Now it needs to pin down a partner.

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.

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.

The Swiss major may have to pay over $3bn for the dual-acting Factor XI/XIa inhibitor that it originally developed before the drug was passed on to Anthos Therapeutics, founded by private equity firm Blackstone and the Swiss major in 2019.

The company needs a string of Phase III wins this year to keep on track to reach $80bn revenues in 2030, with analysts still skeptical. Meanwhile, investors were relieved to learn that any fine related to a China corruption probe would be relatively modest.

The Phase III HYPERION study in recently diagnosed PAH is ending early due to sotatercept’s strength. Phase III ZENITH similarly stopped early in November.

The company announced data that exceeded expectations and prompted a jump in its stock price shortly after its shares plunged on news of a related Lilly drug’s discontinuation.