ADVERTISEMENT

Research & Development

AC Immune Perks Up On Positive Parkinson’s Data

The Switzerland-based group’s alpha-synuclein-targeted immunotherapy shows promise in slowing progression of the degenerative brain condition.

Teva’s Estradiol Approved As The First Generic To Imvexxy By The FDA

The US FDA’s approval of the first generic rival to Mayne Pharma’s Imvexxy (estradiol) comes days after the agency released product-specific guidance, which was demanded by the originator through citizen petitions.

ASH: Early Results Ready Lupeng’s Rocbrutinib For Potential Head-To-Head With Jaypirca

Lupeng's BTK inhibitor rocbrutinib has shown an 80.0% ORR in a Phase I trial in patients who had received a covalent or non-covalent BTK inhibitor plus BCL-2 inhibitor, setting the stage for a comparative trial, possibly with Jaypirca.

ASH: J&J’s Tecvayli Set For Stronger Competition With CAR-Ts In Myeloma

J&J's late-breaking Phase III MajesTEC-3 data at the American Society of Hematology meeting highlighted curative potential for the bispecific T-cell engager in multiple myeloma.

Formycon Partners With Zydus To Capture US-Canada Keytruda Biosimilar Market

Formycon has again stepped closer to financial certainty with another pembrolizumab biosimilar deal. This time, it unlocked a significant opportunity for the US and Canadian markets.

FDA Publishes PSGs For GLP-1 Giants Mounjaro, Wegovy, Victoza/Saxenda

The US FDA has delivered its December batch of product-specific guidances for generic development, marking only the second timely release of the year.

Indegene Exec On R&D Operations In The Age Of GenAI, One Click Submissions

Senior Indegene executive discusses why pharma R&D organizations of the future will need to be agile, modular and AI-native by design. Industry pilots are pointing the way to potential one click regulatory submissions.

Podcast: Kairos Pharma’s Approach To Resensitizing Tumors

In this episode of the In Vivo podcast, Kairos Pharma's chief scientific officer discusses developing therapies to reverse drug resistance in oncology, with ENV-105 showing promising Phase II results in resensitizing hormone-resistant prostate cancer.

Phrontline’s Two-Pronged Shot At Bispecific, Dual-Payload ADCs

To develop bispecific, dual-payload antibody-drug conjugates, Phrontline Biopharma’s strategy is to tune the activity of each payload to a similar level and engineer both toxins to fit within a branched linker, its CEO tells Scrip in an interview.

Kymera Keeps Rising With More Positive Dupixent-In-A-Pill Data

Early atopic dermatitis data on the oral STAT6 degrader helps the US firm’s hopes of matching the Sanofi and Regeneron injectable blockbuster on efficacy.

Next-Gen CAR-T Approaches Gain Spotlight At ASH

Next-gen CAR-T therapies showcased at the American Society of Hematology's annual meeting promise improved efficacy and safety, with Novartis, Gilead, and Kelonia advancing pivotal trials and exploring in vivo approaches.

ASH: Lilly’s Jaypirca Looks Headed For The Front Line

Data from the Phase III BRUIN CLL-313 trial presented at ASH showed clear superiority for the non-covalent BTK inhibitor as a single agent compared with bendamustine/rituximab.