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By PharmaCompass
2025-12-11
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In this week’s Phispers, Eli Lilly announced yet another investment in the US — this time to build its largest API facility in the country at the cost of US$ 6 billion.
Indian biopharma Biocon is buying out stakes of Viatris and others in order to make Biocon Biologics its wholly-owned subsidiary. Their stake has been valued based on a valuation of US$ 5.5 billion for Biocon Biologics.
Pfizer has big ambitions in weight management. After acquiring Metsera, Pfizer has entered into a deal worth up to US$ 1.9 billion with China’s YaoPharma to develop a new weight loss drug.
In other deals, Novartis signed a US$ 1.7 billion discovery partnership with Relation Therapeutics to explore new immuno-dermatology targets. And China’s Kelun-Biotech and America’s Crescent Biopharma signed a deal to develop and commercialize each others’ cancer therapies.
In drug approvals, the US Food and Drug Administration (FDA) approved the first gene therapy for Wiskott-Aldrich syndrome, a rare immune disorder. The agency also cleared AIM-NASH, the first AI tool to support doctors in evaluating metabolic dysfunction-associated steatohepatitis (MASH) in clinical trials.
Bristol Myers Squibb (BMS) secured fifth approval for Breyanzi. It has now become the first CAR-T therapy approved for treating marginal zone lymphoma, a rare type of B-cell non-Hodgkin lymphoma.
In clinical trials, Roche’s experimental drug giredestrant cut the risk of early-stage breast cancer returning by 30 percent compared with standard hormone therapy in a phase 3 trial. Meanwhile, FDA has mandated randomized control trials for the approval of new chimeric antigen receptor (CAR) T-cell therapies to treat cancer.
Lilly to invest over US$ 6 bn in new API plant in Alabama — its largest site in US
Eli Lilly has announced a more than US$ 6 billion investment to build a new active pharmaceutical ingredient (API) manufacturing facility in Huntsville, Alabama — its largest US site yet. The plant will produce small-molecule and peptide medicines, including orforglipron, Lilly’s first oral GLP-1 weight-loss drug that is expected to gain US approval next year. The investment is part of Lilly’s push to strengthen US-based production and reduce reliance on imported APIs. Earlier this year, the company committed at least US$ 27 billion towards expanding US manufacturing.
Biocon makes Biocon Biologics its 100% subsidiary, buys out others’ stakes
Viatris is selling its entire stake in Biocon Biologics, and the Indian biopharma will buy all of Viatris’ shares in Biocon Biologics for US$ 815 million. This way, Biocon will consolidate its biosimilars and generics businesses under one entity. To complete the integration, Biocon will acquire minority stakes held by Serum Institute Life Sciences, Tata Capital Growth Fund II, and Activ Pine LLP via a share swap. Biocon Biologics has been valued at around US$ 5.5 billion.
Pfizer inks up to US$ 1.9 bn deal with China’s YaoPharma for its obesity drug
Pfizer has signed a deal with China’s YaoPharma to develop and commercialize an experimental weight-loss drug — YP05002. YaoPharma is a subsidiary of Shanghai Fosun Pharmaceutical. The medicine belongs to the popular GLP-1 class of drugs. YaoPharma will finish the current early-stage trial, after which Pfizer will take over the development and worldwide commercialization of the drug. YaoPharma will receive US$ 150 million upfront and could earn an additional US$ 1.94 billion if the drug reaches key milestones and gets approved.
FDA approves Waskyra, first gene therapy to treat rare immune disorder WAS
FDA has approved Waskyra (etuvetidigene autotemcel), the first gene therapy for Wiskott-Aldrich syndrome (WAS), a rare immune disorder that causes frequent infections, bleeding issues, and eczema. The one-time treatment, developed by Italy’s non-profit Fondazione Telethon, uses patients’ own blood stem cells that are modified to restore the faulty WAS gene. It is approved for both children (six months and older) and adults with the condition.
AI tool to evaluate MASH: FDA has approved the first artificial intelligence (AI) tool to support doctors in evaluating MASH in clinical trials. The cloud-based tool, known as AIM-NASH, analyzes liver biopsy images to detect fat buildup, inflammation, and scarring — the key markers of MASH.
Breyanzi bags another approval: BMS has scored another win for its CAR-T therapy Breyanzi (lisocabtagene maraleucel), which has now become the first treatment of its kind approved for marginal zone lymphoma in adults who have failed at least two prior therapies. With this latest FDA nod, Breyanzi has become the first CAR-T therapy cleared to treat five different blood cancers.
Roche’s drug cuts risk of early-stage ER-positive breast cancer recurring by 30%
Roche said its experimental pill giredestrant cut the risk of (estrogen receptor-positive, human epidermal growth factor receptor 2-negative) early-stage breast cancer returning by 30 percent compared with standard hormone therapy in a phase 3 study. Roche says this is the biggest advance in ER-positive breast cancer treatment in 25 years. The medication has the potential to become the new standard of care for early-stage disease.
Novartis signs up to US$ 1.7 bn dermatology deal with UK’s Relation Therapeutics
Novartis has entered a strategic partnership with London-based Relation Therapeutics in a deal worth up to US$ 1.7 billion to discover new drug targets for atopic diseases. The agreement centers on Relation’s AI-powered “Lab-in-the-Loop” platform, which analyzes patient tissue and genetic data to identify disease-causing genes with greater precision.
Kelun-Biotech, Crescent ink deal to develop each other’s cancer therapies
China’s Kelun-Biotech has partnered with US-based Crescent Biopharma for two new cancer medicines — Crescent’s CR-001 (a bispecific antibody) and Kelun-Biotech’s SKB105 (an antibody-drug conjugate). Both candidates are being developed for the treatment of solid tumors and are expected to enter early-stage trials in early-2026. Crescent will pay Kelun US$ 80 million upfront and milestone payments of up to US$ 1.25 billion, plus tiered royalties, on sales of Kelun's ADC. Crescent will receive an upfront payment of US$ 20 million from Kelun-Biotech and is also eligible to receive additional milestones of up to US$ 30 million, plus tiered royalties on net sales of CR-001. In return, Kelun will get China rights to CR-001.
FDA mandates randomized control trials for new CAR-T therapies
FDA is tightening its rules for approving new CAR-T-cell therapies to treat cancer. Companies will now need better and more reliable data before their products can be approved. The agency wants companies to run randomized controlled trials, not just single-arm studies. While accelerated approvals may still be granted, full approval will generally require evidence from controlled trials.
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