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The EMA has recommended conditional EU marketing authorization for Anktiva (nogapendekin alfa inbakicept) plus Bacillus Calmette-Guérin (BCG) to treat BCG-unresponsive NMIBC carcinoma in situ.
Recommendation was based on safety and efficacy data in 100 adults, showing a 71% CR rate, with responses lasting a median of ~27 mos and extending up to 54+ mos; CR rates among responders were 66% at…
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The US FDA has granted 510(k) clearance to LumosityRx, a prescription digital therapeutic, designed to improve attention in adults (22-55yrs.) with attention deficit hyperactivity disorder (ADHD)
Assessed in the GAMES Study (n>500), LumosityRx showed significantly improved TOVA Attention Comparison Score (1EP) vs a control app, with 44.2% pts achieving clinically meaningful attention gains (>1.4 points…
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Roche has reported P-III (lidERA Breast Cancer) trial assessing giredestrant (QD) vs SoC endocrine therapy in pts (n=~4,100) with medium or high-risk stage I-III ER+, HER2- breast cancer
At the interim analysis, trial met its 1EP of improved invasive disease-free survival (iDFS) by 30%, with 92.4% vs 89.6% pts alive & invasive disease free…
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Lynk Pharmaceuticals has entered into an exclusive development & licensing agreement with Formation Bio, granting the latter worldwide rights to LNK01006 (excl. Greater China), a highly selective TYK2 inhibitor
LNK01006 will be developed by Formation’s new subsidiary, Bleecker Bio, following recent US FDA IND clearance, with a P-I trial planned to start in the…
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The Chinese NMPA has approved Boehringer Ingelheim's Jascayd for the treatment of adults with progressive pulmonary fibrosis (PPF)
Approval was based on the P-III (FIBRONEER-ILD) trial of Jascayd vs PBO, which met its 1EP of reduced FVC at Wk. 52 & showed a significant reduction in death risk
Additionally, Jascayd'ssNDA for PPF is under…
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Relation has entered into a multi-program, strategic collaboration with Novartis to identify & advance novel targets for atopic diseases, leveraging Relation’s Lab-in-the-Loop platform
As per the deal, Relation will lead patient-derived observational studies to create high-resolution functional cell atlases, while Novartis will secure global development & commercialization rights to any resulting targets
In return,…
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The US FDA has approved ProVee System for the treatment of benign prostatic hyperplasia (BPH)
Approval was backed by the ProVIDE study assessing ProVee in men, which met its 1 & 2EPs, showing significant & durable symptom relief as well as improved urinary flow through 12mos. compared to sham, with preserved sexual function &…
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Polpharma Biologics has signed a licensing agreement with Brazil-based Libbs Farmacêutica for an autoimmune biosimilar
Under this strategic partnership, Polpharma Biologics is fully responsible for the development and manufacturing of the product
Libbs will exclusively handle the product’s commercialization, marketing, and distribution in the Brazilian market
Ref: Polpharma Biologics | Image: Polpharma Biologics | Press Release
Related News:- Polpharma Biologics Launches…
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Formycon has entered into an exclusive licensing & supply agreement with Zydus Lifesciences Global FZE, UAE (Zydus' subsidiary) to commercialize Formycon’s FYB206, a biosimilar version of Merck’s Keytruda (pembrolizumab), in the US & Canada
As per the deal, Formycon will be responsible for development, registration, manufacturing & supply of the product, while Zydus Lifesciences…
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Pfizer has entered into an exclusive global collaboration & license agreement with YaoPharma for YP05002, a GLP-1 receptor agonist for chronic weight management
As per the deal, YaoPharma will complete the ongoing P-I trial of YP05002 & grant Pfizer exclusive global rights for further development, manufacturing & commercialization, receiving $150M upfront & ~$1.935B in…

