NEWS

Biogen Reports P-II (CELIA) Trial Results on Diranersen in Early Alzheimer’s Disease

Shots: Biogen has reported the global P-II (CELIA) trial data assessing diranersen [60mg (Q24W), 115mg (Q24W), or 115mg (Q12W); intrathecal) vs PBO over 76wks. in 416 pts with mild cognitive impairment due to Alzheimer’s disease (AD) or mild AD dementia Although CELIA did not meet its 1EP of dose response on CDR-SB change from baseline…

May 15, 2026

AstraZeneca’s Fasenra Receives the US FDA Approval for Hypereosinophilic Syndrome

Shots: The US FDA has approved AstraZeneca's Fasenra (benralizumab) for the treatment of pts (≥12yrs.) with hypereosinophilic syndrome (HES) without an identifiable non-hematologic secondary cause Approval was based on the P-III (NATRON) trial data assessing Fasenra (30mg, SC, Q4W) vs PBO, both in addition to background HES therapy in 133 HES pts for 24wks. Trial met…

May 15, 2026

AstraZeneca Reports the P-III (VOLGA) Trial Data on Imfinzi + Enfortumab Vedotin (EV) for Muscle-Invasive Bladder Cancer

Shots: Trial enrolled 695 MIBC pts undergoing radical cystectomy who were ineligible for or declined cisplatin & randomized them to Arm 1 [neoadj. 3 Imfinzi + EV cycles with Imjudo (2 cycles), then adj. Imfinzi (9 cycles) + 1 Imjudo cycle], Arm 2 [neoadj. Imfinzi + EV (3 cycles), then adj. Imfinzi (9 cycles)], or…

May 14, 2026

Revvity Receives FDA Clearance for Total Testosterone ChLIA Assay

Shots: Revvity has received the US FDA clearance for its Total Testosterone automated chemiluminescence immunoassay (ChLIA), expanding its endocrine diagnostics portfolio The portfolio enables direct ChLIA measurement of total testosterone, SHBG, & free testosterone, supporting both first & second-line diagnostic testing for suspected male hypogonadism Processed on IDS’ random-access automation platforms, the expanded portfolio enables…

May 14, 2026

Zydus to Acquire Assertio in ~$166.4M All-Cash Deal

Shots: Assertio Holdings’ Board has approved a definitive agreement with Zydus Worldwide DMCC, a subsidiary of Zydus, to acquire all outstanding Assertio shares, delisting it from the Nasdaq Assertio’s Board determined Zydus’ proposal constituted a “Superior Proposal” under the Garda merger agreement & authorized termination of the Garda transaction As per the deal, Zydus will…

May 14, 2026

Taiho Oncology (Part of Taiho Pharmaceutical) Reports the US FDA Approval of Inqovi + Venetoclax for Newly Diagnosed AML

Shots: The US FDA has approved Inqovi (decitabine & cedazuridine) + venetoclax for the treatment of newly diagnosed acute myeloid leukemia (AML) pts, who are 75yrs. or older, or ineligible for intensive induction CT Approval was backed by P-II (ASCERTAIN-V) trial in adults with newly diagnosed AML ineligible for intensive induction CT Trial showed a…

May 14, 2026

BeOne Medicines Receives US FDA Accelerated Approval for Beqalzi (Sonrotoclax) to Treat R/R Mantle Cell Lymphoma

Shots: The US FDA has granted accelerated approval to BeOne's Beqalzi for the treatment of adults with r/r mantle cell lymphoma, after ≥2L of systemic therapy, incl. a BTK inhibitor; regulatory review is ongoing in the EU Approval was supported by the global P-I/II (BGB-11417-201) assessing Beqalzi in r/r MCL pts (n=125), which showed 52%…

May 14, 2026

Fosun Pharma Obtains Option on AriBio’s Alzheimer’s Disease (AD) Therapy AR1001

Shots: Fosun Pharma & AriBio have entered into an exclusive global option agreement for the development, registration, manufacturing, & commercialization of AR1001 for AD, expanding their partnership beyond Greater China & 10 ASEAN countries AriBio will receive a $60M option fee & retain the right to exercise the option within the agreed period, while Fosun…

May 14, 2026

Pfizer Receives the EC Approval for Hympavzi to Treat Hemophilia A and B

Shots: The EC has approved Pfizer's Hympavzi (marstacimab; QW, SC) for the treatment of pts (≥12yrs., ≥35kg) with hemophilia A with FVIII inhibitors or hemophilia B with FIX inhibitors, based on P-III (BASIS) study During the active treatment period, Hympavzi achieved a 93% reduction in mean treated ABR vs on-demand therapy (1.39 vs 19.78), plus…

May 13, 2026

Cepheid Receives IVDR CE Mark for Xpert GI Panel to Detect 11 Gastrointestinal Pathogens

Shots: Cepheid has received IVDR CE marking for the Xpert GI Panel, a multiplex PCR assay designed to detect 11 clinically relevant GI pathogens from a single stool sample using the 10-color multiplexing technology on GeneXpert Systems The assay simultaneously identifies bacterial, viral, & parasitic pathogens directly from stool specimens in Cary-Blair transport media, requiring…

May 13, 2026

NEWS

Biogen Reports P-II (CELIA) Trial Results on Diranersen in Early Alzheimer’s Disease

AstraZeneca’s Fasenra Receives the US FDA Approval for Hypereosinophilic Syndrome

AstraZeneca Reports the P-III (VOLGA) Trial Data on Imfinzi + Enfortumab Vedotin (EV) for Muscle-Invasive Bladder Cancer

Revvity Receives FDA Clearance for Total Testosterone ChLIA Assay

Zydus to Acquire Assertio in ~$166.4M All-Cash Deal

Taiho Oncology (Part of Taiho Pharmaceutical) Reports the US FDA Approval of Inqovi + Venetoclax for Newly Diagnosed AML

BeOne Medicines Receives US FDA Accelerated Approval for Beqalzi (Sonrotoclax) to Treat R/R Mantle Cell Lymphoma

Fosun Pharma Obtains Option on AriBio’s Alzheimer’s Disease (AD) Therapy AR1001

Pfizer Receives the EC Approval for Hympavzi to Treat Hemophilia A and B

Cepheid Receives IVDR CE Mark for Xpert GI Panel to Detect 11 Gastrointestinal Pathogens

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