NEWS

Orbis Medicines and Novo Partner on Oral Macrocycle Drugs in a ~$1.4B Deal

Shots: Orbis Medicines has entered into a strategic collaboration & license agreement with Novo to discover & develop next-generation oral macrocycle therapeutics for cardiometabolic diseases As per the deal, Orbis will receive ~$1.4B in upfront, and development & commercial milestone payments, plus tiered royalties on future product sales, while Novo will also make a strategic…

6 hours ago

Dualitas Therapeutics and Roche Partner to Advance Novel Bispecific Antibodies for I&I Diseases in a ~$1B Deal

Shots: Dualitas has entered into a research collaboration & license agreement with Roche to advance novel bispecific antibodies for immunology & inflammation (I&I) diseases, using Dualitas' DualScreen Bispecific Discovery Engine As per the deal, Dualitas will receive $36.5M upfront & additional research, development & commercial milestone payments, representing the total deal value of ~$1B, in addition…

7 hours ago

Bayer’s Kerendia Secures US FDA Approval for Chronic Kidney Disease Associated with T1D

Shots: The US FDA has approved Kerendia (finerenone, 10 & 20mg) for the treatment of adults with chronic kidney disease (CKD) associated with type 1 diabetes (T1D) Approval was supported by the global P-III (FINE-ONE) trial assessing Kerendia (10 or 20mg, QD) + SoC vs PBO in 242 pts with CKD associated with T1D Kerendia +…

8 hours ago

Aptitude Receives US FDA Clearance for Next-Generation Metrix COVID Test

Shots: The US FDA has granted 510(k) clearance to the next-generation Metrix COVID Test, with development supported by BARDA. The test is cleared for OTC and professional use in CLIA-waived settings The handheld molecular test delivers approximately 3-fold higher analytical sensitivity & 30% faster results than EUA-authorized product, targeting urgent care & other decentralized settings Aptitude…

10 hours ago

Roche Reports the P-III (CELESTIMO) Trial Data on Lunsumio in Follicular Lymphoma

Shots: Roche has reported the P-III (CELESTIMO) trial assessing Lunsumio (mosunetuzumab) + lenalidomide vs MabThera + lenalidomide in pts with r/r follicular lymphoma who have received ≥1L of prior systemic therapy Trial met its 1EP, showing a statistically significant & clinically meaningful improvement in PFS, while OS data remained immature at the interim analysis; the…

11 hours ago

Arrowhead Reports Topline P-I/IIa Trial Data on ARO-DIMER-PA for Mixed Hyperlipidemia

Shots: Arrowhead has reported P-I/IIa (ARO-DIMER-PA-1001) study data assessing the safety, tolerability, PK, PD, & effects on LDL-C and TGs of single-dose (part 1) & multiple doses (part 2) of ARO-DIMER-PA in ~78 adults with mixed hyperlipidemia ARO-DIMER-PA single doses produced dose-dependent mean maximal reductions in serum PCSK9 of 72% & APOC3 of 88%, along with…

12 hours ago

Sling Therapeutics Doses First Patients in P-III (ORBIT) Trial of Linsitinib for Thyroid Eye Disease

Shots: Sling Therapeutics has dosed the first patients in the global P-III (ORBIT) trial assessing linsitinib (150mg, PO, BID) vs PBO in ~130 adults with mod. to sev. active thyroid eye disease (TED) for 24wks. The trial will assess the proportion of proptosis responders at Wk. 24, defined as a ≥2 mm reduction in the…

1 day ago

Biogen and Eisai Report MHLW Approval of Leqembi Pen (SC) for Early Alzheimer’s Disease

Shots: The MHLW has approved Leqembi Pen (SC autoinjector) administered as 500mg given QW as two pens, each delivered in ~15secs, for the treatment of early Alzheimer's disease Approval was supported by 18mos. P-III Clarity AD data in pts with mild cognitive impairment (MCI) due to AD or mild AD dementia & multiple SC administration…

1 day ago

Vera Therapeutics Reports the P-III (ORIGIN 3) Trial Data on Trutakna (Atacicept-vymj) in IgA Nephropathy

Shots: Vera has reported the P-III (ORIGIN 3) trial data assessing Trutakna vs PBO in adults with primary IgAN at risk for disease progression, which met all of its prespecified endpoints. The company is planning to submit an sBLA to the FDA for full approval in Q4’26 In 428 pts, Trutakna preserved kidney function at…

1 day ago

Lundbeck Reports the MHLW Approval of Vyepti (Eptinezumab) for the Preventive Treatment of Migraine

Shots: The Japanese MHLW has approved Vyepti (eptinezumab) for the prevention of migraine attacks in adults Approval was backed by extensive clinical data, incl. P-III (PROMISE-1, PROMISE-2 & DELIVER) studies as well as P-III (SUNRISE) trial, which assessed Vyepti in a predominantly Asian population; NDA was further supported by the SUNSET LTE trial conducted in Japanese…

1 day ago

NEWS

Orbis Medicines and Novo Partner on Oral Macrocycle Drugs in a ~$1.4B Deal

Dualitas Therapeutics and Roche Partner to Advance Novel Bispecific Antibodies for I&I Diseases in a ~$1B Deal

Bayer’s Kerendia Secures US FDA Approval for Chronic Kidney Disease Associated with T1D

Aptitude Receives US FDA Clearance for Next-Generation Metrix COVID Test

Roche Reports the P-III (CELESTIMO) Trial Data on Lunsumio in Follicular Lymphoma

Arrowhead Reports Topline P-I/IIa Trial Data on ARO-DIMER-PA for Mixed Hyperlipidemia

Sling Therapeutics Doses First Patients in P-III (ORBIT) Trial of Linsitinib for Thyroid Eye Disease

Biogen and Eisai Report MHLW Approval of Leqembi Pen (SC) for Early Alzheimer’s Disease

Vera Therapeutics Reports the P-III (ORIGIN 3) Trial Data on Trutakna (Atacicept-vymj) in IgA Nephropathy

Lundbeck Reports the MHLW Approval of Vyepti (Eptinezumab) for the Preventive Treatment of Migraine

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