NEWS

AstraZeneca Reports the US FDA’s NDA Acceptance with Priority Review of Baxdrostat for Hard-to-Control Hypertension

Shots: The US FDA has accepted NDA & granted priority review to Baxdrostat as an add-on treatment of pts with uncontrolled or treatment-resistant hypertension (PDUFA: Q2’26 following use of PRV) NDA was supported by the P-III (BaxHTN) trial assessing baxdrostat (1 or 2mg, QD, PO) vs PBO on top of SoCs in 796 pts with…

December 3, 2025

Roche’s Point-of-Care PCR Test Gains FDA’s 510(k) Clearance with CLIA Waiver and European CE Mark to Diagnose Bordetella infections

Shots: Roche has received 510(k) clearance with CLIA waiver & CE-IVDR certification for its point-of-care test to diagnose whooping cough (pertussis) & other Bordetella infections The PCR test on the cobas liat system delivers results in 15min. in GP clinics & emergency rooms, allowing real-time diagnosis during consultation & supporting immediate antibiotic decisions to help…

December 2, 2025

Belite Bio Reports Topline P-III (DRAGON) Trial Data on Tinlarebant for Stargardt Disease Type 1 (STGD1)

Shots: Trial assessed tinlarebant (5mg, QD, PO; n=69) vs PBO (n=35) in 104 STGD1 pts (12-20yrs.), meeting its 1EP of 36% reduction in lesion growth per retinal imaging, quantified as 35.7% using the pre-specified MMRM model & confirmed at 35.4% with a post-hoc autoregressive-MMRM analysis Trial also showed reduced lesion growth rate by 33.6% in fellow…

December 2, 2025

Accord Healthcare Launches Osvyrti and Jubereq (Biosimilar, Prolia & Xgeva) in the EU

Shots: Accord Healthcare has launched Osvyrti & Jubereq, biosimilar versions of Amgen’s Prolia & Xgeva (denosumab), following patent expiry of reference products on Nov 27, 2025 Osvyrti (60mg PFS) is indicated to treat osteoporosis in postmenopausal women & men at increased risk of fractures. It is also used to treat bone loss in pts on…

December 2, 2025

Samsung Bioepis Receive the CHMP Positive Opinion for Byooviz (Biosimilar, Lucentis)

Shots: The CHMP has recommended Samsung Bioepis’ Byooviz (0.5 mg/0.05 ml PFS), a biosimilar version of Lucentis (ranibizumab). The PFS presentation is expected to launch in Q2’26 Byooviz is indicated for the treatment of neovascular (wet) age-related macular degeneration (AMD), visual impairment due to diabetic macular oedema (DME), proliferative diabetic retinopathy (PDR), visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO), and…

December 2, 2025

Johnson & Johnson Reports the EC Approval of Imaavy (Nipocalimab) for Generalized Myasthenia Gravis (gMG)

Shots: The EC has approved Imaavy (nipocalimab) as an add-on therapy to treat anti-AChR or anti-MuSK antibody-positive gMG pts (≥12yrs.) Approval was based on the P-III (Vivacity-MG3) trial assessing Imaavy (30mg/kg, IV loading dose then 15mg/kg, Q2W) + SoC (n=77) vs PBO + SoC (n=76) in gMG pts (N=199; 153 were Ab +ve), which showed…

December 2, 2025

Regeneron and Tessera Therapeutics Enter ~$275M Collaboration to Advance TSRA-196 for Alpha-1 Antitrypsin Deficiency (AATD)

Shots: Regeneron has entered into a global collaboration with Tessera Therapeutics to develop & commercialize TSRA-196 as a one-time gene editing treatment of AATD As per the deal, Tessera & Regeneron will equally share global development costs & potential future profits for TSRA-196. Tessera will receive $150M in upfront & equity investment plus $125M in near…

December 2, 2025

Akebia Therapeutics Acquires Q32 Bio’s Complement Inhibitor ADX-097 for ~$592M

Shots: Q32 Bio has sold ADX-097, a P-II complement inhibitor, to Akebia Therapeutics As per the deal, Akebia will acquire ADX-097 from Q32 Bio for ~$592M, incl. $12M in upfront & near-term milestones ($7M at signing, $3M after 6mos., $2M payable upon the earlier of a milestone or end-2026), plus development, regulatory & commercial milestones &…

December 2, 2025

Cleveland Diagnostics’ IsoPSA Test Receives the US FDA Premarket Authorization for Prostate Cancer Diagnosis

Shots: The US FDA has granted a PMA to the IsoPSA in vitro diagnostic (IVD) kit for the diagnosis of high-grade prostate cancer Approval was based on the clinical evidence from a prospective study of the IsoPSA test conducted at 14 sites across the US, as well as data from supporting analytical validation studies IsoPSA, a…

December 1, 2025

AbbVie Reports P-III (ECLIPSE) Trial Data on Aquipta (Atogepant) for the Acute Treatment of Migraine

Shots: AbbVie has reported the P-III (ECLIPSE) trial data assessing Aquipta/Qulipta (atogepant, 60mg, PO, QD) vs PBO as an acute treatment of migraine in 1,223 adults (with or without aura) Trial met its 1EP, showing atogepant was superior to PBO for pain freedom at 2hrs. in the first treated migraine attack (with or without aura; 24.3%…

December 1, 2025

NEWS

AstraZeneca Reports the US FDA’s NDA Acceptance with Priority Review of Baxdrostat for Hard-to-Control Hypertension

Roche’s Point-of-Care PCR Test Gains FDA’s 510(k) Clearance with CLIA Waiver and European CE Mark to Diagnose Bordetella infections

Belite Bio Reports Topline P-III (DRAGON) Trial Data on Tinlarebant for Stargardt Disease Type 1 (STGD1)

Accord Healthcare Launches Osvyrti and Jubereq (Biosimilar, Prolia & Xgeva) in the EU

Samsung Bioepis Receive the CHMP Positive Opinion for Byooviz (Biosimilar, Lucentis)

Johnson & Johnson Reports the EC Approval of Imaavy (Nipocalimab) for Generalized Myasthenia Gravis (gMG)

Regeneron and Tessera Therapeutics Enter ~$275M Collaboration to Advance TSRA-196 for Alpha-1 Antitrypsin Deficiency (AATD)

Akebia Therapeutics Acquires Q32 Bio’s Complement Inhibitor ADX-097 for ~$592M

Cleveland Diagnostics’ IsoPSA Test Receives the US FDA Premarket Authorization for Prostate Cancer Diagnosis

AbbVie Reports P-III (ECLIPSE) Trial Data on Aquipta (Atogepant) for the Acute Treatment of Migraine

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