NEWS

Bayer Reports Post-Hoc Data from P-III (ARANOTE) Trial of Nubeqa to Treat Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)

Shots: Bayer has reported post-hoc analyses from P-III (ARANOTE) trial assessing Nubeqa (darolutamide; 600mg, BID) + androgen deprivation therapy (ADT) (n=446) vs PBO + ADT (n=223) in mHSPC pts (N=669) Post-hoc analyses showed that 42.6% pts achieved ultra-low PSA levels (<0.02ng/mL) vs 7.8% pts on PBO & this response was associated with prolonged rPFS, delayed…

April 30, 2025

Henlius and Sandoz Enter a Global Collaboration Agreement to Commercialize HLX13 (Biosimilar, Yervoy)

Shots: Henlius has granted Sandoz exclusive rights of the HLX13, a biosimilar version of Yervoy (ipilimumab), which is being assessed in a Henlius-led P-I/III trial for inoperable HCC, targeting enrollment of 656 pts As per the deal, Sandoz will register & market HLX13 in Australia, Canada, EU, Japan, & the US in exchange for milestone-based…

April 30, 2025

AbbVie’s Rinvoq (Upadacitinib) Receives the US FDA’s Approval for Giant Cell Arteritis

Shots: The US FDA has approved Rinvoq (15mg; QD) to treat adults with giant cell arteritis (GCA) following the EC’s Approval in Apr 2025 Approval was based on P-III (SELECT-GCA) trial assessing Rinvoq, where GCA pts (n=428) in 1st study period received either Rinvoq (7.5 or 15mg, QD) + 26wk. corticosteroid (CS) taper regimen or PBO +…

April 30, 2025

Eli Lilly Partners with Creyon Bio for Accelerated Discovery and Development of RNA-Targeted Oligonucleotides for Various Diseases

Shots: Eli Lilly has entered into a global licensing & multi-target research collaboration with Creyon Bio to identify, develop & market novel RNA-targeted oligonucleotide therapies for Lilly’s named targets using Creyon’s AI-powered Oligo Engineering Engine As per the deal, Lilly will get exclusive rights of lead candidates & handle further research, development & marketing upon…

April 30, 2025

Abeona Therapeutics’ Zevaskyn Receives the US FDA Approval for Recessive Dystrophic Epidermolysis Bullosa (RDEB)

Shots: The US FDA has approved Zevaskyn (prademagene zamikeracel) for treating wounds in adult & pediatric RDEB pts based on the intra-pts controlled P-III (VIITAL) trial & has also granted RPD PRV to Abeona, which the company intends to monetize; Zevaskyn to be commercially available in Q3’25 The P-III Trial assessed Zevaskyn in RDEB pts,…

April 30, 2025

Personalis Reports Interim VICTORI Study Data of NeXT Personal Assay for the Detection of Colorectal Cancer (CRC)

Shots: Personalis has reported interim VICTORI study data assessing its NeXT Personal assay for the detection of early residual or recurrent CRC via ctDNA using blood samples from 71 pts with resectable Stage I-IV CRC At 15.75mos. mFU, 100% pts with recurrences, incl. distant metastases, were detected via ctDNA before imaging, with 87% detected within…

April 29, 2025

Regeneron’s Lynozyfic (Linvoseltamab) Receives the EC’s Conditional Approval for R/R Multiple Myeloma

Shots: The EC has granted conditional approval to Lynozyfic for the treatment of adults with r/r multiple myeloma based on P-I/II (LINKER-MM1) trial data assessing Lynozyfic in >300 pts; P-II dose expansion portion is ongoing. BLA under the US FDA’s Review (PDUFA: Jul 10, 2025) In the trial, 117 pts on 200mg had a 71% ORR, with…

April 29, 2025

The CHMP Adopts Positive Opinion on Alnylam Pharmaceuticals’ Vutrisiran to Treat ATTR Amyloidosis with Cardiomyopathy (ATTR-CM)

Shots: The CHMP has recommended vutrisiran to treat ATTR-CM adults based on global P-III (HELIOS-B) study assessing it vs PBO in ATTR-CM pts; EC's decision expected in Jun 2025. MAA under PMDA review, with global applications planned in 2025 & beyond Study met all ten 1 & 2EPs across both overall & monotx. arms, showing improved…

April 29, 2025

Relmada Therapeutics Presents Initial P-II Trial Data of NDV-01 for High-Grade Non-Muscle Invasive Bladder Cancer (HG-NMIBC) at AUA 2025

Shots: Relmada has reported initial P-II trial data assessing NDV-01 in 20 pts with HG-NMIBC (8 BCG-naïve, 12 BCG-unresponsive), where 2 pts had CIS & 18 had papillary disease (Ta/T1); 26 pts are enrolled, with 20 reaching 3mos. & 7 reaching 6mos. assessments Trial showed 85% ORR, 83.3% HGRFS in Ta/T1, & 100% CR in…

April 29, 2025

Krystal Biotech’s Vyjuvek (Beremagene Geperpavec-svdt) Receives the EC’s Approval for Dystrophic Epidermolysis Bullosa (DEB)

Shots: The EC has approved Vyjuvek to treat wounds in DEB pts with COL7A1 mutations from birth in all 30 EEA states, with first EU launch set in Germany by mid-2025; MAA under PMDA’s review with decision anticipated in H2'25 Approval was based on comprehensive clinical dataset, incl. P-I/II (GEM-1) & P-III (GEM-3) trial data, showing…

April 29, 2025

NEWS

Bayer Reports Post-Hoc Data from P-III (ARANOTE) Trial of Nubeqa to Treat Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)

Henlius and Sandoz Enter a Global Collaboration Agreement to Commercialize HLX13 (Biosimilar, Yervoy)

AbbVie’s Rinvoq (Upadacitinib) Receives the US FDA’s Approval for Giant Cell Arteritis

Eli Lilly Partners with Creyon Bio for Accelerated Discovery and Development of RNA-Targeted Oligonucleotides for Various Diseases

Abeona Therapeutics’ Zevaskyn Receives the US FDA Approval for Recessive Dystrophic Epidermolysis Bullosa (RDEB)

Personalis Reports Interim VICTORI Study Data of NeXT Personal Assay for the Detection of Colorectal Cancer (CRC)

Regeneron’s Lynozyfic (Linvoseltamab) Receives the EC’s Conditional Approval for R/R Multiple Myeloma

The CHMP Adopts Positive Opinion on Alnylam Pharmaceuticals’ Vutrisiran to Treat ATTR Amyloidosis with Cardiomyopathy (ATTR-CM)

Relmada Therapeutics Presents Initial P-II Trial Data of NDV-01 for High-Grade Non-Muscle Invasive Bladder Cancer (HG-NMIBC) at AUA 2025

Krystal Biotech’s Vyjuvek (Beremagene Geperpavec-svdt) Receives the EC’s Approval for Dystrophic Epidermolysis Bullosa (DEB)

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