This week PharmaShots’ news was all about the updates on clinical trials, regulatory developments, biosimilars, biotech, and pharma. Check out our full report below:

• Roche collaborated with KSQ on their novel inhibitor of USP1 as a new treatment option for patients with cancers 

Read more: KSQ 

• Astellas signed a ~$962M deal with 4D Molecular Therapeutics for rare ophthalmic targets using 4DMT's Intravitreal R100 vector 

Read more: Astellas 

• Fulcrum and CAMP4 collaborated to develop rare blood disorder therapies 

Read more: Fulcrum 

• BeiGene and DualityBio partnered on differentiated antibody-drug conjugate therapy for Solid Tumors while DualityBio will lead the preclinical research activities and support IND filings 

Read more: BeiGene 

• Acadia & Neuren expanded the license agreement to acquire Ex-North American rights to Trofinetide and global rights to NNZ-2591 

Read more: Acadia 

• InnoCare and ArriVent collaborated to evaluate ICP-189 + furmonertinib for NSCLC and will provide the benefit to global patients early 

Read more: InnoCare 

• LianBio collaborated with AstraZeneca to evaluate NSCLC combination therapy in the P-I trial which is expected to initiate in H2’23 

Read more: LionBio 

• Gilead partnered with CHAI and the Pentato to advance the development of dispersible pediatric therapies and improved HIV treatment in children  

Read more: Gilead 

• NANOBIOTIX signed a license agreement with Janssen to co-develop and commercialize first-in-class radioenhancer NBTXR3 

Read more: NANOBIOTIX 

• RemeGen and Innovent collaborated to conduct clinical trials for RC88 and RC108 with Tyvyt (sintilimab) in patients with advanced solid tumors 

Read more: RemeGen 

• The US FDA, EMA, and MHRA accepted Dr. Reddy's rituximab biosimilar candidate DRL_RI for substantive review 

Read more: Dr. Reddy's 

• Aurobindo Pharma subsidiary CuraTeQ in pact to commercialize biosimilar of BioFactura’s recombinant monoclonal antibody Stelara 

Read more: Aurobindo Pharma 

• Roche highlighted P-III trial (OCARINA II) results for investigational SC formulation of ocrelizumab which was found non-inferior to IV infusion in MS  

Read more: Roche 

• Daré Bioscience reported additional results from an exploratory P-IIb Study (RESPOND) for Sildenafil with improvement in arousal and orgasm, as well as sexual desire for female sexual arousal disorder 

Read more: Dare Bioscience 

• ADC paused Zynlonta trial enrolment after observing seven deaths and five adverse events for patients with previously untreated DLBCL 

Read more: ADC  

• Incyte's Opzelura meets the positive results in the P-III study and induced treatment success in a higher proportion of children with AD  

Read more: Incyte 

• Ionis reported 85-week results from the P-III (NEURO-TTRansform) study of Eplontersen with improvement in in measures of neuropathy disease  

Read more: Ionis 

• HUTCHMED dosed the first patient in the P-I study of HMPL-415 for advanced malignant solid tumors in China 

Read more: HUTCHMED 

• Axsome Therapeutics dosed the first patient in an ADHD therapy trial 

Read more: Axsome Therapeutics 

• BMS highlighted the sub-study results of the P-III trial (CheckMate -901) for Opdivo in urothelial carcinoma and met the dual 1EPs of OS & PFS at the final analysis 

Read more: BMS 

• The NMPA has accepted the NDA of Ardelyx’s Tenapanor to treat Hyperphosphatemia in China 

Read more: Ardelyx 

• The NMPA approved Daiichi Sankyo and Astrazeneca’s Enhertu for HER2 low metastatic breast cancer, based on the P-III trial (DESTINY-Breast04) results 

Read more: Daiichi Sankyo 

• The US FDA accepted BeiGene’s sNDA of Brukinsa + obinutuzumab for follicular lymphoma therapy, based on the P-II study (ROSEWOOD) which showed an efficacy benefit 

Read more: BeiGene 

• TFDA granted accelerated marketing approval for Zepzelca in adult patients with metastatic SCLC with disease progression on or after Pt-based CT 

Read more: PharmaMar 

• The NMPA accepted the Junshi Biosciences’ sNDA of toripalimab + axitinib as 1L treatment of unresectable or metastatic renal cell carcinoma 

Read more: Junshi Bioscience 

• Roche gets EC nod for Columvi as a fixed course induced early and long-lasting complete responses for patients with relapsed or refractory diffuse large b-cell lymphoma 

Read more: Roche 

• Ichnos Sciences’ ISB 2001 receives the US FDA’s orphan drug designation for the treatment of multiple myeloma 

Read more: Ichnos sciences 

• Korro Bio entered into a definitive merger agreement with Frequency Therapeutics to advance RNA editing programs 

Read more: Korro Bio 

• Aerin Medical highlighted two-year results supported Aerin Medical treatment for nasal airway obstruction  

Read more: Aerin Medical 

• Gilead received the US FDA’s approval of Veklury (remdesivir) sNDA for COVID-19 in patients with Severe Renal Impairment, based on the results from a P-I study (GS-US-540-9015) & the P-III trial (REDPINE)  

Related Post: PharmaShots Weekly Snapshots (July 03 – 07, 2023)