This week PharmaShots’ news was all about the updates on clinical trials, regulatory, biotech, pharma, M&A, DigiHealth and MedTech. Check out our full report below:

Merck and Eisai provided updates on the P-III trial (LEAP-010) of Keytruda + Lenvima for recurrent or metastatic head and neck squamous cell carcinoma

Read more: Merck and Eisai

BridgeBio highlighted the P-III (ATTRibute-CM) study results of Acoramidis for transthyretin amyloid cardiomyopathy at ESC 2023

Read more: BridgeBio

BMS highlighted long-term follow-up results from P-III (VALOR-HCM) LTE study & the (EXPLORER) cohort of the (MAVA-LTE) study of Camzyos for symptomatic obstructive hypertrophic cardiomyopathy

Read more: BMS

Denali Therapeutics highlighted P-I/II trial for DNL310 in children to treat MPS II (Hunter Syndrome) at SSIEM 2023 showed normal & sustained levels of CSF heparan sulfate & lysosomal lipids (improved lysosomal function) along with a reduction in serum NfL

Read more: Denali Therapeutics

Sirnaomics completed the patient dosing of STP707 in P-I study for Multiple Solid Tumors

Read more: Sirnaomics

Boston Scientific highlighted the (ADVENT) study results of FARAPULSE pulsed field ablation system for atrial fibrillation, demonstrated the superiority of the FARAPULSE PFA system on the secondary safety endpoint of the study

Read more: Boston Scientific

Abbott reported (ILUMIEN IV) OPTIMAL PCI clinical trial results of OCT Intravascular Imaging, demonstrated improved stent expansion with a 7% increase in MSA over angiography guidance alone

Read more: Abbott

Medtronic secures CE mark for Inceptiv spinal cord stimulator with closed-loop sensing to treat chronic pain

Read More: Medtronic

ImmunoGen & Takeda collaborated to develop and commercialize Elahere (mirvetuximab soravtansine-gynx) for Pt-resistant ovarian cancer in Japan

Read more: ImmunoGen & Takeda

Acer Therapeutics reacquire Olpruva rights from Relief Therapeutic

Read more: Acer Therapeutics and Relief Therapeutic

Inventiva received financing of ~$38.79M from investors for the development of its pipeline

Read more: Inventiva

MC2 Therapeutics collaborated with Huadong to develop and commercialize Wynzora cream in Greater China

Read more: MC2 Therapeutics

Janssen submits the sBLA of Rybrevant to the US FDA as 1L treatment of locally advanced or metastatic non-small cell lung cancer, based on the P-III trial (PAPILLON) results

Read more: Janssen

The US FDA has approved BMS’ Reblozyl (luspatercept-aamt) as 1L treatment of anemia in adults with lower-risk myelodysplastic syndromes, based on interim results from a P-III trial (COMMANDS)

Read more: BMS

The US FDA has granted 2 additional BTDs to Daiichi Sankyo’Enhertu in adult patients with multiple HER2 expressing cancers, based on a P-II (DESTINY-PanTumor02) and P-II (DESTINY-CRC01) trials

Read more: Daiichi Sankyo

The MHLW has accepted the sNDA for GSK’ Nucala (mepolizumab) in adults with chronic rhinosinusitis with nasal polyps, based on the P-III trial (MERIT)

Read more: GSK

Verastem Oncology & GenFleet collaborated to advance three programs targeting RAS pathway-driven cancers & identify new combination approaches with Verastem lead assets, avutometinib & defactinib

Read more: Verastem Oncology & GenFleet

Twist Bioscience & Ono Pharmaceuticals collaborated to discover and develop antibodies for the treatment of autoimmune diseases using Twist Biopharma solution library of librarie:

Read more: Twist Bioscience & Ono Pharmaceuticals

Cybin inks agreement to acquire DMT drug developer Small Pharma and create an international clinical-stage leader in novel psychedelic therapeutics

Read more: Cybin and Small Pharma

Danaher to Acquire Abcam for ~$5.7B Abcam will operate as a standalone company within the Life Sciences segment of Danaher

Read more: Danaher and Abcam

Novo Nordisk acquire Embark Biotech in deal worth over ~$514M and bolsters obesity pipeline

Read more: Novo Nordisk and Embark Biotech

Serina Therapeutics to merge with AgeX Therapeutics to advance Serina’s pipeline of small molecule drug candidates targeting CNS using the POZ Platform

Read more: Serina Therapeutics and AgeX Therapeutics

Otsuka Pharmaceutical to acquire Mindset Pharma for ~$60M and strengthen the pipeline in the area of psychiatric & neurological disorders

Read more: Otsuka Pharmaceutical and Mindset Pharma

Zevra Therapeutics to acquire Acer Therapeutics for ~$91M & expand Zevra's rare disease portfolio, with the addition of Olpruva for UCDs

Read more:

Related Post: PharmaShots Weekly Snapshots (August 21 – 25, 2023)