Latest News

M&A

PerkinElmer to Acquire BioLegend for $5.25B

Shots: PerkinElmer to acquire BioLegend for ~$5.25B in cash and stock transaction. The acquisition is expected to close by the end of 2021 The acquisition will allow PerkinElmer to build its growth in areas such

Biotech Clinical Trials

Denali Reports Results of DNL310 in P-I/II Study in Patients with the Lysosomal Storage Disease Hunter Syndrome (MPS II)

Shots: Denali reports data from the P-I/II study evaluating DNL310 (qw, IV) for both CNS and peripheral MPS II. All patients received doses of DNL310 after switching from idursulfase enzyme replacement therapy on Day 1

Regulatory

The US FDA Declines to Approve Incyte’s Retifanlimab to Treat Patients with Squamous Cell Carcinoma of the Anal Canal

Shots: The US FDA has issued a CRL to the BLA of retifanlimab. The BLA submission is based on P-II POD1UM-202 trial assessing retifanlimab in prior treated patients with LA or m-SCAC who have progressed

Clinical Trials

AbbVie Presents Results of AGN-190584 in P-III GEMINI 1 Study for Presbyopia at 2021 ASCRS

Shots: The P-III GEMINI 1 study involves assessing AGN-190584 (pilocarpine 1.25%, qd) ophthalmic solution in 323 patients in a ratio (1:1) with presbyopia for 30days. The study demonstrated that AGN-190584 met both its 1EPs &

Regulatory

Alexion’s Ultomiris (ravulizumab) Receives CHMP’s Positive Opinion Recommending its Approval for Children and Adolescents with PNH

Shots: The CHMP’s positive opinion is based on a P-III study assessing Ultomiris and showed effectiveness in completing C5 complement inhibition @26wks. for children & adolescents aged ≤18yrs. with PNH The study demonstrated that there

Biotech

AstraZeneca’s Vaxzevria Demonstrates Effectiveness After One Dose Against Beta/Gamma and Delta Variants of SARS-CoV-2 Virus

Shots: RWE data from CIRN with support from the Public Health Agency of Canada and the Canadian Institutes of Health Research demonstrated that one dose of Vaxzevria was 82% effective against hospitalization or death caused

Regulatory

AstraZeneca’s Bydureon BCise (exenatide extended-release) Receives the US FDA’s Approval for the Treatment of Type2 Diabetes

Shots: The approval is based on results of the P-III BCB114 trial evaluating Bydureon BCise (qw, injectable suspension) vs PBO in 82 patients aged b/w 10 – 18 yrs. with T2D as an adjuvant to

Biotech

ImaginAb Signs a Multi-Year Non-Exclusive License Agreement with Boehringer Ingelheim for CD8 ImmunoPET Technology

Shots: ImaginAb to receive license fees for providing ongoing technical, clinical, and regulatory support to facilitate the successful implementation of its CD8 ImmunoPET technology Following the new agreement, ImaginAb will supply clinical doses of 89Zr

Biosimilars

Meiji and Dong-A ST Sign an Exclusive License Agreement with Intas to Commercialize DMB-3115, Proposed Biosimilar to Ustekinumab

Shots: Meiji and Dong-A ST to receive an upfront & will be eligible to receive development & sales milestones along with profit share. The companies collaborated to commercialize DMB-3115 proposed biosimilar to ustekinumab for the